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Opening of the discussion group on "Possible mechanisms, including criteria, for future updates of the lists of background materials" (topic 2) [#2228]
Dear all,

The discussion group on "Possible mechanisms, including criteria, for future updates of the lists of background materials" (topic 2) is now open for comments at http://bch.cbd.int/onlineconferences/discussiongroups_ra.shtml .

This discussion will take place from 11 to 18 April 2011 (1:00am GMT) concurrent to the discussion on topic 3.

You may post comments in this discussion group by going to the website above and by either creating a new thread or replying to this posting. Alternatively, when viewing this message through email, you may also reply to it using the address at the end of the email, and your comment will be automatically posted in the discussion group.

Thank you and best regards,
Manoela

----

Introduction to the topic of discussion:

At the end of each section of the "Guidance on Risk Assessment of LMOs" (http://bch.cbd.int/onlineconferences/guidance_ra/), a link to background documents is available. The lists of background documents were prepared by the Open-ended Online Group and AHTEG as reference to the various sections of the Guidance.

At their last meeting, the Parties to the Protocol mandated the Open-ended Online Group and AHTEG to propose mechanisms for future updates of these lists of background materials.

Under this topic of discussion, Participants to the Open-ended Online Group and AHTEG will be invited to focus on:

*** "who" should be responsible for selecting the documents for the list and what "criteria" should be used for the selection of relevant background documents***

to be included in the list taking into account the long-term sustainability of any proposed mechanism.
(edited on 2011-04-14 22:07 UTC by Ms. Manoela Miranda, UNEP/SCBD)
posted on 2011-04-11 01:05 UTC by Ms. Manoela Miranda, UNEP/SCBD
RE: Opening of the discussion group on "Possible mechanisms, including criteria, for future updates of the lists of background materials" (topic 2) [#2232]
Dear participants,

As a follow-up to Manoela’s introductory remarks, I have been asked to say a few things to introduce the topic for discussion in this part of the Online Forum: development of “a mechanism, including criteria, for future updates of the lists of background materials” (see the mandate of the Open-ended online forum and the AHTEG in COPMOP decision BS-V/12). This is meant as a thought-starter and guidance for the subsequent discussions in this forum.

The Guidance on Risk Assessment of Living Modified Organisms (http://bch.cbd.int/onlineconferences/guidance_ra/) consists of four guidance documents, and a list of relevant references and background materials which are meant to provide further explanation and examples to the Guidance.  These references (see footnote 1) will remain available to the users and will need to be updated from time to time in the future, subject to direction and decision of the COPMOP.

Discussions during this part of the online forum online forum will focus on the following topic:
Possible mechanisms, including criteria, for future updates of the lists of background materials.

It is noted that the process for providing current references and updating the list requires clear and explicit arrangements to ensure high level quality in a sustainable manner and responsive to the COPMOP.
The discussions should be aimed at setting the criteria for the quality of background materials, and criteria for the process of updating the lists of background materials.
As experts in the online forum you are therefore invited to express your opinion freely on the following guiding questions.
1. What types of criteria are necessary to ensure the quality of information and the relevance of the background materials to the Guidance. Examples are:
o Criteria for the source of background materials
Suggestions: documents published by reputable international organizations; documents published by stakeholders specifically identified as working directly in the field of risk assessment; documents from other sources subjected before acceptance to a review process (to be established).
o Criteria for the quality of background material document, and its maintenance on the list.
Suggestions: relevance to (a specific field of) LMO risk assessment, date of publication (i.e., not older than a certain number of years)
o Time intervals for the lists list to be updated.
Suggestions: at regular intervals (e.g., every two years); on an ad hoc basis in response to developments in the field of LMO risk assessment.

2. Who will be responsible for selecting the new documents to augment the list, taking into account the criteria that are set under point 1?
Suggestions for possible responsible entities: the SCBD, possibly in consultation with a number of appointed experts; Parties of the CPB in a consultation process.

Your comments will be further discussed in the AHTEG, resulting in a proposal to COPMOP.

