Post Market Environmental Monitoring of Genetically Modified Herbicide Tolerant Crops (Working group report from the 4th International Workshop on PMEM of Genetically Modified Plants, Quedlinburg, Germany 2010)

Der kommerzielle Anbau gentechnisch veränderter Pflanzen (GVP) muss gemäß der Gesetzgebung der Euro­päischen Union überwacht werden. Hier fassen wir die Diskussionen einer Arbeitsgruppe zusammen, die sich während des 4. Internationalen Workshops zum Anbaubegleitenden Monitoring von GVP vom 3. bis 4. Mai 2010 in Quedlinburg getroffen hat. Die Arbeitsgruppe hatte zum Ziel, die Notwendigkeit, das Ausmaß und den Aufbau eines Monitoring von gentechnisch veränderten herbizidtoleranten Pflanzen zu diskutieren. Der folgende Arbeitsgruppen-Bericht fasst die spezi­fischen Fragen, die sich bei einem solchen Monitoring stellen, zusammen und es wird versucht, die Frage zu beantworten, was überwacht werden sollte und wer eine solche Überwachung durchführen sollte. Zusätzlich werden die größten Herausforderungen bei der Überwachung von herbizidtoleranten GVP präsentiert, und es wird diskutiert, wie diesen begegnet werden könnte.    According to European Union (EU) legislation, genetically modified (GM) crops released for commercial cultivation have to be monitored. Here we summarise the discussion of a working group that convened during the 4th International Workshop on Post Market Environmental Monitoring (PMEM) of Genetically Modified Plants in Quedlinburg from 3–4 May 2010 to discuss the necessity, extent and design of PMEM plans of genetically modified herbicide tolerant (GMHT) crops. The following workshop report summarises the questions specific to the monitoring of GMHT crops and seeks to answer what should be monitored and who should perform such a monitoring. In addi­tion, the main challenges when monitoring GMHT crops are presented and it is discussed how these challenges could be addressed.   &nbsp

A quantitative risk assessment for skin sensitizing plant protection products: Linking derived No-Effect levels (DNELs) with agricultural exposure models.

Chemical skin sensitizers produce allergic contact dermatitis, which is one of the most frequent occupational diseases associated with chemical exposures. Skin exposure is the major route of exposure when using plant protection products (PPPs). Therefore, skin sensitization is an important factor to be addressed during the regulatory risk assessment of PPPs. The main regulatory decision criterion considered when performing risk assessment for skin sensitizers is the dose applied. The equally important criteria "potency of the substance" is insufficiently considered by two potency categories as potency may vary up to five orders of magnitude. "Frequency of exposure" to the skin sensitizer is not considered at all. Consequently, an improved risk assessment methodology is essential to adequately assess health risks from skin sensitizers, especially for agricultural operators using PPPs. A quantitative risk assessment (QRA) approach for addressing PPPs sensitizing potential is proposed here. This QRA combines a methodology to derive a substance-specific threshold for skin sensitizers, a Derived No-Effect Level (DNEL), and an agricultural exposure model used for assessing chronic health risks of PPPs. The proposed QRA for skin sensitizing PPPs is a clear improvement over current risk assessment to ensure the safe use of skin sensitizers in an occupational context

Towards Flexible Coexistence Regulations for GM crops in the EU

The European Union (EU) is currently facing a challenge that might unnecessarily hamper the adoption of GM crops: regulating the coexistence of genetically modified (GM) and non-GM crops. Member states are currently implementing or developing both "ex ante" coexistence regulations and "ex post" liability schemes to ensure that both GM and non-GM crops can be cultivated in the EU. In this article, we explore in detail how national and/or regional policymakers can build in a certain degree of flexibility in "ex ante" coexistence regulations in order to reduce the regulatory burden on certain agricultural options and avoid jeopardising the economic incentives for coexistence. We use the example of GM maize as a case study, being the only GM crop planted over a significant area in the EU. We conclude that flexibility could be integrated into regulations at different levels: (i) at the regulatory level by relaxing some of the regulatory rigidity in "ex ante" regulations; (ii) at the farm level by allowing the substitution of isolation distances by pollen barriers; and (iii) at the national/regional level through plural coexistence measures, consistent with heterogeneity of farming in the EU. Copyright (c) 2010 The Authors. Journal compilation (c) The Agricultural Ecomomics Society and the European Association of Agricultural Economists 2010.

A conceptual framework for the design of environmental post-market monitoring of genetically modified plants

Genetically modified plants (GMPs) may soon be cultivated commercially in several member countries of the European Union (EU). According to EU Directive 2001/18/EC, post-market monitoring (PMM) for commercial GMP cultivation must be implemented, in order to detect and prevent adverse effects on human health and the environment. However, no general PMM strategies for GMP cultivation have been established so far. We present a conceptual framework for the design of environmental PMM for GMP cultivation based on current EU legislation and common risk analysis procedures. We have established a comprehensive structure of the GMP approval process, consisting of pre-market risk assessment (PMRA) as well as PMM. Both programs can be distinguished conceptually due to principles inherent to risk analysis procedures. The design of PMM programs should take into account the knowledge gained during approval for commercialization of a specific GMP and the decisions made in the environmental risk assessments (ERAs). PMM is composed of case-specific monitoring (CSM) and general surveillance. CSM focuses on anticipated effects of a specific GMP. Selection of case-specific indicators for detection of ecological exposure and effects, as well as definition of effect sizes, are important for CSM. General surveillance is designed to detect unanticipated effects on general safeguard subjects, such as natural resources, which must not be adversely affected by human activities like GMP cultivation. We have identified clear conceptual differences between CSM and general surveillance, and propose to adopt separate frameworks when developing either of the two programs. Common to both programs is the need to put a value on possible ecological effects of GMP cultivation. The structure of PMM presented here will be of assistance to industry, researchers, and regulators, when assessing GMPs during commercialization