Third Real-time Online Conference for Asia and the Pacific, 19 April 2012 from 3:00 to 6:00 GMT
Download the conference documents here.
Dear Participants,
Good morning! Welcome to the Third Real-time Online Conferences on Risk Assessment and Risk Management for Asia and the Pacific. It is a great pleasure for us at the Secretariat to be gathered here once again with you.
Your input today is very important and will serve as a basis for the deliberations by the AHTEG at its fourth meeting which will take place in Montreal, Canada from 4 to 8 June 2012. Moreover, the outcome and recommendations of the real-time conferences will be forwarded to the Parties of the Cartagena Protocol at their meeting in October 2012.
It is noted that our conference today will be chaired by Dr. Rofina Yasmin Othman from Malaysia. Dr. Othman was very kind to accept a last-minute invitation to replace Dr. Vilasini Pillai in chairing the conference.
I have a couple of technical notes before we proceed with the conference:
1) I would kindly ask you to type or paste your intervention on the Text Box (centre-bottom of the screen) before requesting the floor because you will have only 60 seconds to send your intervention once the floor is given to you.
2) The Secretariat is available to answer questions through the HelpDesk. To access the online HelpDesk, please use the tab in the top-left corner of the screen. In case of emergency please call us at +1-514-287-6681. This number is also available at the top-right corner of the screen.
We have a full agenda and, without further delay, I would like to welcome all of you to this conference and invite our Chair, Dr. Rofina Yasmin Othman, to preside over the conference.
The Secretariat wishes you a very fruitful discussion! |
Thank you, Secretariat.
Distinguished colleagues,
Good morning and welcome to the third real-time conference for Asia and the Pacific. My colleague, Dr. Vilasini Pillai, sends her apologies for not being able to be here with you today due to unforeseen reasons.
I am honoured to substitute Vila and serve as the Chair of this conference. |
Since the last meeting of the Parties to the Protocol in 2010, following the mandate in decision BS-V/12, the Open-ended Online Expert Group and the AHTEG have made considerable progress in revising the Guidance on Risk Assessment of LMOs. The Open-ended Group and the AHTEG also developed two new guidance documents: on “post-release monitoring of LMOs”, and on “risk assessment of LM trees”.
Our work today will focus on providing comments to these guidance documents as well as on considerations about the need for further guidance on specific topics of risk assessment and risk management, and recommendations to the COP-MOP including considerations for future activities related to the Guidance on Risk Assessment.
The outcome of the third series of online conferences will serve as inputs for the deliberations by the AHTEG during its fourth meeting scheduled to take place from
4-8 June 2012 in Montreal, Canada.
This series of real-time conferences is, therefore, the last chance that experts in the Open-ended Online Forum will have to provide input to the work of the AHTEG before it submits its final outcome to the Conference of the Parties of the Protocol (COP-MOP) in October 2012.
The importance of active participating and sharing your views today cannot be stressed enough.
On this note, I declare our conference open and look forward to your active participation throughout the conference.
We will move now to Item 2. Organizational Matters; sub-item 2.1 Adoption of the agenda. |
The task before us is the adoption of our agenda. I invite you to turn to the provisional agenda contained in document UNEP/CBD/BS/REGCONF-RA&RM/3/1, which was prepared by the Secretariat and reflects the objective of our meeting.
Unless you have amendments or objections to any of the items, I propose that we adopt the agenda of the meeting as contained in document UNEP/CBD/BS/REGCONF-CB-RA&RM/3/1. |
I see no requests for the floor.
The provisional agenda as before us is adopted.
Let us now turn to agenda Item 2.2 Organization of work. |
I hope that our conference today will end at about 6:00 (GMT), plus or minus 30 minutes as needed to complete our task today.
Also, I propose that we have a break of 15 minutes half-way through the conference or as needed.
I trust that you have prepared your interventions on the basis of the annotations to the provisional agenda that was circulated by the Secretariat as document UNEP/CBD/BS/REGCONF-RA&RM/3/1/Add.1.
I would like to propose that we use the guiding questions, which were circulated by the Secretariat by email prior to the conference, to assist our deliberations today on each substantive item in our agenda.
Due to a full agenda, I will attempt to progress swiftly through its items and I kindly ask that you take part in the discussion in a prompt, direct and open manner.
Is there any objection to this organization of work? |
I see no objection. The proposed organization of work is adopted.
I will now invite you to turn to item 3 on the agenda. |
Under this item, our first substantive issue is:
ITEM 3.1. COMMENTS ON THE GUIDANCE DOCUMENTS PREPARED BY THE OPEN-ENDED ONLINE EXPERT GROUP AND THE AD HOC TECHNICAL EXPERT GROUP ON RISK ASSESSMENT AND RISK MANAGEMENT
We will have three sub-items under 3.1 as follows:
(a) Guidance on Risk Assessment of Living Modified Organisms;
(b) Monitoring of living modified organisms released into the environment;
(c) Risk assessment of living modified trees.
The latest draft versions of the guidance documents, which have been circulated by the Secretariat on 2 April 2012, will be used as the basis for our discussions today.
This being an extensive agenda item, we will likely spend approximately half of our time today or roughly one and a half hour discussing these sub-items. |
I will now open the floor for your reactions to the first guiding questions under:
(a) GUIDANCE ON RISK ASSESSMENT OF LIVING MODIFIED ORGANISMS
(i) Does the Guidance provide a useful tool to assist you in performing or reviewing an LMO risk assessment? What amendments would you propose to increase its usefulness?
