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Current Activities of the Online Forum on Synthetic Biology

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Opening of discussion [#8598]
Dear participants of the Online Forum on Synthetic Biology,

Welcome to the second round of discussion implementing the Decision XIII/17. My name is Maria Andrea Orjuela and I work in The National Commission for the Knowledge and Use of Biodiversity (CONABIO) in México. I have been involved in biosafety since 2006 in Colombia, and I began to work at CONABIO five years ago. Here, I am involved in risk assessment and biosafety of GMOs assessments. Furthermore I work on different aspects related to genetic diversity, its characterization, knowledge and conservation. I was also a member of the Ad Hoc Technical Expert Group on Synthetic Biology that met in Montreal in 2015.

It is a pleasure for me to moderate one of the opening discussions under the forum and on such important topic “Evidence of benefits and adverse effects of organisms, components and products of synthetic biology vis-à-vis the three objectives of the Convention”, that will be held from July 17th to 31st. This topic is directly linked to the terms of reference of AHTEG as mandated by COP 13.

We just completed a lively first round of discussions, during which we have touched on many topics ranging from controlling vector borne diseases to applications involving CRISPR and gene drives all of which served as a brainstorming opportunity for further discussions.

For the discussion starting today, I would like to invite participants to limit the scope of this discussion specifically on existing evidence of benefits and adverse effects of the organisms, components and products of synthetic biology. Moreover, I kindly urge participants to include references (journal articles, websites, etc.) to support the claims of evidence.

I would like to remind you that as previously agreed by the AHTEG and noted by SBSTTA, in order to facilitate a common understanding during the discussion, the term “organisms” refer to living entities, while the terms “components” and “products” refer to non-living entities.

I wish to encourage all you, to structure your contributions in a way that facilitates the work of the AHTEG. In this sense I suggest clarify first if you are talking about benefits or adverse effects and then specify in your contribution if you are discussing in organisms, components and/or products of synthetic biology. Furthermore, please ensure that your intervention is linked to the CBD objectives by clearly identifying if the evidence that you are talking about is related to:

1) The conservation of biological diversity
2) The sustainable use of the components of biological diversity
3) The fair and equitable sharing of the benefits arising out of the utilization of genetic resources.

The forum will take place over the next two weeks. Your points of view and feedback will be appreciated and I sincerely hope that we can build a fruitful discussion that helps us to develop a useful foundation on this topic for the discussions of the AHTEG on synthetic biology.

I encourage you to participate actively.

Kind regards,

María Andrea Orjuela
posted on 2017-07-17 01:03 UTC by Ms. María Andrea Orjuela Restrepo, Mexico
This is a reply to 8598 RE: Opening of discussion [#8600]
Dear Andrea

Welcome to the Synbio Forum and congratulations for your choosing as moderator for this second topic. I really appreciated as you planed to conduct the discussion and how you specify the items. For me I think that it is time to understand the link or to match synthetic biology with biosafety. If so, it is easy for all of us to back to the Cartegena Protocol, essentially about risk and benefit of LMO in term of organisms. The challenge will be about components and products of synthetic biology. Those who experimented in the past the risk on LMO, it becomes crucial to share experiences or lessons learnt among us.

sincerly

Jean Bruno MIKISSA
posted on 2017-07-17 10:02 UTC by Mr. Jean Bruno Mikissa, Gabon
This is a reply to 8598 RE: Opening of discussion [#8601]
Dear all,
Thanks to Maria for agreeing to chair the next round of lively discussion. 
My name is Boet Glandorf and I work at the GMO Office in the Netherlands as a risk assessor of LMOs for over 15 years. As many others, I am involved in discussions on risk assessment of LMOs under the Cartagena Protocol and am a member of the AHTEG synthetic biology.

I would like to start this discussion by trying to answer the question posed to us, e.g. to provide existing evidence of benefits and adverse effects of organisms, components and products of synthetic biology vis-à-vis the three objectives of the Convention

I will limit myself to evidence on benefits and adverse effects of organisms obtained by synthetic biology on the:
1) conservation of biological diversity
2) sustainable use of the components of biological diversity

This limitation is based on my opinion that benefits and adverse effects of components and products of synthetic biology will not be different from components and products obtained by any other techniques. For me, the main discussion is on living organisms. This is supported by the lively online discussion of the last two weeks.

As indicated many times before, living organisms obtained by synthetic biology that are applied so far are LMOs that have been risk assessed using the current risk assessment framework. Quite some experience have been gained with these LMOs indicating that these LMOs (mainly LM plants) are as safe as existing as non-modified varieties. In other words, adverse effects of LM plants are not different than that of non-LM plants.
References are (among others) reports from Perseus on taking stock of environmental risk assessment of LM plants http://www.stw.nl/sites/stw.nl/files/Biotechnology-and-Safety-Call-2_call-Perseus-Report.pdf and the report of the national Academy of Science
http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=23395

Less attention has been given to benefits of LMOs. Only one LM event is approved in the EU for commercial cultivation, e.g. Bt mais MON810, that is mainly adopted in Spain. A survey by the JRC indicates that farmers spray less insecticides and obtain higher yields when growing MON810 (http://ftp.jrc.es/EURdoc/JRC37046.pdf).

Other LMOs that are applied in recent years are LM mosquitoes to suppress local Aedes aegypti populations in order to suppress diseases such as dengue and zika. Release of these LM mosquitoes seems to result in a lowered dengue incidence, which can be considered as a beneficial effect (http://www.oxitec.com/dengue-fever-cases-drop-91-percent-neighbourhood-piracicaba-brazil-oxitecs-friendly-aedes-released/). 

Kind regards,
Boet Glandorf
posted on 2017-07-17 13:12 UTC by Ms. Boet Glandorf, Netherlands
This is a reply to 8601 RE: Opening of discussion [#8604]
Responding to #8601 claim of reduced herbicide use with a Monsanto variety in Spain, and to last week's discussion of case by case risk assessment. Thank you for the opportunity to comment in this forum.

I am Steve Suppan, a Senior Policy Analyst for the Institute for Agriculture and Trade Policy (IATP). Per #8601, while Chuck Benbrook's analysis of U.S. Department of Agriculture's (USDA) 1996-2012 herbicide and pesticide use data (https://enveurope.springeropen.com/articles/10.1186/2190-4715-24-24) shows a use decrease at the outset of the introduction of herbicide and pesticide resistant varieties, use accelerates with the increase of weed and pest resistance that results from using the GM product as designed and per product instructions.  For a more general review of environmental impacts, including indirect impacts on biodiversity of transgenic modifcation of agricultural plants, see http://www.sciencedirect.com/science/article/pii/S0013935117300452?via%3Dihub 

If genomic editing of agricultural plants succeeds in the laboratory to build resistance against plant diseases (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5130979/), and if those disease resistance traits can be conferred in commercial scale seed production without loss of genomic information, presumably there will be little, if any, need for pesticides and herbicides. However, under a USDA proposed rule (https://www.aphis.usda.gov/brs/fedregister/BRS_20170119.pdf) to not regulate most genomically edited plants, the USDA would “generally not require data from outdoor plantings”. If the rule is finalized, a genomically edited plant variety could enter into commerce without the public review of field trial data. IATP criticized the proposed rule for this reason and several others. (https://www.iatp.org/blog/201707/biotech-trade-empire-strikes-back-usda and https://www.iatp.org/documents/comment-importation-interstate-movement-and-environmental-release-certain-genetically)

The Biotechnology Innovation Organization (formerly the Biotechnology Industry Organization) also opposed (https://www.bio.org/sites/default/files/BIO_Comments_On_340_Proposed_Rule_06192017.pdf) the proposed rule, but for reasons very different from IATP's. BIO proposes that USDA use an "upfront risk assessment" proposed in the rule to determine not to regulate "whole classes" of genomically edited organisms. If USDA finalizes the genomically edited plant rule according to BIO's wishes, the frequency of case by case risk assessment will be reduced to enable more rapid commercialization of and international trade in genomically edited organisms. Because many participants in this forum have assumed that risk assessment of LMOs will continue to be on a case by case basis, I thought it important to bring to your attention that BIO envisions a "more efficient" future for risk assessment of LMOs.

Finally, because the institutional framework of scientific discussions can be influenced by policy, politics and budgets, let me note that the USDA Secretary Sonny Perdue was BIO's Governor of the Year in 2009.

Thank you for your consideration of this information.
posted on 2017-07-17 20:43 UTC by Mr. Steve Suppan, Institute for Agriculture and Trade Policy
This is a reply to 8604 RE: Opening of discussion [#8605]
The benefits of LMOs ( inc REAL synBio organisms) are primarily those claimed by the developers. Usually these are production or quality benefits that provide an economic advantage at certain stages of the production and supply chain. These may also result in collateral benefits to biodiversity and/or sustainable ag, for example the reduction of insecticide use in certain Bt and virus sensitive crops (e.g Bt cotton, rainbow papaya).  This results in a net biodiversity benefit in that the populations of beneficial species remain in these crops while being reduced in conventionally insecticide treated crops.  
Some HT (GM and non-GM) cropping systems have been shown to reduce in field weed populations ( the primary  agronomic beneficial objective) compared to conventional weed control (Sweet & Lutman (2006) A commentary on the BRIGHT programme on herbicide tolerant crops and the implications of the BRIGHT and Farm Scale Evaluation programmes for the development of herbicide tolerant crops in Europe.  Outlooks on Pest Management, December 2006, 249-254 ) . This agronomic benefit is thus accompanied by a reduction in botanical diversity and in other biodiversity so that there can also be collateral harm.  In addition overuse of these herbicide systems has resulted in weed resistance development. However all of these effects ( as indicated by 8601 and by Sweet and Bartsch   (2012) Synthesis and overview studies to evaluate existing research and knowledge on biological issues on GM plants of relevance to Swiss environments. Vdf Hochschulverlag AG an der ETH Zurich. ISBN 978-3-7281-3498-1 & ISBN 978-3-7281-3499-8 (open access)) are effects which can also be associated with NON biotech crops.  Pesticide  resistance is as old as pesticides and not an invention of GM crops. 
I therefore support the view of 8601 that –to date – the effects of biotech crops on biodiversity are similar to those of  conventional crops. This is because in most cases the effects are associated with the management of these crops.  The impacts of HT crops in N and S America has been enhanced by the fact that they have become extremely popular with farmers which has encouraged farmers to change their systems to adopt them. In some cases this has had additional impacts on biodiversity, just as moving to mono-cropping of large areas of arable land did last century.

In future new biotech, including real SynBio, will develop organisms with benefit claims from their producers which may also provide biodiversity benefits and/or fit within sustainable production systems. However  they may themselves, or due to human management/mismanagement, have different impacts from those of current LMOs and their management, or conventional organisms (e.g. gene drive, RNAi etc..).  In any assessment of impacts it will be important to assess, case by case, using scenario analysis, the different management regimes to which each new organism will be subjected, including sub-optimal systems.  It is only by doing this that both beneficial and harmful biodiversity impacts can be considered in advance of release.

Finally  a comment on 8604 : 8601 did not comment on herbicides in Bt maize in Spain and it is not helpful to lump together HT and Bt crops as the impacts and issues are totally unrelated and should be considered case-by case.
Jeremy Sweet , J T Environmental Consultants, Cambridge, UK.
posted on 2017-07-17 23:22 UTC by Mr. Jeremy Sweet, JT Environmrntal Consultants Ltd
This is a reply to 8605 RE: Opening of discussion [#8606]
Mr. Sweet [#8605] raises the question of what is a "real" synthetic biology organism versus something else.  There are, obviously, quite a variety of "real" synthetic biology organisms, some of which may be manageable under existing frameworks designed for LMOs and some of which are not.

Consistent with our definition, and some opportunities previously discussed here to improve it, a "real" synthetic biology organism is, by all logic, an organism that incorporates synthetic nucleotides, natural or novel (i.e. not ACTG), or the progeny of one that does.  This same logically and scientifically sound delineation may be easily extended to components and products.

Edward Hammond
(edited on 2017-07-18 01:07 UTC by Mr. Edward Hammond)
posted on 2017-07-18 01:06 UTC by Mr. Edward Hammond, Third World Network
This is a reply to 8606 RE: Opening of discussion [#8607]
Just a quick  response Edward Hammond's post "..an organism that incorporates synthetic nucleotides, natural or novel "

I am not sure what the definition of synthetic means here. DNA can be extracted from natural hosts via technologies like PCR or even direct genomic purification - PCR faithfully copies the DNA sequence. Of course DNA can be chemically synthesised and the same exact sequence can be constructed as the one obtained by PCR. The two DNA sequences are chemically identical.  So are these two molecules of DNA synthetic or natural? In synthetic biology DNA is often chemically synthesised so the process of production would be synthetic but the actual product can be identical to the natural sequence.

The same argument is often used for natural product production in non-natural hosts. The end product can be chemically and structurally identical yet produced using a different methods. This is often refereed to as synthetic but the confusion perhaps is in the production process not the actual end product which is indistinguishable from the 'natural' product.

I think it is important that when we use terms such as natural or synthetic we contextualise them so readers of the forum who may not be experts can interpret the points being posed. The same also applies  to 'real synbio organisms'.  Again what does this mean? It was accepted at the last AHTEG that current synbio organisms are LMO's and fall under the conventions definitions. I am assuming that at the moment we don't have any 'unreal' synbio organisms?
posted on 2017-07-18 11:07 UTC by Mr. Paul Freemont, Imperial College London
This is a reply to 8606 RE: Opening of discussion [#8608]
Dear all
Greetings
The discussion in the first round was exciting.

Here, I limit my self on the benefits of synthetic biology on the conservation of biological diversity
and the sustainable use of the components of biological diversity.
Synthetic biology has numerous benefits from vis-à-vis the three objectives of the convention. The substitution of energy-intensive and environmentally unfriendly chemical routes by low energy-cost and environmentally benign biological processes for the production of chemicals is a major goal of sustainable use of the components of biological diversity. For example, 1, 3-propanediol is produced by a chemical method, which needs high   cost and is non-friendly to the environment. Although low production, it is also produced in nature by fermentation of glycerol. No natural microorganism can directly use sugars to produce 1.3 propanediol. In contrast, 135g/l titer of 1.3propanediol has been produced using synthetic biology. Therefore synthetic biology is more preferable to respond to challenges associated with bioenergy, industrial chemicals amongst other applications that would otherwise impractical in the business as usual. Furthermore, it saves directly using natural resources for different industrial applications.
posted on 2017-07-18 11:18 UTC by Mr. Taye Birhanu, Ethiopia
Attachement Synbio3.pdf - 318 KB
This is a reply to 8608 RE: Opening of discussion [#8609]
Dear all, I wish to appreciate our commitment during Topic one oneline discussion.

Dear Taye, thanks for your contribution.

Can we have access to the link you used for the results presented in your text?

All the best,

Josephine Makueti
posted on 2017-07-18 12:47 UTC by Ms. Makueti Josephine Therese, Cameroon
This is a reply to 8607 RE: Opening of discussion [#8610]
On Mr. Freemont's question [#8607], synthetic nucleotides simply means nucleotides that are synthesized.

There is nothing complicated, confusing  or hard to understand about that concept, which is a desirable characteristic for its practical use and for common understanding.
(edited on 2017-07-18 13:12 UTC by Mr. Edward Hammond)
posted on 2017-07-18 13:09 UTC by Mr. Edward Hammond, Third World Network
This is a reply to 8610 RE: Opening of discussion [#8611]
Dear Ms.Josephine Therese  (#8609)
Greetings!!
Would you please find reference PDF attached below my previous text(#8608)
(edited on 2017-07-18 15:52 UTC by Mr. Taye Birhanu)
posted on 2017-07-18 14:41 UTC by Mr. Taye Birhanu, Ethiopia
This is a reply to 8607 RE: Opening of discussion [#8612]
The AHTEG definition of “synthetic biology” does not illuminate Prof. Freemont’s discerning observation:

“Of course DNA can be chemically synthesised and the same exact sequence can be constructed as the one obtained by PCR. The two DNA sequences are chemically identical.  So are these two molecules of DNA synthetic or natural? In synthetic biology DNA is often chemically synthesised so the process of production would be synthetic but the actual product can be identical to the natural sequence.”


The relevance of the observation can be illuminated by the SPDA definition:

“Synthetic Biology: the extremely intensive use of artificial information in the manipulation of natural information” (Peruvian Society for Environmental Law 2016, p3) (See [#8434] in Topic 1 for an unpacking of the definition by the rules of formal logic).

Should the benefits or hazards of processes which use artificial information be distinct, then classification by intensity can facilitate the appropriate measures for benefit-sharing and biosafety, which correspond to the three objectives of the CBD.
posted on 2017-07-18 16:21 UTC by Mr. Joseph Henry Vogel, University of Puerto Rico-Rio Piedras
This is a reply to 8601 RE: Opening of discussion [#8613]
Dear participants of the Online Forum on Synthetic Biology,

I am Hideyuki shirae, belonging to Japan Biological Informatics Consotium which is an incorporated general association dealing with national projects regarding Biotechnology and Bioinformatics Sciences, in Japan.  This is my first intervention in the forum so I would like to thank our moderator in this topic 2.

I agree with Mr Boet Glandorf [#8601] who pointed out as “benefits and adverse effects of components and products of synthetic biology will not be different from components and products obtained by any other techniques. For me, the main discussion is on living organisms. “ And, as he indicated, Last two weeks discussion on Topics 1 & 3 mainly focused on plant pests produced by genome editing technology and gene-drive made mosquitos.  And I have the same opinion as Mr Boet Glandorf indicated that “Quite some experience have been gained with these LMOs indicating that these LMOs (mainly LM plants) are as safe as existing as non-modified varieties. In other words, adverse effects of LM plants are not different than that of non-LM plants.”

In previous online forum on this synthetic biology held from April to July in 2014, more participants seem to be recognized the LMOs under the Cartagena Protocol(CPD) the same as the organisms derived from synthetic biology.  In the course of the last two week discussion, more participants agreed that the risk assessment methods of CPD fully worked the organisms produced by synthetic biology in the present.  However, the scientific field of synthetic biology acutely is expanding in a variety of business fields and also new technology may arise one after another soon. I believe that we should judge it on a case-by-case basis with deliberation when such difficult new issues of the risk evaluation will come out.

As for the discussion of [#8607 and [#8610], I think nucleotides always are synthesized in vivo/vitro enzymatically and sometimes done by chemical methods. However, the products synthesized by both methods are identical if we do not use any unnatural form nucleotides.  I think the definition of “synthetic nucleotides simply means nucleotides that are synthesized” [#8610] is not suitable in this online forum in order to advance.  We may had better seting the right definition of “the organisms derived from synthetic biology” again.

Thank you for your attention.
posted on 2017-07-19 08:11 UTC by Mr. HIDEYUKI SHIRAE, Japan
This is a reply to 8613 RE: Opening of discussion [#8614]
I support the considerations made by Mr. Shirae as per the synthesis of nucleotides. Even in Nature nucleotides are synthesised, as chemistry is the communication language of Life.

Joaquim A. Machado
posted on 2017-07-19 10:30 UTC by Mr. Joaquim A. Machado, Brazil
This is a reply to 8614 RE: Opening of discussion [#8615]
In reference to “[C]hemistry is the communication language of Life” [#8614], “communication” will be understood as “information transmitted or conveyed” (Merriam-Webster). One will then infer that “Life” refers to “information”. N.B. “information” is absent in the AHTEG definition.
posted on 2017-07-19 11:41 UTC by Mr. Joseph Henry Vogel, University of Puerto Rico-Rio Piedras
This is a reply to 8615 RE: Opening of discussion [#8616]
The argument of [#8613] and [#8614] obfuscates the simple and readily discernible reality that nucleotide synthesis may easily and unambiguously be distinguished from processes, natural and human-influenced, that came before it.  To say that one may not make that distinction is akin to arguing that the seeds of LMOs germinate, as do the seeds of non-LMOs, ipso LMO seeds and non-modified seeds are the same.  We know that is not the case, and it is obvious that such reasoning is flawed.

Edward Hammond
posted on 2017-07-19 13:30 UTC by Mr. Edward Hammond, Third World Network
This is a reply to 8598 RE: Opening of discussion Fred Gould North Carolina State University [#8617]
Dear Maria Andrea Orjuela,
         Thank you for moderating this aspect of the forum. I was chair of a recent US National Academies of Science report titled "Genetically Engineered Crops: Experiences and Prospects". Especially in the sections of the report on "prospects' we delved into potential benefits and adverse effects of crops developed using the new and emerging tools of synthetic biology and accompanying bioinformatics. As such I am very interested in your topic of “Evidence of benefits and adverse effects of organisms, components and products of synthetic biology vis-à-vis the three objectives of the Convention.” I hope that the AHTAG will use some of the evidence covered in the report.
          I agree with many of the points made by other commenters in the forum that it is the phenotype of the novel organism and not the method by which it was produced that matters in terms of the three objectives of the convention. With advances in TILLING techniques it is very possible to make a herbicide resistant crop without using any genetic engineering methods. My feeling is that if a crop is made resistant to a novel herbicide, the benefits and adverse effects will be related to the herbicide resistance trait and not whether it was made by a specific breeding/engineering method.
          In our report we discuss in some detail how new -omics methods could be used to determine if a new crop variety had a chemical composition (DNA, RNA, Protein, small molecules) that differed substantially from existing varieties. These methods that focus on the phenotype, if implemented appropriately, could decrease costs of regulation by exempting a large portion of new crop varieties from unnecessarily detailed safety assessment while allocating more effective approaches to safety assessments of new varieties with novel properties. Some people and organisations are concerned that use of -omics will lead to more and more expensive regulation. I hope that the committee will carefully read parts of our report on -omics to better understand what is actually proposed in the report.
posted on 2017-07-19 15:37 UTC by Mr. Fred Gould, North Carolina State University
This is a reply to 8615 RE: Opening of discussion [#8618]
That's exactly what Life's process is: Communication. I recommend the excellent books of Cesar Hidalgo ( Why Information Grows ) and Werner Loewenstein ( Physics in Mind ).

All the best,

Joaquim
posted on 2017-07-19 17:18 UTC by Mr. Joaquim A. Machado, Brazil
This is a reply to 8598 RE: Opening of discussion [#8619]
Dear participants,

Thank you for your contributions until today. Nevertheless I want to remember you the importance to be focus on “EVIDENCE” of benefits and adverse effects of organisms, components and products of synthetic biology vis-à-vis the tree objectives of the Convention.

I encourage you to continue sharing your contributions,

Best regards,

M. Andrea Orjuela-R.
posted on 2017-07-19 17:36 UTC by Ms. María Andrea Orjuela Restrepo, Mexico
This is a reply to 8619 RE: Opening of discussion [#8620]
I strongly believe that the most positive impact of Synbio is the brand new capacity of constructing orthogonal logic gates in cells, this way taking biological coevolution to where we have never gone before in theoretical and applied terms.