Hans Bergmans
Chair of the Sub-working Group on the Roadmap

1:  The lists of references are available at: http://bch.cbd.int/onlineconferences/roadmapref_ahteg_ra.shtml#introduction (Roadmap); http://bch.cbd.int/onlineconferences/stackedref_ahteg_ra.shtml (LMOs with stacked genes or traits); http://bch.cbd.int/onlineconferences/abioticref_ahteg_ra.shtml (Living modified crops with tolerance to abiotic stress); and http://bch.cbd.int/onlineconferences/mosquitoesref_ahteg_ra.shtml (Living modified mosquitoes).
posted on 2011-04-11 06:11 UTC by Mr. Hans Bergmans, PRRI
RE: Opening of the discussion group on "Possible mechanisms, including criteria, for future updates of the lists of background materials" (topic 2) [#2242]
POSTED ON BEHALF OF HIROSHI YOSHIKURA
-----
Dear Dr. Hans Bergmans,

My present comment relates to your message on 2011-04-11.

I looked at the list of references and found most documents published by relevant international organizations are already there. The current one is well balanced. Therefore, it is most reasonable at least to update the list by adding the references produced by the international fora.
However, the such references, such as those of OECD, may not be sufficient. There are important monographs that can be indispensable for risk assessments. The present issue raised by you could be updating of such materials.

I note,
1. Even if we agree on criteria that you mentioned in your message, it is a very difficult enterprise. The relevant literature may increase exponentially in future.

2. Who should be responsible for selecting the new documents? We may agree, for example, that AHTEG should bear that responsibility, but we may still need a screening process. It will be a very costly process.

Your thinking behind the questions is, I guess, how to maintain the quality of the reference. But, in my view, it is almost impossible to list all the relevant high quality references (I am very pessimistic).
One possibility could be to pool automatically references used in various risk assessments made in the framework of CBD in a site open to the public. This pool may contain sometimes junk information, but the choice is on the hand of the users. Is this unacceptably wild idea? (The idea is somehow that of Wikipedia).

Another point I would like to make in this connection is that the ecology is advancing in unprecedented way owing to the use of genomics. The complexity of ecosystem is realized more than ever (Oswald J. Schmitz, Resolving Ecosystem Complexity, Princeton, 2010, for example). The reference should include such materials, if possible, to look at risks of LMOs in a larger ecological and evolutionary perspective.

Hiroshi
posted on 2011-04-12 17:43 UTC by Ms. Manoela Miranda, UNEP/SCBD
Criteria for selection of background materials [#2260]
I agree with the suggestion of Dr. Hiroshi Yoshikura that literature
used in the Party’s risk assessments be included in the pool of
references. I likewise agree that it would almost be impossible to
list all the relevant high quality references.

I also agree with Dr. Halos and Dr. Tappeser’s suggestion of including
various available information and putting them under different
categories. Categorizing documents as to source and content would
greatly help risk assessors in delineating which reference would be
relevant for a specific application.  An abstract/brief description of
the contents would also be very useful in selecting relevant and
reliable references.  Perhaps entries on the authors’ affiliation,
type of publication (scientific article, review, leaflet, monograph,
etc.), type of activity (study of primary data generated, secondary
data, meta analysis, reanalysis, critique, etc.) could also be
included to facilitate selection of references.

The inclusion of various types of references will  expand the menu of
available information, and it should be up to the risk assessor to
discern which set of information would be most useful, depending on
protection goals determined by the national policies.  To limit the
influx of “junk information”, perhaps references submitted by the
parties can be “vetted” by the national competent authorities prior to
inclusion in the list.  Non-Parties, NGOs, public research
institutions and other organizations may be invited to post
references. The amount of so-called ‘junk’ that accumulate may be
daunting but perhaps a classification scheme may help even neophyte
risk assessors discern which of the references are reliable. An
abstract or a short description of the contents of the said reference
and source of information (type of organization) would also be most
helpful.

This list of reference should be kept updated. However, older
references may still be very useful especially in dealing with taxa
which may not be as thoroughly studied in recent times For example,
scientific literature on lesser known species may be decades old but
may still be valid and useful.

The Philippines maintains that government-designated risk assessors
should be qualified to differentiate literature with useful and valid
information from those that merely contain unsupported conjecture.
For less experienced and less confoident risk assessors, the BCH
roster of experts are actually part of the capacity building
activities that have been established  over the past few years. This
roster of experts has however been largely untapped. Perhaps this
roster of experts can be called upon, as needed, to help less
experienced risk assessors to select quality information among various
references.

We encourage risk assessors from parties to take full responsibility
in updating their science and keeping abreast of developments, gaining
confidence in making risk assessments and drawing conclusions from
such.  Aside from externally sourced capacity-building activities,
hands-on experience is an effective enabling facilitator.