The floor is open for your comments. |
| Thank you Chairman.
Generally speaking, the document, especially Part I, is comprehensively well developed.
However, in terms of usefulness, it seems the document make too much complicated impression, especially considering the users who have limited experience with LMO risk assessment. Also, it makes impressions that the document deals with issues beyond the provision of the Protocol.
Following three points should be considered.
1. To clarify that Roadmap does not deal with the whole “environmental risk”
2. To clarify that RA of “agronomic practices” are out of the provision of Annex III
3. Not to use the term, “cumulative effects”
If possible, I would like to explain each. |
| thank you . please go ahead and explain these items |
| 1) To clarify that Roadmap does not deal with the whole “environmental risk”
・Since it states in the first part of the document (line 64) that “This “Roadmap” provides guidance on assessing environmental risks of living modified organisms”, it seems that Roadmap deals with the assessment of the impact of LMO on the whole environment. The Roadmap should concentrate on RA of LMO on biological diversity, as mentioned in the document (line 67), “this Roadmap compliments Annex III”.
・At least the sentence in line 64, 69 and 74 should be rewritten, such that showing the objective of the document is to provide the guidance on RA of LMO on biological diversity. |
| ok this is noted can we hear also comments form jack |
| I believe that the document is useful to countries.
Minor amendments
Line 255 “e.g., a (near-)isogenic line as the primary choice of comparator.” Given the qualifications preceding (ie some frameworks) this should be amended to: “e.g., an isogenic line (or if necessary and appropriate a near-isogenic line) as the primary choice of comparator.”
Line 257 “additional comparators may prove useful” should be changed to “additional reference lines/genotypes may prove useful”. There should always be one comparator that is without exception used and any other reference should be justified as scientifically valid.
Line 261 substitute “references” for “comparators”
Line 270 “In such cases additional comparators may be necessary”. This is not warranted. Comparators implies that they are good controls. The LMOs listed are by design not equivalent to any existing comparator with a history of safe use. This line should be deleted and replaced with: “In such cases, it may not be possible to reduce the uncertainties in the level of risk of the LMO, or a non-comparative risk assessment may be necessary to identify and evaluate potential adverse effects (for more guidance on some of these examples, please refer to Part II of this Guidance)”
Additional bibliographic reference for the Roadmap and Part II (abiotic stress) if not already listed:
Heinemann, J.A.; Kurenbach, B.; Quist, D. Molecular profiling — a tool for addressing emerging gaps in the comparative risk assessment of GMOs. Environ Int. 37:1285-1293; 2011 |
| any other comments on this substitution of terms? |
| Regarding lines 64, 69 and 74, the Protocol also must have regard to human health and thus I support the language in the roadmap as is |
| Can I continue to explain other points? |
| 3) Not to use the term, “cumulative effects”
・The term of “cumulative effects” are used in the document. It would be understandable in case of chemical substances which are not easily decomposed. However, it is not clear what kind of effects is imagined in case of LMO. This kind of words, which is vague and unsupported by evidence, had better not be used. Related lines are lines 335, 405, 511, 549 in the Part I and lines 774, 777, 787, 805, 815 in Part II A. |
| (a) (i) GUIDANCE ON RISK ASSESSMENT OF LIVING MODIFIED ORGANISMS
I have a comment based on several sessions of regional and informal workshops on biosafety RA
Guidance docs for beginners, not making dictionaries:
Forum must assist to understand ANNEX III for the beginners. But the past discussion has been likely making more confusion than understanding. With the feedbacks of the NFPs at the party countries of the Protocol over past several months on the draft docs, while the draft docs had been tested, it is yet cumbersome, and language cosmetics shall be minimum to avoid further complication. But different views, off course, should be respected to reflect a useful guidance doc. With points, no further addition is preferred but testing and uses should be promoted. |
| Impacts interact. The risk assessment literature is quite clear on the importance of this aspect. Effects on biodiversity affect the environment; policies will come forth from governments when the costs are greater than benefits, etc and it will not matter if these costs are directly due to the LMO or are a secondary consequence of a primary impact of the LMO. Governmental agents want to be alerted to such things; as advisors we ought not leave them with surprises. "Cumulative effects" should stay |
| would anyone else like to comment on the points raised |
| I believe that cumulative effects is a well supported term and concept. For example, the use of multiple different cry genes can create selections for cross resistance. This kind of effect is well discussed in the literature and is a landscape effect arising from the use of different LMOs simultaneously and a cumulative effect of the use of multiple kinds of LMOs |
| 2) To clarify that RA of “agronomic practices” are out of the provision of Annex III
・Line 485-488 states that “The evaluation of consequences may also consider the adverse effects associated with the existing practices that will be introduced along with the LMO (such as various agronomic practices, for example, for pest or weed management).
・Such assessment of adverse effect caused by changes in agronomic practices would be out of the provision of Annex III. Of course, not only LM crops, but the introduction of new crop varieties in general would be evaluated from various aspects, such as productivity, pest control management, product’s quality etc. Biosafty of LMO might be one of such aspects to be taken into consideration when new crop varieties are introduced.
・Thus the considerations on agronomical changes had better be deleted in the description of steps of Roadmap, instead, if needed, be inserted in the last part of Related Issues in line 629-639 ; like that, “After accomplishing RA of LMO on biological diversity and if the risk is acceptable, the new LM crops, similar to non-LM crops, if necessary, would undergo a process of agronomical and environmental evaluation in a usual way.”
