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ACGM NEWSLETTER No. 31

AUGUST 2002

 

Welcome to ACGM Newsletter 31. This Newsletter contains information and guidance for those undertaking activities covered by the Genetically Modified Organisms (Contained Use) Regulations 2000 and is designed to provide information on where guidance on these regulations can be found. Full documents referred to here are available at:

http://www.hse.gov.uk/dst/scdir/htm under 'Journals/Newsletters from the Directorate of Science and Technology'

Hard copies can be obtained through the ACGM Secretariat 0151 951 4718 or by e-mailing Jane.Rheinheimer@hse.gsi.gov.uk.


ACGM News

The forty-seventh meeting of the Advisory Committee on Genetic Modification took place on Tuesday 12 February 2002 at 10.30 am at the Health and Safety Executive, the Globe Room, Rose Court, 2 Southwark Bridge, London SE1 9HS. The meeting included:

  • the Secretary's report on the emergency amendment to the GMO (Contained use) Regulations 2000 (CU2000) and the closure of the Public Register;
  • the role of ACGM;
  • a review and evaluation of the ACGM Open Meeting.

A summary of the meeting is available at: http://www.hse.gov.uk/foi/acgm47.htm

Newsflash

Excluding information from the public register kept under the Genetically Modified Organisms (Contained Use) Regulations 2000

HSE has recently published a guidance leaflet on the Genetically Modified Organisms (Contained Use) (Amendment) Regulations 2002, which were signed earlier this year by the Minister. These Regulations were developed in the interest of national security and in the light of potential terrorist activity after September 11 2001. The guidance leaflet is available on the website, http://www.hse.gov.uk/pubns/indg357.pdf. A copy of the leaflet is enclosed with hard copies of this newsletter. A brief summary of the regulations is also available on the website with this newsletter.

Notification issues

Fees


This document contains a list of the current fees for notification of GM premises and GM activities. Please note that the fees change every year, usually in April so if you submit a notification around this time, please contact the Notifications Officer to check on the current fees.

Interim guidance on connected programmes


As most GM centres are aware, Regulation 13 allows users to notify more than one activity in a single notification, i.e. connected programmes of work. Some of the connected programmes notified to date have been too open ended and fail to describe boundaries to the work. Guidance has been prepared to give advice on what is acceptable as a connected programme of work and what information to include in such a notification. This guidance was originally issued with Newsletter 30 but is provided here with revised content and format and is recommended reading for all notifiers.

Significant changes


Guidance was on making changes to notifications, and when they should be notified to the Competent Authority, was originally issued with Newsletter 30. This guidance is currently under review and although many of the ideas concerning significant changes incorporated in the original document, 'Connected programmes of work and notification of significant and other changes', are likely to remain, there may be a reduction in the degree of flexibility permissible in notifying changes to work at some risk classes. If you are proposing to make changes to a notified project or connected programme we suggest that you contact us for technical advice on whether the changes require notifying to the Competent Authority.

Administrative and other changes to notified information


We have great difficulty in ensuring that we contact the right person, at the right site if we are not kept up to date with changes in notified information. This document aims to highlight the need to inform the Competent Authority when changes occur to notified information and is recommended reading for all notifiers.

A checklist to avoid the most common mistakes in notifications


This document details the most common mistakes made in notifications, how to avoid them and refers to relevant guidance issued in previous newsletters. The guidance aims to help your notification proceed smoothly as omissions and errors cause delays in the notification process.

Risk assessment

Risk assessment of genetically modified micro-organisms: a format that offers one possible way of achieving good practice


HSE Specialist Inspectors see a large number of risk assessments for a wide range of work during inspections and when reviewing notifications, and have found that they vary widely in quality and content. This document contains guidance on undertaking a risk assessment for genetically modified micro-organisms and provides one possible format for risk assessments.

Interim guidance on risk assessment of genetically modified micro-organisms eliciting altered immune responses


The ACGM considers that infectious organisms eliciting altered immune responses require special consideration when assessing the risks involved. This document provides information on strategies for immune modulation and hazards that need to be considered when risk assessing these activities.

Enforcement & Incidents

Enforcement


This paper describes action taken since the beginning of 2001, following inspection of GM centres. The purpose of highlighting enforcement action is to draw your attention to the kinds of issues that some centres have missed, so that you can check that none of these failures is present in your premises.

Incidents


This document provides a brief description of an incident that has been investigated and lessons that can be learnt from the incident.

Contacts

Changes in HSE contact details


This document contains details of who to contact with enquiries and how to contact them.

Organisation of TD6


As some of you will be aware, there have been changes to TD6 personnel, as well as an increase in the numbers of inspectors, to reflect the strength of public feeling concerning biological agents and GM issues. This document shows who is in TD6 and how TD6 is organised.

Newsletters by e-mail

If you would like to receive a copy of the ACGM Newsletter and associated documents by e-mail please send an e-mail to Jane.Rheinheimer@hse.gsi.gov.uk. We would be grateful if you could inform others in your organisation, (particularly those involved in risk assessment and notification) of this facility to ensure that guidance issued in newsletters receives a wide circulation.

Published on HSE web site 18 September 2002