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Testing of the Roadmap for Risk Assessment

This Discussion Group is now closed. Please see the Calendar of events for upcoming activities.

Objective

The objective of this Discussion Group is to test the draft Roadmap prepared by the AHTEG Sub-working Group on the Roadmap for accuracy and completeness. Experts are invited to answer the questionnaire provided and report back on their testing experience. In addition to the draft Roadmap and questionnaire for testing, risk assessment case-studies, other background documents and guiding questions are available to assist in the discussions.
 
Essential documents for download:    

Ongoing discussions

To start a new topic please click on the button 'Create a new thread' below. You must be registered in the Open-ended Online Forum AND signed-in to the BCH to post a message.

Background documents

This is the latest version of the draft Roadmap for Risk Assessment that should be used as the basis for the testing exercise.
This questionnaire should be use side-by-side with the draft Roadmap when performing the testing exercise. It is recommended that a case-study be used in the testing as well. Please download the questionnaire, fill out the answers and upload it as an attachment to your message in this page's "Ongoing discussions".
*** If you are not able to open this file, please copy and paste the following address in your web browser: http://www.agbios.com/cstudies.php?book=ESA&ev=MON810&chapter=Preface
This is an application for using LY038 maize as animal feed in the European Union, and provides data that are relevant for feed safety assessment. The application also takes into account the possibility that the LMO is accidentally released. An environmental risk assessment is included in this application should such an accidental release take place.
This document is part of a case study on MON15985 cotton that is intended as a training tool for risk assessors. The document provides the technical information that is relevant for the testing of the Roadmap. This document is being generously made available by AgBios (http://www.agbios.com).
All employers have a legal obligation under the Health and Safety at Work etc Act 1974 to assess and manage health and safety risks. Accidents at work and occupational health issues can be damaging to business and have adverse affects on people’s lives. It is not always possible to identify and eliminate every risk, but duty holders are required to protect employees and others in connection with their business as far as 'reasonably practicable' by completing a risk assessment. The definition of 'reasonably practicable’, set out by the Court of Appeal is: “‘Reasonably practicable’ is a narrower term than ‘physically possible’ … a computation must be made by the owner in which the quantum of risk is placed on one scale and the sacrifice involved in the measures necessary for averting the risk (whether in money, time or trouble) is placed in the other, and that, if it be shown that there is a gross disproportion between them – the risk being insignificant in relation to the sacrifice – the defendants discharge the onus on them.” A risk assessment is a process allowing duty holders to focus on those risks that have the potential to cause harm, and to make judgments on the suitable remedies taking into account reasonable practicability. Following the risk assessment, it may be necessary to produce an action plan and priorities the improvements needed. The action plan must be implemented and managed by the duty holder or their responsible person. The risk assessment should be reviewed on an ongoing basis to make sure that it remains up to date and effective. The risk assessment must take in to account all employees, subcontractors, suppliers and members of the public; essentially any person that has the potential to be harmed by the process of a business at its premises or out in the field. There are five basic steps to any risk assessment: 1. identify the hazards 2. decide who might be harmed by them and how 3. evaluate the risks and decide on precautions 4. record the findings and implement any remedial action 5. review the risk assessment regularly and update it if necessary Employers can complete the assessment themselves provided that they are aware of the potential hazards and appropriate remediation. In specialist areas such as water hygiene, asbestos, fire or disabled access it is usually advisable to get help from someone who is competent. Statistics show that health and safety failures are consistently linked to one or more of the following factors: o Inadequate control systems o Ineffective supervision or management o Poor communication o Lack of training o Failure to conduct a suitable and sufficient risk assessment For more information about Risk Assessments or managing the risks, please contact Nemco Utilities at www.nemco-utilities.co.uk

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Guiding questions

The guiding questions below are aimed at assisting the testing of the draft Roadmap. A questionnaire for the testing as well as the draft Roadmap and additional background documents are indicated above. After answering the questionnaire, please upload it to the discussion group by attaching it to your message.

You are kindly asked to test the draft Roadmap, with the following guiding questions in mind:

  • Does the Roadmap provide a useful, complete and user-friendly tool to assist you in performing an LMO risk assessment?
  • Is the Roadmap clear and helpful in particular also for risk assessors with less experience?
  • Is the Roadmap applicable to all types of LMOs and applications within the scope of the Protocol?
  • Is there any issue or concept that is missing from the current draft Roadmap and should be included?
  • Are the concepts presented in the Roadmap clear?

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Overview of the topic

The AHTEG established a Sub-Working Group (SWG) for the developing a Roadmap for Risk Assessment. The development of the draft Roadmap has been undertaken through rounds of discussion within the SWG as well as under the Open-ended Online Forum.

Paragraphs 8 and 9 of Annex III of the Protocol provide a description of the risk assessment process and points to be considered in the process. The Annex does however not describe how the steps described in paragraph 8 are to be linked to the points to consider in paragraph 9. In general, the structured approach that is required for risk assessment is not detailed in Annex III.

The Roadmap aims to provide the description of such a structured approach, based on Annex III. It describes rationales for the steps in paragraph 8, and the interrelationship between the steps. It then lists points to consider for each step, and provides explanations where necessary. The Roadmap starts with general considerations and overarching issues, that should be taken into account during the entire risk assessment process.

The Roadmap applies to risk assessment of all types of LMOs and applications within the scope of the Protocol. It is meant to be useful, inter alia, in developing capacity in countries where a risk assessment framework is not yet available.

The Roadmap is also meant to provide a framework for risk assessment information. A general need is felt for a better organization of the information that is available on risk assessment of LMOs within the context of Annex III. The BIRC contains some 200 information and guidance documents, but it would be helpful if these documents were organized on basis of the step in risk assessment where they provide information on. Examples are: documents on biological characteristics of recipient organisms, on traits introduced into LMOs, on how to characterize receiving environments, etc.

For more information on the work of the AHTEG and its SWGs, please follow this link.

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Update on 2009-12-14
United Nations