・For the same reason, “Effects on the abiotic environment and ecosystem”, in Part II, B, line 1058-1076, should be deleted or rewritten as related issues. |
| Thank you for the clarifications. anymore comments? |
| Cumulative effects
How this could be explained as a term? What can be cumulated? There is so far no report on such an aspect by cultivating THE LMO crops, and yet imaginary rather than precautionary. |
| this should have a response? |
| I would like to make a comment on agronomic practices |
| ok last comment for this section |
| Cumulative-it is so in the field of pesticieds--when a pest begins to become resistent to a pesticide, another might be introduced so the cumulative effect keeps the pest at bay. Thank you |
| With respect to agronomic practices: the Roadmap makes the case for a comparative assessment to identify potential adverse effects on protection goals. Depending on the goal, that may involve agronomic practices. The important element of the guidance is the protection goal and that is not aided by excluding areas for comparison. |
Thank you very much. we willnow move on.The second question related to the Guidance is:
(ii) Is there any issue or concept that is missing from the revised Guidance that should be included? If so, please propose a draft text to address the missing issue(s).
The floor is now open for your reactions. |
| A concept similar to the stepwise nature of testing and evaluation as expressed in the ‘monitoring’ document.
I note that the Roadmap makes many references to different scales of release (trial to full) and thus minor modifications at select places would be all that is necessary. |
no more comments . i guess the draft ismore or less inclusive.I thank all of you for your discussion on the Guidance. I propose that we move now to the next sub-item:
(b) MONITORING OF LIVING MODIFIED ORGANISMS RELEASED INTO THE ENVIRONMENT
and I invite your reactions to its first guiding question:
(i) Are all relevant scientific issues properly addressed in this guidance document? If not, please specify what amendments you would advise.
The floor is now open for your reactions. |
| Tank you Chair.
・The document still seems to include some issues to be discussed. One of the issues is related to the two types of monitoring, i.e., CSM and general monitoring.
・In the context of risk assessment of LMO, general monitoring cannot be included, because it is stated that “General monitoring may be undertaken to account for effects that were not anticipated in the risk assessment” (line 34-35, which is inconsistent with Annex III, 8(f).
・Monitoring in Annex III would be conducted in the case where there is uncertainty regarding the level of risk. Therefore general monitoring, where even the risk may not be identified, cannot be included in monitoring according to the Annex III 8(f). |
| interesting point. comments? |
| First I post my prepared comments, okay?
I am generally satisfied that the Guidance is a useful tool. It could be improved by providing more specifics on the proper implementation of the different monitoring approaches. However, I think this issue could largely be made up through the use of good references.
Specific comments:
Lines 67-69 appear to apply only when the public regulator designs a monitoring plan, but describes characteristics that would be generic to whomever is required to draw up the plan. I suggest deleting the sentence “The monitoring plan should be transparent, of scientific quality and presented in sufficient detail so that the relevance of the data can be appraised. ” and replaced with: “Regardless of who designs the plan, it should be transparent, of scientific quality and presented in sufficient detail so that the relevance of the data can be appraised.1” and placed after the last sentence in line 73.
Line 165 the word “transgenic” is problematic. Given attempts to rename products of modern biotechnology by various other names (e.g., cisgenics, intragenics etc), it is best to revert to the language of the protocol to prevent any misunderstanding of the products that are regulated under the Protocol. The phrase ‘transgenic traits introduced’ should be deleted and replaced with “kind of traits introduced through modern biotechnology”.
Line 168 replace “The duration necessary” with “How long it would take”
Line 199 replace “to allow verification to the quality and relevancy of” with “to allow verification of the quality and relevancy of”
Line 205 is prescriptive on the regulator as written in “the report should clearly describe how the scientific results relate to the original regulatory need for monitoring.” This may be appropriate if the regulator has delegated responsibility to the notifier, but not if the regulator is conducting the monitoring activity. It should be deleted in its present form. If a substitute sentence is necessary, I suggest: “Since monitoring is both a scientific and regulatory activity, the report should make clear to the competent authorities that the choice of parameters and indicators was and continues to be appropriate and effective, and the report should evaluate for all stakeholders how well the monitoring objectives are being met.”
The section “Challenges” should be deleted. 1. it isn’t ‘guidance’; 2. it presents no new information; 3. it repeats information from earlier parts of the document. Lines 216-220 introduce the idea that costs, manpower and resources should be considered. This is more appropriate as a “points to consider” sentence in “How to monitor”.
Lines 221-224 are redundant with text in lines 57-60. The text is unnecessary in this section.
Lines 225-229 are not guidance. These challenges are well covered in the appropriate ‘points to consider’ under each specific guidance heading above. Delete. |
| thank you for this detailed intervention |
| Monitoring should be without imaginary precaution, but with the relevant experience for the practicality
Monitoring is a typical issue which should incorporate experiences from others, but the present discussion seems lacking consideration of the contribution with the both long term monitoring in research and LMO crops uses in some countries. Scientific facts should be well considered based on practical experiences.
general surveillance (GS)
Recognizing EU legislation includes GS, but this should not be the central component, but as an optional element as not always possible. Also this may be deviation from ANNEX III of the Protocol? Science-based hypothesis and targets should be well defined.
GS should be done within the existing national regulatory framework, such as environment protection law and not with the stand alone biosafety law. |
| interesting points on stand alone laws. to phillip |
I have remarks that I have broken down into a few sections. The first:
Q 3.1(b) and elsewhere
A) Risk assessment is not new, and LMOs are far from the first subjects for this attention. In my own country, basic risk assessment was built into the US Food, Drug and Cosmetic Act of 1938.
