- Latest available (Revised)
- Original (As made)
There are currently no known outstanding effects for the The Genetically Modified Organisms (Deliberate Release) (Scotland) Regulations 2002, SCHEDULE 5A.
Revised legislation carried on this site may not be fully up to date. At the current time any known changes or effects made by subsequent legislation have been applied to the text of the legislation you are viewing by the editorial team. Please see ‘Frequently Asked Questions’ for details regarding the timescales for which new effects are identified and recorded on this site.
Regulation 16(2)(g) and schedule 4
Textual Amendments
1. This schedule describes in general terms the objective to be achieved and the general principles to be followed in the design of the monitoring plan referred to in regulations 16(2)(g) and 28(f).
2. The objective of a monitoring plan is to—S
(a)confirm that any assumption regarding the occurrence and impact of potential adverse effects of the genetically modified organism or its use in the environmental risk assessment are correct, and
(b)identify the occurrence of adverse effects of the genetically modified organism or its use on human health or the environment which were not anticipated in the environmental risk assessment.
3.—(1) Monitoring takes place after the consent to the placing of a genetically modified organism on the market.S
(2) The interpretation of the data collected by monitoring should be considered in the light of other existing environmental conditions and activities. Where changes in the environment are observed, further assessment should be considered to establish whether they are a consequence of the genetically modified organism or its use, as such changes may be the result of environmental factors other than the placing of the genetically modified organism on the market.
(3) Experience and data gained through the monitoring of experimental releases of genetically modified organisms may assist in designing the post marketing monitoring regime required for the placing on the market of genetically modified organisms as or in products.
4. The design of the monitoring plan should—S
(a)be detailed on a case by case basis taking into account the environmental risk assessment,
(b)take into account the characteristics of the genetically modified organism, the characteristics and scale of its intended use and the range of relevant environmental conditions where the genetically modified organism is expected to be released,
(c)incorporate general surveillance for unanticipated adverse effects and, if necessary, (case-)specific monitoring focusing on adverse effects identified in the environmental risk assessment—
(i)whereas case-specific monitoring should be carried out for a sufficient time period to detect immediate and direct as well as, where appropriate, delayed or indirect effects which have been identified in the environmental risk assessment, and
(ii)whereas surveillance could, if appropriate, make use of already established routine surveillance practices such as the monitoring of agricultural cultivars, plant protection, or veterinary and medical products. An explanation as to how relevant information collected through established routine surveillance practices will be made available to the consent-holder should be provided,
(d)facilitate the observation, in a systematic manner, of the release of a genetically modified organism in the receiving environment and the interpretation of these observations with respect to safety to human health or the environment,
(e)identify who (applicant, users) will carry out the various tasks the monitoring plan requires and who is responsible for ensuring that the monitoring plan is set into place and carried out appropriately, and ensure that there is a route by which the consent holder and the Scottish Ministers will be informed on any observed adverse effects on human health and the environment (time points and intervals for reports on the results of the monitoring must be indicated), and
(f)give consideration to the mechanisms for identifying and confirming any observed adverse effects on human health and environment and enable the consent holder or the Scottish Ministers, where appropriate, to take the measures necessary to protect human health and the environment.]
The Whole Instrument you have selected contains over 200 provisions and might take some time to download. You may also experience some issues with your browser, such as an alert box that a script is taking a long time to run.
Would you like to continue?
The Whole Instrument you have selected contains over 200 provisions and might take some time to download.
Would you like to continue?
The Whole Instrument you have selected contains over 200 provisions and might take some time to download. You may also experience some issues with your browser, such as an alert box that a script is taking a long time to run.
Would you like to continue?
Latest Available (revised):The latest available updated version of the legislation incorporating changes made by subsequent legislation and applied by our editorial team. Changes we have not yet applied to the text, can be found in the ‘Changes to Legislation’ area.
Original (As Enacted or Made): The original version of the legislation as it stood when it was enacted or made. No changes have been applied to the text.
Geographical Extent: Indicates the geographical area that this provision applies to. For further information see ‘Frequently Asked Questions’.
Show Timeline of Changes: See how this legislation has or could change over time. Turning this feature on will show extra navigation options to go to these specific points in time. Return to the latest available version by using the controls above in the What Version box.
Access essential accompanying documents and information for this legislation item from this tab. Dependent on the legislation item being viewed this may include:
This timeline shows the different points in time where a change occurred. The dates will coincide with the earliest date on which the change (e.g an insertion, a repeal or a substitution) that was applied came into force. The first date in the timeline will usually be the earliest date when the provision came into force. In some cases the first date is 01/02/1991 (or for Northern Ireland legislation 01/01/2006). This date is our basedate. No versions before this date are available. For further information see the Editorial Practice Guide and Glossary under Help.
Use this menu to access essential accompanying documents and information for this legislation item. Dependent on the legislation item being viewed this may include:
Click 'View More' or select 'More Resources' tab for additional information including: