Dear participants to the Open-ended Group and AHTEG,

Many thanks to all who have actively participated and provided valuable feedback to the discussions on "monitoring" and "LM trees". 

In continuing with our series of online discussions, I would like to invite you to participate in a final round of online discussion on the "Guidance on Risk Assessment of LMOs" (version of 13 January 2012; available at http://bch.cbd.int/onlineconferences/discussiongroups_ra.shtml#ongoing_disc).

In this discussion, you are kindly invited to focus on editorial improvements to the Guidance when making suggestions for changes.

In view of the advanced stage of the document, only suggestions clearly marked directly to the text of the Guidance (version of 13 January 2012) will be taken into account at this stage.

This discussion will take place from 31 January till 15 February 2012 at 1:00 a.m. GMT.

If you have any question on how to participate in this discussion, please do not hesitate to contact me.

Thank you and best regards,
Manoela

Dear Manoela and participants to the Open-ended Group and AHTEG,

Thank you very much for the development of this document and the opportunity to contribute. I understand this will be not a discussion, but just editorial improvements to the Guidance. In my opinion the “Part I” is in an advanced stage and this will be applicable and practical. However, the section presented as “Part II”  is not quite advanced and will be difficult to improve just with editorial changes.

The annex have terms that mention will be added, I hope you will do that on Bonn and let us know which were the chosen definitions.

I am submitting now just editorial changes, but will be working more on Part II and distributing it to the National experts on the particular subjects in order to be able to improve it. I hope we can have more inputs before the deadline.

All the best,

Adriana

POSTED ON BEHALF OF LUCETTE FLANDROY

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Dear Manoëla, dear participants, dear membres of the AHTEG,


First of all, a great thank to the AHTEG, and especially to Hans Bergmans for the elaboration of the general roadmap on which I concentrated till now, to have reached this very well improved stage of the roadmap, taking into account various preceding and sometimes conflicting comments.

In the herejoined version, I just made some small additions, mainly to clarify the reading and understanding of the text in some places, and to make the text coherent with the rest of its content.

I had liked to make 2 additions as well in the Annex of the Flowchart, line 609-6010, but track-changes seem impossible to bring there.

I thus propose them here:

- in the frame " Planning phase of the Risk Assesment", in the section "The choice of comparators", I propose to add : " ..... or other reference line ...... " between "parental line" and " in the likely potentail receiving environment", to be in line with the text on this section.

- in the frame " Step 4", I would add at the end " ........, taking into account uncertainties."

Thanks again for the long and fruitful work on this roadmap.


Lucette Flandroy

POSTED ON BEHALF OF BEATRIX TAPPESER

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dear Helmut, dear Hans, dear All
I like to thank once again especially Hans and Helmut who have invested a lot of dedicated and hard work into the deveolpment of the Road Map. I think we have a good document before as. I only have one small amendment but also corrected some typing errors. Therefore I attach the whole document.

Best regards
Beatrix

Dear participants,

I would like to make following comments. The suggested amendments of the text are shown in the attached file.

If possible, to show the reasons, why and why not the text was changed based on the comments made by Parties and related organizations etc. during the testing period,  might help our discussion.

1. Adverse effects to be evaluated
According to the Annex III of the Protocol, “the potential adverse effects of living modified organisms” are to be evaluated.  In some parts of the draft guidance document, not only the adverse effects of LMO, but also, so to speak, “indirect effects”(ln759-ln760) due to changed agricultural management procedures , such as herbicide application, are included in the adverse effects to be evaluated.

In the Japanese risk assessment, since the effects due to agronomic changes are not the direct effects of LMO and no large scale cultivation of LM crops is practiced in Japan, we have no experience in the evaluation of indirect effects due to agronomic changes in the risk assessment of GM crops.  I understand those indirect effects would be evaluated in EU, according to the regulation.  Even though, according to the EFSA Guidance Document on the ERA of GM plants, an item of “Impacts of the specific cultivation, management and harvesting techniques” seems to be treated as one of the “Specific areas of risk to be addressed in the ERA”.

The contents of the risk assessment, such as risk scenarios or data used, on indirect effects might be very different from those on direct effects of LMO. In order to avoid the confusion by readers, I would think that the evaluation of indirect effects due to agronomic changes had better also be treated as an additional consideration.
Therefore I would suggest the revision of the text shown in the following lines; ln459-ln462, ln493-ln495, ln759-ln761, ln1057-ln1058.

Further discussion on what is included in the adverse effects to be evaluated might be needed in the expert meetings or MOP6.

2. Monitoring
The guidance document of monitoring is under discussion.  There are many comments that show doubts about the inclusion of GS in the monitoring.

Therefore, the description related to GS in the Roadmap(ln562 and ln582) had better be deleted.

3. “Cumulative effects”
During the recent on-line forum on the monitoring guidance document, an expert defines cumulative effects “as those that arise from combinations of LMOs in the same receiving environment”.  And the other says “super-weeds and super-pests, which are widely reported in the scientific literature provide examples of cumulative effects.  Similarly, the multiple cases of cancer, leukemia, lupus, endocrine diseases related to the technological package associated with GM crops(especially with herbicides tolerant crops) are cumulative.”  Thus, even the experts might have the different image on the words.  The words might cause confusion or misunderstanding to the readers.