There are important non-scientific issues that monitoring must address and they should be reflected in this guidance document. After all, the notion of “safety”—the level of risk a society (or individual) is willing to run is subjective. (Some individuals think that parachute-jumping is a “safe’ sport; others, such as myself, think it is far too risky.) Thus, since monitoring is designed to check on risks and to keep the situation “safe,” it involves valid subjective factors which affect public policy determinations. This is known in the literature as the “perception of risk” and is highly influential in actual governmental decision-making.
The foundational work on this subject-- 25 years years old this week—is “Perception of Risk,” by Paul Slovik, published in Science, new series, vol 236, issue 4799 (April 17, 1987), 280-285, and available on-line at http://socsci2.ucsd.edu/~aronatas/project/academic/risk%20slovic.pdf . It has been cited in 4,000 subsequent scholarly works. The abstract to this article notes:
Studies of risk perception examine the judgements people make when they are asked to characterize and evaluate hazardous activities and technologies. This research aims to aid risk analysis and policy-making by providing a basis for understanding and anticipating public responses to hazards and improving the communication of risk information among lay people, technical experts, and decision-makers. This work assumes that those who promote and regulate health and safety need to understand how people think about and respond to risk. Without such understanding, well-intended policies may be ineffective. |
Second:
In a later book, The Perception of Risk (London, England: Earthscan Publications, Risk, society, and policy series,2000), Slovik elaborates on “work that recognizes the importance and legitimacy of equity, trust, power, and other value-laden issues underlying public concerns. New methods for assessing perceptions of risk are described, and the implications for regulation and public policy are discussed. The issues covered include: societal risk taking; decision-making in mental health law; rating risks; facts versus fears; informing and educating the public about risk; intuitive toxicology; perceived risks and the politics of nuclear waste; perceived risk, trust, and democracy; and technological stigma” (PsycINFO Database Record). This effort by Slovik has been relied on as authority in over 1600 later publications.
B) Thus, this guidance document must include provisions for general monitoring as well as case-specific monitoring because public perceptions may make it imperative in a country for a situation to be followed generally and over time. Indeed, such general monitoring would be useful as regards the possible triggering of the provisions of the Nagoya-Kuala Lumpur Supplemental Protocol on Liability and Redress which many of us have also worked on. |
| lets digests these points for a few seconds more |
| I am supprised we are in monitoring now, could be too fast? the window is too small to read all messages. |
| just starting 3.1b which is section on monitoring in general. next item will be on guidance documents |
next to last:
C) Opposition by some colleagues to the inclusion of guidance on general monitoring in this document is puzzling since the Cartagena Protocol is legally a floor, not a ceiling. As sovereign entities, nations can, of course, choose to monitor as they will or not at all; we are charged with giving adequate advice for any of their choices. And as experts our advice-giving should be commodious, not restrictive. For example, nothing in the establishment of the Protocol’s Roster of Experts (where many of us are listed) limits the scope of the advice we may give to Parties.
Risk assessments in other arenas (foods, drugs, consumer hazards, fire hazards) are replete with examples of unexpected consequences, and of effects which are the results of consequences and/or extraneous factors. Without general monitoring, many of these will be missed—with potentially dire impacts. We are not omniscient. Let us be modest enough to admit that we do not know what exactly it is that we don’t know. Close to the subject matter of our work is the experience with Mad Cow disease, manifesting itself unexpectedly and, apparently, after many years of latency.
General monitoring is especially appropriate for uncovering certain sorts of information that might suggest revising the risk assessment. As the Codex PRINCIPLES FOR THE RISK ANALYSIS OF FOODS DERIVED FROM MODERN BIOTECHNOLOGY (CAC/GL 44-2003) note “When new scientific information relevant to a risk assessment becomes available, the assessment should be reviewed to incorporate that information and, if necessary, risk management measures adapted accordingly.”
The Codex GUIDELINE FOR THE CONDUCT OF FOOD SAFETY ASSESSMENT OF FOODS DERIVED
FROM RECOMBINANT-DNA PLANTS CAC/GL 45-2003 goes on to elaborate:
16.Unintended effects caused by genetic modification may be subdivided into two groups: those that are “predictable” and those that are “unexpected”. Many unintended effects are largely predictable based on knowledge of the inserted trait and its metabolic connections or of the site of insertion. Owing to the expanding information on plant genomes and the increased specificity in terms of genetic materials introduced through recombinant-DNA techniques compared with other forms of plant breeding, it may become easier to predict unintended effects of a particular modification. Molecular
biological and biochemical techniques can also be used to analyse potential changes at
the level of gene transcription and message translation that could lead to unintended
effects. |
| Wei, to expand the window please click on the box with four small arrows next to "Exit" button on the top-right corner of the screen. This will expand the size of the conference window. |
| one more from phillips then we will seek comments on his interventions |
end of my prepared remarks:
17. The safety assessment of foods derived from recombinant-DNA plants involves
methods to identify and detect such unintended effects and procedures to evaluate
their biological relevance and potential impact on food safety. A variety of data and
information is necessary in order to assess unintended effects because no individual
test can detect all possible unintended effects or identify, with certainty, those relevant
to human health. These data and information, when considered in total, provide
assurance that the food is unlikely to have an adverse effect on human health. The
assessment for unintended effects takes into account the agronomic/phenotypic
characteristics of the plant that are typically observed by breeders in selecting new
varieties for commercialization. These observations by breeders provide a first screen
for plants that exhibit unintended traits. New varieties that pass this screen are
subjected to safety assessment as described in Sections 4 and 5.