Best regards,

Joaquim A. Machado
posted on 2017-07-19 17:47 UTC by Mr. Joaquim A. Machado, Brazil
This is a reply to 8598 RE: Opening of discussion [#8621]
Hello every one, I'm very glad to have Maria Andrea as our moderator for the second topic, Greetings

Taking into account the very complex issue of Symbio, due to the emerging and evolving nature of the technique, different areas of expertise, analysis regarding the objectives of the Convention, dual use nature of the technique, as well as competing interests, in my view there are only shades of opinions instead of black or white.

There are very well known examples of concerns and it doesn’t mean that we have to prohibit, but the potential of misuse or adverse effect are real and it’s our task at the end to shed light about it.

Examples are:
Chemical synthesis of poliovirus
Reconstruction of the 1918 flu virus and the issue about H5N1
Accidentally increasing the virulence of mousepox as part of an experiment to control mice as pests

On the other hand, “…. lack of full scientific certainty should not be used as a reason for postponing measures to avoid or minimize such a threat. ¨ (preamble of the Convention on Biodiversity)

Topic 1 [#8574]

“I would like to highlight that the absence of evidence about negative impacts originated by Synbio doesn't mean their absence”

Finally, I would like to draw attention to this specific example:

“CRISPR/Cas9 gene drive (CGD) promises to be a highly adaptable approach ……..CGD has been shown to be effective in laboratory crosses of insects, yet it remains unclear to what extent potential resistance mechanisms will affect the dynamics of this process in large natural populations……….. This study highlights the need for careful modeling of the population dynamics of CGD prior to the actual release of a driver construct into the wild.” 
Evolution of Resistance Against CRISPR/Cas9 Gene Drive. Robert L. Unckless, Andrew G. Clark and Philipp W. Messer
GENETICS February 1, 2017 vol. 205 no. 2 827-841
https://doi.org/10.1534/genetics.116.197285

Best Regards,
Lazaro Regalado
posted on 2017-07-19 20:14 UTC by Mr. Lazaro Regalado, Cuba
This is a reply to 8617 RE: Opening of discussion Fred Gould North Carolina State University [#8622]
Digital sequence information* does not have a phenotype per se but its creation, use, and management is intrinsic to synthetic biology and is extremely relevant to the third objective. So it definitely cannot be said that phenotype alone is what "matters in terms of the three objectives of the convention" [#8617].

It could prove to be that, in many applications, the phenotype of a synthetic biology organism winds up as the most salient consideration with respect to the first and second objectives. As a practical matter, however, stopping at the point of simply asserting that synthetic biology organisms, components, and products (OCPs) are "like LMOs" does not objectively distinguish synbio OCPs from LMOs. This distinction is needed even if in some instances the frameworks that are applied to synbio OCPs may be similar or the same and those applied to LMOs.

Back to the task at hand, evidence of adverse effects of synthetic biology organisms on biodiversity may be found in the World Health Organization’s Vector Control Advisory Group report (see post [#8435]), which states that evidence indicates that synthetic biology may be used to eliminate insect populations.

No need to re-hash the discussion on whether the particular instance that the Advisory Group reviewed is a good idea or not, the point for the purposes of the present topic is that the Advisory Group concluded that evidence indicates that synthetic biology may be used to "eliminate" populations of insects.  Local or more widespread elimination of an insect species may obviously be detrimental to biodiversity, and not only to the eliminated species but to ecologically-linked species as well.

*Terminology pending review per CBD decision.
posted on 2017-07-19 21:07 UTC by Mr. Edward Hammond, Third World Network
This is a reply to 8622 RE: Opening of discussion Fred Gould North Carolina State University [#8623]
Dear Mr. Hammond,
Thanks for your comments. It would be helpful if you could explain whether or not there is evidence that the risks and benefits of a crop cultivar with resistance to herbicide  Z based on conventional breeding is expected, a priori, to have different risks and benefits compared to a crop cultivar with resistance to herbicide  Z based on some form of synthetic biology /genetic engineering.
posted on 2017-07-19 21:26 UTC by Mr. Fred Gould, North Carolina State University
This is a reply to 8623 RE: Opening of discussion Fred Gould North Carolina State University [#8624]
Dr. Gould,

Assessment of the risks and benefits - I presume you mean to biodiversity, since this is the CBD frame of reference  - would rely on understanding the specifics of the transformation and/or breeding, would they not?   For instance, the transformation method imparting resistance to herbicide Z could havel unintended effects on the variety of a different nature than, say, those that might result from isolating an herbicide resistant volunteer and introducing that resistance into a commercial variety through conventional breeding.

Edward Hammond
posted on 2017-07-20 00:10 UTC by Mr. Edward Hammond, Third World Network
This is a reply to 8619 RE: Opening of discussion [#8625]
I would like to thank our moderator, Ms. Maria Andrea, for urging us to focus on the EVIDENCE of the benefits and adverse effects of what we are discussing here as that is what we should be doing, and though we cannot help but expect opinions such as those expressed by Ms. Boet Glandorf in #8601, or those mentioned by Mr. Jeremy Sweet in #8605, these statements are largely inferences of the bigger situation out there and as such, should not be taken outright as conclusive of what  they are asserting, since we need to  further scrutinize them whether they are indeed based in reality and not mere theorized  or speculated upon, or inferred from.

We should also be careful in our use  of terminologies here as we could be trapped in tautological discussions here, which is how  the exchanges are going between  Mr. Paul Freemont in #8607, supported by Mr. Shirae in # 8613 and Mr. Machado  in #8614 and Mr. Edward Hammond in #8610/#8616 on what is meant by “synthetic” or between Mr. Joseph Vogel in #8615 and Mr. Joachim Machado in #8618/#8620 on what is “communication” or that between and Mr. Fred Gould in  #8617 and Mr. Hammond in #8622 on “phenotype”, though it is amusing  to see who will have the last say on what and I would say it should be  our moderator who will have that at the end  of our exchanges.

To reiterate, our evidence should be reality-based, not  just theoretical; to illustrate,  Mr. Taye Birhanu’s example on  1,3 propanediol (#8608) is too good to be true, but what are the actual savings of natural resources that he was talking about there, sorry I haven’t  seen the PDF he said  he  has attached, but  how much of a quantity of what natural resources were saved by that example,  and for me, the issue also there is, who benefited in that example, as in, which companies saved money and  thus improved their bottom line by how much, and how about  the local farmers and  consumers dependent on the resource, were they benefited, how, in what way?

Another benefit we should closely scrutinize is that mentioned by Mr.  Machado in #8620, that most positive impact on “constructing orthogonal logic gates in cells,  taking biological co-evolution to where we have never gone before”, can we not further examine what  is the evidence or finding of that, if there’s any, so of what good is that construction of orthogonal logic gates in cells and what are the evidence or facts backing up  the assertion that there are  benefits and adverse effects about  these developments ?

May I suggest, as we may not  have the time to look at the evidence  and links presented later, for those who  will  point to any evidence of benefit or adverse effect, to please summarize them  upfront and of course the link should be there, but at least we can comment  already whether those supposed evidence of benefit or adverse effect already happened or just being speculated upon at the moment, so those things are  clear at the outset. We are here in  session 2, after all, to make a further  analysis of the evidence  of  such  benefits and  adverse  effects of our subject matter.

Thanks, and cheers!
posted on 2017-07-20 05:30 UTC by Mr. Elpidio Peria, Philippines
This is a reply to 8600 RE: Opening of discussion- benefits and concerns [#8626]
Dear Members,
The discussion is going great. Instead of again going into the definition, we may directly have benefits and harmful effects clearly listed under this topic 2 discussion.
In my opinion as far as these modified organisms are under confined condition, definitely it leads to benefits. Its interaction with components of environment creates harmful effects – depending upon its modifications and presence of deleterious genes.
Benefits – synthetic organisms
1. in production- at laboratories, industries and controlled confined environments, these synthetic biology products are highly beneficial in large scale production. It should be encouraged. The product ranges from enzymes to metabolites
2. in research- the knockout, insertion, fusion and mutant lines are highly helpful in analysing the impact of modifications and their more specific roles in specific pathways. Hence, they are highly encouraged in confinement
3. any modification generated if beneficial to the organism as well as the humankind can be considered as a variation added to the biodiversity; can be encouraged.
4. agricultural crops- though their complete impacts are not yet analysed, this can be encouraged at research level and as we concluded in topic 1 – we should go for “case by case” assessment of each event before release.
Regarding “The conservation of biological diversity” – the newly generated variations are not conserved in any national gene banks. Even a separate facility to conserve them is not yet generated. Exceptions are there like SALK libraries which even supply their modified organisms as genetic stocks.
“The sustainable use of the components of biological diversity” – directly as such any LMO or GMO unless confirmed may contribute any deleterious gene to the wild and native sources. But again we should go for “case by case” analysis with stringent regulations.
“The fair and equitable sharing of the benefits arising out of the utilization of genetic resources” – As such ABS is not given much importance in case of genetic resources as well as digital sources. Here again I request that  the members should go for defining the “digital sources” starting from single gene sequence to complete database and any other published resources also. We may discuss this in detail.
[“Introduction of herbicide and pesticide resistant varieties, use accelerates with the increase of weed and pest resistance that, results from using the GM product”] – I support this view and it will induce the conversion of minor pests into major pests in the absence of their natural enemies and due to altered micro-environment.
Many of the negative aspects we have already discussed in topic 1.

Thanks
posted on 2017-07-20 07:40 UTC by Ms. Jeshima k Yasin, India
This is a reply to 8625 RE: Opening of discussion -"synthetic" [#8627]
Dear Members,
Regarding the term “synthetic” any organism modified considerably by means of human efforts at genetic level can be defined as “synthetic” or modified organisms.

In my view,  “synthetic” doesn’t relate to the source, whether the DNA or gene is derived from nature or synthesized in lab. It denotes the organism as a whole, which is carrying a modified genetic material. Here the phenotype has been synthesised by modification of its original version at genetic level.

Such kind of variations if incorporated through natural means will contribute to evolutionary process and eventually gets fixed provided they are favourable alleles of the existing ones.

thanks
posted on 2017-07-20 07:55 UTC by Ms. Jeshima k Yasin, India
This is a reply to 8626 RE: Opening of discussion- benefits and concerns [#8628]
Dear all, dear chair,

My name is Jaco Westra from the department of Gene Technology and Biosafety of the RIVM, the Netherlands. Although my reponse is not about evidence of benefits and adverse effects of organisms, components and products of synthetic biology vis-à-vis the three objectives of the Convention per se, I would like to share my thoughts on this topic since they may be useful for this discussion.


• Again, many elements addressing this topic were discussed in previous discussions. We continue to underline that an assessment of either risk or benefit should commence on a case-by-case basis. This helps and builds information and knowledge which enable more generic analysis.

Biobased economy and circular economy

• Advanced biotechnology, including synthetic biology, can be one of the technical platforms that can help make a shift towards a biobased economy and circular economy. Specifically the use of micro-organisms as production platforms for base chemicals, fine chemicals, commodity chemicals, chemicals for medical use, fuels, food and feed products etc – is a route that is being pursued actively.
• Methods on how to assess the benefits and risks of products  - that is, the chemicals produced by the microorganism platforms – have been well established and very well documented. Specific use of these methods is e.g. prescribed within the EU chemicals legislation (REACH)
• There are a number of things to keep in  mind.
o There is some information available on the expected environmental and social impacts, but the knowledge base is still fairly limited. More information and research is needed. On the one hand there is a need for case specific information on e.g. the level of a Life Cycle Analysis. On the other hand, a more generalized viewpoint on the environmental and social impact of a shift towards a bio-based economy is in order.
o There is a global tendency to make the shift towards a bio-based economy. Biotechnology can be one of the platforms that helps to achieve this. However, not all of the negative effects  arising from this shift towards a bio based economy should be attributed to the use of biotechnology.
o When evaluating the benefits and impacts of one or more alternatives (for a specific chemical e.g., but possibly also on the level of a production platform) the pro`s and con`s of all alternatives should be taken into account.
o Specific cases in this context which need further deliberation and attention
 Algal ponds as (chemical) production units. Their often semi-open use  (because of the need for sunlight) will pose new questions on containment and possible environmental impact.

• The use of modern biotechnological techniques for human and animal health is relatively undisputed in case of applications such as gene therapy. However, the use of genome editing for human germ line modification is heavily debatedThe main element of the discussion is of an ethical nature

• Gene drives as a means to help suppress vector borne diseases like malaria and lyme are being researched at this moment. The possible far-reaching extent of this technology is widely recognized. A careful approach on a step-by-step basis and keeping the crucial aspect of reversibility as a precondition in mind is in order here. 

Kind regards,
Jaco Westra
posted on 2017-07-20 08:00 UTC by Ms. Boet Glandorf, Netherlands
This is a reply to 8601 RE: Opening of discussion [#8629]
Dear Boet,

I disagree with this point [these LMOs indicating that these LMOs (mainly LM plants) are as safe as existing as non-modified varieties. In other words, adverse effects of LM plants are not different than that of non-LM plants.] –

A crop with a sterility gene having open pollination/ cross pollination behaviour can transfer sterility genes through outcrossing and can make even a species extinct. This may force the people to depend on only the modified organism.

thanks
posted on 2017-07-20 08:08 UTC by Ms. Jeshima k Yasin, India
This is a reply to 8625 RE: Opening of discussion [#8630]
Dear Mr Elpidio, (# 8625), thanks for your comments.
I fully agree with You with regard to Mr Taye Birhanu’s example on  1,3 propanediol (#8608).
Remember that I suggested that he should share with us the link for these results, there was no PDF attached as he said.
Could you dear Taye, share the link??? It will be useful for better understanding I hope.

Cheers,
posted on 2017-07-20 08:29 UTC by Ms. Makueti Josephine Therese, Cameroon
This is a reply to 8617 RE: Opening of discussion Fred Gould North Carolina State University [#8631]
Dear Dr Fred, thanks for your contribution.
You mentionned that You hope the AHTEG Committe will read parts of your report on-omics.
Please could you kindly attached that report for better understanding of all the participants in this online discussion?

Regards,
posted on 2017-07-20 08:43 UTC by Ms. Makueti Josephine Therese, Cameroon
This is a reply to 8625 RE: Opening of discussion [#8632]
It has been suggested repeatedly that discussions about terminology and definitions are side-tracking this discussion (e.g., #8625). I would like to argue that these discussions highlight important areas of concern. Without understanding the reasons for the terminological disagreements, there is a danger that the discussion of benefits and adverse effects focuses too narrowly on the obvious and spectacular issues (the extended coverage of mosquito gene drives in the opening discussion being just one example), while missing alternative concerns. In this contribution, I would like to briefly illustrate this with one example, inspired by the repeated requests to consider “information” as central to synthetic biology and biodiversity.

Biodiversity is more than just “plenty of different living things”; its value is to a large extent ensured by the common phylogenetic heritage shared by all living organisms. For instance, only as a result of this shared heritage can we discern patterns of evolution which allow us, e.g, to predict sequence–function relationships that enable the rational engineering of genetic sequences for biotechnology. Moreover, it is only this shared heritage that allows us to confidently assert that natural genetic variation has been ‘field tested’ over millions of years and that evolutionarily stable genetic variants will not be harmful to the organism and its natural environment. Synthetic biology, unless restricted to a contained use, has the potential to disrupt the informational integrity of natural biodiversity. When engineered organisms containing “non-natural information” (see #8393 and related contribution) are released and their genetic information enters the natural gene pool (by vertical and/or horizontal gene transfer), it will jeopardize the informational integrity of natural biodiversity. The scale of potential “informational contamination” enabled by synthetic biology advances could result in a qualitative shift in the seriousness of this problem. At some point, it may no longer be possible assume that genetic information obtained from a natural biodiversity sample is the result of millions of years of natural evolution; it may just as well be the untested product of a recent synthetic biology experiment. This has implications for the analysis, understanding, value (economic, moral and emotional), and use of the informational content of biodiversity (an illustrative, albeit far-fetched analogy would be the use of counterfeit money as a means of warfare – not being able to distinguish real and fake information leads to a general devaluation).

In this context, I disagree, e.g., with the common misconception as presented in #8626, that “any modification generated if beneficial to the organism as well as the humankind can be considered as a variation added to the biodiversity; can be encouraged.” Even “beneficial” engineered variation when entering the natural gene pool can have negative consequences for biodiversity, by endangering its informational authenticity. This kind of negative impact on biodiversity can be the result of non-contained uses of synthetic biology, even in the absence of any of the more obvious problems, such as species extinctions, resource competition, economic disruption, or unexpectedly emerging harmful phenotypes – and it can even be problematic in the absence of interspecies gene flow (although the latter increases the deleterious potential, and its relative frequency even among animal species should not be underestimated, as results of recent large-scale DNA barcoding studies confirm).

The problem of informational authenticity / integrity also needs to be considered when assessing the potential benefits of synthetic biology for biodiversity protection, e.g., by genetically enhancing the robustness of endangered populations to environmental insults: the resulting engineered populations may only share part of the value of the original biodiversity.
(edited on 2017-07-20 09:00 UTC by Mr. Rainer Breitling)
posted on 2017-07-20 08:48 UTC by Mr. Rainer Breitling, University of Manchester
This is a reply to 8611 RE: Opening of discussion [#8633]
Dear Mr Taye,
Please, there no PDF attached

Best regards,
posted on 2017-07-20 08:51 UTC by Ms. Makueti Josephine Therese, Cameroon
This is a reply to 8631 RE: Opening of discussion Fred Gould North Carolina State University [#8634]
Dear Ms. Therese,
Thanks for your request of the US national Academies report "Genetically Engineered Crops: Experiences and Prospects"
I am attaching to this post.
posted on 2017-07-20 10:04 UTC by Mr. Fred Gould, North Carolina State University
This is a reply to 8625 RE: Opening of discussion [#8635]
Many thanks for you mention on my comments, Mr. Elpidio. The main advantage of the construction of orthogonal logic gates in cells is that we are entering a new area of coevolution and creation of additional biodiversity, with robust applications in several areas already indicated by our colleagues.

Wish you all the best,

Joaquim A. Machado
posted on 2017-07-20 11:58 UTC by Mr. Joaquim A. Machado, Brazil
This is a reply to 8632 RE: Opening of discussion [#8636]
As this is my first post under this topic, I would like to thank the Secretariat and the Moderator for providing me the opportunity to participate and to read the very interesting exchange of views that has occurred.  I should start by saying I think it is very laudable, and logical, to try to collect evidence of benefit and harm from applications of synthetic biology.  However, when we are asked to produce evidence for the impacts of a set of technologies for which we don't have any shared definition or understanding (recognizing the effort of the Secretariat and the AHTEG to provide a working definition), it is not surprising that many of the posts would be concerned with definition - and also definitions of what constitutes a harm and a benefit and even the definition of "evidence."  Further, the reason we are having the discussion is that synthetic biology is presumed to be somehow novel - so "evidence" that everyone agrees is evidence related to synthetic biology is likely to be hard to come by.

I'd like to limit my comments to a couple of points.  First, I have to strongly support Prof. Gould in the discussion over the relevance of production method versus phenotype to any benefits or harms (#8617).  This is not a new idea, and it has been articulated in multiple reports of the U.S. National Academies as well as other scientific bodies, and supported by regulatory agencies around the world.  Most especially those with clearly defined protection goals in the environment.  It is further supported by 20+ years of regulatory review of LMO (mostly plants) where huge volumes of non-phenotypic data have been collected with little or no demonstrable benefit to risk assessment.

The counter argument (in #8622) that for the third objective under consideration (equitable distribution of benefits, for those who have not memorized the objective statement under Article 1 of the CPB) sequence information matters is related to evidence of the origin of the organism - not the behavior of the organism in the environment.  I'm in agreement with Dr. Hammond that this objective is very different than the other two.  So I think it needs to be said that in such cases there is no impact from the organism that's being discussed - it is the benefits accrued by human use and propriety etc.  This is very important, but again, very different than the interactions of the organism with biodiversity.

This touches on my next (and last) point, which is the challenge of our task is the unstated philosophical distinction between people for whom "syntheticness" in and of itself constitutes a harm to biodiversity and people for whom it does not.  The idea hinted at in #8632 by Dr. Breitling.  Because value is defined by people, there is a perfectly valid philosophical discussion about whether "syntheticness" constitutes an undesirable component of biodiversity.  But this is not evidence based or scientific.  It's simply a statement of value. 

This is fine, but by trying to offer a scientific rational as to how "syntheticness" is inherently more risky, the post confuses and conflates many other issues.  For example, it is simply untrue to say that organisms in nature and their genomes have been "field tested" over thousands of years such that they can be presumed safe for the organism and it's natural environment.  Natural selection certainly does not select for "safe" or "stable" genotypes.  If it did, we would have the same ecosystems as we did millions of years ago with no evolution at all.  We presume that organisms in the natural environment are safe simply because its convenient for us - and no one that I have heard wants to start analyzing all of the world's native species for their impacts on the conservation and sustainable use of biodiverisity.  However, the presence of many natural (not synthetic or modified) organisms causing huge amounts of ecological damage as invasive species is ample evidence of natural selections indifference to the conservation and sustainable use of biodiversity.  It's worth pointing out that the first great ecological disaster was the evolution of microorganisms that produce poisonous Oxygen as a byproduct of their metabolism - thus altering the atmosphere of planet Earth and making it inhospitable for the previously dominant anaerobic microorganisms.  Natural Selection invented extinction, not humans -imagine the biodiversity that was lost during this extinction.  The post (#8362) presents a common, but erroneous, depiction of the "natural" world as one carefully constructed to be balanced and sustainable in order to contrast it with "synthetic" organisms which then are presumed to contain some ineffible taint that inherently conflicts with this.  This assumed conflict with nature is philosophical rather than evidentiary, and thus confounds any attempts at risk assessment as described under Annex III of the Cartagena Protocol - which is case by case and involves assessment of comparative risk. 

The discussion of whether or not synthetic biology organisms in the environment are inherently undesirable is a philosophical one.  It is certainly a very important discussion, but it has nothing to do with science or evidence.  Trying to argue that it does masks the inevitable responsibility of humans (and in this case Parties to the Convention) to determine what biodiversity we value, instead proposing to pawn it off on "nature" which is indifferent to our goals under the Convention.
posted on 2017-07-20 12:23 UTC by Mr. Andrew Roberts, International Life Sciences Institute Research Foundation
This is a reply to 8636 RE: Opening of discussion [#8637]
Just a brief reaction to clarify some possible misunderstandings in #8636:

1. “there is a perfectly valid philosophical discussion about whether "syntheticness" constitutes an undesirable component of biodiversity.  But this is not evidence based or scientific. It's simply a statement of value.”

There are no value-free scientific assessments. It would be naïve to think otherwise. It is impossible to evaluate “benefits and adverse effects” without an explicit or implicit set of values to provide a frame of reference. But independent of any value judgement, it is important not to forget that the introduction of non-natural information into the gene pool on a large scale has potentially disruptive consequences for a number of basic scientific activities (from evolutionary inference to the prediction of structure–function–phenotype relationships). This is simply a scientific fact, and I consider this a potentially adverse effect on biodiversity.


2. “For example, it is simply untrue to say that organisms in nature and their genomes have been "field tested" over thousands of years such that they can be presumed safe for the organism and it's natural environment.  Natural selection certainly does not select for "safe" or "stable" genotypes.”

It seems unreasonable to doubt the fact that organisms that have survived the rigour of natural selection are “safe for the organism” – this is basically a self-evident, almost tautological statement (analogous to “survival of the fittest”). An “evolutionarily stable genotype” is not an evolutionarily static one (that would be a contradiction in terms), but rather one that has been maintained over many generations, instead of going extinct rapidly, in contrast to many natural spontaneous mutations that never get fixed in a population (and would not fundamentally differ from engineered variants, as has been discussed here earlier).


3. “However, the presence of many natural (not synthetic or modified) organisms causing huge amounts of ecological damage as invasive species is ample evidence of natural selections indifference to the conservation and sustainable use of biodiversity.”

This is a very interesting perspective. The temporal and spatial patterns of biogeography are obviously “biological information”, beyond the genetic information encoded in nucleotide sequences. Invasive species typically result from (accidental or intentional) human action, thus their re-distribution (and resulting “invasiveness”) is not the result of a merely natural process. Incidentally, invasive species provide some of the best documented case studies of the unintended and unpredicted adverse effects of human interventions in complex ecosystems, comparable to some of the applications envisaged for synthetic biology.


4. “The post (#8362 [i.e. #8632]) presents a common, but erroneous, depiction of the "natural" world as one carefully constructed to be balanced and sustainable in order to contrast it with "synthetic" organisms which then are presumed to contain some ineffible taint that inherently conflicts with this.”

It is of course everybody’s right to invent their own interpretations of a text, but I would like to emphasize that my contribution does not mention the terms “natural world”, “carefully constructed”, “balanced”, “sustainable”, “ineffable taint”, or “inherent conflict” (nor “syntheticness”), and that the proposed interpretation is not one to which I would subscribe. The argument of #8362 is entirely from the perspective of an evolutionary and systems biologist, who depends on the integrity of the historical record, i.e. the natural information encoded in the gene pool that constitutes biodiversity, for key parts of his research.
posted on 2017-07-20 13:32 UTC by Mr. Rainer Breitling, University of Manchester
This is a reply to 8635 RE: Opening of discussion [#8638]
Appreciate your  kind response, Joaquim, and what you're saying may be good for all of us eventually, but where's the evidence (studies, findings, etc. pointing to  that)  of what  you said, since, if  there's none, that kind of assertion may just be considered  speculative or theoretical, right?

Thanks!
Elpidio
posted on 2017-07-20 13:48 UTC by Mr. Elpidio Peria, Philippines
This is a reply to 8628 RE: Opening of discussion- benefits and concerns [#8639]
Dear Boet,

I support views about the LMO- algae

But I'm not clear about what you mean by "circular economy"

thanks
posted on 2017-07-20 14:43 UTC by Ms. Jeshima k Yasin, India
This is a reply to 8598 RE: Opening of discussion [#8640]
This is a reply to 8598
posted on 2017-07-20 14:48 UTC by Ms. Joyce Tait, University of Edinburgh
This is a reply to 8598 RE: Opening of discussion [#8641]
Many thanks to Ms. María Andrea Orjuela for monitoring this discussion. This response is submitted on behalf of the UK Synthetic Biology Leadership Council (SBLC) and its Governance Subgroup (GSG).  (https://www.gov.uk/government/groups/synthetic-biology-leadership-council). It is relevant to many of the responses to Topic 1 in this Online Forum, and takes them forward in the context of the second Topic.
While the focus of this second topic on evidence of benefits and risks is important, there is now a general recognition that we cannot ignore the role of regulatory and governance systems in interacting with scientific research and innovation process to determine future outcomes, particularly for biodiversity. Given that this Forum is intended to inform regulatory decision making for the next generation of innovative biotechnologies, it seems unwisely reductionist to discuss evidence of benefits and adverse effects without also considering the regulatory context that will have such a formative impact on innovation trajectories and hence on the future emergence of effects on biodiversity, both positive and negative. Regulation/innovation interactions go well beyond merely preventing products with unacceptable risks from being marketed. They will determine the innovation trajectory of entire industry sectors, including the research choices of scientists, the extent to which small companies are able to participate in shaping the product range of a sector, the balance between disruptive and incremental innovation in a sector, and eventually the relative competitive advantage of nations and regions (Tait, 2007).
We should recognise that these issues are also of concern for citizens in both positive and negative senses. In many cases, particularly in the less developed parts of the world (see the references to Africa below), innovations arising from synthetic biology and gene editing can contribute significantly to major societal needs. It will be important to achieve a governance framework that allows citizens to take advantage of safe and effective benefits in a range of sectors, e.g. health, food security, and environmental protection. Failure in this endeavour will lead to such benefits being foregone and potentially avoidable harms being allowed to occur. As with potential adverse effects (already widely discussed under Topic 1), evidence of such benefits will not necessarily emerge from a short-term focus on specific technological solutions. This further emphasises the need: (i) to ensure that the regulatory decisions we make today do not lead to serious deficits in innovation and its governance in ten to fifteen years’ time; and therefore (ii) to ensure that future regulatory systems are able to be adaptive to the needs of innovative technologies as our knowledge and understanding progresses.
Current regulatory systems for GMOs are often described loosely as being either ‘product-based’ (in the USA and Canada), or ‘process-based’ (particularly the EU and the CBD).The process-based regulatory approach has been most widely criticised as having no rational basis, particularly that of the EU (Baulcombe et al., 2014; Carroll et al. 2016) which is closely modelled on the CBD and its conventions. However, the US attempts to adapt their product-based system to the regulatory needs of gene editing have also been criticised (Kuzma, 2016) and there is a growing consensus that the regulation of innovations based on advanced biotechnologies needs a radical re-think.
Governments internationally are now aware of these interactions and are adjusting their guidance to regulators accordingly. For example in the EU three principles are now in place to guide regulatory decision making - the innovation principle (European Political Strategy Centre, 2016a), backed up by the regulatory principles of proportionality and adaptation (European Political Strategy Centre, 2016b). A recent report from the Netherlands Commission on Genetic Modification (Cogem) (Cogem, 2016) makes the points that: (i) only large companies can afford the high costs of meeting the current EU regulatory requirements and so avoiding the GMO legislation has become a driver for innovation in synthetic biology and gene editing; (ii) given the need for regulatory reform, in future more emphasis will be placed on ‘the product’ rather than the techniques used to create it; and (iii) analysis of the risks of biotechnology applications should be weighed against the benefits or value. Similar moves are under way in other parts of the world, particularly Africa (Karembu, 2017; Cerier, 2007).
These factors are behind the frequent contributions to this Online Forum that reopen discussion of the definition of synthetic biology. This is inevitable because how we define the process of synthetic biology or gene editing is not a neutral decision – it will determine the extent to which these technologies are captured by the existing regulatory system with all its perceived disadvantages. And once a definition has been accepted as the basis of a regulatory system, it is no longer able to be modified, limiting the extent to which the regulatory system can be adapted to future needs of an innovative technology. There is very considerable, and justified, concern among many people working in this area that the current temporary operational definition of synthetic biology will become de facto the formal accepted definition if it is not further explored and discussed when opportunities like this arise. However, the central importance of the definition of synthetic biology would disappear in a regulatory system that is based on the properties of the product rather than the process (synthetic biology) by which it was developed.
The above comments make the case that the nature and mode of operation of the CBD and of its protocols should be part of these discussions. They will greatly influence the extent of the potential contribution of synthetic biology and gene editing to the conservation of biological diversity, the sustainable use of the components of biological diversity, and the fair and equitable sharing of the benefits. Rather than treating the regulatory system itself as an immutable constant and developing only those innovations that are able to meet its requirements, it is important to consider how we could, where necessary and appropriate, adapt the CBD and its protocols to the needs of innovative technologies, in order to maximise their benefits and their contributions to the CBD objectives.
Discussions so far in this Forum have demonstrated that the scale and diversity of scientific discoveries and potential innovative developments in this area cannot be addressed without evolution and adaptation of the regulatory provisions of the CBD itself, to allow a range of different regulatory provisions to be applied to different developments of synthetic biology and gene editing, rather than the current process based approach that has only two options – to capture or not to capture synthetic biology and gene editing within the provisions of the current CBD and its protocols.
Considering how such adaptations might be achieved, a project funded by the British Standards Institution and the UK Economic and Social Research Council, has considered how standards can contribute to such an adaptation process (Tait et al., 2017). This project has been supported by the SBLC, as contributing to Recommendation 4 of its Synthetic Biology Strategy: “Develop a supportive business environment by ensuring that regulation and governance systems are proportionate and appropriate to the needs of industry and that these are aligned with the needs and desires of stakeholders” (SBLC, 2016). Standards can have an important role in adapting existing regulations to meet the needs of innovative technologies. In addition, most relevant to this discussion, they can have a role in the early stages of considering how to regulate a new and disruptive innovative technology. In advance of making a final decision on the relevant regulatory regime they can allow considerations of safety, quality and efficacy to be included in the development of an innovation while discussions on the most appropriate mode of future regulation take place. In some cases, through this approach, decision makers could conclude that there is no need for formal regulatory oversight and that standards and guidelines could be used to deliver an acceptable outcome, thereby moving some innovative developments into a more proportionate regulatory space.
References
Baulcombe, D.et al. (2014). GM Science Update: a report to the Council for Science and Technology. https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/292174/cst-14-634a-gm-science-update.pdf.
Carroll, D. et al. (2016) Regulate genome edited products, not genome editing itself. Nature Biotechnology, 34(5), 478-479.
Cerier, S. (2007) Led by Nigeria, Africa opening door to genetically modified crop cultivation. (https://geneticliteracyproject.org/2017/03/06/led-nigeria-africa-gradually-opening-door-genetically-modified-crop-cultivation/)
Cogem (2016) Trend Analysis Biotechnology, 2016: Summary. (http://www.cogem.net/showdownload.cfm?objectId=1DB4E295-F1D3-E390-8C0673E8CC3C625D&objectType=mark.hive.contentobjects.download.pdf).
European Political Strategy Centre, (2016a) Opportunity Now: Europe’s Mission to Innovate. EPSC Strategic Notes, Issue 15, 5 July, 2016.  (https://ec.europa.eu/epsc/sites/epsc/files/strategic_note_issue_15.pdf)
European Political Strategy Centre, (2016b) Towards an Innovation Principle Endorsed by Better Regulation. EPSC Strategic Notes, Issue 14, 30 June 2016. https://ec.europa.eu/epsc/sites/epsc/files/strategic_note_issue_14.pdf)
Karembu, M. (2017) Beyond the Science: How European-based NGOs blocked crop biotechnology adoption in Africa. (https://geneticliteracyproject.org/wp-content/uploads/2017/03/Karembu_edits_v5.pdf)
Kuzma, J. (2016) Re-boot the debate on genetic engineering. Nature, 531, 165-167.
SBLC (2016) Biodesign for the Bioeconomy: UK Synthetic Biology Strategic Plan. (https://connect.innovateuk.org/web/synthetic-biology-special-interest-group/2016-uk-synbio-strategic-plan).
Tait, J. (2007) Systemic Interactions in Life Science Innovation. Technology Analysis and Strategic Management, 19(3), 257-277.
Tait, J., Banda, G. and Watkins, A. (2017) Proportionate and Adaptive Governance of Innovative Technologies: a framework to guide policy and regulatory decision making. Innogen Institute Report to the British Standards Institution. (http://innogen.ac.uk/reports/1222)
posted on 2017-07-20 15:38 UTC by Ms. Joyce Tait, University of Edinburgh
This is a reply to 8638 RE: Opening of discussion [#8642]
Many thanks for your comments, Elpidio.

In the first round of our group's discussion I provided references about  theoretical and applied studies which demonstrate that we are already far beyond speculation only. I also provided a couple of scientific textbooks which should be read attentively. 

Those papers are already providing manuals and protocols for operations from the biological programming languages until the products of metabolic engineering, now making profitable use of orthogonal logic gates. Years ago the cooperation between Genome Canada and PhytoMetaSyn also provided robust guidance for the years to come, in terms of Synthetic Biology. Nevertheless, I would prefer to concentrate my attention on the outcomes of Artificial Biology.

I do not expect that the awareness about the fact that Life continues to evolve not only in Nature but also in Labs will raise automatically among all the dedicated personal involved with Biodiversity. In this sense, I would recommend the paper published at doi:10.1016/j.robot.2008.09.009 for the basics about the Coevolution Artificial Intelligence/Artificial Biology, just to not mention Dr. George Church again.

Best regards,

Joaquim
posted on 2017-07-20 16:48 UTC by Mr. Joaquim A. Machado, Brazil
This is a reply to 8642 RE: Opening of discussion [#8643]
Thanks to all participants for their views. The literature contains a number of scientific studies which indicate "potential" benefits and adverse effects of organisms, components and products of synbio. In my view, sufficient evidence does not yet exist. It is true that there are attempts that are made as some predecessors have demonstrated in this discussion, but the evidence will have to be based on "long-term" scientific research. And the absence of comparator organisms is an important challenge for the risk assessment of synthetic biological products. This must be done on a case by case basis.
Regards!
posted on 2017-07-20 23:22 UTC by Mr. Freddy Bulubulu Otono, Democratic Republic of the Congo
This is a reply to 8637 RE: Opening of discussion [#8644]
The arguments of Prof. Rainer Breitling [#8632] [#8637] dovetail with the reasons why we should not “move on” from the AHTEG definition of “synthetic biology”, despite the earnest pleas of participants [#8378] [#8382] [#8374] and moderators [#8619] [#8442]. Pity that COP1 had “moved on” rather than examined the definitions of the cobbled treaty in 1994. Fast forward: the spectacular non-compliance of biotechnology with ABS (Pauchard 2017) owes ultimately to the category mistake of defining “genetic resources” as “material” in Article 2 of the CBD (Vogel 2013).

Correctly, the moderators insist on evidence. Prof. Machado ends [#8642] with a reference/deference to Prof. George Church, whose name has become synonymous with “synthetic biology”.  One of Church’s path-breaking endeavors is the Naked-Mole Rat Genome Resource (http://naked-mole-rat.org). As commented in [#8444], the endeavor would not qualify as “synthetic biology” under the AHTEG definition. This is no small feat! The AHTEG definition is so broad as to include almost all of biotechnology, except outstanding endeavors connoted with synthetic biology.

For Providers of the naked mole rat who seek benefit sharing, note well: Users will argue that the CBD does not appertain. Researchers never accessed the “genetic material” of Heterocephalus glaber; they merely navigated the web. The point will be debated and, unlike academics in biology, lawyers are expensive. Economic prediction: To avoid the transaction costs of legal challenges in the jurisdictions of the Parties, research on digitized natural information will migrate to one of the non-Parties: the USA or the Holy See.

Should “natural information” be recognized as the object of access for R&D and bounded openness, the modality of the GMBSM (Article 10 of Nagoya Protocol), the countries of origin would participate in the royalties over the value-added and protected by intellectual property. In the case of the naked-mole rat, the countries are Ethiopia, Kenya and Somalia---all of which could benefit tremendously from royalty payments.

Pauchard, Nicolas. 2017. “Access and benefit sharing under the Convention on Biological Diversity and its Protocol: What can some numbers tell us about the effectiveness of the regulatory regime?” Resources 6 (11). doi:10.3390/resources6010011.

Vogel, Joseph Henry. 2013 “The Tragedy of Unpersuasive Power: The Convention on Biological Diversity as Exemplary,” International Journal of Biology, 2013. Vol 5, No. 4 (December): 44-54. http://www.ccsenet.org/journal/index.php/ijb/article/view/30097/18019
posted on 2017-07-21 02:21 UTC by Mr. Joseph Henry Vogel, University of Puerto Rico-Rio Piedras
This is a reply to 8642 RE: Opening of discussion [#8645]
Thank you for those references,  Joaquim, I'm not sure I can  find the  time to pore over those textbooks you mentioned but looking at that last document you cited,  it reviewed the use of fitness functions in the field of evolutionary robotics, and  perhaps those potential tasks  that have been surveyed there  are, I would say, speculative and maybe at the level of proof-of-concept. 

Perhaps when we further analyze  the evidence of these supposed benefits and  adverse effects, we  may come up  with  a scheme similar to what  we  did  in the last AHTEG that we had in Sept 2015, that  was a good approach to use when scrutinizing the evidence, that one somehow put some clarity as to what we're  talking about  since we  divided those developments  into theoretical, proof-of-concept, trial stage, commercialization. This will  somehow  help us assess the  evidence as to whether they are already happening and  are  impacting  people, businesses or  the environment, or those that are just being hypothesized.

cheers!
posted on 2017-07-21 04:54 UTC by Mr. Elpidio Peria, Philippines
This is a reply to 8639 RE: Opening of discussion- benefits and concerns [#8646]
Dear Jeshima,

Regarding your question in post [#8639] on what is meant with a 'circular economy',
one of the definitions is:
A circular economy is an economic system where products and services are traded in closed loops or ‘cycles’. A circular economy is characterized as an economy which is regenerative by design, with the aim to retain as much value as possible of products, parts and materials. This means that the aim should be to create a system that allows for the long life, optimal reuse, refurbishment, remanufacturing and recycling of products and materials.

So this links to the  sustainable use of biodiversity.


Kind regards, Boet
posted on 2017-07-21 06:25 UTC by Ms. Boet Glandorf, Netherlands
This is a reply to 8612 RE: Opening of discussion [#8647]
Dear Prof. Vogel,

In my opinion, classification by intensity may only be possible at research community level. It may not be accepted by other commercial partners.

thanks
posted on 2017-07-21 07:26 UTC by Ms. Jeshima k Yasin, India
This is a reply to 8646 RE: Opening of discussion- benefits and concerns [#8648]
Dear Boet,

thanks a lot for your explanation. Then, I assume that, circular economy is to be prescribed for synthetic biology products; so that the commercial products do not get in touch with the environment endangering the biodiversity.

I like to get your detailed views in this regard.

thanks
posted on 2017-07-21 07:30 UTC by Ms. Jeshima k Yasin, India
This is a reply to 8613 RE: Opening of discussion [#8649]
Dear Members,

I differ in the view posted here #8613  [and Ms Boet Glandorf [#8601] who pointed out as “benefits and adverse effects of components and products of synthetic biology will not be different from components and products obtained by any other techniques. For me, the main discussion is on living organisms.} the adverse effects of synthetic biology components are not the same as any other technology.

For. eg. in synthetic biology, we ensure that the products and components are having a dominant allele of a gene / or phenotype. In that case the allele introduced in the environment will have deleterious effect in creating epistatic effect and masking and slowly eliminating other favourable alleles present in the biodiversity.

to go further in to the example, if the 100s of transgenic organisms imported by the private companies are let in to the environment (either with or without intention), then the impacts will be huge. A national level organisation facilitating import of LMOs can not monitor each and every wilful or non-intentional release in the environment to study its impact. If there is any specific funds or projects planned by the funding agencies these could be streamlined.

thanks
posted on 2017-07-21 08:00 UTC by Ms. Jeshima k Yasin, India
This is a reply to 8645 RE: Opening of discussion [#8650]
Dear Participants,
Just a note to point out that the major tasks given to the US National Academies committee on "Genetically Engineered Crops: Experiences and Prospects" were:

"1 Assess the evidence for purported negative effects of GE crops and their accompanying
technologies, such as poor yields, deleterious effects on human
and animal health, increased use of pesticides and herbicides, the creation of
“super-weeds,” reduced genetic diversity, fewer seed choices for producers,
and negative impacts on farmers in developing countries and on producers of
non-GE crops, and others, as appropriate.
2 Assess the evidence for purported benefits of GE crops and their accompanying
technologies, such as reductions in pesticide use, reduced soil loss and
better water quality through synergy with no-till cultivation practices, reduced
crop loss from pests and weeds, increased flexibility and time for producers,
reduced spoilage and mycotoxin contamination, better nutritional value potential,
improved resistance to drought and salinity, and others, as appropriate."

The committee also looked at the potential for future impacts of new technologies.

Because of this directive to the committee, the report which I already sent to this forum has many examples where evidence for negative and positive effects was examined. This report could be a good reference for the AHTEG.
posted on 2017-07-21 13:21 UTC by Mr. Fred Gould, North Carolina State University
This is a reply to 8649 RE: Opening of discussion [#8651]
I also support the different view posted by Ms. Jeshima k Yasin [#8649] their examples make sense and additional reasons in my view could be:
• This is a very categorical approach
• There is not time enough to come to this conclusion, the adverse effect could be seen in the medium or long term in the biodiversity and in human health.
• To focus only on living organism, miss the real fact that we can’t separate organism, their components and products neither the different stages of research and production if any, contained use and potential release. By the way, views expressed in others posted to focus only in products are similar for me. In a risk assessment process, responsible researchers, producers and mainly regulators should look at this issue with holistic approach from the very beginning.
Respectfully
Dr Regalado
posted on 2017-07-21 15:51 UTC by Mr. Lazaro Regalado, Cuba
This is a reply to 8598 RE: Opening of discussion [#8652]
Thank you Maria Andrea for moderating this topic and again I find myself (Jim Louter / environmental risk assessment of organisms for Environment Canada) struggling to keep up with the steady stream of comments that arrive in my inbox.  And again I like to begin with your reminder, in post #8598, of the scope of this particular discussion in this 2 week period:

    “For the discussion starting today, I would like to invite participants to limit the scope of this        discussion specifically on existing evidence of benefits and adverse effects of the organisms, components and products of synthetic biology. Moreover, I kindly urge participants to include references (journal articles, websites, etc.) to support the claims of evidence.”

Thank you also for the intervention made by Boet Glandorf (post #8601) as we both have similar responsibilities and also limitations.  For myself, I will focus on living organisms but completely agree with her on the observation that “… benefits and adverse effects of components and products of synthetic biology will not be different from components and products obtained by any other technique. For me, the main discussion is on living organisms.” 

With that in mind, I must also disclose that ‘evidence of benefits’ may or may not a required element in our regulations regarding biodiversity risk assessment. Certain commodities in Canada, such as field crops (organisms), drugs (products), and pesticides (an organism or a product), do require that performance claims be supported by evidence – which is often proprietary.  Other, such as microorganisms used in containment or for release into the environment, do not.  The other avenue available to me, regarding evidence of benefits or adverse effects, is to do is what many of you do: google it or otherwise search the scientific, peer-reviewed, literature. 

Generally, many scientists pursue certain avenues of research because it is linked to a funding or grant application with the objective of either some fundamental science/understanding or some practical application – many of these will either directly or indirectly will lead to ‘benefits’.  There are of course many papers that hypothesize about benefits just as there are papers that hypothesize about risks but these should be excluded from this discussion.