FLERIDA CARINO
posted on 2011-04-14 17:35 UTC by Flerida Cariño, University of the Philippines, Diliman, Quezon City
RE: Opening of the discussion group on "Possible mechanisms, including criteria, for future updates of the lists of background materials" (topic 2) [#2247]
Dear Hans.

Thanks for the invitation for this new sub-forum and for the clear instructions. I would like to comment on criteria for the quality of background material document, and its maintenance on the list.

To get started, I checked the supporting literature for the stacked events text. From 9 citations only three are papers on peer-reviewed journals (this is one of my suggested criteria). The others were either Gene Regulators reports (EFSA, etc.), reports on certain large initiatives (like the Beetle Report), sites (from Genok) ou reports from Ministries (but no Gene Regulators), like that of Austria. The quality varied, therefore. Since the literature items were not associated with suitable criticisms, it was left to the (sometimes neophyte) user of the RA guidance the duty of appreciate and evaluate the texts. This does not look adequate: such an evaluation depends largely on knowledge and experience, what is not expected from most of the RA guidance users.

Therefore, my suggestion for criteria is:
a) Only papers on peer-reviewed journals should be used. Even so, disputed papers (some of them with a long line of rebuttals published in good journals) should not be used.
b) The second good source are the Gene Regulators acts and reports (the National Biosafety Clearing Houses and EFSA, for example)
c) A third source is composed of books, published by experts of R.A., recognized as experts by the scientific community (taking into account publications, activity in BCHs, etc.) and published by renowned editors/ Publisher.

Nothing like general sites or too broad papers should be used, except if their contributions to the text are explicitly identified.

I hope these remarks will spark some discussion and will help improve the reference set.
Kindly
Paulo Andrade
posted on 2011-04-12 19:58 UTC by Mr. Paulo Paes de Andrade, Brazil
Background materials - A new message has been posted to the forum [#2249]
Dear colleagues,

Our regulatory system in the Philippines involves the active participation of
our own scientists who review scientific reports whether published in
peer-reviewed journals or not; whether sponsored by technology developers, by
oppositors of the GM technology or by independent bodies. Good science is good
sceince and bad science is bad science. What we have is a regulatory system that
is accountable to our own people. We will appreciate it if the Secretariat makes
available all written reports relating to LMOs so we can study these ourselves
and make our decision based on our own analysis. The evaluation of some studies
on LMOs have also become contentious so I suggest that we spare the Secretariat
the trouble of settling these contentious issues.
posted on 2011-04-13 03:35 UTC by Saturnina Halos, Philippines
RE: Background materials - A new message has been posted to the forum [#2251]
dear collegues
In reaction to Hans proposals and in support of the intention of Saturninas remarks I like to emphasize that we should be as open and transparent as possible. That means we should not exclude submitted materials, reports, publications etc. What we can do and  should do is some categorisation of the submitted material according to Hans criteria. Categories could be
- peer reviewed publications
- risk assessment reports
- reports from international, multinational and national
    institutions or organisations
- stakeholder contributions
    - industry
    - ngos
    - consumer organisations
and a final category of others.
That would give some guidance to the user
According to my view we should abstain from doing any form of (additional) review.
the two year period for a regular update is a good proposal.
I am not sure about deletion of publications because of "age". Some substantial publications do not get "old", others are outdated quite fast because of the rapid development in the very field the publication addresses.
I would propose to have a time frame of 5 to ten years and define as one task of the regular update to look into the "old" publications and take a decision about deletion or not.
best regards
Beatrix
posted on 2011-04-13 12:52 UTC by Beatrix Tappeser, Federal Agency for Nature Conservation
RE: Background materials - A new message has been posted to the forum [#2291]
Dr. Ossama El-Tayeb, Cairo University.
I like Beatrix advices, especially on tranparency and giving due respect to several possible sources.  Naturally, we all like to emphasize "peer-reviewed" publications but we also know that often these proved to be "less than honest science" and sometimes even formally withdrawn! When commercial intrests have a heavy stake in a science they can often flood scientific literature with very very very "ginuine" research results which may prove less than trustworthy a decade or more later, when it is too late to remedy the environment. More precaution and less "science-based" contexts would guard againest serious and irreversible environmental damage.  RA/Rm is more about precaution than about a series of questions with a yess or no answer.  In real science, certianty is not very common  and conclusions are often relative. We have to find ways of partly neutralizing commercial intrests in RA/RM which does cost the developer money which needs to be internalized into the product cost, hence areas like "impact on an ecosystem", "co-existence", socio-economic impacts  become ugly words for the developer of the tichnology - any technology!
posted on 2011-04-16 17:40 UTC by Mr. Ossama El-Tayeb, Egypt
RE: Opening of the discussion group on "Possible mechanisms, including criteria, for future updates of the lists of background materials" (topic 2) [#2253]
Again, I must differ with our colleague Andrade.  While I agree that articles in peer reviewed journals are important sources, I have difficulty accepting his idea that "disputed papers . . .should not be used."  Who would reject Chapela and Quist (Nature) who accurately called attention to the contamination of maize landraces in Mexico ("disputed" on other grounds) or Pusztai (in the Lancet) indicating possible negative effects from eating GE potatos.  The assessors have to make JUDGEMENTS on which sources are reliable (another indication that assessments are not wholly objective or "scientific" but involve human subjectivity as well).