Thus, because of what the risk assessment literature calls our “bounded rationality,” we cannot eliminate a priori the possible need for general monitoring techniques. These must be retained in our document.
thank you for your gracious attention! |
| any comments on the need for genearl monitoring techniuqes? |
| That 4 arrow crashed me Manoela!
On the issue of general monitoring.
There is no question that general monitoring is an approach used already and to provide guidance we cannot ignore monitoring approaches already in use. Moreover, uncertainty arises in a risk assessment from "unknown unknowns" General monitoring is a way to address the level of uncertainty of these unanticipated potential adverse effects. And GM is science based. There is a good scientific literature to support it.
In the next part, I will post bibliographic references that provide good guidance to countries that might choose this option to reduce uncertainties and to identify, mitigate or avoid potential adverse effects. |
| Thanks I had expended my view, but may need to have time to read and digest. Not sure it is the general monitoring:
I am still strongly against the statement that monitoring sites have to be chosen by the parameters and indicators. At least they should not be the first point to consider. the likely potential receiving environment should be the first important point in choosing monitoring sites. |
| Thank you Chair.
Its too long for me. But I would like to make following prepared comments.
IPCS (International Programme on Chemical Safety), co-established by UNEP, ILO and WHO developed a report ,“Risk Assessment Terminology”, on the harmonization of the terminology in risk assessment in 2004. In the report, “Risk monitoring” is defined as “Process of following up the decisions and actions within risk management in order to ascertain that risk containment or reduction with respect to a particular hazard is assured. Risk monitoring is an element of risk management.” Namely, in case where “hazard” is not identified, any monitoring activities could not be included in “monitoring” of risk assessment. |
| Yet, I believe those general monitoring issues can be quoted or in the references rather than putting a large section, in considering easy catch for beginner starting. Usually other national laws or guidelines in each country has such a statement to quote? |
| As Mr. Tojo commneted, chemical safety and enviromental pollutions nd minings would be examples. |
| Thanks, Kazuo, our Chair lost her connection so I will proceed giving the floor until she comes back |
| There are excellent examples of the use of GM in other areas(particularly in human health). In the present, we have a jurisdiction that mandates it but does not grow LMOs (Europe) and jurisdictions that don't mandate and do grow LMOs (the Americas), so on the ground examples of LMO use are limited. But that does not make the concept flawed or inappropriate for guidance.
I will provide a detailed bibliography to support GM. |
| Jack and all, if you have any bibliography please send it to me with the full reference and if possible the pdf file |
| Good to have you back Yasmin! |
| can i invite some last comments on this section? |
| Thank you again.
Risk monitoring is different from, so-called, “environmental monitoring”.
“Environment Monitoring” monitors changes in environment by various indicators and parameters. On the other hand, “monitoring” in the field of risk assessment monitors hazards, including LMOs, which are identified as hazards in risk assessment. |
thank you isao for this suggested definitions. we will move on
Thank you. Let us please move to the second question regarding the guidance document on “Monitoring”:
(ii) Do you have any bibliographic reference relevant to this guidance document which you would like to suggest?
The floor is open for your suggestions. |
| sorry this actually continues wht we have been talking before :-) |
| The good thing, I like GS in monitoring, taking specific characteristics of LMOs into consideration.
just comment to ISAO, I can not agree to your last statement'". Risk should be monitored to assure safety management.
another comment to Philip, the unintended effects are not easy to be predicted even with the progress of our genomic technology. |
| I will send my list for 3(b) (ii) directly to you then Manoela. |
| thank you jack, phillip now |
| a little late--an example--The US Biosecurity Program (esp after 9/11) conducts extensive general monitoring--for example by requiring the documentation of all transactions, etc--in addtion to case-specific situar=tions (the anthrax scare of 2001)
on Wei's point, because we can't predict with accuracy, general monitoring becomes important. |
| any comments these two statements form wei wei and phillips? |
| To add to Phil: Colony Collapse Disorder and the discover of HIV/AIDS both came about from GM type activities. |
| interesting link. phillip |
| Is Wikipedia an acceptable reference? (a little late-night humor)
http://en.wikipedia.org/wiki/Biosecurity_in_the_United_States |
| Jack, please submit them to the BIRC directly if there are many.
Dear all, the Biosafety Information Resource Centre (BIRC; http://bch.cbd.int/managementcentre/edit/resource.shtml) of the BCH now offers the possibility to link background documents to parts of the guidance. Please use this tool when you wish to submit a document that is relevant to the guidance documents being developed. There is no deadline for such submissions. |
| I am afarid of that discussion topics is deviating from risk to the GM on emminently hazardous items? Are we discussing risk not hazardous items? |
| good point. back to definations? |
| Thanks, Philip, I agre.
another point to flag, I reiterate that the releasing enviroment should be the first point in choosing site to monitor. |
| Dear all, to avoid confusion, please refrain from using "GM" to mean "general monitoring" because it can be easily confused with "genetically modified" |
| thanks manoela. good clarification |
| Thanks.
We should think along with the context of risk assessment, because the guidance is for Annex III. |
| To Kazuo--We are discussing monitoring of risks. The risk literature makes no distinctions as to sourceof the risk when looking at monitoring approaches which should be considered. |
| response from kazuo on this? |
| (all my uses of GM have been to mean general monitoring)
We are addressing the use of monitoring to reduce uncertainties in a risk assessment and some uncertainties cannot be anticipated so a general monitoring approach may be appropriate for some countries on a case by case basis. Again, I see no value in not providing guidance for the effective and appropriate use of an approach that is already out there. |
ok we can pick this up later.