In addition, in some cases, research on a particular synthetic biology organism may lead to a discovery of an adverse effect and in that case, such evidence would be required to be provided and would be used in the risk assessment in Canada.  If there were such evidence in relation to an organism for which an environmental release was sought, it would be subject to strict risk management.
posted on 2017-07-21 17:32 UTC by Mr. Jim Louter, Canada
This is a reply to 8650 RE: Opening of discussion [#8653]
Dear members,

I wish to explain that, examples doesn't mean that there is no evidence. Only difference is I'm not mentioning the events.

#8650 - when benefits and concerns are to be classified in my opinion they should not be restricted as you have listed here. keep options open always so that, there may not be any important thing left outside this forum.

Moreover instead of adding points directly to the benefits or harmful effects, we are again and again listing what is to be discussed. Hence, I request members directly to add the points instead of listing what is to be discussed.

thanks
posted on 2017-07-22 06:59 UTC by Ms. Jeshima k Yasin, India
This is a reply to 8651 RE: Opening of discussion [#8654]
Thanks a lot Mr. Lazaro Regalado for your support.
posted on 2017-07-22 07:01 UTC by Ms. Jeshima k Yasin, India
This is a reply to 8632 RE: Opening of discussion [#8656]
Dear participants,

As this is my first intervention, I thank the Secretariat for the opportunity to participate and to Casper and Maria Andrea for moderating these important and insightful discussions. My name is Maria Mercedes Roca and my training is in plant virology and risk analysis of pathogens and GMOs. I now live in Mexico. I served on the Biosafety Committee for the Honduran Government, as well as on the Risk Assessment (RA) and Risk Management AHTEG. I also had the privilege of moderating an earlier online forum on RA for synthetic biology for the RA AHTEG.

Following  the interventions to date, four main discussion topics draw my attention that require our careful analysis: operational definition, risk assessment of synthetic biology products/components or processes, GM mosquitos  developed by gene-drives/CRISPR, and lessons learned from  more than two decades of LMO’s (GMO) stringent regulations,  invoking  a precautionary approach to regulate biotechnology.  

Having read and studied the couple of hundred postings since the forum begun, I regret that my intervention will also fall into the category of the need to review the definition of synthetic biology. Even though I acknowledge this to be a difficult task in this diverse group with opposing views, I strongly agree with Dr. Vogel several statements and other participants, that an agreed definition has to be our starting point and we have not reached that point yet.  Marching ahead without having clarity on the definition,  will only lead us to the same mistakes we made in the past within the Risk Assessment and Risk Management AHTEG (of marching ahead in order to fulfill a work agenda without reaching consensus),  that resulted in parties not endorsing the RA Guidance during MOP8 in Cancun. We must learn from our mistakes and carefully assess the best way to invest our valuable resources, time and effort.

Thus, I  strongly support the opinions  of several commentators (especially Joyce Tait # 8641, Rainer Breitling # 8632,  Boet Glandorf # 8601, Hieyuki Shikae # 8613, and others)  that  before we answer the questions posed by our moderators, we first have to have a definition of synthetic biology to accomplish two related things:

a). Establish if components and products of synthetic biology developed to date are intrinsically different and riskier from LMOs developed by modern biotechnology. This has to be done on a case-by case basis.

b). Following (a),  we need to establish the correct approach for an Environmental Risk Assessment (ERA) to be able to coherently assess the potential adverse effects and benefits of these components and products.  After years of discussions within the RA AHTEG, the group did not reach consensus on the content of the guidance and the parties rejected the proposed draft document. To date, we still don't have an agreed approach. 

Furthermore, as many have noted, we also need to assess how to evaluate the risk of the process (the particular approach of genetic engineering)  vs. the risk of the product.  By the current standard internationally methodologies to conduct an  ERA, it makes a lot more sense (to me),  to evaluate the product and also adopt  “Best Biosafety Laboratory Practices” to ensure a safe process.

Best regards to all,

Maria
posted on 2017-07-23 05:14 UTC by Dr. Maria Mercedes Roca, CIBIOGEM, Mexico
This is a reply to 8656 RE: Opening of discussion [#8657]
Dear All

Thank you very much for all your many interesting ideas and insights.

As pointed out by several experts, we should avoid over-simplicity when it comes to discussing evidence for adverse effects and benefits. At the same time, I would also like to introduce some further layers of complexity that highlight the difficulties in answering the questions as put forward to us. In many cases, adverse effects and benefits can be a matter of perception emerging from diverging perspectives. Let me try to elaborate this aspect in my respectful submission:

(1) How to identify the cause of an adverse effect or benefit? I will start from diverging perspectives as mentioned: For example, the expansion of large-scale cultivation of genetically engineered soybeans in Brazil can be beneficial for the farmers and the companies, but also have adverse or even detrimental effects on biodiversity. I think we can find evidence for both. I have seen several contributions suggesting that the cause of these adverse effects should be regarded in the same way as those caused by conventional farming. However, for at least 20 years there has been a significant difference: Resistance to glyphosate, 2, 4-D, dicamba, glufosinate, isoxaflutol in crop plants grown in the fields was mostly (but not solely) established through genetic engineering – this includes soybeans. And when we look back to those early years when genetically engineered plants were first introduced, herbicide resistance in crops, such as soybeans, was hailed as major advantage of genetic engineering. Now, 20 years later, it turns out that biodiversity is adversely affected by large scale cultivation of these plants. In the circumstances, we should not give the impression that these effects would have happened anyway even if these crops had not been introduced. Therefore, I think we can agree that there is evidence that large-scale cultivation of herbicide resistant genetically engineered crops became a driving factor in the loss of biodiversity in Argentina and Brazil. To some extent this is also true for the US, if for example we think about the Monarch butterfly and the occurrence of milkweed plants.

(2) What is an adverse effect? Some of us would say that the uncontrolled spread of transgenes within plant species beyond the fields and especially in centres of biodiversity, is in itself an adverse effect. Other would not accept that future biodiversity and its inherent dynamics as a self-organised evolving system needs to be protected. One could speculate about whether this latter perspective is driven by interests in releasing genetically engineered organisms that can escape spatio -temporal control to provide short-term benefits or profits. At least we should agree that there is enough evidence that the unintended spread of transgenes is already a reality in some species and some regions; and that potential spontaneous transboundary movements of these organisms are a relevant issue within the framework of the CBD.

(3) How to identify relevant benefits?  I think the long and ongoing controversy about potential benefits emerging from so-called Golden Rice shows just how difficult the discussion has become over the years. It might be regarded as an eminently absurd situation when even scientists heavily advocate the introduction of the rice in the fields while the producers of the rice (IRRI in the Philippines) are still unable to provide conclusive data on the risks and potential benefits. And if we turn our attention to crops currently being grown, such as those that are herbicide resistant and/or produce insecticidal toxins, there were some advantages in the early years (such as cheaper production) which seem to have at least partially disappeared over a longer period of time due to increasing pressure from herbicide resistant weeds, shifts in the population of pest insects and other emerging effects. Thus, we should agree to be cautious when talking about evidence of benefits. These benefits – if they occur – might be temporary or (as expressed above) only benefit the profits made by particular stakeholders.

(4) What is needed to establish evidence? When in 2005, the EU Commission had to defend itself in the WTO dispute over GMOs, the Commission expressed the following concerns in writing: “As regards food safety, even if some GM products have been found to be safe and approved on a large scale..., the lack of general surveillance and consequently of any exposure data and assessment, means that there is no data whatsoever available on the consumption of these products – who has eaten what and when. Consequently, one can accept with a high degree of confidence that there is no acute toxicological risk posed by the relevant products, as this would probably not have gone undetected – even if one cannot rule out completely acute anaphylactic exceptional episodes. However, in the absence of exposure data in respect of chronic conditions that are common, such as allergy and cancer, there simply is no way of ascertaining whether the introduction of GM products has had any other effect on human health.” (European Communities (2005) Measures affecting the approval and marketing of biotech products (DS291, DS292, DS293). Comments by the European Communities on the scientific and technical advice to the panel. 28 January 2005, http://trade.ec.europa.eu/doclib/html/128390.htm). When I look at the ongoing discussion, I believe some of us would say that this statement was made more than 10 years ago and meanwhile we have gathered much more experience. But on the other hand, we have to accept that there is enough evidence that there is a lack of sufficient data on the monitoring of health effects due to the consumption of food derived from genetically engineered crops (I know there are some US studies about impact on livestock. But these studies do not overcome the problem). And in regard to risk assessment, there is also evidence that there is a lack of data. One example I am currently working on, are the combinatorial effects arising from the use of complementary herbicides (see link http://www.testbiotech.org/sites/default/files/Testbiotech_Factsheet-Glyphosate_and_herbicide_resistant_plants-July_2017.pdf). There other uncertainties in regard to the Bt plants (see http://www.testbiotech.org/sites/default/themes/testbiotech_theme/files_tbt/Factsheet_Bt_Insecticidal_toxins.pdf). There are further uncertainties and unknowns in regard to other traits such as plants that are intentionally changed in their composition (let me know if need further insight). I am sure this short overview about uncertainties and unknowns is far from being perfect. However, I think we have to agree that there is evidence for many unknowns even in regard to those genetically engineered plants that are already on the market. And some of these uncertainties and unknowns are increasing over the time due to long term or cumulative effects. For those who do not agree with this statement: Please let me know if you are aware of controlled long-term feeding studies performed with mixtures of the around 60 genetically engineered events currently authorised for import into the EU.

Thanks for your attention, with kind regards

Christoph Then
posted on 2017-07-23 05:32 UTC by Mr. Christoph Then, Testbiotech
This is a reply to 8656 RE: Opening of discussion [#8658]
The direct impacts of a flawed definition for synthetic biology, elaborated in [#8656] and [#8632], will pale against the indirect impact of jurisdiction shopping,  which was only briefly mentioned in [#8644]. Biotechnology is transnational which means that firms will locate to the environment which most behooves them. This is not a value judgment against industry but a deductive consequence of profit-maximizing behavior.

Bookends to the economic deduction are opinions voiced by industry leaders, shortly after the ratifications of the CBD and Nagoya Protocol (NP).  In 1994, chairman of Bayer A.G., Manfred Schneider, expressed this rationale for relocation: “North America has not replaced Germany as a location for business, but there are certain innovative activities which are best performed in the US” (Nash, 1994, p. D5). Fast forward to the ratification of the NP in 2014. The journal Nature reported: “The new rules will also present challenges for synthetic biologists...This could require dozens of ABS arrangements for a single product, says Tim Fell, chief executive of Synthace, a biotechnology company in London. Such bureaucracy could push European companies to countries — particularly the United States” (Cressey 2014, p. 15).

To such concerns, Braulio Dias, then Executive Secretary of the CBD, responded without demur: “There will be a cost for a transition phase, yes, but it should be for the better” (Cressey 2014, p. 15). In January of 2016, Dias recommended to the SBSTTA what the SBSTTA should recommend to COP13: to “decide not to add to the agenda” the submitted new and emerging issue, titled: “Preventing Jurisdiction Shopping for Transboundary Resources in a Non-Party: The Case of Puerto Rico” (https://www.cbd.int/doc/emerging-issues/PeruvianSocietyEnvLaw-JurisdictionShopping-2015-en.pdf in  https://www.cbd.int/emerging/ )

Dias justified dismissing “Jurisdiction Shopping” by citing “the lack of universal membership to the CBD” as “not within the purview” of SBSTTA (Dias 2016, p. 2). Any reflection of Dias’ argument will reveal the straw man: the transboundary nature of the true object of R&D (natural information) implies jurisdiction shopping even if the US and the Holy See were to become Parties. Dias also cited that “the issue of digital genetic resource information was raised in the context of the Ad Hoc Technical Expert Group on Synthetic Biology” (Dias 2016, p. 2).

Deploying transitivity is fruitful in logic. Inasmuch as “genetic resources” are defined as “material” in Article 2 of the CBD, ‘digital genetic resource information’ becomes ‘digital material information’. Sometimes logic does prevail; the oxymoron met an early fate in the memory hole of the COP.  No one now utters it. “Digital sequence information on genetic resources” has replaced “digital genetic resource information”. The mind-numbing replacement awaits submitted views with a deadline of 8 September 2017 ( http://www.cbd.int/doc/notifications/2017/ntf-2017-049-abs-en.pdf ).

Participants concerned about an un-level playing field (90 degree pitch?) for the location of synthetic biology may also wish to submit a view on the new and emerging issue for COP14: “Lawful Avoidance of ABS: Jurisdiction Shopping and Selection of non-Genetic-Material Media for Transmission” ( http://www.cbd.int/doc/notifications/2017/ntf-2017-054-newemergingissues-en.pdf ). Its deadline is 15 August 2017.

Cressy, Daniel.  2014 (2 October). Biopiracy bans stirs red-tape fears. Nature vol (514): 14-15.

Dias, Braulio. 2016 (18 January) New and emerging issues relating to the conservation and sustainable use of biological diversity: Note by the Executive Secretary, https://www.cbd.int/kb/record/meetingDocument/106931

Nash, Nathaniel C. 1994 (21 December). “Germany Shuns Biotechnology” The New York Times, p. D1,5.
posted on 2017-07-23 17:54 UTC by Mr. Joseph Henry Vogel, University of Puerto Rico-Rio Piedras
This is a reply to 8636 RE: Opening of discussion [#8659]
This is my first post for Topic 2, so I would like to thank the Moderator Maria Andrea and Secretariat the opportunity to contribute to what has been, again, a lively and informative debate.
In response to Andrew Roberts (Post #8637) I also support Fred Gould’s comments in Post #8617 and would like to follow up with respect to the issues of harms and how to assess them.  Rainer Breitling (Post #8637) responded that  “there are no value-free scientific assessments. It would be naïve to think otherwise. It is impossible to evaluate “benefits and adverse effects” without an explicit or implicit set of values to provide a frame of reference.”
The scientific method if applied correctly should be without values – this statement confuses the concept of a frame of reference. With appropriate frames of reference, that is to say controls, it should be possible to measure the changes that a GM component (“new information”) has in relation to a crop and its impact on biodiversity.
The problem for this forum, is that there is a distinct lack of studies conducted in the frame of reference of the three objective of the CBD (CBD 1, 2 &3).   In this case the scientific method follows the path; formulation of a question, establishing a hypothesis, making predictions (based on the hypothesis), testing those predictions (establishing a methodology to obtain unbiased data), analysis of the data with reference to the hypothesis, confirmation or rejection of the hypothesis.  If necessary this is an iterative process, so in the case that the hypothesis is rejected it can be reset in view of the data analysis and the process can be run again.

This is not to imply that there is no data at present. The crop plants that are LMO/GMO have undergone rigorous safety testing at the expense of the companies that produce and sell them. They have to satisfy a number of regulatory agencies in each of the national jurisdictions in which they hope to operate. This they have done successfully as evidenced by the widespread use of a range of modified crops.  However it is unlikely that those studies include a full biodiversity impact analysis in the way that some members of this forum would like them established.  Therefore it could be argued that there is insufficient evidence evaluating impact on biodiversity.

But there are some very important philosophical questions to be asked in relation to establishing such studies and applying scientific methodology.  The hypothesis that seeks to be tested is that a given GM component (synthetic biology component) has a negative impact on biodiversity. The objective of the scientific method is to try and falsify that hypothesis. If the evidence does not falsify it then the hypothesis stands and we have a measure of the negative impact on CBD 1, 2 or 3. 
Now to the difficult bits:
1) Who will pay for and who will conduct such studies?
2) What is the frame of reference against which the studies will be conducted? Not what are the values involved.
3) How long such studies should be conducted for?
Part 1) many would argue should be the companies producing an LMO crop. However they have already conducted all of the studies that are required by the jurisdiction in which they operate and the costs are already high. The CBD itself cannot sustain such costs. So it is unclear where the research dollars should come from. Ideally from an independent body, since if the funds come from either side of the debate they will be considered potentially biased. This also applies to who conducts them.
Part 2) more difficult still. Biodiversity in the cropping system needs to be assessed before, during and after the sowing and growing of a crop. It must be compared to an equivalent area uncropped and an equivalent area cropped using a non-LMO/GMO crop (preferably the progenitor line from which the LMO was derived). If deemed appropriate another reference point might be an equivalent area cropped using a native plant line (whatever that might constitute). But how big should these equivalent areas be? Ultimately this should be on a scale close to the intended use – the point being that the border areas that may have lower biodiversity impacts may have a gradient of impact of roll over encroachment of natural species into the cropped area.  The next question is at what level is the biodiversity going to be measured? Macro species such as birds, mammals, reptiles, invertebrates, and microbes all contribute to the biodiversity. To what depth of soil should this be assessed? Adjacent to the cropped area, how far beyond the boundaries should the biodiversity be assessed? How should distal effects be monitored – impacts on hydro-ecology in water tables and water ways?
Part 3) bids the question, across all of this, for how long should these studies be conducted and at what time points? How long after sowing could effects potentially be observed? At mid-point of growth, post-harvest and beyond the post-harvest period… for how long could an impact be hypothesised to be evident?

The sheer scale of the task should be evident if it is going to be taken seriously. So the evidence that may have been gathered to date is at best only partial and at worst misleading if the appropriate controls (i.e. frame of reference to a non-LMO equivalent that can thereby discriminate the effect of the GM component in the LMO crop).

In the background of all of this is the evidence that the pressing need for agricultural produce to feed a growing world population means that there is continued encroachment of agriculture into previously uncultivated territory. This is as big a concern in terms of impacts on biodiversity and CBD tenets 1, 2 & 3.  It should be noted that many objectives of synthetic biology in agriculture are aimed at improving the productively of crops, reducing the impact of disease and infestation that cause losses, and mitigating failures of crops due to periods of drought. These objectives are to improve productivity not for corporate profit but to reduce the need for continued encroachment on lands not currently turn to agriculture that help to maintain biodiversity (CBD 1, 2 &3).
posted on 2017-07-23 23:17 UTC by Mr. Mark Tizard, Australia
This is a reply to 8659 RE: Opening of discussion [#8660]
Let me begin by thanking Dr Tizard for his valuable brief introduction to the scientific method (#8659). He is absolutely correct that “the scientific method follows the path; formulation of a question, establishing a hypothesis, making predictions (based on the hypothesis), testing those predictions (establishing a methodology to obtain unbiased data), analysis of the data with reference to the hypothesis, confirmation or rejection of the hypothesis.”

At each of these steps, value judgements play an important role: which questions do we consider relevant or interesting? Which hypotheses (out of an infinity universe of possibilities) are valuable enough to be tested? Where do we look for the evidence? Even if the analysis and interpretation of the data were entirely value-free and objective, the selection of hypotheses and data severely constrains the kind of scientific answers we can obtain. There are two kinds of scientists: those that acknowledge that their work is directed by values and those that have so deeply internalized these values that they are comfortable denying the fact, in favour of a supposed but unrealistic objectivity.

In the context of the present discussion, pretending that values are irrelevant to the discussion has numerous negative consequences for our ability to provide rational scientific advice. For one, as I explained before (#8632), the debate is in danger of suffering from severe “attentional bias” (and a resulting "availability bias), i.e. it might focus too narrowly on questions directed by a small set of implicit consensus values and on issues that are most widely discussed already, at the expense of potentially more important issues that are not so trivially obvious. A considerable body of scientific literature, mostly in the cognitive and neurosciences, highlights the negative impact of attentional biases on rational decision making, in particular in the evaluation of benefits and adverse effects (threats).

Moreover, Dr Tizard’s post illustrates very clearly how a failure to understand the basic value-driven aspects of the scientific methodology leads to impossible choices in its application, even if we could agree on the main question to be answered. The issues begin with the statement of the hypothesis. Dr Tizard proposes that: “The hypothesis that seeks to be tested is that a given GM component (synthetic biology component) has a negative impact on biodiversity.” This hypothesis then “stands” until we have found evidence that refutes (falsifies) it. But from an alternative set of values, we could also claim that “The hypothesis that seeks to be tested is that a given GM component (synthetic biology component) has NO negative impact on biodiversity.” From a purely logical and value-free scientific standpoint, these two hypotheses are equivalent (if one is true, the other isn’t, and vice versa); their practical consequences obviously are not. Even the resulting experiments would be entirely different. I could make a strong rational, yet subjective and philosophical, case in favour of the first formulation of the hypothesis, but would like to point out that taken to its logical conclusion this would imply a strong case for a moratorium on synthetic biology in non-contained settings. I would expect that this is a point that would deserve some consideration in this forum, but this is only possible when the pretence of value-free scientific arguments is given up.

Another question in post #8659 shows how far-reaching the problem is: “The next question is at what level is the biodiversity going to be measured? Macro species such as birds, mammals, reptiles, invertebrates, and microbes all contribute to the biodiversity.” The answer to this question obviously depends quite considerably on our (subjective) assessment of which aspects of biodiversity we value, i.e consider relevant. Is it just about the number of species? Is it about the total informational content (genome complexity)? Is it about historical integrity as a source for scientific inference? Is it about recreational potential (perhaps driven by macrospecies) or about resources for future bio-mining (microbes probably win)? Perhaps unintentionally, but revealingly, plants are missing from the list of contributors to biodiversity…

To conclude, I would like to reiterate that a rational assessment of the “benefits and adverse effects” of synthetic biology depends on the values of the assessor and gains credibility when these values are made explicit. This is not only essential for the future policy making (“Is an invasive species, with its transient impact on local biodiversity, a legitimate source for eradication by genetic engineering, or is it the potential beginning of a radically new and valuable evolutionary trajectory? To which extent do the economic and medical benefits for one component of biodiversity (Homo sapiens) override potential negative effects for other species, and vice versa, and how is this evaluation affected if either of these impacts is only local and / or uncertain?”), but already plays a role in the identification of the many facets of biodiversity that are potentially impacted one way or another by synthetic biology, and the subsequent search for scientific information to assess this impact. The additional importance of value judgements when assessing the likelihood of hypothetical scenarios has already been amply illustrated in the discussion so far.
posted on 2017-07-24 07:33 UTC by Mr. Rainer Breitling, University of Manchester
This is a reply to 8659 RE: Opening of discussion [#8661]
Greetings to All!

Let me start by doing what – in haste – I forgot to do at the first discussion, i.e. introducing myself.  My name is Piet van der Meer. I have been involved in the negotiations for the CBD and the CPB from the late 80s to 2000, while I served as the regulatory authority for GMOs in the Netherlands. As of 2000, I provide support to governments and public sector organisations about biosafety and I teach about biotechnology regulation at the universities of Ghent and Brussels in Belgium.

Many thanks to María for moderating this discussion and for her clear request to focus this discussion on documented evidence pertaining to benefits and adverse effects of organisms, components and products of synthetic biology in relation to three objectives of the CBD. Also appreciated is her reminder that for this discussion the “organisms” refers to living entities, while the terms “components” and “products” refer to non-living entities.

This discussion has been very lively and diverse, but - as with Topic 1- also fanned out beyond the demarcations set by the moderator. This is in part caused by the participants themselves and in part by the fact that some topics are apparently still not sufficiently delineated for a focused debate. In addition, for several key terms in the guiding question, participants have raised questions as to what is meant by those terms, e.g. “synthetic biology”, “risks”, “benefits”, and “evidence”.

Here some suggestions how we could improve the focus of our debate and some reactions to earlier posts.

First, I support the proposal of Glandorf, Hammond, and others that this debate best first focuses on the potential benefits and risks in relation to the first two objectives of the CBD, and then separately addresses the third objective, i.e. the fair and equitable sharing of the benefits arising out of the utilization of genetic resources, as that is of a very different nature than the first two
objectives.

Second, with regard to the key terms in the discussion:
- “Synthetic biology”: while I understand the wish of the moderators not to re-open the discussion on what we mean by synthetic biology, I share the view of Vogel, Roca and others that the current debate shows that it is not very meaningful to discuss benefits and risks of something of which the discussion participants have very different views on what that something is. Explanations of synthetic biology range from very broad (e.g. “any organism modified considerably by means of human efforts at genetic level”) to a more sharply defined field of use of different biotechnological applications based on ‘design’ (I support the latter description). Then there are also descriptions that need further explanation, such as Hammond’s description of ”an organism that incorporates synthetic nucleotides”, of which Freemont and others raised the pertinent question as to what he meant by “synthetic”. Notate bene: coming to be a better understanding of what we mean by synthetic biology for the sake of a meaningful discussion does not mean that we are looking for a legal or regulatory definition. Legal definitions would only then be needed if we have concluded that the application of synthetic biology could have legal consequences, such as additional safety regulations. Such a conclusion has not been drawn.

- “Risk”: the term “risk” is explained in the CPB, i.e. “risks to the conservation and sustainable use of biodiversity”.  In this context, I support the comment of Glandorf and others that we should focus our discussion on living organisms resulting from synthetic biology, because the non-living products are subject to existing product regulation, such as for medicines, pesticides, additives, etc. As regards living organisms resulting from synthetic biology, I agree with the posts of Mikissa, Shirae and others that current and foreseeable applications of synthetic biology involve the use of LMOs and are therefore subject to the case by case assessment as laid down in the CPB. With regard to that risk assessment under the CPB, we should recognise that is based – as Gould and others pointed out - on the relevant characteristics of the recipient organism, the introduced changes, the intended use and the receiving environment. (Also important are the observations of Sweet that we have to make a distinction between the effects resulting from the genetic modification and the effects of management or mismanagement). All this is done, as the CPB prescribes, in an evidence based, scientifically sound and transparent manner. This is why statements such as “Synthetic biology … has the potential to disrupt the informational integrity of natural biodiversity” (Breitling), may be legitimate statements of value, but I agree with Roberts that it is neither evidence based nor scientifically sound.

“Benefit”: the CBD shows that benefits can include a wide range of benefits, such as environmental, economic and social benefits. It would be helpful if the practitioners of synthetic biology, when they share evidence relevant to potential benefits, whether such benefits would be environmental, economic, social, or a combination of those.

Regarding the concept of “evidence”: this does not necessarily has to some final ‘proof’ of certain benefits or risks, but also includes evidence that suggests that certain benefits or risks are likely or unlikely to materialize. The contribution of Taye Birhanu is a good example of that, i.e. recognizing that the substitution of energy-intensive and environmentally unfriendly chemical routes by low energy-cost and environmentally benign biological processes for the production of chemicals is a major goal of sustainable use of the components of biological diversity. Likewise, the post of Jaco Westra helps appreciate the diversity of the aspects of synthetic biology that could result in benefits in several areas.

Regards
Piet
posted on 2017-07-24 08:31 UTC by Mr. Piet van der Meer, Ghent University, Free University of Brussels, Belgium, PRRI
This is a reply to 8661 RE: Opening of discussion [#8662]
Let me follow Prof van der Meer’s example and belatedly introduce myself. I am trained biochemist and currently Professor of Systems Biology at the University of Manchester, UK, where a large part of my work focuses on the development of computational tools for the design of bioengineered organisms, as part of the Manchester Centre for Synthetic Biology. I was also a member of the EU expert group that developed that EU definition of Synthetic Biology that underlies the definition used in this forum ( https://ec.europa.eu/health/scientific_committees/emerging/docs/scenihr_o_044.pdf ).

Prof. van der Meer (#8661) claims that “statements such as “Synthetic biology … has the potential to disrupt the informational integrity of natural biodiversity” (Breitling), may be legitimate statements of value, but I agree with Roberts that it is neither evidence based nor scientifically sound.”

It would of course be extremely unfair to suggest that the comments of Prof. van der Meer or Dr Roberts (#8636) are deliberate attempts by two professional pro-GMO lobbyists to undermine the credibility of a scientific argument that they find challenging. I would instead suggest that appreciating the argument does rely on a certain familiarity with the scientific approaches of bioinformatics and computational biology, which rely on the informational integrity of natural genetic information. The informational basis of much of bioinformatics, in particular (but not limited to) the analysis of functional genetic sequences has been discussed, e.g., by Marc Ostermeier (2007; Chemistry & Biology 14(3):237-238) and Frances H. Arnold (2011, Microbe 6(7):316-318), and the relevance of informational integrity for our understanding and exploitation of genetic information has been presciently explored (using a playful analogy) by J.L. Borges (1941; La biblioteca de Babel).

A large part of our work when analysing genomic information (e.g. to guide the engineering of organisms by synthetic biology!) relies on self-evident assumptions such as: “genetic information that is found widespread in a population of living natural organisms is encoding a function that is not detrimental to the organism, has not had a negative impact on its environment until now, and is a functional part of a well-functioning (‘genetically fit’) biological system that with continuous small-step variations has been part of a larger set of genetic sequences all of which have been advantageous to the organisms carrying them, sufficiently so to be maintained by purifying / stabilizing selection and not to be removed by negative selection or genetic drift over millions of years of evolution”. These assumptions are rarely spelled out, as they are so obvious, but they are critical, e.g., when trying to understand the functional relevance of individual residues in enzymatic protein sequences (entirely based on sequence similarity and conservation) or when predicting targets for genetic intervention in the engineering of metabolic pathways (based on evolutionarily justified objective functions, using methods such as flux balance analysis).

It requires little imagination to understand that the basis of these scientific enterprises is potentially challenged when it is no longer possible to assume a priori that a specific genetic sequence obtained from nature is there as a result of the historical process of evolution, rather than because it has been transferred (horizontally or vertically) from a sequence designed and engineered in a synthetic biology laboratory. An analogous example is provided by invasive species; when we know that a specimen found in the environment has been derived from a deliberate and well-documented introduction (think, rabbits in Australia), we can discount for its appearance in unexpected places in our evolutionary interpretation. But, doing so requires a thorough and comprehensive knowledge of natural biodiversity and its distributional processes, and when either of these is lacking, we might arrive at seriously misleading scientific interpretations of the observed natural patterns. In the case of the genetic interferences enabled by synthetic biology, both of these aspects are not necessarily guaranteed.

Thus, I fully support Dr Robert’s implication (#8636) that invasive species might be a relevant comparator for the non-contained use of synthetic biology. Especially, examples of the unintended negative impacts of biocontrol agents (from cane toads to harlequin ladybirds) illustrate the limits of a case-by-case assessment (and, understandably, many countries have chosen a rather rigorous ban on the introduction of natural biodiversity into their area of legislation). In the context of my argument about informational integrity as an important aspect of biodiversity that needs protection, beyond mere species numbers, it is perhaps illuminating that fifty years ago the classic textbook of zoogeography (de Lattin, 1967) ended with an epilogue bemoaning the fact that a loss of biodiversity and the destruction of natural distribution patterns by human agency endangered the informational foundation for conducting this research at the core of biodiversity studies. Synthetic biology adds just another facet to this issue. What we do about this may be a value-based decision, but the argument and facts themselves are entirely evidence-based, rational and scientifically sound.
posted on 2017-07-24 12:41 UTC by Mr. Rainer Breitling, University of Manchester
This is a reply to 8598 RE: Opening of discussion [#8663]
I was interested and encouraged by [#8659] and [#8660] starting to ask some of the practical questions about actually studying the impacts on biodiversity and possibly doing so with an awareness of the subjective values influencing these studies.

“Therefore it could be argued that there is insufficient evidence evaluating impact on biodiversity.” [#8659] From what I’ve seen, I would be one of those who would argue this. The scope of such studies and the cost are important challenges. However a solution is highly relevant if the CBD is serious about actual implementation of a precautionary approach/the precautionary principle.

If this question of how to practically and thoroughly study the effects on biodiversity remains unanswered, I can’t see how the CBD is doing anything other than merely “paying lip service” to precaution in the face of major scientific uncertainties while in practice facilitating “proaction” (the opposite of precaution, essentially assuming that there are no negative impacts on biodiversity until such time as conclusive evidence of significant adverse impacts has been proven, although this may not even be studied. For more on this issue of the practical application of precaution not being well defined or implemented by the CBD see: Scott, Deborah. “Framing and Responding to Scientific Uncertainties: Biofuels and Synthetic Biology at the Convention on Biological Diversity.” 56 Jurimetrics J. 245–260, 2016, http://www.research.ed.ac.uk/portal/files/25508968/Scott_Jurimetrics_2016_Framing_Responding_Scientific_Uncertainties.pdf).

I would be among those who’d think that companies seeking to profit from the use of synthetic biology should pay for studies that evaluate broader impacts on biodiversity. [#8660] Rightly points out that subject values must be agreed upon to define how broadly such investigations into impacts on biodiversity can go. The issue of potential real or perceived bias due to who funds the studies as mentioned in [#8659] is a very real and important one for further consideration too.

I would like to highlight the importance of involving Indigenous Peoples directly in establishing the values [#8660] discusses. I was pleased to see some contributions from Indigenous Peoples in this forum and hope to see more work by the CBD to ensure that those who stand to benefit financially from synthetic biology are not over-represented in framing the issues.
posted on 2017-07-24 18:54 UTC by Mr. Matthew Legge, Canadian Friends Service Committee (Quakers)
This is a reply to 8662 RE: Opening of discussion [#8664]
Dear All,

Before responding to a next post, let me express the hope that we all agree that these online discussions should be conducted in a professional manner in the sense that reactions to specific posts should address the substance of those posts and not derail in assumptions about the motives of the authors of those posts. References to ‘anti or pro GMO-lobbyists’ have - however veiled - no place in a mature and respectful discussion.

Looking forward to the remainder of the debate,

Piet
posted on 2017-07-24 21:56 UTC by Mr. Piet van der Meer, Ghent University, Free University of Brussels, Belgium, PRRI
This is a reply to 8663 RE: Opening of discussion [#8665]
Dear All,

Following up on the post by Legge about studying potential effects on biodiversity: such studies often take as points of reference specific national protection goals that have been elaborated on the basis of the general objectives of the CBD, and it is indeed good practice in many countries that all stakeholders are consulted in elaborating those specific protection goals.

As regards risks assessments: one of the great accomplishments of the Biosafety Protocol is that it reflects international agreement on the general principles and methodology of conducting environmental risk assessments for LMOs, including LMOs used in synthetic biology.

Finally, a quick note in relation to the reference to “companies seeking to profit from the use of synthetic biology”: please note that much of the research on synthetic biology is conducted in the public sector, aimed at strengthening sustainable development in many sectors.

Best regards

Piet
posted on 2017-07-24 22:04 UTC by Mr. Piet van der Meer, Ghent University, Free University of Brussels, Belgium, PRRI
This is a reply to 8662 RE: Further analysis of evidence of benefits and adverse effects of organisms, components and products of synthetic biology vis-à-vis the three objectives of the Convention [#8666]
Dear all,

rather than distinguishing public or private sector, I would rather   like to highlight that there are certain sectors that are referred to in the background document.

"challenges associated with bioenergy, agriculture, health and chemical production, amongst other applications."
(para.6,  SYNTHESIS OF VIEWS IN RESPONSE TO PARAGRAPH 10 OF
DECISION XIII/17 ON SYNTHETIC BIOLOGY )

Sector unit illustrations are found also in the CBD technical series (cf. reference below). 

5.1. Bioenergy applications  5.2. Environmental applications  5.3. Applications to alter wildlife populations  5.4. Agricultural applications    5.5. Applications to replace natural materials 
5.6. Applications for chemical production

I strongly feel that the technical series would need updating and further revisions based on discussions here online and future AHTEG meeting (some documents in the reference are not peer-reviewed) as the field is rapidly evolving.

Reference:
SYNTHESIS OF VIEWS IN RESPONSE TO PARAGRAPH 10 OF  DECISION XIII/17 ON SYNTHETIC BIOLOGY
http://bch.cbd.int/synbio/synbio%20synthesis_29jun17_final.docx?download

CBD technical series
https://www.cbd.int/doc/publications/cbd-ts-82-en.pdf
posted on 2017-07-25 00:16 UTC by Mr. Ryo Kohsaka, Japan
This is a reply to 8664 RE: Opening of discussion [#8667]
I fully support Dr. Van der Mier. Let's talk openly and friendly about Science and Technology advancements and about clever ways to regulate potential impacts while allowing progress.  I have never seen the Technology Vector moving backwards, anyway.
posted on 2017-07-25 02:19 UTC by Mr. Joaquim A. Machado, Brazil
This is a reply to 8661 RE: Opening of discussion [#8668]
Dear all

Thanks Piet for your contribution and others. I think that the discussion at this stage involves very good. I also think that it is time to have common understanding terms, like definition of synthetic biology, the scope of synthetic biology (field or labo), as I before mentioned in my previous post, if living organism refers to LMO we can't do out the scope of Cartegena Protocole and then, the terms of "benefits" "risks" or "effects" are well documented during the negociations of both CPB and supplementary Protocol. I don't defend those protocols but I think that they are usefull and guide us during this discussion.

Jean Bruno
posted on 2017-07-26 07:25 UTC by Mr. Jean Bruno Mikissa, Gabon
This is a reply to 8668 RE: Opening of discussion [#8669]
I agree with Dr Mikissa (#8668) and earlier contributors, that at this stage we can be expected to have a common working understanding of what synthetic biology is. In particular, I would like to call attention to a specific aspect of the AHTEG definition of synthetic biology, namely that synthetic biology is “a further development and new dimension” of modern biotechnology – this implies that synthetic biology is continuously evolving. This can also be observed when tracing the history of the term over the last five decades: synthetic biology has always referred to the most recent technologies of genetic engineering, i.e. the most recent “further development and new dimension”. GMOs/LMOs of the 1970s and 80s, usually based on one or a few transgenes, would have been the synthetic biology organisms of their times; nowadays far more ambitious genetic engineering would usually be required for an activity to qualify as synthetic biology.

This obviously means that a large part of earlier discussions on LMOs will equally apply to synthetic biology (e.g., regarding their potential benefits, such as reductions in pesticide or herbicide use, increased sustainability etc.). Reiterating these debates is hardly going to be fruitful (and in the worst case the accumulation of irrelevant evidence creates an illusion of validity, while in fact the decisive data on the effects of the recent technological advances of interest are not yet available [#8663]).

Thus, the “dynamic” AHTEG definition of synthetic biology also implies that the main objective of a forum like this will remain to identify where *new* technological trends create *new* "benefits", "risks" or "effects" that may have been outside the scope of attention during earlier stages of the evolution of our ability to “understand, design, redesign, manufacture and/or modify genetic materials, living organisms and biological systems”, or that possibly even were not foreseen in the original debates because they emerge specifically as the result of unpredicted technological advances.

As explained in earlier posts (e.g., #8652 and #8601), at this point there seems to be no reason to assume that “the benefits and adverse effects of components and products of synthetic biology [would] be different from components and products obtained by any other techniques.”

But at the level of the living organism, there have been advances that in my impression may not have been within the scope of serious consideration when the Cartagena Protocol was developed (in 2000; i.e. by same accounts in the same year that the synthetic biology revolution really was born, with the seminal publications of Elowitz & Leibler Nature 2000, 403:335 and Gardner et al. Nature 2000 403:339). The most striking example is probably the fact that gene drive technologies (and related developments) have created the realistic ability to genetically engineer entire natural populations, rather than individual organisms. Previously, it could be reasonably assumed that a genetic modification would remain contained within a population of LMOs (even when released into the field), and as the engineered organism has no obvious genetic fitness benefit in the absence of artificial selection pressure, a wider spread of the modification would be unlikely, even if hybridisation occurred. This is no longer the case for gene drives: their basic principle requires that hybrids between an original LMO and a natural population have no loss of genetic fitness (Esvelt et al. eLife 2014:e03401), and that the genetic alteration spreads in a super-Mendelian manner through a natural population (Hammond et al. Nature Biotechnology, 2016, 34:78). Gene drives are analogous to, e.g., Wolbachia-mediated mitochondrial introgression (Champer et al. Nature Reviews Genetics 2016, 17:146),  which is well known for driving the spread of genetic information across  species boundaries (Raychoudhury Evolution 2008, 63:165; Ballard Molecular Biology and Evolution 2000. 17:1126; Dumas et al. BMC Evolutionary Biology 2013, 13:181). This is an important new comparator that did not have to be considered in earlier debates on LMOs. Obviously, the ability (and desire) to genetically engineer natural *populations* rather than *organisms* also has important consequences for the Cartagena Protocol’s provisions regarding the movement of LMOs across borders, which seem all but obsolete with respect to gene drive technologies.

The additional technological advance not necessarily foreseen in earlier stages of development is the rapid improvement of our ability to chemically synthesize DNA. The availability of cheap, rapid and reliable access to large pieces of “synthetic DNA” (i.e., DNA that has been synthesized without recourse to a physical DNA template) has mostly implications for fair access and benefit sharing, and these have been raised in detail in earlier contributions (e.g., #8658 and references therein).
posted on 2017-07-26 08:55 UTC by Mr. Rainer Breitling, University of Manchester
This is a reply to 8641 RE: Opening of discussion [#8670]
POSTED ON BEHALF OF Mr. Hiroshi Yoshikura
---------------------------------------------------
This is the first posting of mine in the second round.
1. The topic of this round of the forum is “Evidence of benefits and adverse effects of organisms, components and products of synthetic biology vis-à-vis (i) conservation of biological diversity, (ii) sustainable used of the components of biological diversity and (iii) fair and equitable sharing of the benefits arising out of the utilization of genetic resources. As Dr. Joyce Tait noted in her posting (#8641), this formulation could be “unwisely reductionist”. The effect of an organism on biodiversity is not determined by its properties alone but also by the receiving environment. On one hand an environmentally friendly organism in one environment could become a pest in another environment, like rabbits introduced into Australia where they found no predators. On the other hand, however invasive in one environment, a new organism may disappear in another environment where it cannot find empty niches. The risk can be evaluated only through case-by-case approach.
2. When technological uncertainties are discussed, it is important to note that the breeding is a process of elimination; starting from hundreds of events, undesired traits are discarded while maintaining manageable and desirable traits (using criteria of “familiality” according to Recombinant DNA Safety Considerations (The Blue Book), OECD, Paris, 1986).
3. If the products of synthetic biology are to be regulated under Cartagena Protocol, “evidence of benefits and adverse effects of organisms, components and products of synthetic biology vis-à-vis the three objectives of the Convention” should be considered in the context of Annex III of the protocol, which recommends “risks ….. should be considered in the context of the risks posed by the non-modified recipients or parental organisms in the likely potential receiving environment” and “risk assessment should be carried out on a case-by-case basis”.
References
Mark A. Davis: Invasion Biology, Oxford University Press, 2009
Hiroshi Yoshikura, previous Chair of Codex Task Force on Foods Derived from Modern Biotechnology
posted on 2017-07-26 13:08 UTC by Ms. Melissa Willey, UNEP/SCBD/Biosafety
This is a reply to 8669 RE: Opening of discussion [#8672]
Prof. Breitling contextualizes the adjective “new” in the AHTEG definition of synthetic biology over the history of such endeavors . In reference to the GMOs/LMOs of the 1970 and 80s : “nowadays far more ambitious genetic engineering would usually be required for an activity to qualify as synthetic biology” [#8669].

The historic trend has indeed been to utilize, ever more intensively, genetic engineering (artificial information) than the genetic resource (natural information). But correlations have a way of sometimes ending. Observers, conditioned to the correlation, will commit the post hoc fallacy should they conflate the increasing intensity of utilization with “newness”. For example, imagine an endeavor is highly intensive in genetic engineering and continues to be more intensive than other endeavors, over the years and decades. By the AHTEG definition, the endeavor will no longer be synthetic biology because, as time lapses, it will no longer be “new”.

The SPDA definition defines synthetic biology in terms of the intensity of use of artificial information in the manipulation of natural information (See [#8434] in Topic 1 for an unpacking of the definition by the rules of formal logic).  Hence, if an endeavor persists to be more intensive than others, it would continue to be classified as synthetic biology.  One must step back and ask: why bother?

The justification can be inferred from many postings. One should bother if “the benefits and adverse effects of components and products of synthetic biology [are] different from components and products obtained by any other techniques” [#8669] [#8649] [#8613] [#8601]. In other words, classification affords economies in crafting policies for biosafety and ABS.
posted on 2017-07-26 19:49 UTC by Mr. Joseph Henry Vogel, University of Puerto Rico-Rio Piedras
This is a reply to 8669 RE: Opening of discussion [#8674]
Dear all,
First of all as it's my first time commenting on this topic I'd like to thank María for moderating this discussion and I appreciate the challenge of keeping the discussion within the scope.
I would like to support the statements made about a case-by-case analysis for benefits and risks in particular J. Sweet (#8605), J.Yasin (#8626), A.Roberts (#8636), P.Meer (#8661), S.Suppan (#8604).
I would like to comment on a couple of points related to evidence of benefits and adverse effects, more specifically on the use of gene drive mechanism. It should be noted that at this stage the research on gene drive mechanism for suppression or replacement of malaria vector mosquito is still at an early phase, despite being promising, and that therefore the evidence is coming from contained use in laboratory.
In terms of potential benefit of this technology for vector control purpose and therefore for public health purpose has been studied in the following publications:
Hammond et al., CRISPR-Cas9 gene drive system targeting female reproduction in the malaria mosquito vector Anopheles gambiae published in Nature http://www.nature.com/nbt/journal/v34/n1/full/nbt.3439.html
- Galizi et al., A synthetic sex ratio distortion system for the control of the human malaria mosquito published in Nature Communication https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4057611/
- Windbichler et al., A synthetic homing endonuclease-based gene drive system in the human malaria mosquito published in Nature  http://www.nature.com/nature/journal/v473/n7346/full/nature09937.html
- Eckhoff et al., Impact of mosquito gene drive on malaria elimination in a computational model with explicit spatial and temporal dynamics published in PNAS http://www.pnas.org/content/114/2/E255.full
- Haut Conseil des Biotechnologies, Recommandation du CEES relative à la Saisine du 12 octobre 2015 sur l’utilisation de moustiques modifiés par les biotechnologies pour la lutte antivectorielle published by HCB http://www.hautconseildesbiotechnologies.fr/sites/www.hautconseildesbiotechnologies.fr/files/file_fields/2017/06/06/hcbceesmoustiquesrecommandation2juin2017.pdf
- Haut Conseil des Biotechnologies, Avis du Comité Scientifique en réponse à la saisine du 12 octobre 2015 concernant l’utilisation de moustiques génétiquement modifiés dans le cadre de la lutte antivectorielle, published by HCB http://www.hautconseildesbiotechnologies.fr/sites/www.hautconseildesbiotechnologies.fr/files/file_fields/2017/06/06/aviscshcbmoustiques170607.pdf
as well as in the recent Vector Control Advisory Group of WHO that we had mentioned in discussion 1 previously http://apps.who.int/iris/bitstream/10665/255824/1/WHO-HTM-NTD-VEM-2017.02-eng.pdf

Regarding the potential adverse effects, I think most of the publications that I just mention also cover potential adverse effects and uncertainties and propose a careful case by case approach to ensure that those effects are studied before any field evaluation of this technology. On this topic the report from National Academy of Sciences Engineering and Medicine, Gene drives on the horizon, Advancing Science, Navigating Uncertainty, and Aligning Research with Public Values, published by NASEM https://www.nap.edu/catalog/23405/gene-drives-on-the-horizon-advancing-science-navigating-uncertainty-and is particularly enlightening

I would also like to share the efforts done by our project - Target Malaria - to ensure that the identification of potential adverse effects includes stakeholders' inputs and is as inclusive as possible. As presented during a recent symposium organised by ILSI and the National Academy of Sciences (http://ilsirf.org/event/genedrives_july2017/) Target Malaria engages its stakeholders to gather concerns and includes this in its problem formulation exercise. This is done with a variety of stakeholders including scientists from ecology, epidemiology, entomology, biology fields, civil society groups, regulators and other government representatives and more broadly the communities of endemic countries where this technology could become part of the arsenal to fight malaria.
Others such as NEPAD (New Partnership for African Development) have also been organising dialogues to start discussing the benefits and adverse effects of gene drive mechanism for vector control within the African continent, starting to address some of the transboundary questions raised here (#8657).

I don't think that at this stage anyone can provide any final evidence about the benefits and potential adverse effects of gene drive mechanism for vector control, however it should be noted that there are significant efforts going into that from various stakeholders, and that this discussion is being inclusive.
posted on 2017-07-27 17:08 UTC by Ms. Delphine Thizy, Imperial College London
This is a reply to 8674 RE: Opening of discussion [#8675]
Taking as a reference the definition of genetic resource and of genetic material of the Convention of Biological Diversity:
"Genetic resources" means genetic material of real or potential value.

"Genetic material" means any material of plant, animal, microbial or other origin that contains functional units of inheritance.

The genetic resource can be understood as the genetic material of organisms, ie the DNA / RNA molecule, in this case a tangible DNA / RNA molecule and as it is in nature, taking into account that the synthetic biology between Genetic materials, living organisms and biological systems partially or totally artificially, the principle and objectives of the Convention may not reach the organisms, components and products of synthetic biology, so I It is difficult to demonstrate the benefits and adverse effects of these organisms, components and products within the objectives of the Convention on Biological Diversity:

1. The conservation of biological diversity
2. The sustainable use of components of biological diversity
3. Fair and equitable sharing of benefits arising from the use of genetic resources.

The three objectives of the agreement relate to access to genetic resources, which are provided by countries of origin and are in situ. However when we refer to organisms, components and products of synthetic biology, these principles are not applicable since the developments of synthetic biology are obtained artificially.

At present, it is not clear how the objectives of the Convention on Biological Diversity can be applied, although synthetic biology is based on genetic sequences and digital chemical structures for the development of organisms, components and products, since the definitions of genetic resources and Genetic material of the agreement speak of "material" ie a fully tangible molecule but does not link the sequences and digital chemical structures and found in databases.

I believe that this discussion has not been widely given and should be an important input to be addressed at the next meeting of the AHTEG, since this will depend on the form and instruments with which synthetic biology can be approached.

Similar positions can be referenced in intervention # 8626 and # 8644.
posted on 2017-07-27 20:29 UTC by Mr. Carlos Augusto Ospina Bravo, Colombia
This is a reply to 8674 RE: Opening of discussion [#8676]
Ms Thizy (in post #8674) gives a very complete picture of the current state of affairs with regard to considerations of the benefits and possible adverse effects of gene drive for the first case in which the technology is likely to be offered up for regulation, public debate and if accepted in those most important spheres as possible release. It should be clear that a) there is no experimental evidence beyond the laboratory and thus no evidence currently to apply to the question of adverse effect in relation to the three objectives of the CBD. Her post does however give a clear picture of the approach that is being taken which could be considered a precautionary approach (rather than the stifling application of a precautionary principle). As Ms Thizy describes there has been a recent forum which included discussion of the gene drive application to control malaria. It should be noted that this forum was the most recent of many fora that have taken place in various locations around the world. Many of those have been triggered by the scientific communities own desire to careful self-monitor and navigate this important series of issues. This is typified by a series of publications by amongst others Kenneth Oye, et al (2014) http://science.sciencemag.org/content/345/6197/626,
Bruce Webber, et al (2015) http://www.pnas.org/content/112/34/10565.full.pdf and Omar Akbari, et al (2015) http://science.sciencemag.org/content/349/6251/927. In addition one of the originators of the concept of CRISPR as the engine of a self-duplicating gene drive, Kevin Esvelt has an entire website devoted to these important questions https://wyss.harvard.edu/safeguarding-gene-drives/.
posted on 2017-07-27 20:52 UTC by Mr. Mark Tizard, Australia
This is a reply to 8598 RE: Opening of discussion [#8677]
Firstly, I’d like to thank Maria Andrea for chairing and the secretariat for this discussion. Reminding the current topic:  “Evidence of benefits and adverse effects of organisms, components and products of synthetic biology vis-à-vis the three objectives of the Convention”.
I agree that benefit or adverse effect will depend on what you are considering.  But though large areas of plantations do have an adverse impact on biodiversity, I disagree that the example given is a specific adverse effect of a LMO (post #8657). Whether the large plantations in Brazil were herbicide tolerant soybean obtained through conventional breeding (including organic farming) or modern biotech, both the benefits and adverse effects will be similar. I agree with many of the arguments made that it is mainly the phenotype of the organism and not the method by which it was produced that is important to reach conservation and sustainable use of biodiversity. In addition, technologies, including biotechnologies, can increase productivity and having higher yields per planted area diminishes the need of deforestation for farming, and leaving intact environments is a benefit for biodiversity.

In some cases, managing the environment is needed to prevent biodiversity loss. There are undoubtedly a number of current conservation approaches that are benefiting the conservation of biodiversity (like increasing the number of egg hatched macaws and re-introducing them into nature, poisoning some invasive rodents that are bringing native birds to the threat of extinction, monitoring systems… and several other tactics). But current approaches are not capable to prevent the biodiversity loss on a satisfactory way. Synthetic biology can be an important complementary tool to some conservation problems, for instance, saving wild-life threat of extinction due to natural diseases, climate change (e.g. to enable adaptation), invasive species, etc. It can also be used to reduce habitat lost, reduce pollution (consume or degrade pollutants, substitute older and more pollutant activities, …), perhaps with time decreasing the costs of conservation of biodiversity, etc. There are, in the scientific literature, many examples of potential benefits for the three aims of the convention, including steps towards a more accessible tool so that less developed countries can develop themselves solutions tailored for their own needs (it is a way of benefit sharing). There are also in the scientific literature considerations on the possible adverse effects and attention on how to advance safely on a case by case approach. At this stage though, most of these technologies are at the research stage. As pointed out in the post #8641, “we cannot ignore the role of regulatory and governance systems in interacting with scientific research and innovation process to determine future outcomes, particularly for biodiversity”. I agree with the #8601 that “As indicated many times before, living organisms obtained by synthetic biology that are applied so far are LMOs that have been risk assessed using the current risk assessment framework”. As in post #8670 that risks should be reflected compared to non-modified organisms, I would add or compared to current alternative approaches.
posted on 2017-07-28 01:09 UTC by Ms. Lúcia de Souza, PRRI - Public Research and Regulation Initiative/ANBio (Associação Nacional de Biossegurança - Brazilian Biosafety Association)
This is a reply to 8677 RE: Opening of discussion [#8678]
Dear Participants,

I appreciate so much your important and interesting views you presented in this Online Forum on Synthetic Biology. I would like to thank Ms. Maria and CBD Secretary for this opportunity. My name is Marina Rosales, I am professor at Federico Villarreal University and I member of IUCN’s Commission on Ecosystem Management.

The conservation of biological diversity includes the protection, care, management and maintenance of ecosystems, habitats, wildlife species and populations, within or outside of their natural environments, in order to safeguard the natural conditions for their long-term permanence (https://www.iucn.org/downloads/en_iucn__glossary_definitions.pdf). In this regard, the analysis of evidence of benefits and adverse effects of organisms, components and products of synthetic biology (SB) could have effects on conservation of ecosystems and natural habitats and the maintenance and recovery of viable populations of species in their natural surroundings, also in the case of domesticated or cultivated species, in the surroundings where they have developed their distinctive properties (https://www.cbd.int/convention/articles/default.shtml?a=cbd-02).

The biological diversity components are the life-support system of the planet, the capacity of the planet to meet the needs of all living organisms, including people. It is crucial to consider resilience-based ecosystem stewardship (F.S. Chapin et al. (eds.), Principles of Ecosystem Stewardship, DOI 10.1007/978-0-387-73033-2 1, © Springer Science+Business Media, LLC 2009). Therefore, synthetic biology (SB) as a new technology, should develop research and build evidence on the field to enhance risk assessment on ecosystems conservation and biological diversity. Species (gene drive) that are intended for release into ecosystems could have adverse effects on trophic change (niche substitution), could directly affect targeted organism and indirectly affect the abundance of non-target organism in ecosystems or persistence and transfer genetic material (https://elpais.com/elpais/2015/03/12/ciencia/1426166239_909448.html ), being research and monitoring with ecosystem approach in long term is priority.  Furthermore, could be unintentionally introduction into the genomes of their free-living wild relatives from transgenes engineered to other microorganisms or species (http://www.nature.com/nrg/journal/v4/n10/full/nrg1179.html?foxtrotcallback=true https://www.unocero.com/2015/03/14/descubren-genes-en-los-humanos-procedentes-de-otras-especies/ and http://revistas.unal.edu.co/index.php/actabiol/article/view/19986/27963). Introgression from genetically modified (GM) crops into wild relatives. This effects does not permit sustainable use of biological diversity components. https://www.researchgate.net/publication/277726022_(The_effects_of_the_presence_of_Bt-transgenic_oilseed_rape_in_wild_mustard_populations_on_the_rhizosphere_nematode_and_microbial_communities).

It is important to consider this new technology should be managed considering stewardship including responsibility for the state of the ecosystems of which we are part. The challenge is to anticipate change and shape it for sustainability in a manner that does not lead to loss of future options. Ecosystem stewardship recognizes that society’s use of resources must be compatible with the capacity of ecosystems to provide services, which, in turn, is constrained by the life-support system of the planet (DOI 10.1007/978-0-387-73033-2 1)

It is urge this technology  develop on the framework "Sustainable use of biological diversity components",  in a way and at a rate that does not lead to the long-term decline of biological diversity, thereby maintaining its potential to meet the needs and aspirations of present and future generations( https://www.cbd.int/convention/articles/default.shtml?a=cbd-02).The land change use, especially primary forest, is a driver of lost biodiversity habitats to increase crops of modern biotechnology (https://www.nytimes.com/es/2017/02/25/la-deforestacion-del-amazonas-regresa-con-fuerza/). On the other hand, many native crop species will compete with this technology and could effect on native genetic resources erosion. There is big bridge of separation between developed and developing countries. SB could benefit the economies of developed countries, so we need to invest in technology to develop biotechnology for production and assessment risk and management effects of SB products in social –ecological systems. The shape of new bioeconomies and their social, economic and cultural impacts will need to include the mechanisms to enhance the good governance and transparency to assesses and manage the SB risks.

The fair and equitable sharing of the benefits arising out of the utilization of genetic resources should be part of incentives of biological diversity and ecosystems services conservation and its sustainable use.  SB uses parts of copy models of species that belongs to ecosystems and biological diversity. In this regard, intellectual property rights – IPR should participate its benefits monetary and non-monetary revenues with conservation and sustainable uses initiatives at developing countries.

SB is a technology could have potential positive effects on conservation biological diversity in different issues (https://drive.google.com/file/d/0ByJvTQW8e0viVEJMS190ejhlV2M/view and https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2909387/ ), taking account ecosystems as an integral natural components with inherent complexity and dynamics at multiple temporal and spatial scales (stochastic ecological systems), we should develop assessments and management risk on the base long term monitoring for the synthetic biology organisms and its products, derivate from genetic engineering, information technology, nanotechnology, and biochemistry. It is vital to include in the management and risk assessment the ecosystem approach (https://www.cbd.int/doc/publications/ea-text-en.pdf).There are special and functional relations between ecosystems to must be taken account in the assessments on the field since SB organisms could have negative effects no wanted outside of ecosystems where it is applied this technology.  The effects between ecosystems are frequently non-linear and will likely have associated time-lags.  There is a need for this to reflect the fact that impacts are in both directions – into and out of a particular ecosystem. Not just adjacent and downstream, but those have other connections as well. The ecosystems services and its functions should be part of the assessments since could be had changes on its functionality in the long term. Management of ecosystem processes has to be carried out despite incomplete .knowledge of ecosystem functioning. (https://www.cbd.int/doc/publications/ea-text-en.pdf).

Finally, it is essential to consider precautionary approach maintain to assess the implications of Gene Drives and related techniques and their potential impacts,  including field trials, technical support and capacity building, for the assessment to be undertaken. The assessment should be based on scientific and empirical evidence (WCC-2016-Res-086-EN).
posted on 2017-07-28 01:11 UTC by Ms. Marina Rosales Benites de Franco, IUCN
This is a reply to 8677 RE: Opening of discussion [#8679]
Dr. Lúcia de Souza states “In addition, technologies, including biotechnologies, can increase productivity and having higher yields per planted area diminishes the need of deforestation for farming, and leaving intact environments is a benefit for biodiversity” [#8677].

Economics would not support any such sweeping conclusion. Increased productivity due to technological improvements can increase the demand for other inputs, such as changes in land use. The paradox was identified by Stanley Jevons in 1865 and quickly became eponymous. It also goes by the descriptive term “rebound effect”. For a jargon-free and open-access exposition, see York (2006)


York, Richard. 2006. “Ecological Paradoxes: William Stanley Jevons and the Paperless Office” Human Ecology Review, Vol. 13, No. 2, pp. 143-147. http://www.humanecologyreview.org/pastissues/her132/york.pdf
posted on 2017-07-28 03:57 UTC by Mr. Joseph Henry Vogel, University of Puerto Rico-Rio Piedras
This is a reply to 8679 RE: Opening of discussion [#8680]
Dear participants
The discussion is great and very technical. I would like to thank Maria Andrea for moderating, Secretariat and the participants.
The benefits of Synbio products, components and organisms are well noted by most of the participants.  Although, there are no practical experiences in adverse effects of synthetic biology, there have been ample of experiences in LMOs as noted by Professor Marina Rosales (#8678). Therefore, the adverse effect that will have had even if, synthetic biology, it should be considered like an extreme form of LMOs.  It is impossible to predict exactly what will have happened as a result of Synbio organisms, components and products.Whereas; it is possible to guess the adverse effect from LMO points of view.
  https://www.theatlantic.com/technology/archive/2014/09/beyond-gmos-the-rise-of-synthetic-biology/380770/
posted on 2017-07-28 10:18 UTC by Mr. Taye Birhanu, Ethiopia
This is a reply to 8598 RE: Opening of discussion [#8681]
Hello again everyone. My name is Jenna Shinen and I am the Life Sciences Specialist in the Biodiversity Division, in the Office of Conservation and Water, at the U.S. Department of State.  I am pleased to see the continued discussion on the forum, and thank the moderators for their work and the thoughtful comments of the other participants in the forum.
Research in the field of biological engineering, much of which conducted by public-sector institutions, improves our understanding of biological systems and contributes to efforts addressing food security, natural resource protection, and novel energy sources, all of which can contribute to the conservation and sustainable use of biological diversity.  Indeed, over forty years of research, education, and product development using recombinant DNA techniques have led to clear benefits relevant to the Convention’s objectives, and these benefits will continue to emerge with continued application of biological engineering tools and techniques.  There is a broad range of applications for synthetic biology technologies with potential benefits for biodiversity, including applications that assist in species conservation efforts, environmental remediation, and invasive species control.  Genetic engineering has already improved crop production methods by reducing soil erosion, decreasing fuel and chemical pesticide use, increasing disease- and pest-resistance within plants, increasing on-farm insect biodiversity, enhancing crop product quality, and improving farm productivity and farmer income.  We again point out the references made in the U.S. National Academy of Sciences report "Gene Drives on the Horizon" (https://www.nap.edu/catalog/23405/gene-drives-on-the-horizon-advancing-science-navigating-uncertainty-and) as well as a subsequent report on "Preparing for Future Products of Biotechnology" (https://www.nap.edu/catalog/24605/preparing-for-future-products-of-biotechnology) for relevant summaries of peer-reviewed literature of assessing benefits and risks related to synthetic biology tools as well as its products and components.  We also note that a great deal of the biological engineering research and development is aimed at reducing dependence on petroleum products as the primary substrates for production of many important chemicals and fuels (http://dx.doi.org/10.1787/5jxwwfjx0djf-en).

The United States joins other contributors in acknowledging that the Cartagena Protocol already recognizes the need to consider potential adverse effects that living modified organisms (LMOs) may have on the conservation and sustainable use of biological diversity, and also take into account risks to human health.  Nevertheless, great care should be exercised when drawing linkages between the products of biological engineering and the potential risks and benefits to biodiversity and human health to avoid unjustifiably inhibiting innovation. Review of any such linkages between the products of biological engineering and potential risks and benefits should be based on the available scientific evidence.  Where potential risks are identified, an assessment of the likelihood of those risks occurring should be conducted, taking account of relevant scientific factors.  In the May 2016 NAS report on genetically engineered crops  (https://www.nap.edu/catalog/23395/genetically-engineered-crops-experiences-and-prospects), the study committee, comprising an international cadre of technical experts from multiple sectors, found “no substantiated evidence of a difference in risks to human health between currently commercialized genetically engineered (GE) crops and conventionally bred crops, nor did it find conclusive cause-and-effect evidence of environmental problems from the GE crops.  In the absence of evidence of likely harm, the United States supports taking the least restrictive measures possible to achieve reasonable and appropriate safety objectives.  Governments, academia, and private sectors should consider transparent, collaborative review of governance and oversight mechanisms and address risks associated with applications of genome editing and synthesis technologies in ways that allow for continued innovation and that preserve the opportunity to leverage the benefits these technologies can provide.

I look forward to a continued discussion on this topic.

Best regards,
Jenna
posted on 2017-07-28 14:08 UTC by Ms. Jennifer Shinen, U.S. Department of State
This is a reply to 8598 RE: Opening of discussion [#8682]
Dear participants,
My name is Swantje Strassheim and I work for the German Federal Office of Consumer Protection and Food Safety in risk assessment on synthetic biology. With the discussion soon coming to an end, I would like to thank our moderator Maria Andrea Orjuela and share some thoughts on the questions she posed.

I think that we can agree that it is difficult to find sound examples (including evidence in form of scientific literature) for benefits and adverse effects of synthetic biology organisms, components and products. Furthermore, I think there are two reasons for that: i) is it challenging to identify possible effects (both positive and negative) on biodiversity as these are often indirect and difficult to measure and ii) we do not have an agreed-on definition on synthetic biology.

The problem of an agreed-on definition, which has been also been raised by comments such as [#8636], [#8641] and [#8656], can probably be solved, if we use the operational definition proposed by the AHTEH as a definition that tries to include all research activities that have been “labelled” as synthetic biology (genetic circuits, genome synthesis, metabolic pathway design, minimal organisms, artificial cells and xenobiology). The definition can, however, not be used to address the question whether synthetic biology, its organisms, components and products require a risk assessment tool different from the ones we already have (in the case of the CBD this is the Cartagena Protocol). As stated in post [#8601] “organisms obtained by synthetic biology that are applied so far are LMOs” and can be risk assessed using the current framework of the Cartagena Protocol. These organisms are already covered and should not be the topic of our discussions.
I am thus really looking forward to our next topic of discussion, which asks for examples of organisms produced with the help of synthetic biology that do not fall under the definition of living modified organisms under the Cartagena Protocol. This will hopefully help bringing the discussion from a too general one that also encompasses LMOs that can be assessed with existing tools to one that focuses on identifying synthetic biology organisms that might need an adapted risk assessment approach.
posted on 2017-07-28 14:11 UTC by Ms. Swantje Strassheim, Germany
This is a reply to 8680 RE: Opening of discussion [#8683]
The three objectives of the CBD are inherently economic, defined as “the study of how societies use scarce resources to produce valuable commodities and distribute them among people” (Samuelson and Nordhaus, 2005, 4). Yet Decisions by the COP have been taken as if economics did not exist. Even simple principles can inform the discussion. In previous posts [#8367] [#8434] [#8475], emphasis was placed on the “economics of information” (Samuelson and Nordhaus, 2005, pp. 194-195) to inform Objective #3. The application of that economics suggests the modality of “bounded openness” for the GMBSM of Article 10 of the Nagoya Protocol. In the recent post [#8679], Jevons’ Paradox can inform Objective #1. Its application suggests ”living within limits”, which was the title of Garrett Hardin’s capstone oeuvre (1993).  Objective #2 will largely emerge if Objectives #1 and #3 are realized.

Any resistance to deploying economics, as somehow too technical, does not bode well.


Hardin, Garrett. 1993. Living within Limits: Ecology, Economics  and Population Taboos. New York: Oxford University Press.

Samuelson, Paul A. and William D. Nordhaus. ECONOMICS, 18th ed. New York: McGraw-Hill.
posted on 2017-07-28 15:10 UTC by Mr. Joseph Henry Vogel, University of Puerto Rico-Rio Piedras
This is a reply to 8674 RE: Opening of discussion [#8684]
I'd like to thank Delphine Thizy of Imperial College London for supplying references to papers on gene drive for suppression of malaria.
Here I'd just like to add a few theoretical and empirical papers that may be of interest in regard to gene drives that are expected to be either temporally or spatially limited (or both).