In the regulation of EU, the assessment of ”cumulative long-term effects” also is to be carried out.  In this context, the EFSA Guidance Document explains the long term effects divided into two categories, such as Category I(delayed effects) and Category II(widely grown effects).  However, it does not use the word of “cumulative”.

In order to avoid confusion and misunderstanding, I would think that it had better not use the word of “cumulative”.  I would suggest the deletion of the word of “cumulative” from the document.  Related lines in the document are as follows; ln306, ln379, ln484-ln485, ln525-ln526, ln743, ln746, ln757, ln774, ln784.

Sincerely,

Isao Tojo

POSTED ON BEHALF OF HIROSHI YOSHIKURA

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General Comment on Risk Assessment

I really appreciate AHTEG for the revision of “Guidance on risk assessment of living modified organisms”, which became much clearer than before. However, clarification of smog, I found several issues have be addressed before conclusion of the present document.

1.    Part II should be developed separately from Risk Assessment, because finalization of documents relating to “specific types and traits” should be considered after finalization of Risk Assessment document. Hasty process may result in discordant provisions among guideline documents. In addition, while the last paragraph of Preface says “this Guidance is not prescriptive”, Part II is already sufficiently prescriptive. I do not oppose, however, to attachment of Part II to Part I after finalization of the both. 

2.    The definition of important terms, “hazard identification”, “hazard characterization”, “exposure assessment”, and “risk characterization”, should be agreed on by CBD before further advancement of drafting procedures, because they are crucial for proper interpretation of this guidance document. The terms can be defined to be consistent with other UN organizations, such as, FAO/WHO codex alimentarius commission.

Comments more indetail:

3.    PREFACE: Sentences relating to Article 8 should be deleted as the article relates only to “notification” (See inside of the attached file).

4.    INTRODUCTION: The Protocol never says that the risk assessment is structured process (word search never identifies the word “structured” in the text.). I my view it is science based multidisciplinary interactive process. Generally we have to consider many aspects in parallel during the assessment. It never proceeds smoothly from step 1 to step 5 as delineated in the section of “CONDUCT OF SAFETY ASSESSMENT”. Please note that paragraph 8 of Annex III says, “Risk assessment entails, as appropriate, the following steps:” It does not say, “Risk assessment proceeds in the following order”. Therefore, I propose complete rewriting of “CONDUCTING THE RISK ASSESSMENT” (See inside of the file)

Explicit explanation on relation between risk assessment and risk management is necessary. The scheme adopted by a sister UN body, codex alimentarius, can be useful reference. (See the file for proposed wording).

5.    OVERARCHING ISSUES: Quality and relevant information: I welcome the 6th bullet point dealing with release for generating information. OECD’s concept of familiarity will be useful in scale-up processes (See inside of the file).

6.    PLANNING PHASE OF THE RISK ASSESSMENT: The choice of comparators: The cultivars that we are familiar have not been systematically subjected to extensive evaluation, but men have become familiar with them after long history of use. Systematic investigation, as suggested in the present Guidelines, may not give information or know-how to the extent that is obtained through the long history of use. It should be stressed that the comparative safety assessment is powerful only when LMOs are derived from organisms with long history of use (conventional counterpart), because the risk assessment can focus on the introduced gene(s) and events associated with the modification. For LMOs without conventional counterpart(s), it is natural to know the organisms well before embarking on genetic modification by using a guideline like the present one. Currently it is an unnecessary burden for developers to collect systematic information on organisms to which we are already familiar. (See inside of the file)

7.    CONDUCTING THE RISK ASSESSMENT: The content of Step 1 is mostly derived from paragraphs 8 and 9 in Annex III. It is important to note that paragraphs 8 is under the section of METHODOLOGY, whose first paragraph (paragraph 7) recognizes that “The process of risk assessment may on the one hand give rise to a need for further information about specific subjects, which may be identified and requested during the assessment process, while on the other hand information on other subjects may not be relevant in some instances. Therefore, the steps provided in paragraph 8 should be applied always where appropriate. Paragraph 9 is preceded by qualification “Depending on the case”. Therefore, points to consider under paragraph 9 should be considered always “depending on the case”.

Points to consider regarding characterization of the LMO: The original wording in Annex III is much easier to understand than the proposed one. So the bullet points in paragraph 9 should be reproduced without change.

Points to consider regarding the potential adverse effects resulting from the interaction between the LMO and the likely potential receiving environment: Many of the bullet points, particularly bullet points (v) – (y), were not found in Annex III and may cause unnecessary confusion. For example, any substances are potentially allergenic at least to somebody. All the plants and many bacteria have toxins. If toxins are removed from plants, they cannot survive in the environment. Some plant toxins are used by insects to protect themselves. Most toxins found in toads are derived from insects that ingested toxic plants. It is important to realize that toxins play an important role in maintaining biodiversity. Toxin-antitoxin system in microbes is another example. Herbicide and/or pesticide resistance becomes apparent only when the environment is under strong selection pressure for such organisms. It has been reported that hybrids between weed and cultivated plants are like cultivated plants. Usually multiple genes, preferential survival and proliferation determined by many factors (genetic, environmental or climate) are involved for plants to become weedy.

