Biosafety Co-ordinating Committee Regulations, 2002

7188 Citation and commencement. Objective. Interpretation. Gazzetta tal-Gvern ta' Malta ENVIRONMENT PROTECTION ACT, 2001 (ACT No. XX of 2001) Biosaf ety Co-ordinating Committee Regulations, 2002 BY VIRTUE of the powers conferred by section 9 and 11 of the Environment Protection Act, the Minister responsible for the environment has made the following regulations: 1. (1) These regulations may be cited as the Biosafety Co­ ordinating Committee Regulations, 2002. (2) These regulations shall come into force on such date as the Minister responsible for the environment may by notice in the Gazette appoint and different dates may be so appointed for different provisions and different purposes of these regulations. 2. The objective of these Regulations is to set up a committee with the aim to achieve an integrated approach on biosafety, the contained use of genetically-modified micro-organisms, the deliberate release into the environment of genetically-modified organisms and the placing of the market of genetically-modified organisms, in order to achieve a high level of protection of human health and the environment taken as a whole, without prejudice to other relevant Regulations. 3. In these regulations, unless the context otherwise requires: "Competent Authority" means the Malta Environment and Planning Authority as prescribed by the notice entitled Nomination of the Planning Authority as the Central Authority, and such othe~ body or person as the Minister responsible for the environment may by order in the Gazette prescribe and different bodies or persons may be designated as the competent authority for different provisions and different purposes of these regulations; "contained use" means any activity in which micro-organisms are genetically modified or in which such genetically modified micro-organisms are cultured, stored, transported, destroyed, disposed of or used in any other way, and for which specific containment measures are used to limit their contact with the general population and the environment; ls~26 ta' Awissu, 2002 "deliberate release" means any intentional introduction into the environment of a geneticaily modified organism or a combination of genetically modified organisms for which no specific containment measures are used to limit their contact with and to provide a high level of safety for the general population and the environment; "genetically modified micro-organism" (GMM) means a micro-organism in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination. Within the terms of this definition : (i) genetic modification occurs at least through the use of the techniques listed in Annex I, Part A of the Contained Use of Genetically Modified Micro-Organisms Regulations, 2002; (ii) the techniques listed in Annex I, Part B, are not considered to result in genetic modification of the Contained use of Genetically modified Micro-Organisms Regulations, 2002; "genetically modified organisms" (GMO) means an organism, with the exception of human beings, in which the genetic material has been altered in a way that does nor occur naturally by mating and/or natural recombination; Within the terms of this definition: (a) genetic modification occurs at least through the use of the techniques listed in Schedule I A of the Deliberate Release into the Environment of Genetically Modified Organisms Regulations, 2002; (b) the techniques in Schedule I A, Part 2, of the Deliberate Release into the Environment of Genetically Modified Organisms regulations, 2002, are not considered to result in genetic modification. "main regulations" mean the Contained use of Genetically Modified Micro-Organisms Regulations, 2002 (Legal Notice 169 L.N. 169 °r2002 . . h . f andL.N.170of of 2002) and the Deltberate Release mto t e Environment o 2002. Genetically Modified Organisms Regulations, 2002 (Legal Notice 170 of 2002); 7189 7190 Integrated approach. Establishment of the BCC. Composition and terms of reference of the BCC. Establishment of the scientific support and advisory sub­ committee. Gazzetta tal-Gvern ta' Malta "Minister" means the Minister responsible for the environment; "notifier" means the person submitting the notification; "notification" means the submission to the Competent Authority of the requisite information specified in the main regulations; "placing on the market .. means making available to third parties, whether in return for payment or free of charge; "time-frames" means the time-frames for d 0 ifferent notifications and processes cited in the main regulations; "user'' means any natural or legal person responsible for the contained use of genetically modified,micro-organisms. 4. The Competent Authority shall ensure that the conditions of, procedure for the grant of the permit and compliance monitoring shall be fully coordinated, in order to guarantee an effective integrated approach by all authorities competent for this procedure. S. For this purpose, there shall be a Biosafety Co-ordinating Committee, hereafter referred to as the BCC or the Committee. 6. (1) The composition and terms of reference of the BCC shall be as shown in Schedules I and ll respectively. (2) The Competent Authority shall appoint a secretary to the Committee. (3) The members of the Committee shall be so appointed for a term of three years. Provided that the Chairman and the other members of the Committee may resign their office at any time by giving notice in writing to the Minister, and the Minister may at any time remove the Chairman and, or any of the members of the Committee on grounds of disability to perform their functions, bankruptcy or neglect of duty. (4) Without prejudice to any of these regulations, the Committee may regulate its own procedures and meetings. 7. (1) A Scientific Support and Advisory Sub-Committee may be set up by the Chairman in order to assist the BCC on specific scientific issues: Is-26 ta' Awissu, 2002 Provided that, once set up, a permanent representative of this sub-committee will be on the BCC for a period specified in subregulation 6(3). (2) The Chairman may set up any other sub-committees to assist the BCC as it may he required. 8. Any person requiring any permit under the main regulations shall submit the notifications for a permit to the Competent Authority, which shall forward such notifications to the Biosafety Co-ordinating Committee. 9. (1) Should such notifications be required under the main regulations, individual institutions represented in the Committee and mentioned in Schedule I to these regulations shall assess the notifications in terms of their legal remits and requirements and report back to the BCC within the period set in the main regulations. (2) The Committee may decide to forward the notifications to the Scientific Support and Advisory Sub-Committee or to any other public entity for consultation before finalising its recommendations. (3) Based on the assessment and consultations mentioned in sub-regulations (1) and (2), the Committee will forward its recommendations to the Competent Authority within the period set in the main regulations. ( 4) The Competent Authority shall assess these recommendations and the notifications and shall forward its decision to the notifier or user on the legal basis set in the main regulations. Pennit procedures. Submission of notifications 10. Any monitoring compliance and enforcement activities of RMoni!o: · g • • equm:ments relevance to the mam regulations or the BCC shall be undertaken by the individual institutions represented in the Committee and mentioned in Schedule I to these regulations, and the committee shall act in terms of the legal remits and requirements of the institutions and report back to theBCC. 11. The Schedules I to II to these regulations are being published Language of in the English language with the English text of these regulations. Schedules . 7191 7192 Gazzetta tal-Gvern ta' Malt~ SCHEDULE I Composition of the Biosafety Co-ordinating Committee The Biosafety Co-ordinating Committee shall consist of: (a) the Director of the Environment Protection Directorate or his authorised representative as Chairman of the Committee, (b) a public officer responsible for biosafety, designated by the Chairman of the Malta Environment and Planning Authority, (c) a public officer responsible for public health, designated by the Minister responsible for public health, (d) a public officer responsible for occupational health and safety, designated by the Chairman of the Occupational Health and Safety Authority, (e) a public officer responsible for biodiversity protection, designated by the Chairman of the Malta Environment and Planning Authority, (f) a public officer responsible for agriculture and fisheries, designated by the Minister responsible for agriculture and fisheries, (g) a scientist to act as a representative and Chairman of the Scientific Support and Advisory Sub-Committee, (h) any other representative as required by the Competent Authority. Is-26 ta' Awissu, 2002 SCHEDULE II The terms of reference of the Biosafety Co-ordinating Committee shall include the following: (a) to ensure the implementation of the provisions of the main regulations; (b) to evaluate the notifications required in connection with the main regulations and these regulations; (c) to supply the recommendations resulting from the evaluation referred to in (b) above to the Competent Authority within the time-frames set in the main regulations; ( d) to ensure that appropriate monitoring and enforcement measures are taken in accordance with the provisions of these regulations and the main regulations; (e) to collaborate with relevant entities forming the BCC with respect to monitoring, inspections and enforcement; (f) to deal with infringements of permit conditions; (g) to identjfy any existing laburaturies or installations which fall under the scope of these Regulations and the main regulations; (h) to establish criteria for emergency plans; (i) to set up procedures for consultation of the public; (j) to establish a public register of locations utilised for the deliberate release of genetically modified organisms; (k) to ensure that confidentiality of information and intellectual property rights with respect to genetically modified micro-organisms and genetically modified organisms are respected; (I) to Hase with the Malta Standardisation Authority in connection with labeling and packaging requirements and ensure that the products placed on the market comply with specified labelling and packaging requirements; (m) to advise the Competent Authority on educational campaigns and training exercises necessary; (n) to liase with other entities involved in related issues, including nature protection, phytosanitary requirements, civil protection, land use, waste management, etc.; 7193 7194 Gazzetta tal-Gvern ta' Malta ( o) to establish a reporting system aimed at supplying the general public and the Competent Authority with relevant information; (p) to keep abreast of developments in the field of biosafety and genetically modified organisms; (q) to propose any improvements required for the implementation of these regulations and the main regulations; (r) any other function as may be conducive to the better performance of its functions under these regulations and the main regulations.