A Synthetic Gene Drive System for Local, Reversible Modification and Suppression of Insect Populations
By: Akbari, Omar S.; Matzen, Kelly D.; Marshall, John M.; et al.
CURRENT BIOLOGY   Volume: 23   Issue: 8   Pages: 671-677   Published: APR 22 2013

Engineered reciprocal chromosome translocations drive high threshold, reversible population replacement in Drosophila
http://www.biorxiv.org/content/early/2016/11/17/088393

Invasion and migration of self-limiting gene drives: a comparative analysis
http://www.biorxiv.org/content/early/2017/07/06/159855

Evaluating Strategies For Reversing CRISPR-Cas9 Gene Drives
http://www.biorxiv.org/content/early/2017/06/21/144097

There are more similar papers referred to within these papers that could also be useful to the committee.
posted on 2017-07-28 16:30 UTC by Mr. Fred Gould, North Carolina State University
This is a reply to 8679 RE: Opening of discussion [#8685]
Sorry, that this is not really within the topic but I thought I should reply to Mr. Joseph Vogel’s comment.
Over the years more people gained access to food and some people do acquire more food than they need, etc.  Yet, it is important to note that we still have some 900 million people starving, growing population and other factors contribute to a need to increase food production using less land, water, etc. Food is not a luxury item, it is a right everybody should have. Thus, for those who can afford and increased their demand of food beyond their need, we probably need to tackle the issue through awareness/educative measures (reduce excessive food consumption, reduce food waste at all levels, …) in addition to other strategies for sustainable consumption, etc (i.e. tackle the rebound effect in the context needed and as appropriate). Considering the huge number of people who go hungry to bed every night, adding those who are undernourished now and the still increasing number of people in the world, there is a consensus that there is a need to produce more food, and not only increase production, we need to produce more with less, and among other things we need to increase productivity (sustainable intensification of agriculture-SI, etc). Today we can feed more people using less land than in past, some agricultural inputs gave way to less toxic ones, etc. Despite some improvements, there are a number of environmental footprints coming from agriculture. Food security is a challenge and we will need to tackle at many different fronts, many beyond those I mentioned above and out of the scope of this forum. For the soybeans in Brazil, if the production was using less technology improvements, we would probably cause even more damage to our own environment, or be importing this sort of commodity from other countries, and/or having other additional economic problems, etc. 

In case you might want to consider some information on SI, there are a number of sources, such as:
- Sustainable Intensification of Agriculture (FAO)
http://www.fao.org/policy-support/policy-themes/sustainable-intensification-agriculture/en/
- Sustainable Intensification in Agriculture
http://www.futureoffood.ox.ac.uk/sites/futureoffood.ox.ac.uk/files/Sustainable%20Intensification%20Comments.pdf
posted on 2017-07-29 01:45 UTC by Ms. Lúcia de Souza, PRRI - Public Research and Regulation Initiative/ANBio (Associação Nacional de Biossegurança - Brazilian Biosafety Association)
This is a reply to 8678 RE: Opening of discussion [#8686]
I would like to see more thoughts on the  language "empirical evidence"  in terms of  its required robustness necessary for taking important biosafety decisions.
posted on 2017-07-29 02:21 UTC by Mr. Joaquim A. Machado, Brazil
This is a reply to 8685 RE: Opening of discussion [#8687]
Dr. Lúcia de Souza alludes to the many ways that hunger is a distributional problem but concludes with the “need to increase productivity” [#8685]. Although hunger may not be merely a distributional problem as once thought (Lappé and Collins, 1986),  my posting was not about that debate [#8679]. It was about Jevons’ Paradox: increased productivity can increase demand for natural resources. The policy issue is whether to limit changes in land use when opportunity costs  rise [#8680]. Unwittingly and ironically, the transgenic soy cultivation cited at the close of  Dr. de Souza’s comment, is also on topic. It is a good example of Jevons’ Paradox (Altieri and Pengue, 2006).


Altieri, Miguel and Walter Pengue. 2006 (January).  “GM soybean: Latin America's new colonizer”. Seedling. https://www.grain.org/article/entries/588-gm-soybean-latin-america-s-new-colonizer

Lappé, Frances and Joseph Collins. 1986. World Hunger: 12 Myths. New York: Grove Press.
posted on 2017-07-29 03:45 UTC by Mr. Joseph Henry Vogel, University of Puerto Rico-Rio Piedras
This is a reply to 8604 RE: Opening of discussion [#8688]
Dear all,
I am Yongbo Liu, from Chinese Research Academy of Environmental Sciences. I participated the last AHTEG meeting in Montreal.
I agree with many of the points made by other commenters in this topic discussion. I want to highlight the view of Mr Boet Glandorf [#8601] who pointed out as “benefits and adverse effects of components and products of synthetic biology will not be different from components and products obtained by any other techniques. For me, the main discussion is on living organisms.”
This topic 2 discuss the “evidences” of SynBio related with the conservation, sustainable use and fair and equitable sharing of biodiversity. I agree with Ms Strassheim who thought it is difficult to find sound examples (evidences) [#8682]. Besides the two reasons that she pointed out (difficult to measure effects and definition), there is no living organisms from SynBio at present, at least not reported. Even for LMOs that have been environmentally released almost two decades, there is not yet a scientific consensus on biodiversity effects of LMOs.
Therefore, in my view, at present, the evidences for biodiversity effects of SynBio may be more feasible from some existed engineered organisms with specific traits from other modern biotechnology methods. The benefits or adverse effects on biodiversity will be related to organisms with specific traits, and not because the organisms from SynBio or other engineering methods (including breeding) ([#8617] expressed similar view). Of course, the SynBio method will be more powerful in the future, for example, one may be able to synthesize “any artificial organisms” (with chassis and bioparts). I agree with “I would like to highlight that the absence of evidence about negative impacts originated by Synbio doesn't mean their absence” [#8621].
Thanks for your attention.
posted on 2017-07-29 16:00 UTC by Dr. Yongbo Liu, China
This is a reply to 8598 RE: Opening of discussion [#8689]
Dear all,
I would like to thank CBD Secretary for this opportunity. My name is Ahmed Sabah from Iraq and I work in Ministry Of Health and Environment. I have been involved in biosafety and biotechnology since 2007, Furthermore I work on different aspects related to genetic diversity and convention on biological diversity.
The discussion in this round is very exciting, my concept in general about synthetic biological that The behavior of synthetic biological systems is inherently uncertain and unpredictable so I think the regulations have not been developed to assess the potential ecological risks associated with synthetic biology.

Kind regards,

Ahmed Sabah
posted on 2017-07-29 18:41 UTC by Mr. ahmed sabah, Iraq
This is a reply to 8598 RE: Opening of discussion [#8690]
Being a lawyer I have followed the discussion with a view on how it may serve to create a reasonable regulatory framework. Although regulation is a topic for the next rounds it should be taken as a background also for the rather scientific and philosophical issues of the current round. Having in mind the question posed  (“evidence of benefits and adverse effects of organisms, components, and products of synthetic biology vis-à-vis the three objectives of the Convention”) I find a few issues need further clarification, including:
1. What is an “effect”? Obviously a causal relationship between A and B. If A is not defined it does not make sense to look for B. This point has rightly be made by J. Vogel. Many contributors took a bottom up approach listing the major strands called SynBio. I believe this is a reasonable way to finally come to a risk orientated more general definition. At a later stage this may generate a set of criteria which allow the screening of those techniques and products that need in-depth regulatory oversight.
2. What does “evidence” mean? Does evidence of adverse effects only mean scientifically proven effects (if such thing exists at all)? This would be very shortsighted in view of the precautionary approach of the Cartagena Protocol . I do not believe that the CBD COP would set aside precaution. But where ends precaution and starts mere speculation? Is it of importance who bears the burden of proof?
3. What are “adverse” effects? Are they only direct ones such as intended and side effects on identified target and non-target species, or do they also comprise indirect effects like on agricultural practices such as extensive use of herbicides, spread of monocultures, etc.? Is there sufficient “evidence” that insecticide plants are better targeted than chemical insecticides, and that herbicide tolerant plants lead to less and better targeted use of chemical pesticides?
4. What does “benefit” mean? Is it only the immediate gain for the user, such as the increase in plant yield and profitability for the individual farmer, or can an immediate gain be an adverse effect if assessed in broader systemic terms? Such as having a rebound effect on ever more consumption of meat, on wasting food because it is so cheap, on the use of round up herbicides, on displacing smaller scale integrated and organic agriculture? 
5. Other than with risk assessment methodology no regulation (with the exception of the EU Chemicals Regulation called “REACH”) has as yet ventured into prescribing a methodology of benefit assessment. How would that look like?
6. Is SynBio the new main road towards biodiversity protection, or is it a possibly welcome but very limited tool that should not distract politics from the real causes, which mainly is intensive agriculture, consumption of meat, low prices of agricultural products,  etc. The round discussed gene drive at some length: is that really the royal road to human health and biodiversity protection?
7. Is SynBio as propagated by its enthusiasts leading us into a technology trap in which adverse effects of one technological progress (such as maximization of yield of plants, intensive pig and cattle farming) are managed  by ever more technical sophistication?
8. Can components of SynBio have direct or indirect adverse effects? Is the growing exchange and trade of bioparts of any concern?
9. What are the exposition scenarios of “adverse effects”? The round mainly discussed deliberate release into the environment. How about unintended release from contained systems? How about unintended release from storage, trade and transportation?  How about hobby experimentation by laypersons?
10. Are military uses of SynBio a “benefit”? If so to what extent has the military made use of SynBio, and to what extent?
11. Is there any information on how SynBio may be used for terrorist purposes (those assumed to be “adverse effects”)?
12. Concerning access to genetic resources and benefit sharing (ABS): Are benefits only to be shared if arising from the use of the biological material, such as by techniques of breeding, insertion of transgenes, etc. Or may they also arise if a researcher takes information about a gene and its property from a data base or other media, synthesizes the gene and inserts it into an organism? My answer would be yes if the provider state of the organism containing the original gene claims in its legislation and PIC/MAT that benefits  to be shared are also those arising from information about its genetic resources. I trust that these questions will be discussed in the rounds to come but they are important to know as a background if we talk about benefits in the ABS realm.
posted on 2017-07-29 20:43 UTC by Mr. Gerd Winter, University of Bremen
This is a reply to 8598 RE: Opening of discussion [#8691]
Dear all—

My thanks to our moderator Maria Andrea for guiding this session.  This is my first post during this session, which covered many interesting and informative topics. I have a few thoughts to contribute on several topics relevant to these discussions.

First, Maria Andrea has asked us to provide evidence of the benefits and adverse effects of:  organisms, components, and products of synthetic biology (all three, as requested by the COP) for each of the three objectives of the Convention.  This, of course, results in 9 separate categories.

Most of our discussions have focused on 2 of the 9 categories:  Benefits and adverse effects of LMOs, i.e., organisms, on objective #1, conservation of biological diversity, and objective #2 sustainable use of the components of biological diversity.  Some of this has been speculative as few LMOs produced using synthetic biology have yet been introduced.  Of the 36 products listed in the US National Academy of Sciences (NAS) report "Preparing for Future Products of Biotechnology", only 6 are listed as “on market” and of these 4 are genetically engineered crops (Table S-1).  (Link to report in #8681.) Gould (#8617 and #8634) and others have mentioned another US NAS report, “Genetically Engineered Crops: Experiences and Prospects” (link also in #8681).  Because this is a 420-page report summarizing many hundreds of scientific papers), I thought it would be helpful to excerpt a few findings relevant to objective #1 and objective #2 of the Convention:

“FINDING: Planting of Bt varieties of crops tends to result in higher insect biodiversity than planting of similar varieties without the Bt trait that are treated with synthetic insecticides.

“FINDING: In the United States, farmers’ fields with glyphosate-resistant GE crops sprayed with glyphosate have similar or more weed biodiversity than fields with non-GE crop varieties.

“FINDING: Although gene flow has occurred, no examples have demonstrated an adverse environmental effect of gene flow from a GE crop to a wild, related plant species.

“Overall, the committee found no conclusive evidence of cause-and-effect relationships between
GE crops and environmental problems. However, the complex nature of assessing long-term
environmental changes often made it difficult to reach definitive conclusions.”

That said, as pointed out by Breitling #8669, gene drives (and other new types of modifications) were not considered when the Cartagena Protocol was developed.  Tait and the UK Synthetic Biology Leadership Council (#8641) and others, however, point out that to assess benefits and adverse effects, one must look at BOTH the organism (again, case-by-case) and the regulatory environment.  Gould (#8684) points out the variety of approaches to gene drives currently under investigation.  Likewise, guidance for safely testing and evaluating these new approaches is actively under development (#8596 under Topic 1) and will be further discussed under Topic 5.

Our moderator, Maria Andrea, in #8671, asked us to explicitly address the COP’s question about the benefits and adverse effects from the non-living “products” and “components” of synthetic biology as they relate to objective #1 and objective #2 of the Convention.  Glandorf (#8601) states her opinion (shared by #8613, #8652, #8669, #8688) that “benefits and adverse effects of components and products of synthetic biology will not be different from components and products obtained by any other techniques”.  I agree, and would like to add that non-living components (e.g., DNA synthesized from chemicals) and non-living products (chemicals, pharmaceuticals, etc.) made by organisms engineered using synthetic biology are extensively regulated, as well.  In addition, using estimates for the US, the economic value of the non-living products and components of the biotechnology sector is greater than the living organisms produced. Biologics (drugs produced using genetically engineered organisms), biochemicals, feedstocks, etc. account for about $200 billion per year of the $325 billion annual output (Carlson, Nature Biotechnology 34, 247–255, 2016).  Westra (#8682) points out the hoped-for benefits of a biobased and circular economy objectives #1 and #2.  He and others (for example, under the human health thread under Topic 1), also point out the importance of synthetic biology techniques for producing biologics to improve human health.

Finally, I would like to briefly comment on the last 3 of the 9 categories our moderator has asked us to address.  As suggested by van der Meer (#8661) and others, benefits and adverse effects of organisms, components, and products of synthetic biology in relation to objective #3 of the convention, i.e. the fair and equitable sharing of the benefits arising out of the utilization of genetic resources, “is of a very different nature than the first two”.  Here, in my view, it is not the components or even the organisms (as organisms) that is of direct concern, rather the fair and equitable sharing of the economic (and other) benefits of the products of biotechnology.  This is clearly a concern, but not one limited to biotechnology.

Regards,
Bob Friedman
posted on 2017-07-29 23:40 UTC by Mr. Robert Friedman, J. Craig Venter Institute
This is a reply to 8687 RE: Opening of discussion [#8692]
Obviously the rationalia "more food, more food security" has been used to sell more agricultural insumes. I am not saying that this is imoral, this is just a simple mathematical rule. But there is evidence that we can't establish food security on this reasoning.Anyway, I never start my talks on Biotechnology showing graphics forecasting millions and billions of people starving.

Sorry for this message a bit out of focus for the mainstream discussion.
posted on 2017-07-30 01:20 UTC by Mr. Joaquim A. Machado, Brazil
This is a reply to 8690 RE: Opening of discussion [#8693]
Prof. Gerd Winter poses 24 questions as he sensibly requests clarification of the benefits and adverse effects of synthetic biology [#8690]. Although answering a question with a question is usually bad form, when faced with a deluge of questions, it is warranted. I will ask the overarching question: Who pays for the clarification?

An answer can be inferred in postings [#8475] and [#8554]. The argument was made that a regulated market in insurance could manage the varied risks of synthetic biology, where those who benefit from the “organisms, components, and products of synthetic biology” pay the costs associated with the benefits. Governments could finance the corresponding regulatory structure through an ad valorem tax on insurance premiums. The structure would reflect answers to many of Prof. Winter’s questions. The role of the regulators would then become two-pronged: to license endeavors which wish to apply for insurance case-by-case; and to monitor the evolution of the industry so that no insurer becomes “too big to fail”, which would be a de facto limit on indemnification.

Mandatory insurance would promote efficiency but not necessarily conservation. Outstanding are the “rebound effects”, which is an expression of “Jevons Paradox”. In order for technology not to augment land conversion, new limits on changes in land use must accompany the technology ([#8679] [#8683] and [#8687]). However, any such imposition is beyond our relative expertise in economics, law and so on.

Unfortunately, the requisite discusion about limiting land conversion is not happenning in the political sphere. When will the taboo be broken? At the outset of the mass extinctin crisis, E.O. Wilson wrote: “In the end, I suspect that [biodiversity conservation] will all come down to a decision of ethics” (1988, p16). Grappling with that suspicion, Prof. Wilson titled his 32nd book “Half Earth: Our Planet’s Fight for Life” (Wilson, 2016): “to save biodiversity, we need to set aside about half the earth’s surface as a natural reserve” (Wilson, quoted in Dreifus, 2016).

Key to setting anything aside is the alignment of economic incentives, which brings us back to “bounded openness” as the modality for the Global Multialteral Benefi-Sharing Mechanism (Article 10 of the Nagoya Protocol).



Dreifus, Claudia. 2016 (29 Feb).  “In ‘Half Earth,’ E.O. Wilson Calls for a Grand Retreat”, The New York Times, https://www.nytimes.com/2016/03/01/science/e-o-wilson-half-earth-biodiversity.html?_r=0

Wilson, E.O. 2016. Half Earth. Washington, D.C: Island Press.

Wilson, E. O. 1988. “The Current State of Biological Diversity” pp. 3-18, in Biodiversity, E.O. Wilson, ed. Washington D.C: National Academy Press.
posted on 2017-07-30 04:09 UTC by Mr. Joseph Henry Vogel, University of Puerto Rico-Rio Piedras
This is a reply to 8690 RE: Opening of discussion [#8694]
I would  like to pick up  from  Mr.  Gerd Winter ‘s post (#8690) when he asked what do we mean by “evidence” and  he posed the question : “does it only mean scientifically-proven  effects “ , which he said  is  short-sighted given the precautionary approach of the Cartagena Protocol. I was  also going  along the same track  asking  what kind of evidence do we have  from our exchanges thus far since our main task here in session 2 is  to do a “further  analysis” of the evidence as instructed by our ever-patient moderator Maria Andrea (#8671) and I proposed that in analyzing this evidence presented here we  need to determine whether they are  reality-based  or   purely theoretical or speculative (#8625).

But somehow Ms. Joyce Tait (#8641) said that it seems  unwisely reductionist to discuss evidence of benefits and  adverse effects without also considering the  regulatory context; Mr. Christoph Then (#8657) reminded  us that we should avoid over-simplifying when it comes to discussing evidence for adverse effects and benefits though he later  suggested we  should  agree to be cautious when  talking about evidence of benefits as these benefits might be temporary  and he said there is evidence for many unknowns even  for these genetically-engineered plants already in the market.

But then,  on this matter of existing GE plants, we have Mr. Fred Gould (#8650) kindly providing us the NAS study which  will serve as a reference for AHTEG, though he did not say this is already DIRECT evidence  of the benefits and adverse effects of  organisms, products and  components of  synthetic  biology as this NAS study involved GE crops. Perhaps eventually, like what was said by  Mr. Rainer Breitling (#8669)  that “a larger part of earlier discussions for LMOs will equally apply to synthetic  biology” , this NAS study relating to GE crops may  be eventually subjected to an INFERENCE or a PRESUMPTION ; posts by  Ms. Jennifer Shinen (#8681), Mr. Robert Friedman (#8691), Mr. Yongbo Liu (#8688), also reinforce this point, that evidence for GE crops are now also generally being presented as evidence  for SB organisms, products and components.

There’s no problem  with these assertions for as long as they are acknowledged as mere inferences and that  there is for now truly no direct evidence  of benefits and adverse effects  so far of synthetic biology organisms, products and  components  on, for  example, biodiversity, as pointed out by  Mr. Freddy Bulubulu (#8643) or  Mr. Mark Tizard (#8659) or Ms. Swantje Strassheim (#8682), who  said it is difficult to  find sound examples for benefits and adverse effects of SB organisms, products and  components for the reasons  she  had cited.  Over-all, it was good that such insufficiency of evidence was pointed out and with that,  I don’t think we should look for some “final proof” as what Mr. Piet van der Meer (#8661) seems to be hinting at, that  seems to be contrary to the scientific method.

From all of these exchanges that we had, maybe it was good we had a continued tug-of-war over our operational definition on whether to use it or not since that unclarity that we had there also foreshadowed our seeming ambivalence including  on the evidence, which  led us to some uncomfortable economic  paradoxes as consistently pointed out by  Mr. Joseph Henry Vogel (#8658, #8672, #8679, #8683, #8687, #8693). All these are not bad actually, it only  shows we need  more evidence - inference-based, empirical, reality-based, theoretical, speculative, etc. -  to further light  our path as we move forward.

It was good to have these exchanges  with you. On to the next!

Cheers!
posted on 2017-07-30 06:35 UTC by Mr. Elpidio Peria, Philippines
This is a reply to 8691 RE: Opening of discussion [#8695]
I have been following the debate with great interest and want to thank everyone for all the different opinions, texts, links to publications etc. I just wanted to make 3 quick points -

1. Synbio is a continuation of the tools and capabilities of genetic engineering which as everyone knows has a long history. For a quick review of where the research is going at the leading edge please have a look at this weeks Nature - see https://www.nature.com/nature/journal/v547/n7664/pdf/547477a.pdf
This article provides a summary of the ongoing research and you will notice that many groups are trying to establish a full engineering framework for GE- the overall aim is to understand living systems and apply this for potential applications. I would see technological  developments in the field accelerating with more automation and greater understanding- please note that many of these advances are taking place in microbial unicellular hosts although this may extend into more complicated cell-based systems.

2. The application of synbio and the developing toolkit for new enablers of biotechnology I believe is at the centre of the forums debate which from my perspective seems to have a major focus on GM plants and gene drive and biodiversity and the convention. There seems to be little debate on technology advances for contained use as found in industrial biotechnology processes (which already exist) but will be further enabled by the toolkit of synbio. These more industrial processes are focused in developing a more bio-based economy and quite rightly forum members have focused on the potential  products from these processes and the arguments appear more socio-economic based and equitable sharing of resources. This area needs thorough debate I believe but on a case by case basis and i fully agree with some of the concerns raised in the context of the broader remit of the convention. However I hope that most forum members would believe that removing our dependence on petrochemical production processes would be a positive result for biodiversity and in particular tackling climate change etc.