8.    Step 2 – Step 5 and Part II: I suggest deletion for this time. Hazard identification described in Step 1 has to take into account considerations given in Step 2 (likelihood), Step 3 (evaluation of consequence) and Step 4 (estimation of overall risk). Step 5 is rather in the hands of risk managers. Sentence in INTRODUCTION, “risk assessment is defined as a scientifically based process and common actions undertaken when conducting the risk assessment include “hazard identification”, “hazard characterization”, “exposure assessment”, and “risk characterization” will give sufficient orientation for users if definition of these terms are given. These terms can be defined to be consistent with other UN organizations, such as, FAO/WHO. Proposed wording obtained through modification of DEFINITIONS OF RISK ANALYSIS TERMS RELATED TO FOOD SAFETY” is as follows;

Hazard identification: The identification of hazards capable of causing potential adverse effects on conservation and sustainable use of biological diversity in the likely potential receiving environment, taking also into account risks to human health.

Hazard characterization: The quantitative and/or qualitative evaluation of the nature of the adverse effects associated with the use of LMOs.

Exposure assessment: The quantitative and/or qualitative evaluation of the likely exposure of the protection target concerning conservation and sustainable use of biological diversity.

Risk characterization: The quantitative and/or qualitative estimation, including attendant uncertainties, of probability of occurrence and severity of known or potential adverse effects on conservation and sustainable use of biological diversity in the likely potential receiving environment, taking also into account risks to human health, which should be based on hazard identification, hazard characterization and exposure assessment.

Sincerely yours,

Hiroshi

Apropos of the suggestion of using internationally acceptedf approaches to linking risk assessment and risk management I would recommend a link to ISO 31000 risk management.

Dear participants,

Thank you very much for the effort to provide the draft on the Guidance on Risk Assessment of Living Modified Organisms. My concerns are as follows (line by line) and the modifications are shown in the attached file.

(1) Line 62: No sentences were found in the Cartagena protocol stating that the risk assessment should be carried out as a structured process. The term “structured process” sounds excessive and should be deleted.

(2) Line 75: Annex I of Convention on Biological Diversity describes the “Identification and Monitoring”, which support the CBD article 7 (a). The CBD article 7 (a) says “Identify components of biological diversity important for its conservation and sustainable use having regard to the indicative list of categories set down in Annex I;” As it is obvious, the CBD article is not related to risk assessment. The sentence in line75-76 should be deleted.

(3) Line 106, 356, 397: The terms used in the Cartagena protocol should not be twisted. The term “potential risks” should be changed to “adverse effects”.
For the same reason, “potential effects” should also be changed to “adverse effects”.

(4) Line 142: The meaning of the sentence in the Cartagena protocol AnnexIII 8-(f) seems to be skewed. Removing this sentence is recommended.

(5) Line 173-175: These topics should be evaluated in a risk management process. This document provides a guidance of risk assessment and should be separated from a guidance of risk management.

(6) PLANNING PHASE OF THE RISK ASSESSMENT (Line 178-):
According to the Cartagena protocol Annex III 3., the familiarity and the scale-up concepts proposed by OECD will be taken into account for a risk assessment process. The distinction between the development-scale (pilot-scale) and the application-scale would allow case-by-case basis assessment in accordance with the Annex III 6. 

(7) Line 213, 256, 519: The guidance should only focus on risk assessment. The risk assessment and the risk management (coordination to minimize and/or control unfortunate events) are totally different processes. To avoid confusion, the sentences associated with the risk management should be deleted.

(8) Line 525-598: The title of this document is “Guidance on Risk Assessment of Living Modified Organisms” and the document is not about risk management. To avoid unnecessary confusion and misreading, any ideas concerning risk management as well as description of risk management and descriptions of risk management should not be included in this document. Step 5 is beyond the category of risk assessment. This step should be removed. 

(9) Part II:
The Part II section seems too specific and prescriptive as a guidance document. To gain the international consensus, the discussion should be focusing on the concept of risk assessment and should not extend to such specific and commercialized topics as seen in Part II. The Part II section should be separated from this guidance and discussed independently. 


Sincerely,
Kazuaki Matsui

Thank you Manoela and colleagues for inviting comments.

My comment concerns line 928: "On a case by case basis in the future, information available from “omics” technologies, for example..."

Both qualifiers "case by case" and "in the future" are unnecessary and are inaccurate. Current research and the opinion of many experts supports the use of omics on a case by case basis. This is not a future proposition, but one being used now. Few experts believe that omics is at the moment useful as a routine procedure. There are good recent reviews of expert opinions published in the internationally peer-reviewed literature.

It is time to update this text to: "On a case by case basis, information available from “omics” technologies, for example..."

With best wishes
Jack

POSTED ON BEHALF OF ADRIANA OTERO ARNAIZ

(See attached file)