As I mentioned in an earlier posting, good assessments include "thinking outside the box' in order to stretch the view of what might be possible and anticipate at least some "surprises".  Assessments limited to conventional knowledge are often very limited indeed.

Studies should be of the "holistic system" of the LMO and the receiving environment, not of what our colleague Dr Ossama has called "managed systems" of artificial portions or aspects of the LMO or artificial environments.

Also from an earlier posting of mine on another thread:
Very little research has been done on the impacts of LMOs and published in the peer-reviewed open literature.  And most of
what exists has been sponsored by industry and thus of suspect validity due to normal conflict-of-interest cautions.  The most
survey of this work is: ”A literature review on the safety assessment of genetically modified plants,” by José L. Domingo and
Jordi Giné Bordonaba, Environment International 37 (2011) 734–742. Some relevant conclusions:

"In spite of the notable increase in the number of citations, those concerning specifically to studies focused on demonstrating
the health safety of GM foods remain very limited."

On the greater number of refereed health studies from industry, despite the possible conflict of interest: "Anyhow, this
represents a notable advance in comparison with the lack of studies published in recent years in scientific journals by those
companies (Domingo, 2007). The scientific community
may finally be able to critically evaluate and discuss all that information, which was not possible until now. Scientists know
quite well how different may be the information published in reputed international journals, which has been submitted to
peer-review processes, from those general comments/reports not submitted to this selective procedure."

Overall: "In the period here reviewed, October 2006–August 2010, a few reviews on health risks of GM foods/plants have been also
published (Dona and Arvanitoyannis, 2009; Magaña-Gómez and de la Barca, 2009; Key et al., 2008). In general terms, all these
authors agree in remarking that more scientific efforts are clearly necessary in order to build confidence in the evaluation and
acceptance of GM foods/plant by both the scientific community and the general public. Especially critical is the recent review by
Dona and Arvanitoyannis (2009), who remarked that results of most studies with GM foods would indicate that they may cause some
common toxic effects such as hepatic, pancreatic, renal, or reproductive effects, and might alter the hematological, biochemical,
and immunologic parameters. These authors also concluded that the use of recombinant GH or its expression in animals should be
re-examined since it has been shown that it increases IGF-1 which, in turn, may promote cancer. A harsh response to that review
was recently published in the same journal (Rickard, 2010). This is indeed only an example on the controversial debate on GMOs,
which remains completely open at all levels."

Countries should make an effort to fund such research and should also require applicant corporations to conduct it (in open and
transparent fashion) in order to build up solid information for decision-making.
posted on 2011-04-13 20:30 UTC by Dr. Philip L. Bereano, University of Washington
BACKGROUND MATERIALS [#2261]
I agree with the suggestion of Dr. Hiroshi Yoshikura that literature
used in the Party’s risk assessments be included in the pool of
references. I likewise agree that it would almost be impossible to
list all the relevant high quality references.

I also agree with Dr. Halos and Dr. Tappeser’s suggestion of including
various available information and putting them under different
categories. Categorizing documents as to source and content would
greatly help risk assessors in delineating which reference would be
relevant for a specific application.  An abstract/brief description of
the contents would also be very useful in selecting relevant and
reliable references.  Perhaps entries on the authors’ affiliation,
type of publication (scientific article, review, leaflet, monograph,
etc.), type of activity (study of primary data generated, secondary
data, meta analysis, reanalysis, critique, etc.) could also be
included to facilitate selection of references.

