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Key Regulatory Issues » Post-Release Monitoring

Title: Monitoring of GMOs Released into the Environment
Publication date: December 02, 2014
Posting date: December 02, 2014

THIRD WORLD NETWORK BIOSAFETY INFORMATION SERVICE

Dear Friends and Colleagues

Monitoring of GMOs released into the environment

A report published by GenØk-Centre for Biosafety in Norway proposes a framework for monitoring of GMOs released into the environment. Specifically, it provides information and considerations for monitoring carried out under the Norwegian Gene Technology Act, which is at the same time robust, comprehensive and useful for safeguarding the environment and human and animal health. The framework is adaptable to biosafety frameworks in other regulatory contexts.

GMO monitoring is the observational science undertaken when a GMO is to be released into the environment, which aims at detecting the occurrence of changes (e.g. in the receiving environment(s) or in the GMO) that could lead to adverse effects. Monitoring aims to detect both anticipated and unanticipated effects that are direct and indirect, immediate and delayed, by observing changes in the environment or in human or animal health and determining whether these changes are related to one (or more) GMO(s).

GMO monitoring may serve three principle functions:
1. Monitoring can be a science-based means for confirming the conclusion on hazards anticipated in the risk assessment;
2. Monitoring can survey for adverse effects that were not identified in, or could not have been anticipated in, a singular risk assessment;
3. Monitoring may be used to evaluate the effectiveness of selected risk management strategies.

The report distinguished between the two main types of monitoring: case-specific monitoring and general surveillance. Case-specific monitoring deals with monitoring for potential adverse effects that were identified and evaluated in the risk assessment of a specific GMO, or to verify the effectiveness of risk management strategies that were enacted with the GMO release, based on specified protection goals. General surveillance surveys for unanticipated adverse effects that were not identified in the risk assessment. This includes monitoring for interactive or cumulative adverse effects that by definition could not have been anticipated in a singular risk assessment and is particularly useful where there is a limited understanding of persistence, accumulation or exposure of the GMO or its products in the environment, or where different GMOs may interact, or new agricultural management strategies may be employed.

The report recommends a monitoring plan that is clear in its requirements, detailed in its description, practical and feasible in its management, robust in its analysis and interpretation, and consistent in its reporting. With this aim there are a number of general considerations that may be kept in mind in the development of a monitoring framework:
1. The monitoring plan should be flexible and adaptive to respond to new information, realities, and/or monitoring needs;
2. The collection of baseline data in both the specific GMO and the potential receiving environment is critical to detect changes and establish causal relationships;
3. Review and assessment of monitoring should ensure scientific quality and integrity in the conduct of monitoring, and ensure that the objectives set forth at the beginning of the monitoring are met;
4. Additional risk assessment studies may be deemed necessary based on the results from monitoring;
5. Monitoring should begin early in the development of a GMO;
6. Observation and management of long-term, indirect and cumulative effects;
7. The capacities to carry out the required monitoring activities should be taken into account when designing a plan or determining its feasibility, in order to identify and estimate any additional resources needed to carry out the activity;
8. Monitoring for human and animal health impacts may require additional methods and/or information sources;
9. The competent authority may request, as appropriate, the exporter to carry out the implementation and coordination of monitoring activities.

The full report is available here: http://genok.no/wp-content/uploads/2014/07/GenOk_Biosafety_Report_2013_02.pdf

With best wishes,

Third World Network
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Biosafety Report 2013/02

GenØk - Centre for Biosafety,
Tromsø,
Norway
December 2013

Monitoring of GMOs released into the Norwegian environment: A case study with herbicide-tolerant GM rapeseed

David Quist

Summary

Monitoring GMOs approved for release into the environment is a requirement under both EU and Norwegian legislation, in order to safeguard desired protection goals from potential adverse effects arising from their use. Achieving this objective requires that monitoring be practical and feasible, its use of resources effective, and that its outcomes are useful for producing new knowledge. This report aims to help ensure monitoring carried out under the Norwegian Gene Technology Act (NGTA) is robust, comprehensive, and useful for meeting the stated aims of safeguarding the environment and human/animal health.

In Part I of this report, we describe the rationale and means for monitoring GMOs in the environment and present both general considerations and a detailed recommended framework for the description of monitoring activities, including their use, review and reporting within the context of national biosafety legislation.

Part II of this report illustrates the practical implementation of monitoring activities, using the proposed framework, with a real case of a herbicide-tolerant GM oilseed rape (OSR), MON88302, under regulatory review in the EU. Potential exposure pathways are discussed that highlight some possible unintended adverse effects for the environment, biodiversity and human and animal health, including critical uncertainties and knowledge gaps. Annex I to this report illustrates how this framework may be implemented in practice.

Outcomes from this exercise make it clear that further information and direction for the development of a monitoring plan will be needed to ensure the monitoring activities undertaken are practical and feasible. Mechanisms for information gathering, particularly on agronomic, biogeographic and ecological details, exposure pathways is needed to determine the purposes and types of monitoring that may be required, and what kinds of questions should be addressed. A problem formulation and options assessment (PFOA, see Box 1) involving multiple actors is therefore recommended in order for a more integrative assessment to consider a more diverse set of decision-making options under the NGTA regarding the use of GM OSR in Norway.

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Box 1. Problem Formulations and Options Assessment (PFOA)

A PFOA “process directly involves the people (i.e. the stakeholders) in an assessment of the positive and negative impacts of a GMO. The process centers an Environmental Risk Assessment (ERA) on the stakeholders to collaboratively identify and analyze both the benefits and harms of a GMO. A PFOA is transparent, inclusive of all appropriate stakeholders, and rationally informed by the best available science. It serves to strengthen an ERA by incorporating deliberations with scientific assessments.” [1]

This mechanism provides an opportunity for greater integration the environmental, social, legal and cultural context. Local and lay knowledge also plays a role in formulating problems and options. Hence, the PFOA provides a platform to into integrate these considerations as a broad holistic approach to the environmental risk assessment of a GMO.

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[1] Problem Formulation and Option Assessment Hand Book, A guide to PFOA process and how to integrate it into the Environmental Risk Assessment (ERA) of GMOs; By Kristen C. Nelson and Michael J. Banker, A publication from the GMO ERA Project, 2007.


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