Thank you very much for your interventions. Let us please proceed to the third sub-item under 3.1.:
(c) RISK ASSESSMENT OF LM TREES
and I would like to invite you to comment on the first guiding question:
(i) Are all relevant scientific issues properly addressed in this guidance document? If not, please specify what amendments you would advise.
The floor is open for your reactions. |
| My prepared remarks:
First use of the word ‘transgene’ should be footnoted to definition “Use of Terms” prepared for Part I and Part II previously to avoid any ambiguity.
Throughout the document the word “transgenic” is ambiguous and unnecessary and should be deleted and replaced with “products of modern biotechnology” or equivalent as appropriate. Given attempts to rename products of modern biotechnology by various other names (e.g., cisgenics, intragenics etc), it is best to revert to the language of the protocol to prevent any misunderstanding of the products that are regulated under the Protocol.
Line 57-59 “Currently about 30 to 40 different tree species have been modified through modern biotechnology through the insertion of transgenes, and have been introduced into the environment for small scale releases” should be replaced with “Currently about 30 to 40 different tree species have been modified through modern biotechnology, and have been introduced into the environment for small scale releases”.
Line 67-68 “Poplars are the only transgenic forest trees planted for commercial cultivation should be replaced with “Poplars are the only LM forest trees planted for commercial cultivation”
Line 97 replace ‘transgenic trees’ with “LM trees”
Line 156 replace “or both may be transgenic” with “or both may be products of modern biotechnology” |
| hi, Jack. But in my opinion, modern technogy does not contain transgenic tecknology only. |
| any more comments? kazuo perhaps? |
| transgenic is one part of the modern technology. though the protocol may have its defination. |
| (c)(i)
The LM tree document should be bound to Roadmap, and the context should be minimum to avoid lengthy instruction which is contained in Roadmap. Yet the present simple(r) form is more desired rather than add-on. |
| simplicity is always a good thing, comments? |
Thank you. I invite you to turn to the last question regarding the guidance on “LM trees”:
(ii) Do you have any bibliographic reference relevant to this guidance document which you would like to suggest?
The floor is open for your suggestions. |
| (c)(ii)
There are new actions to make biology documents of tree species such on eucalypts at OECD forum, and close look of the documents availability is valid.
Close link with IUFOR is also cardinal to link tree biotechnology information. |
| I thought we were just uploading the bibliographic suggestions ourselves. |
| yes that will have to be done too i believe. but we could discuss the usefullness of any forum would like to suggest |
| Jack, if you want to mention the bibliography here too please go ahead |
| any more suggestions here? |
if not then i will move on
Thank you very much for all the interventions.
Before we have a short break, I would like to proceed to agenda item 3.2.
ITEM 3.2. FORMAT OF THE GUIDANCE FOR CONSIDERATION OF THE CONFERENCE OF PARTIES SERVING AS THE MEETING OF PARTIES TO THE CARTAGENA PROTOCOL ON BIOSAFETY AT ITS SIXTH MEETING.
As you are aware, the three background documents that form the basis for our discussions today will be brought for consideration by the COP-MOP at its sixth meeting.
Under this agenda item, you are invited to share your views on how the three documents should be formatted and presented to the COP-MOP. |
I will now open the floor for your reactions to the first guiding question under Item 3.2.:
(i) How could the background documents (Guidance on Risk Assessment of LMOs; Monitoring of LMOs released into the environment; and Risk assessment of LM trees) be formatted to facilitate its consideration by the Parties at their sixth meeting? For example, should the three documents be merged into one or should they remain as separate documents?
The floor is open for your comments. |
| Thank you.
It seems Part II of RA document and newly developed two documents, i.e. monitoring and RA of LM trees, still need further discussion.
In the report to COP-MOP6, it should explain what kinds of guidance documents are prepared as a whole and to what extent they are progressed.
Also the report to the COP-MOP6 should include the major comments during the on-line forum and other opportunities, and should clarify what kinds of issues have been discussed. |
| noted. thank you for these final comments on the tree documents and reporting to cop-mop |
| The 3 documents have been through numerous reviews and both multiple face to face and online meetings. They are advanced text that only needs finalising at AHTEG 4.
At this stage of the process, ‘monitoring’ and ‘trees’ should take their place merged into the series of documents under Part II. However, I would consider it possible to elevate ‘monitoring’ as a second document in Part I given that its scope is bigger than a specific LMO or trait. This would also address the point made above to update the “roadmap” with the stepwise manner of testing and approval (lines 42-44 of “monitoring”). |
| what about this suggestion? |
I will now open the floor for your reactions to the second guiding question under Item 3.2.:
(ii) If merged into a single guidance document, how should the resulting document be structured? For example, can the two new documents (“monitoring” and “LM trees”) fit into the existing structure of the Guidance comprising Part I (Roadmap) and Part II (Specific LMOs or traits)?
The floor is open for your comments. |
| 1) Consideration shall be on correspondence with ANNEX III, 2) The two new docs should be tested extensively before making suggestions as integration-combination or stand alone? |
| I think Jack's suggestion is a good idea. |
| Part I and II were not tested prior to being considered by MOP5. Why a different procedure for the two new documents? They should be merged and presented to MOP6. If the Parties believe that all or part of the merged document requires more testing, then that should come from them. |
| I agree with jack's observation. We are offering advice. These documents can (and probably will) be amended as exoperience grows in different countries. |
| Our Mission is provide relevant advices: testing is valid to provide usefulness of certain combination? |
| more so for these new documents? |
| I see merging them as consistent with our terms of reference. Our terms don't specify an additional testing of each document as it is prepared. That, as I said earlier, is always the choice the Parties can make at the MOP. |
Maybe we can think some more about this in the break.