The inclusion of various types of references will expand the menu of
available information, and it should be up to the risk assessor to
discern which set of information would be most useful, depending on
protection goals determined by the national policies.  To limit the
influx of “junk information”, perhaps references submitted by the
parties can be “vetted” by the national competent authorities prior to
inclusion in the list.  Non-Parties, NGOs, public research
institutions and other organizations may be invited to post
references. The amount of so-called ‘junk’ that accumulate may be
daunting but perhaps a classification scheme may help even neophyte
risk assessors discern which of the references are reliable. An
abstract or a short description of the contents of the said reference
and source of information (type of organization) would also be most
helpful.

This list of reference should be kept updated. However, older
references may still be very useful especially in dealing with taxa
which may not be as thoroughly studied in recent times For example,
scientific literature on lesser known species may be decades old but
may still be valid and useful.

The Philippines maintains that government-designated risk assessors
should be qualified to differentiate literature with useful and valid
information from those that merely contain unsupported conjecture.
For less experienced and less confident risk assessors, the BCH roster
of experts are actually part of the capacity building activities that
have been established  over the past few years. This roster of experts
has however been largely untapped. Perhaps this roster of experts can
be called upon, as needed, to help less experienced risk assessors to
select quality information among various references.

We encourage risk assessors from parties to take full responsibility
in updating their science and keeping abreast of developments, gaining
confidence in making risk assessments and drawing conclusions from
such.  Aside from externally sourced capacity-building activities,
hands-on experience is an effective enabling facilitator.

Flerida Carino
posted on 2011-04-14 17:35 UTC by Flerida Cariño, University of the Philippines, Diliman, Quezon City
RE: BACKGROUND MATERIALS [#2267]
POSTED ON BEHALF OF JANET GOUGH, NEW ZEALAND

-----

I am also in agreement with the views expressed in this posting, particularly the approach of categorising documents and providing background information about the authors, type of publication and type of activity.

The issue of maintaining the list of documents remains unresolved and is likely to be a very intensive task.  While for many countries this will be a matter that will be addressed internally from the perspective of the country’s own requirements, where there is limited expertise in risk assessment this will be daunting.  Therefore guidance as to how to evaluate information is needed.    While I am in sympathy with the view that older studies may indeed contain valuable information that should be lost, there should be a mechanism for removing out of date and discredited documents, and material later found to be obsolete.
posted on 2011-04-14 22:15 UTC by Ms. Manoela Miranda, UNEP/SCBD
RE: Opening of the discussion group on "Possible mechanisms, including criteria, for future updates of the lists of background materials" (topic 2) [#2292]
Dr. Ossama El-Tayeb, Cairo University.
Phil elaborated swuccinctly the views I expressed in previous postings (very few on grounds of involvement in a"turning point" national revolution!) as also elaborated by Beatrix.  I concure, and must warn againest taking all studies being equally motivated. Apologies for being rather blunt but the idea, for example, that socioeconomic considerations being part of the decision-making but not the risk assessment pulls me back to compromise languages during negotiation of the Protocol where the exact opposite was understood to be shaped into the language of Article 26.
posted on 2011-04-16 17:56 UTC by Mr. Ossama El-Tayeb, Egypt
RE: Opening of the discussion group on "Possible mechanisms, including criteria, for future updates of the lists of background materials" (topic 2) [#2290]
Dear all
Bearing in mind the practicability, the cost and the need for a sustainable mechanism, I propose the following:
- Using the BIRC and modification of common format of the “BIRC reference records” on the BCH so that relevant background materials on the BIRC can be linked to the specific sections and steps of the roadmap and additional guidance materials produced by the AHTEG
- The Design of the new common format should also allow the categorization (for example as to source, content… ) of the added record and include a brief description of the content to assist the risk assessor in selecting the relevant and reliable background material
- Modification of the common format for these two type of records namely “Risk Assessment Generated by a Regulatory Process” and “Risk assessment generated by an independent or non-regulatory process” so that they can be linked as well to the roadmap and the guidance document as appropriate and when relevant.

With regard to who should be responsible for selecting the documents for the list of relevant background documents, I believe that we should be as open and transparent as possible. I think we can use the same approach that is used to register a reference records.

With regards to the criteria of selection, I think this should be limited to a guidance note (in the same page that is used for the registration on the BCH or a foot note in the common format) that allows the record owner to decide whether it is useful to incorporate this reference record in the roadmap and guidance documents or not. And it should be left up to the person that conduct the risk assessment to discern the most useful background materials based on his own country situation and policy.

