The Genetically Modified Organisms (Contained Use) Regulations 2014

Regulations 10(2), 11(2), 12(2),14(1), 28(3) and 33(6)

SCHEDULE 6 U.K. Information required for a notification under regulation 10(2), 11(2) or 12(2)

A notification required for the purposes of regulation 10(2), 11(2) or 12(2) must contain the following information except where it is required only for a specified regulation—

(a) the name, address and telephone number and any fax number and any e-mail address of the notifier;

(b) any centre number allocated by the competent authority in respect of the premises at which the contained use is to be undertaken and the date of the notification required by regulation 9(2) relating to those premises;

(c) the name of the person with specific responsibility for supervision and safety of contained use;

(d) information on the training and qualifications of that person;

(e) the recipient or parental micro-organism to be used;

(f) the donor micro-organism to be used;

(g) where applicable, the host-vector system to be used;

(h) the source and intended function of the genetic material involved in the modification;

(i) the identity and characteristics of the genetically modified organism;

(j) the purpose of the contained use, including its expected results;

(k) for regulation 10(2) the approximate culture volumes to be used;

(l) for regulation 11(2) the culture volumes to be used;

(m) a description of the containment and other protective measures to be applied, including—

(i) information on waste management, including the type and form of wastes to be generated, their treatment, ultimate form and destination; and

(ii) for regulation 10(2) justification for not applying any containment measure at containment level 2;

(iii) for regulation 11(2), for class 3 contained use, justification for not applying any containment measure at containment level 3;

(iv) for regulation 11(2), for class 4 contained use, justification for not applying any containment measure at containment level 4;

(n) for regulations 10(2) and 11(2) a copy of the risk assessment;

(o) for regulations 10(2) and 11(2) the advice received in relation to that assessment from a genetic modification safety committee;

(p) for regulation 12(2) a copy of the risk assessment;

(q) information in relation to any accident prevention and emergency plans including—

(i) the information necessary for the competent authority to evaluate any emergency plan;

(ii) confirmation that the emergency services, and any body or authority liable to be affected by an accident to which any emergency plan relates, will be informed of the contents of the emergency plan and of any relevant revisions;

(iii) for regulation 11(2), in addition—

(aa) any specific hazards arising from the location of the installation;

(bb) the preventive measures applied, including safety equipment, alarm systems and containment methods;

(cc) procedures and plans for verifying the continuing effectiveness of the containment measures;

(dd) a description of the information provided to workers;

(r) for regulation 11(2) a description of the parts of the installation;

(s) for regulation 11(2) whether the genetically modified organism is likely to be subject to transboundary movement.