I thank you all for your participation and interesting interventions that we had so far.
I now suggest that we break for 15 minutes.
We shall continue our discussion on the next substantive issue on the agenda (Item 3.3) as soon as we return from the break.
I kindly ask you to be back to your computers in exactly 15 minutes as we still have important discussions ahead of us.
The meeting is adjourned until 4.35 GMT. |
Dear all,
Welcome back to our conference. I hope you had time to rest a bit and, without further ado, I invite you to turn to the third substantive item in our agenda:
ITEM 3.3. CONSIDERATION OF THE NEED FOR DEVELOPMENT OF FURTHER GUIDANCE ON SPECIFIC ASPECTS OF RISK ASSESSMENT AND/OR RISK MANAGEMENT OF LIVING MODIFIED ORGANISMS
As you may be aware, a number of Parties to the Cartagena Protocol have indicated a need for guidance on various specific topics of risk assessment and risk management. For the last four years, following a mandate by the COP-MOP, the Open-ended Group and the AHTEG have developed guidance on general risk assessment of LMOs (i.e. the Roadmap) and on 5 specific topics of risk assessment and risk management (i.e. LMOs with stacked genes or traits, LM crops tolerant to abiotic stress, LM mosquitoes, LM trees, and monitoring of LMOs released into the environment).
Under this agenda item, you are invited to express your views as to whether and how the CBD Secretariat should continue to facilitate a process for developing further guidance on risk assessment and risk management. |
I will now open the floor for your reactions to the first guiding questions under Item 3.3.:
(i) Is there a need for the development of further guidance on risk assessment and risk management? If so, on which specific topics should further guidance be developed?
The floor is open for your comments. |
| Thank you Chair!
The guidance developed so far has successfully brought together the various approaches to conducting risk assessments, in essence providing guidance on approaches that can be taken. However, it still lacks the inclusion of technical details that would be of particular use to those new to risk assessment or with limited capacity/access to the those with the necessary skills and expertise. For example: guidance on how to establish the relevance and appropriateness of comparators and comparable environments; determine when the comparative approach may not be suitable or effective and what, if any, approach may satisfactorily substitute; determine the statistical power necessary to avoid false negative findings. |
| a "begginers guide" as suggested before? |
| 3.3 (i) Definitely, test and use the present docs especially further test on Roadmap. Get relevant feedback over certain time frame to deposit enough experiences in the BCH on the progress of RA and AIA.
But listing of LMOs proven to be not harmful to the environments, may be valid for as a beginner reference. |
| Thank you.
Firstly Roadmap should be completed. And in the next step, related specific guidance should be developed. No new issues should be started before those documents are finalized.
It should carefully examine work program in order to avoid overlapping of works which are conducted by other international organizations. |
| I see my last sentence got cut. It should finish with "negative findings."
I wouldn't necessarily say that it would only be relevant to beginners, but it would be practical information certainly of use to beginners.
Regarding Kazuo's point: How can you prove an LMO has no potential adverse effect in all environments? |
| Experienced basis on LMO-FFP can be examples. Extensive uses can support the issue. |
| any more interventions on this point? |
| I just can't see how a list of LMOs for which adverse effects have not been detected either because they don't create any or because of different monitoring approaches, risk assessments, time periods or environmental differences is useful, and it certainly isn't case by case as set by the Protocol. |
| there should be some points need further works. for example the technology for monitoring, but it could be too technical. |
| and also co-existence, for example |
| I agree with Wei Wei. But we can't be afraid of it being technical. The idea is to take the technical and make it accessible for the country. |
thank you for these points. interesting points on when is technical too technical.
Let us please move to the final question under Item 3.3.:
(ii) If a need for further development of guidance exists, what kind of process(es), facilitated by the CBD Secretariat, could be considered for addressing this need?
The floor is now open for your reactions. |
| Sorry last one, Is there any seious claim associated with A27 on many extensive uses of LMOs-FFP? Deregulation oriented information also helps as references for countries to subtract lengthy processes to simply the RA and decision-making, while specific environmental aspects always should be considered as case by case. |
| a last response to this perhaps? |
| The kind of guidance I suggested above could be effectively sought through commissioning reports (like the “Background Study Papers” series in the FAO) after the Secretariat has defined the scope and nature of the desired information and the Parties have agreed to a process through which potential authors are nominated and evaluated.
While the up front cost of commissioning these works might be high, it is unlikely that the total cost of this process would exceed the cost to run the AHTEGs especially when the cost of travel, salaries and on-site expenses not paid by the Secretariat are included in the calculation. |
| perhaps we can hold a work report on the further need by reviewing the current references. |
| reading and writing will not cost too much |
| glad to hear that wei wei! |
Thank you very much for your comments. Let us please move to the last substantive item of our agenda:
ITEM 3.4. RECOMMENDATIONS TO THE CONFERENCE OF PARTIES SERVING AS THE MEETING OF PARTIES TO THE CARTAGENA PROTOCOL ON BIOSAFETY, INCLUDING CONSIDERATIONS FOR FUTURE ACTIVITIES RELATED TO THE GUIDANCE ON RISK ASSESSMENT
The sixth meeting of the COP-MOP will take place in October 2012 in Hyderabad, India. At that meeting, the Parties to the Cartagena Protocol will deliberate on a number of issues including risk assessment and risk management.