I also think that background materials for the issues that are relevant for conducting risk assessment as well as the decision making process, such as socioeconomics, need to be incorporated in the roadmap under specific guidance section for those issues.

Ossama
posted on 2011-04-16 17:35 UTC by Mr. Ossama Abdelkawy, Syrian Arab Republic
RE: Opening of the discussion group on "Possible mechanisms, including criteria, for future updates of the lists of background materials" (topic 2) [#2304]
Dear Participants,

I think one can extract some interesting and important points in line with the Protocol and that are also shared in different postings, such as the interest of:
(1) Determine the strength of scientific evidence (information and knowledge) and the quality of data;
(2) Identifying the relevant and meaningful technical and scientific evidence;
(3) making maximum use of available resources (including use of available data) between different countries and different regions of the world and transparency of the decisions
These are all important to undertake an adequate risk assessment (RA), i.e. RAs to be carried out in a scientifically sound manner, in accordance with Annex III and taking into account recognized risk assessment techniques (article 15) and guidelines developed by, relevant international organizations (annex III).

The item (1) determines the quality of the data/strength of scientific evidence. Although this is a very important point, it is not always very obvious and it can be time consuming to be evaluated even for experienced assessors. For quality:
-Peer review is the traditional method used for improving quality, though per se not a guarantee and there are other information of relevant international organizations that do give important insight to RA.
- Some publications have being criticized by the scientific community for not using best available science, i.e.: relevant international standards, risk assessment techniques [protocols] developed by the relevant international organizations and to have some other technical flaws. 
I believe Prof. Paulo Andrade has raised a very important aspect: to think of practical ways of distinguishing in an easier way the quality of the information. If parties find useful to have those publications that were considered controversial by scientific community/independent relevant bodies then those publications should at least come together with its criticisms. This is important so that whenever a party, especially those which are less experienced take it into consideration, they are aware of the points that should be taken with special attention.

The item (2) Identifying the relevant and meaningful technical and scientific evidence is, for instance, reflected in the different postings that find categorizing the information into different groups. I agree that this is indeed very helpful. I just want to remind that this is no easy job, as the same publications can fall into different groups and finding searchable words that describe well the publication is no easy task. For instance, the idea of having contributions from NGOs as a group would put together those NGOs that are scientific oriented and in conformance with the RA as in annex III of the Protocol together with the ones that defend aspects such as ideologies, perceptions or others that cannot be used for the RA as in annex III.

I believe it is a very good idea that literature used in the Party’s risk assessments be included in the pool of references (the posting of Dr.Hiroshi Yoshikura). Besides, I believe that if the references are listed in the party´s decision that would give both transparency and confidence on the decision process and if the decision is useful for other parties (the item (3): transparency and making the information useful among different countries with similar environments). In the sense that one can have an idea if RA addressed environmental concerns substantiated through application of sound scientific method and if its relevant for the other interested party. I hope we can also find ways to motivate parties to make pertinent information available at the BCH. I think this is still not yet working as expected.

Of course, in the important process of brainstorming what´s nice to have we are often not considering the workability of making it available without an unjustified burden of work and consequently use of resources. We should not forget to consider that as a next step.

My best regards, Lúcia
posted on 2011-04-17 19:21 UTC by Ph.D. Lúcia de Souza, PRRI - Public Research and Regulation Initiative/ANBio (Associação Nacional de Biossegurança - Brazilian Biosafety Association)
RE: Opening of the discussion group on "Possible mechanisms, including criteria, for future updates of the lists of background materials" (topic 2) [#2307]
I appreciate this opportunity to comment on the subject of "lists of background materials" for the Roadmap. 

Annotating this guidance document must be approached with prudence and caution.  Having working in the discipline of ERA for GM crops for over 18 years, it is my opinion that there is a wide diversity of "guidance" that in the literature.  Some promotes ideologies at the expense of sound risk assessment principles.  Other literature promotes basic research and scientific theory, which in itself can be laudable, but in the context of risk assessment can mislead and confuse the risk assessor.  There are also a small number of publications that have been published and later discredited by independent reviewers,  which has no place in the information provided supplemental to the Roadmap.  My concern is that this vast body of publications will confuse the intended audience of this guidance rather than aid it.