3. My last point relates to the next generation of synbio researchers as exemplified by the iGEM competition - these young and enthusiastic colleagues want to apply their skills to solve major global problems - unfortunately their voice is missing from the forum although several turned up at the cop-mop meeting in Cancun.  From my experience this next generation is highly sensitised to the many complexities of the ongoing debate as expressed in the forum and though the development of training in  human practise and in the UK Responsible research and innovation framework,  i am fully confident that this generation will be leaders in applying the next generation of tools of biotechnology in a responsible, open  and inclusive manner.
posted on 2017-07-30 11:09 UTC by Mr. Paul Freemont, Imperial College London
This is a reply to 8694 RE: Opening of discussion [#8696]
In post #8694 Mr. Elpidio Peria refers to an earlier post #8659 made by me, in relation to the generation of data regarding the evidence of benefit or adverse effect of synthetic biology (in that particular scenario the assessment of a GM crop). My point was focussed on the complexity of generating biodiversity impact data and the need for appropriate comparisons. In that case it would be conventional crop use compared directly with the related GM crop use AND also with no cropping – this is necessary to understand the adverse effect of cropping per se and then any additional (if any) effect of the synthetic biology (GM) component in terms of the biodiversity in a given location – that difference alone can be attributed to the synthetic biology (GM) component and would need to be viewed in proportion to the impact of conventional cropping (i.e. is it significantly different. The major point in #8659 is the complexity of determining how to conduct the studies to make these assessments meaningful and the costs of doing so (and how that is achieved). Also the point that agriculture as an activity of mankind on the planet has impacted biodiversity (both positively and negatively). How much more or less that impact will be with the inclusion of synthetic biology will almost certainly vary on a case by case basis and that is how it is currently assessed by the regulatory frameworks in national jurisdictions and with the context of the Cartagena protocol.
posted on 2017-07-30 13:47 UTC by Mr. Mark Tizard, Australia
This is a reply to 8696 RE: Opening of discussion [#8697]
Further to my previous post #8696 and the case by case review and regulation of synthetic biology applications in the sense of GM crops. Jim Loutner’s post #8652 provides a clear indication of the processes in Canada that relate to assessment and regulations of a GMO (LMO) that is released into the environment in particular the benefit and adverse effects.  In Australia the Office of the Gene Technology Regulator (OGTR) has a well-defined process for what are classed as Dealings with Intentional Release (DIRs) of LMOs (as they administer the Gene Technology Act, 2004 [https://www.legislation.gov.au/Details/C2016C00792]). Their objective is two-fold, to ensure there is no risk of harm to the health of the Australian public and also to ensure that there is no harm to the Australian environment, i.e. if there are concerns in relation to the Environment Protection and Biodiversity Conservation (EPBC) Act (1999). [http://www.environment.gov.au/epbc/publications/factsheet-epbc-act-frequently-asked-questions]  Thus in Australia, as in Canada, for all LMOs that have been released so far in the agricultural setting (exclusively plants at this point in time) there is a body of evidence for each LMO detailing benefit and adverse effects, the latter being lower than an acceptable level of risk (since it is disingenuous to declare a zero risk). These data are on record, though that is most often not available to the public (for a range of reasons). In addition if an LMO is being used to generate food products it is subject to review in relation to the standards enforced by Food Standards Australia New Zealand (FSANZ) [https://www.legislation.gov.au/Details/C2004C00171].

As synthetic biology advances and “artificial biology” (described by previous posts) generates novel organisms and products these will de facto be LMO (GMO) and will fall under the purview of the OGTR    and if they are to be released or have the opportunity to be released into the open (uncontained) environment they will be assessed in relation to the EPBC Act, 1999.  As the field is still relatively young, the commercialization of products that might seek to be “released” has not yet advanced to review, stage. However laboratory contained research, in a pipeline towards release of a product, is already captured by the OGTR as it holds records of gene technology dealings that are conducted in Australia by reporting through Institutional Biosafety Committees, a legal requirement upon every research institution in Australia.

Thus there is an extensive body of information and data that sit between the concepts (in synthetic biology) that arise in the minds of scientists and the point at which a benefit or adverse effect can come to pass in the environment with impact on the three objectives of the CBD.  There are many checkpoints along that pathway (with increasing rigour and intensity) up to the point of a potential release.
posted on 2017-07-30 13:59 UTC by Mr. Mark Tizard, Australia
This is a reply to 8598 RE: Opening of discussion [#8699]
Dear participants in the forum,

For the second round of discussion implementing the Decision XIII/17, our moderator invited us to present information (preferably with references) on “Evidence of benefits and adverse effects of organisms, components and products of synthetic biology vis-à-vis the three objectives of the Convention”.

In addressing the questions for topic 2, I would like to make a reference to the Global Industry Coalition’s information submission which provides a review of peer-reviewed scientific evidence on the impact of LMOs. The submission can be reached via the link http://bch.cbd.int/database/record.shtml?documentid=112053.

In addition, I would like to comment on the post from Joyce Tait representing the Synthetic Biology Leadership Council of the UK (#8641) that makes an important statement that “there is now a general recognition that we cannot ignore the role of regulatory and governance systems in interacting with scientific research and innovation process to determine future outcomes, particularly for biodiversity”. This post describes how regulatory and governance frameworks can shape innovation trajectories, and can unnecessarily prevent the realization of potential future benefits and allow avoidable harms if an overly precautious approach is taken to innovation.  Similar point is raised also in the post of Ms. Lúcia de Souza (#8677) and Ms Ms. Jennifer Shinen (#8681).

Such developments can be avoided when the level of regulation and risk management measures are commensurate with the level of risk associated with the biotechnology products and that take into account the risk and benefits of exiting alternatives. Potential, or established effects (either adverse or beneficial) arising from the use of synthetic biology organisms, components and products can only be comprehensively assessed if compared to alternative existing or future solutions that have same or similar use.

Along with the CBD, other international bodies, for example the United Nations Development Programme (UNDP),   recognize the importance of innovation for the achievement of the UN Sustainable Development Goals and can provide much needed assistance and support to Parties to access and/or develop innovative solutions for their specific needs, maximize societal benefits, and at the same time advance the objectives of the Convention.

The UNDP presents a good overview about the “principles of innovation”:  http://www.undp.org/content/undp/en/home/ourwork/development-impact/innovation/principles-of-innovation.html.  Another example of collaboration on the achievement of the SDGs is the UN Global Impact initiative which promotes: (1) Do business responsibly by aligning their strategies and operations with Ten Principles on human rights, labour, environment and anti-corruption; and (2) Take strategic actions to advance broader societal goals, such as the UN Sustainable Development Goals, with an emphasis on collaboration and innovation https://www.unglobalcompact.org/what-is-gc/mission.

Kind regards to all participants in the forum,
Ana
posted on 2017-07-30 14:46 UTC by Ms. Ana Atanassova, Bayer CropScience
This is a reply to 8691 RE: Opening of discussion [#8700]
I am Joyce Tait, Director of the Innogen Institute in the University of Edinburgh and I would like to follow up on my earlier contribution on behalf of the UK Synthetic Biology Leadership Council (#8641), with thanks to our moderator for her attempts to keep us all on topic (#8671). This contribution responds particularly to the points raised in #8690 (Gerd Winter), #8691 (Robert Friedman) and #8694 (Elpidio Peria), each of which summarises very effectively many of the issues that have been raised under Topic 2. Considering particularly ‘evidence of the benefits and adverse effects of the organisms, components and effects of synthetic biology’, these submissions point to challenges that arise in responding to this requirement.
In the early days of the development of regulatory systems for GM crops I made an unsuccessful attempt to guide discussion in the direction of the distinction between ‘proactive’ and ‘reactive’ approaches to regulation of potentially hazardous technologies (http://www.sciencedirect.com/science/article/pii/001632879290032B), focusing attention on the nature of the regulatory system and its fitness for purpose, rather than on the entities to be regulated. The reactive approach, responding to scientifically-based evidence of adverse effects (see #8690), was compared to a proactive approach, acting in advance of scientific evidence of hazard, as required to varying degrees for different interpretations of the precautionary principle. Several contributions to this Forum have emphasised the need to abide by the requirements of the precautionary principle, as embodied in the Cartagena Protocol, implying taking regulatory action in advance of having evidence of harm, and without any balancing consideration of benefits, but we are being asked to provide that evidence. Could this be the dilemma underlying the circular nature of the discussions so far in this Online Forum?
The challenge facing us is thus to propose to what extent we should restrict research and development of synthetic biology and related technologies in advance of having evidence of benefits and adverse effects of the entities concerned. This would require a formal risk analysis-based focus on uncertainty and probabilities as well as specification of expected benefits and adverse effects and so far the latter have received much more attention than the former.
For each of the relevant criteria on which to base such a regulatory decision, (i) probability of outcome, (ii) scale of expected benefit, (iii) degree of predicted hazard, entities proposed for regulation will lie on a continuum ranging from very low to very high. Considering only the extreme ends of the spectrum, and focusing on negative outcomes or hazards, there are four possibilities: low probability/low hazard; low probability/high hazard; high probability/low hazard; and high probability/high hazard. If one were also to include benefits in the calculation, for each of the four hazard-based classes, there would be an additional four possibilities based on high or low probabilities of large or small benefits. Given that such decisions are expected to be made in advance of having scientific evidence on which to base them, most of the data available will be qualitative and subject to biases arising from the interests and values of decision makers or advocates.
This is not to suggest that such an approach be adopted, but merely to highlight the challenge underlying the task faced by this Forum. At the very least it points to the need to find different ways of dealing with entities with a very diverse range of potential outcomes. One relevant example is the Arctic apple (http://www.arcticapples.com/okanagan-specialty-fruits/) with its high probability of modest societal and economic benefits and very low probability of a very low level of hazard. This can be contrasted with the use of gene drives, using related biotechnology-based processes (e.g.CRISPR-Cas9), to modify mosquitoes with a high probability of significant benefits to people and an unknown probability of at least some harm to ecosystems (https://www.nap.edu/catalog/23405/gene-drives-on-the-horizon-advancing-science-navigating-uncertainty-and). As noted above, such categorisations are inevitably subjective and so will probably be challenged, but the point is still valid that there will be entities at both ends of these scales.
This leads to the proposition that any regulatory system for these technologies will need to be able to adapt in a way that is proportionate to the properties of such a broad range of entities, including a conclusion that some of them do not fall within its remit. It is not yet clear that the CBD and its Protocols have that capability. From the point of view of those seeking to ensure that less developed countries can achieve solutions based on these technologies that are tailored to their specific needs (#8677, Lucia de Souza), it is also important that the regulatory system can be adapted in a way that continues to ensure safety and efficacy, without being prohibitively time-consuming and costly.
With thanks to all for a very interesting discussion,
Yours, Joyce Tait
posted on 2017-07-30 15:45 UTC by Ms. Joyce Tait, University of Edinburgh
This is a reply to 8598 RE: Opening of discussion [#8703]
Many thanks to Maria Andrea Orjuela for moderating this discussion.
Given that the ambit of the CPB is LMOs, I will thus limit my comment to LMOs produced by synthetic biology methods that would be released into the environment.  In the context of South Africa, such products would be assessed under the GMO Act, as in deed are GMOs produced by other methods.  To date all synthetic biology research is conducted in laboratories under conditions of containment and thus no evaluation of a product intended for release into the environment has been performed.  Ultimately, I believe it is the phenotype of the organism and its intended use that will determine its impact on biodiversity in relation to the 3 objectives of the CBD, i.e. case by case assessment is imperative, as is the current practice.

Regards

Kelebohile Lekoape
posted on 2017-07-30 20:23 UTC by Ms. Kelebohile Lekoape, Bayer CropScience
This is a reply to 8598 RE: Opening of discussion [#8704]
Thank you María for moderating the second topic and for your reminders of the scope of the topic and that our contributions should facilitate the work of the AHTEG (this includes the AHTEG contributing to the completion of the assessment as requested in paragraph 2 decision XII/24).

We appreciate the various posts that have provided references to existing evidence of benefits and adverse effects of the organisms, components and products of synthetic biology (e.g. #8617 and references therein).

We agree with the several posts which have reminded us that adverse effects such as herbicide tolerance are not unique to a plant being a LMO (#8601, #8605).

Many posts continue to refer to the scope of the operational definition. We too continue to have reservations about its breadth. Regardless, the development of self-limiting gene drives (e.g. http://www.biorxiv.org/content/early/2016/06/06/057307) may mitigate and/or obviate the concerns regarding gene drives expressed in many posts in this forum. This changing landscape should inform our deliberations, as well as those of the AHTEG.

We maintain that the benefits and adverse effects of organisms, components and products of synthetic biology are no different than those of any other LMO (as noted in COP decision XIII/17), and can be risk-assessed on a case-by-case basis using existing regulatory frameworks and methodologies (e.g. New Zealand’s Hazardous Substances and New Organisms (HSNO) Act). For example, in New Zealand, non-living products of ‘synthetic biology’ could be regulated as hazardous substances under the HSNO Act if they meet one or more thresholds defined in its hazard classification regulations. Non-living, non-hazardous novel pharmaceuticals, foods or agricultural compounds or medicines could potentially be regulated under the Medicines Act, Food Act, or Agricultural Compounds and Veterinary Medicines Act, respectively. We therefore agree with the observations in posts #8601, #8613, #8652, #8661 and #8670, which note that the main discussion pertains to the synthetic biology LMOs (also regulated under the HSNO Act in New Zealand via its new organisms provisions), as well as the receiving environment.

Mariska Wouters
(edited on 2017-07-30 21:43 UTC by Ms. Mariska Wouters)
posted on 2017-07-30 21:40 UTC by Ms. Mariska Wouters, New Zealand
This is a reply to 8598 Posting for Royden Saahn [#8706]
I am posting this for Royden Saah who is a project coordinator for Island Conservation

Dear Dr. Regalado,

Thank you for your comments in Post#8621.  Researchers are attempting to create a synthetic biology systems that could potentially benefit biodiversity, such as gene drives used to manage invasive animals known to cause extinctions (https://doi.org/10.1016/j.ecolecon.2004.10.002). However, there are important concerns about the robustness of these gene drives considering genetic diversity in the populations of invasive species.

Because of this, I would like the AHTEG to also consider the recent publication (http://journals.plos.org/plosgenetics/article?id=10.1371/journal.pgen.1006796) on resistance which states,

“The variation in resistance rates among lines we observed in this study has important implications for the feasibility of gene drive strategies in the wild. The likelihood that resistance evolves against a drive should be determined primarily by those individuals that have a high rate of resistance allele formation, even when the average rate in the population is low. This will be particularly relevant for target populations that harbor high levels of genetic diversity, such as A. gambiae. It also has important implications for the assessment of gene drive parameters in the laboratory, which should include cage experiments of large, genetically diverse populations followed over many generations, instead of focusing on crosses of isogeneic lines. Finally, variation in drive parameters among individuals will need to be included in our theoretical models, which currently rely on rather simplistic assumptions such as constant resistance and conversion rates across the whole population.”

Thank you for your attention,
Royden Saah
posted on 2017-07-30 23:47 UTC by Mr. Fred Gould, North Carolina State University
This is a reply to 8598 RE: Opening of discussion [#8707]
Dear forum participants,

In this discussion, our moderator has requested that participants include references to support their claims. I take the opportunity to again refer to the Global Industry Coalition’s (GIC) information submission which provides a review of scientific evidence. The submission is attached to this post, and the public database where the literature can be found is here: http://biotechbenefits.croplife.org/.

The GIC’s review is focused on LM crops, as the four decades of experience that we have with conducting risk assessments for LMOs to be released into the environment largely concerns these LMOs. This experience is relevant to our considerations of synthetic biology – particularly since many of the claims of adverse effects are the same as they were for LM crops decades ago, and adverse impacts specific to the use of biotechnology have not materialized. Further, as noted by many in this discussion (as well as in the Topic 1 discussion), existing approaches to risk assessment for LMOs apply to organisms that may be considered by some to have been produced using “synthetic biology”.

Despite the efforts of our moderator, like Topic 1, examples of adverse effects of LM crops in this discussion generally continue to be unsubstantiated broad claims. These include, for example, excessive use of pesticides, development of herbicide resistance, loss of biodiversity, and detrimental unintended effects. To the contrary, a finding of the report of the National Academy of Science referred to by many others in this discussion is that there is no conclusive evidence for environmental problems caused by LM crops (National Academy of Science 2017). Comments in this discussion have called for scrutiny of claimed benefits – the same is needed for claims of adverse effects. This was pointed out repeatedly in the Topic 1 discussion – for any claim, it is necessary to consider context and relevance to the claims being made. Also, as noted by many others, impacts should be considered in comparison to appropriate alternative scenarios – in this case, the impact of planting an LM crop compared to planting a non-LM or conventional crop.

Claims of increased or excessive use of pesticides with the adoption of LM crops are not supported by the evidence, which to the contrary shows reductions in the volume of insecticide used where Bt crops have been adopted in comparison to that used on conventional crops. An observed consequence of this is higher on-farm insect biodiversity. Further, insecticide use may also be reduced in nearby non-Bt crops (Brookes & Barfoot 2017; Klumper & Qaim 2014; National Academy of Science 2017).

Reductions in the volume of herbicides with the adoption of herbicide tolerant LM crops are also observed in some countries. In other countries, increases in the amount of herbicide active ingredient have been observed, however this is also the case for herbicides used with conventional crops. It is important to note the overall beneficial impact of the use of safer herbicides (environmentally and for human health) with LM crops in comparison to conventional alternatives. Further, reduced need for chemical inputs with LM crops have indirect impacts that contribute to climate change mitigation due to reduced on-farm fuel use and increased soil carbon sequestration (Brookes & Barfoot 2017).

The development of herbicide resistance is not a specific impact of LM crops – it can occur with any herbicide active ingredient, it has and will continue to arise regardless of the crop production method, and it is a not a failure of the technology. Where herbicides are used with herbicide tolerant LM crops, the implementation of diversified weed management plans with multiple modes of action are recommended. Where such approaches have been taken, shifts in the volumes of active ingredients of different herbicides have been observed, with reduced reliance on a sole herbicide (Brookes & Barfoot 2017). It is also noteworthy that some herbicide tolerant LM crop systems have similar or greater weed biodiversity compared to the conventional crop (National Academy of Science 2017).

The claims of loss of biodiversity associated with the expansion of LM crop cultivation are also non-specific. As pointed out in #8677 (also #8685), land is required for agriculture and expansion can occur regardless of the production method. However, data indicates that in the past five decades, arable land devoted to agriculture has increased by only ~9% globally, despite grain production more than doubling in that time (Godfray et al 2010). By 2050, the global population is expected to reach 9.8 billion (United Nations 2017), and it is recognized that there is a need to produce more food (estimates range from 70-100%) to meet global demand, while at the same time there is a need to reduce environmental impacts (Godfray et al 2010). Forecasts based on agricultural production trajectories in the latter half of the 20th century (when the world population reached 6 billion) emphasize the need for deployment of significant technological advances to develop more productive crops with increased yields, and reduced water, pesticide and fertilizer requirements (Tilman et al 2001). Therefore, innovation in agriculture, including advancements in biotechnology, is essential. The expansion of LM crop cultivation has also been associated with increased inputs in this discussion, however this claim is not supported by the evidence cited above demonstrating reduced chemical inputs and broader environmental benefits.

On the issue of unintended effects, the example of Golden Rice has been presented in this discussion as well as the Topic 1 discussion. A publication (http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0169600) was provided showing that the introgression of the transgene from a donor line to a commercial variety produced unexpected phenotypic effects. The authors associated these effects with the insertion of the transgene in a coding region and disruption of the functioning of an endogenous gene (in the donor line). This report demonstrates that transgenic loci can perform differently in different genetic backgrounds, which is why breeding and selection are very important for the selection and development of LM cultivars. Where a variety containing the transgenic trait does not perform to commercial standards it is not a commercially viable product – it will be screened out in the breeding program. The development of LM crop varieties involves several years of trait characterization, breeding and introgression under appropriate conditions of containment or isolation. Therefore it is incorrect to extrapolate observations under containment as representative of unintended/detrimental characteristics of LM crops used commercially and that have obtained regulatory approvals. LM crops (and other LMOs developed for specific purposes, e.g. LM microbes) are developed for optimal performance in managed environments. If gene flow occurs when an LM crop is released into the environment, which itself requires overcoming a series of biological and physical obstacles, detrimental traits will be selected against and not become established or persist outside of the managed environment (see Stewart et al 2003).

Another point that needs to be made concerns the use of “synthetic nucleotides” as a defining feature of synthetic biology. This would greatly simplify our discussions if it were true, however synthetic nucleotides have long been used in biotechnology applications and are not a new or differentiating feature. For example, synthetic nucleotides have been used as probes in southern hybridization analysis since the mid 1970s, as primers in PCR since the early 1980s, and in the gene constructs used to develop LMOs, including LM crops, since the 1990s. This point has already been deliberated by the AHTEG in 2015.

Brookes, Graham and Peter Barfoot (2017) Environmental impacts of genetically modified (GM) crop use 1996–2015: Impacts on pesticide use and carbon emissions. GM Crops & Food 8(2) 117-147, http://dx.doi.org/10.1080/21645698.2017.1309490

Godfray, Charles, John Beddington, Ian Crute, Lawrence Haddad, David Lawrence, James Muir, Jules Pretty, Sherman Robinson, Sandy Thomas and Camilla Toulmin (2010) Food security: the challenge of feeding 9 billion people. Science 327:812-818, http://science.sciencemag.org/content/327/5967/812.full

Klümper, Wilhelm and Matin Qaim (2014) A meta-analysis of the impacts of genetically modified crops. PLoS One 9(11) e111629, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4218791/

National Academy of Science (2017) Genetically Engineered Crops: Experiences and Prospects.

Stewart, Neal, Matthew Halfhill and Suzanne Warwick (2003) Transgene introgression from genetically modified crops to their wild relatives. Nature Reviews 4: 806-817, http://www.nature.com/nrg/journal/v4/n10/full/nrg1179.html

Tilman, David, Joseph Fargione, Brian Wolff, Carla D’Antonio, Andrew Dobson, Robert Howarth, David Schindler, William Schlesinger, Daniel Simberloff and Deborah Swackhamer (2001) Forecasting agriculturally driven global environmental change. Science 292: 281-284, http://science.sciencemag.org/content/292/5515/281.full

United Nations (2017) World population prospects, key findings and advance tables, 2017 revision. https://esa.un.org/unpd/wpp/Publications/Files/WPP2017_KeyFindings.pdf
posted on 2017-07-31 00:54 UTC by Ms. Felicity Keiper, Bayer CropScience
This is a reply to 8707 RE: Opening of discussion [#8711]
Dear Members
There are more than 100 comments described the impact of synthetic biology on biodiversity here in the discussion. Thanks to all members for their wonderful contributions. But the major concern is the “evidence” indicated here all are of short term analyses. Short term analyses are on par with speculative theories and hypothesis. To make a considerable impact on biodiversity, any introduced component should overcome the buffering action of the members of any ecosystem and it needs lot of time to create a stable impact to be analyzed. Moreover the idea “anyway the ecosystem is getting spoiled, why not synthetic biology too” cannot be supported under any circumstance.

Hence, in my opinion whatever has been proposed as the “evidence” here is not enough to confirm the impacts on biodiversity and it needs in-depth as well as wider coverage of research on these aspects.

Thanks
posted on 2017-07-31 05:05 UTC by Ms. Jeshima k Yasin, India