SIST EN 12686:1999

Biotechnology - Modified organisms for application in the environment - Guidance for the sampling strategies for deliberate releases of genetically modified microorganisms, including viruses

This European Standard provides guidance concerning the procedures for setting up a valid sampling strategy to meet the objectives of a monitoring strategy for GMMs released into the environment. Since monitoring methods of microorganisms in environmental samples usually require pretreatment of the samples, for example the extraction and isolation of GMMs and/or their nucleic acid, this is included in scope of this European Standard. The sampling is to provide material to which subsequent analytical or biological methods for monitoring of GMMs can be applied.

Biotechnik - Veränderte Organismen zum Einsatz in der Umwelt - Leitfaden für Probenahmestrategien bei der absichtlichen Freisetzung gentechnisch veränderter Mikroorganismen, einschließlich Viren

Diese Europäische Norm gibt Anleitungen für den Ablauf der Erarbeitung einer validen Probenahmestrategie, um damit die Zielstellungen einer Überwachungsstrategie für in die Umwelt freigesetzte GVM zu erfüllen. Weil bei Untersuchungsverfahren zur Überwachung von Mikroorganismen in Proben aus der Umwelt üblicherweise eine Vorbehandlung der Proben erforderlich ist, zum Beispiel die Extraktion und Isolation der GVM und/oder deren Nukleinsäure, wurde das in den Anwendungsbereich dieser Europäischen Norm einbezogen.

Biotechnologie - Organismes modifiés disséminés dans l'environnement - Guide des stratégies d'échantillonnage pour les disséminations volontaires de microorganismes génétiquement modifiés, y compris de virus

La présente norme européenne donne des indications relatives aux procédures de mise au point d'une stratégie d'échantillonnage valable pour satisfaire aux objectifs d'une stratégie de surveillance des microorganismes génétiquement modifiés disséminés dans l'environnement.  Dans la mesure où les méthodes de surveillance nécessitent habituellement un prétraitement de l'échantillon des microorganismes contenus dans les échantillons prélevès dans l'environnement, par exemple l'extraction et l'isolement des microorganismes génétiquement modifiés et/ou de leur acide nucléique.

Biotehnologija - Spremenjeni organizmi za uporabo v okolju - Navodilo za strategije vzorčenja namernega sproščanja genetsko spremenjenih mikroorganizmov, vključno z virusi

General Information

• Status: Published
• Publication Date: 30-Nov-1999
• ICS: 07.080 - Biology. Botany. Zoology
• ICS: 07.100.01 - Microbiology in general
• Technical Committee: BTH - Biotechnology
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 01-Dec-1999
• Due Date: 01-Dec-1999
• Completion Date: 01-Dec-1999
• Directive: 90/219/EEC - Contained use of genetically modified micro-organisms
• Directive: 90/220/EEC - Deliberate release into the environment of genetically modified organisms
• Directive: 90/679/EEC - Protection of workers from risks related to exposure to biological agents at work
• Mandate: M/BC/CEN/91/19 - Mandate for CEN on biotechnology
• Ref Project: EN 12686:1998 - Biotechnology - Modified organisms for application in the environment - Guidance for the sampling strategies for deliberate releases of genetically modified microorganisms, including viruses

Overview

EN 12686:1998 (CEN) - titled Biotechnology - Modified organisms for application in the environment - Guidance for the sampling strategies for deliberate releases of genetically modified microorganisms, including viruses - provides guidance for designing and implementing valid sampling strategies to support environmental monitoring of genetically modified microorganisms (GMMs). The standard covers sampling as the link between a monitoring strategy and the analytical or biological methods used to detect and quantify GMMs, and explicitly includes sample pretreatment steps such as extraction and isolation of organisms or their nucleic acids.

Key topics and requirements

• Sampling strategy design: Guidance to ensure samples meet the objectives of a broader monitoring plan (target selection, representativeness, spatial/temporal coverage).
• Sample types and media: Consideration of environmental matrices where GMMs may be present (soil, water, air, biota) and how matrix choice affects sampling.
• Sample pretreatment and preparation: Inclusion of steps required before analysis - for example, extraction and isolation of GMMs and/or their nucleic acids to make samples compatible with downstream analytical or biological detection methods.
• Analytical compatibility: Emphasis on collecting material suitable for the chosen detection techniques (culture, molecular assays, bioassays) and on minimizing loss or alteration of target organisms during sampling.
• Quality and validity: Procedures that support the validity and traceability of samples (documentation, chain of custody, storage and transport conditions, and measures to avoid contamination).
• Operational considerations: Practical advice on frequency of sampling, sample volumes, equipment selection, and health & safety/biosafety precautions for deliberate releases.

Applications

EN 12686:1998 is intended for organizations and professionals who plan, authorize, or execute deliberate releases of GMMs and need robust environmental monitoring, including:

• Biotechnology and agricultural companies conducting field trials of genetically modified microorganisms or viral vectors
• Environmental and biosafety regulators setting monitoring requirements for deliberate releases
• Research institutions studying environmental fate, persistence and dispersal of GMMs
• Environmental consulting firms performing post-release monitoring and compliance verification
• Public health and risk assessment bodies evaluating environmental exposure

Related standards

EN 12686 complements other standards and guidance in GMO monitoring, biosafety and laboratory sampling/analysis (national and international ISO/CEN guidance). Users should apply EN 12686 alongside relevant biosafety regulations and analytical method standards to build a complete monitoring program.

Keywords: EN 12686:1998, sampling strategies, genetically modified microorganisms, GMM monitoring, environmental sampling, sample pretreatment, extraction, isolation, CEN standard.

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Biotechnik - Veränderte Organismen zum Einsatz in der Umwelt - Leitfaden für Probenahmestrategien bei der absichtlichen Freisetzung gentechnisch veränderter Mikroorganismen, einschließlich VirenBiotechnologie - Organismes modifiés disséminés dans l'environnement - Guide des stratégies d'échantillonnage pour les disséminations volontaires de microorganismes génétiquement modifiés, y compris de virusBiotechnology - Modified organisms for application in the environment - Guidance for the sampling strateg
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