As I first step, recognising that the Roadmap is an "evergreen" document, my recommendation is to produce a list of internationally recognized guidance materials produced by governments and government-recognized bodies such as OECD and UNEP.  These are the guidance documents that LMO developers must follow along with Annex III of the Protocol.

Tom Nickson
posted on 2011-04-17 23:10 UTC by Mr. Thomas Nickson, Consultant
RE: Opening of the discussion group on "Possible mechanisms, including criteria, for future updates of the lists of background materials" (topic 2) [#2322]
THIS MESSAGE WAS SUBMITTED SHORTLY AFTER THE CLOSING OF THIS DISCUSSION AND IS BEING POSTED ON BEHALF OF GEORGINA CATACORA-VARGAS, BOLIVIA

-----

Dear all,

Thanks for very useful insights on Topic 2.

The following are the comments and suggestions from the Plurinational State of Bolivia

We agree with Mrs. Cariño on re: ”The inclusion of various types of references will expand the menu of available information, and it should be up to the risk assessor to discern which set of information would be most useful”.

We also agree with the suggestions made by Dr. Tappeser, Mrs. Cariño and others in relation to the inclusion of various types of information, categorization of documents and inclusion of additional information to describe the type and source of background material.

We disagree with background material focused only on peer-reviewed journals and the exclusion of ”disputed / discredited” documents for the reasons mentioned by Prof. Bereano.

Building up on previous comments posted by the forum participants, our general suggestions are:

-    That Parties, non-Parties and other relevant institutions and organizations are allowed to make submissions on background material.

-     It will be very useful to include the literature used by Parties in their risk assessment and risk management (RA&RM) procedures; however, submissions should not be restricted to this information since most RA&RM have been done in developing countries and not all the information would be relevant to other Parties / countries.

-     When applicable, to link the background material to the specific parts of the RA Guidelines and steps of the road map (as suggested by Dr. El-Tayeb)

-     The documents submitted to be organized in the following categories based on their sources (which is somehow relate to the type of information submitted). We would like to note that our suggestion for organizing the background information does not include the category ”peer-reviewed” because this is related to a review status that could apply to different sources and types of documents (e.g. some documents elaborated by inter-governmental organizations and NGOs can be peer-reviewed).. Accordingly, we move it to “accompanying information”.

Hence, the categories suggested for organizing background materials are:

-     Scholar publications, including, inter alia, journal articles, book chapters and proceedings of conferences.

-     Risk assessment reports, which, in the case of official risk assessment reports elaborated by Parties and linked to LMO applications, the inclusion of the decisions on ”approval”, ”non-approval” or ”approval of with conditions”, and the reasoning of such decisions, will be highly useful.

-     Reports from multinational, national or regional regulators.

-     Reports from inter-governmental organizations.

-     Contributions from other biosafety-related actors, sub-categorized under: i) industry; ii) NGOs; iii) producers (including – but not restricted to - farmers and peasant) organizations; iv) indigenous people organizations; and v) consumers organizations.  

-     Others documents

We think that this would be the easiest approach for the general organization of the background material to be submitted. In order to facilitate a quick review of the documents by users, and the establishment of searching tools, we also suggest the submission of each background material with the following accompanying information:

i)     Abstract

ii)    Subject matter (such as the LMO in question, the field of risk assessment that the document deals with, specification of its content – e.g. review, survey, methodological analysis)

iii)   Key terms

iv)   Authors and their affiliation

v)    Review status (in the case of peer-review to indicate who are the peer-reviewers and their affiliations, if known; and/or a brief description of the peer-review process particularly when the review have been done by anonymous peers. This would not apply to articles published in journals).

As for the intervals for updating the list of background material, we suggest:

-    To update it on yearly basis (given the constant generation of new information). This can be done by opening a specific period (e.g. one week) for submissions of new background documents by Parties non-Parties and other relevant institutions and organizations.

-    Submission for updating the list by Parties through their national competent authorities and by the others, through previously nominated representatives for this activity (only one person per non-Party or relevant institution/organization).

-    Set a system to: i) avoid duplication in the submitted background material e.g. a search tool (by author or title) that allows the verification if the document that Parties, non-Parties or relevant institution/organization wish to submit, already is included in the list; and ii) update / edit the suggested “accompanying information” (in the case of (ii), the identification of who and when made the update/edition will be useful information).

Thanks and kind regards to all,

Georgina Catacora-V.
posted on 2011-04-18 14:31 UTC by Ms. Manoela Miranda, UNEP/SCBD