Similar to the practice at the face-to-face AHTEG meetings organized by the Secretariat, you are invited to provide recommendations to the Parties with regard to risk assessment and risk management, including considerations for future activities related to the “Guidance on Risk Assessment of Living Modified Organisms”. |
I will now open the floor for your reactions to the first guiding question under Item 3.4.:
(i) What recommendations with regard to risk assessment and risk management would you like to propose for consideration by the COP-MOP at its sixth meeting?
The floor is open for your comments. |
| Thank you.
Cooperation with other related organizations should be further promoted. |
| I recommend again the biosafety issues on synthetic biology (SB). SB became a hot topic recently and the technology has made great progress. |
| Wei, its not scope of the Protocol. |
| its an interesting paradigm yes? |
| Ok, it is my proposal. SB products will become living. SB technology is similar to GM. so why not. It is not far from the Sythetic LMO |
| I've not seen any application of SB that is not "in vitro modification of nucleic acids" resulting in a living thing afterward. Seems in the scope to me. Why is it not? |
| At the time of the protocol negotiation, "in vitro modification of nucleic acids" was narrowly defined or understood, and did not contain such a wide context on creating a whole genome as far as I uncderstand. |
| Thank you Kazuo. That is an interesting observation and perhaps a research topic! |
| Also it is premature as no visible product is coming up for AIA and RA. |
| SB is a kind of modern technology |
| looks like perhaps this should be a topic to be raised? if what was modified was never living in the first place. |
Thank you for the interventions.
I would like to proceed to the second and last guiding question under Item 3.4.:
(b) Would you like to make a recommendation to the COP-MOP regarding any consideration for future activities related to the Guidance on Risk Assessment?
I will now open the floor for your reactions. |
| another recommendation is to review the status the risk assessment and management in those countries who decleared they have mature system. that will be useful. |
| Requests supports on proactive organization of regional and national workshops to implement RA to raise relevant experiences rather than making more paper works. |
| also we can review the countries who declare they do not have such a system to see what they need. |
| any more suggestions. support of activities is always a factor |
In the interest of time and keeping the work programme that we agreed at the beginning of the conference, I will now close the discussion on item 3.
Thank you all for your interventions. |
We will now move to
ITEM 4. OTHER MATTERS
I will open the floor for approximately 5 minutes or more if needed for any suggestions, comments etc that you may wish to make that are relevant to the mandate of this conference.
The floor is now open. |
| I have a point for the map. it is possible to make here or later? |
| Ra-Guidance: Line 272 “In such cases additional comparators may be necessary”. Better to add ‘e.g. alternative practices’ in the end. That could be a good way to address the comparator in the case of specific traits of LMOs. |
| tahnk you. anyone else for some final interventions? |
| Not sure if I'll be able to say this later, so I would like to thank the Chair and the Secretariat for organising and conducting the conference. |
I guess We are approaching the end of our conference, but before I move on to the next agenda item, I would like to invite the Secretariat to make some final remarks.
Secretariat, you have the floor. |
Dear all,
We are approaching the end of the Real-time Online Conference for Asia and the Pacific.
It was a great pleasure for us at the CBD Secretariat to be gathered here today with the purpose of discussing important issues on risk assessment of LMOs. The result of our conference is a set of views and recommendations that will not only assist the AHTEG but also be brought for consideration by the Parties to assist them in elaborating their decision on Articles 15 and 16.
I would like to thank all of you for participating in this conference and for the fruitful discussions.
I would like to give special thanks to Dr. Rofina Yasmin Othman for accepting a last-minute invitation to chair this conference – a task which she has done in a very skilful manner. Thank you, Yasmin!
The full transcript of this conference will be available at this same address for future reference.
We will keep you informed of upcoming activities under the Open-ended Online Forum.
Thank you all, have a good afternoon! |
Thank you, Secretariat.
I would like also to thank all the participants and guests who have joined today for making this groundbreaking initiative a success. I would also like to thank the colleagues in the Secretariat for their tireless efforts and extremely valuable assistance in making this Conference possible.
With that, I now declare the Third Regional Real-time Online Conference on Risk Assessment and Risk Management: Asia and the Pacific closed.
Thank you! |
| best wishes and hope we meet again soon!
yasmin
from Kualla Lumpur |
| Thanks to all and hope to see you soon! |
| Thanks to Yasmin, SCBD and colleagues. |
| Bye for now and best wishes from Montreal! |
List of Participants
| Chair Person |
# |
|
Rofina Yasmin Othman
Ministry of Science, Technology and Innovation (MOSTI)
|
98 |
| Party |
# |
|
Wei Wei
China
|
19 |
|
ISAO TOJO
Japan
|
12 |
|
Kazuo Watanabe
Japan
|
18 |
| Observers |
# |
|
Jack Heinemann
University of Canterbury, New Zealand
|
25 |
|
Philip L. Bereano
University of Washington
|
10 |
| Secretariat |
# |
|
Charles Gbedemah
UNEP/SCBD/Biosafety
|
- |
|
Giovanni Ferraiolo
UNEP/SCBD/Biosafety
|
- |
|
Manoela Miranda
UNEP/SCBD/Biosafety
|
11 |
|
Philippe Leblond
UNEP/SCBD/Biosafety
|
- |
|
