EUROPEAN COMMUNITIES PART I GENERAL Citation and commencement 1 These Regulations may be cited as the Genetically Modified Organisms (Deliberate Release) Regulations (Northern Ireland) 2003 and shall come into operation on 15th April 2003. Interpretation 2 1 In these regulations – “the Advisory Committee on Releases to the Environment” means the Committee appointed by the Department under Article 22A of the Order ; “antibiotic resistance markers” means genes employed in the modification of an organism to make that organism express resistance to a particular antibiotic or antibiotics; “application for consent to release” shall include any notification made under the First Simplified Procedure (crop plants) Decision ; “approved product” means a product permitted to be marketed by a consent granted under Article 8(1) of the Order or in accordance with Article 15(3), 17(6) or 18(2) of the Deliberate Release Directive or Article 13(2) or (4) of the 1990 Directive ; “ the Commission ” means the European Commission; “the Contained Use Directive ” means Council Directive 90/219/ EEC on the contained use of genetically modified micro-organisms as amended by Commission Directive 1994/51/ EC and Directive 98/81/EC ; “the Deliberate Release Directive” means Council Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms; “electronic communication” means the same as in the Electronic Communications (Northern Ireland) Act 2001 ; “environmental risk assessment” means the environmental risk assessment required to be contained in an application for consent to release or market genetically modified organisms by regulation 11(1)(c) and regulation 16(2)(c); “ the Executive ” means the Health and Safety Executive for Northern Ireland; “the First Simplified Procedure (crop plants) Decision” means Commission Decision 94//730/EC ; “genetically modified organisms” means a genetically modified organism or a combination of genetically modified organisms; “higher plant” means a plant belonging to the taxonomic group Spermatophytae ( Gymnospermae or Angiospermae ); “monitoring plan” means the plan required by regulation 16(2)(g); “the Order” means the Genetically Modified Organisms (Northern Ireland) Order 1991; “the register” means the public register kept by the Department under Article 19 of the Order; “the 1990 Directive” means Council Directive 1990/220/EEC on the deliberate release into the environment of genetically modified organisms as amended by Commission Directive 1994/15/EC and Commission Directive 1997/35/EC ; “the 1994 Regulations ” means the Genetically Modified Organisms (Deliberate Release) Regulations ( NI ) 1994 ; 2 The Interpretation Act (Northern Ireland) 1954 shall apply to these regulations as it applies to an Act of the Northern Ireland Assembly. Purpose of the Order and meaning of expressions used 3 1 Article 3 of the Order (purpose of Order and meaning of “genetically modified organisms” and related expressions) is amended as follows. 2 For paragraph (1) there shall be substituted – 1 This Order has effect for the purpose of ensuring that all appropriate measures are taken to avoid damage to the environment which may arise from the escape or release from human control of genetically modified organisms. . 3 In paragraph (4) (definition of organism which is genetically modified) for sub-paragraph (a) (modification of prescribed artificial technique) there shall be substituted – a have been artificially modified, or . 4 After paragraph (4) insert – 4A Genes or other genetic material in an organism are “artificially modified” for the purposes of paragraph (4) if they are altered otherwise than by a process which occurs naturally in mating or natural recombination. This paragraph is subject to paragraphs (4B) and (4C). 4B For the purposes of paragraph (4) – a genes or other genetic material shall be taken to be artificially modified if they are altered using such techniques as may be prescribed for the purposes of this sub-paragraph; b genes or other genetic material shall not be regarded as artificially modified by reason only of being altered by the use of such techniques as may be prescribed for the purposes of this sub-paragraph. 4C An organism shall be taken not to be a genetically modified organism for the purposes of this Order if it is an organism of a prescribed description. 4D In paragraphs (4B) and (4C) “prescribed” means prescribed by regulations made by the Department. . 5 Paragraphs (5) and (6) are omitted. Meaning of “damage to the environment” etc 4 1 Article 4 of the Order (meaning of “damage to the environment” etc) is amended as follows. 2 For paragraph (2) (meaning of “environment”) substitute – 2 The “environment” includes land, air and water and living organisms supported by any of those media. . 3 In paragraph (3) (meaning of “damage to the environment”) omit “to the living organisms supported by the environment”. 4 For paragraph (6) (meaning of “harm”) substitute – 6 “Harm” means any adverse effects as regards the health of humans or the environment. . 5 For paragraph (9) (meaning of organism being under a person’s “control”) substitute – 9 Organisms of any description are under the “control” of a person where he keeps them contained by measures designed to limit their contact with humans and the environment and to prevent or minimise the risk of harm. . 6 For paragraph (11) (meaning of organism being “marketed”) substitute – 11 Genetically modified organisms of any description are “marketed” by a person when products consisting of or including such organisms are placed on the market by being made available to other persons, whether or not for consideration. . Techniques of genetic modification 5 1 Until the coming into operation of the first regulations under Article 3(4B)(a) of the Order, genes or other genetic material shall be taken, for the purposes of paragraph (4) of that Article to be artificially modified if they are altered using any of the following techniques: a recombinant nucleic acid techniques involving the formation of new combinations of genetic material by the insertion of nucleic acid molecules, produced by whatever means outside an organism, into any virus, bacterial plasmid or other vector system and their incorporation into a host organism in which they do not naturally occur but in which they are capable of continued propagation; b techniques involving the direct introduction into an organism of heritable material prepared outside the organism including micro-injection, macro-injection and micro-encapsulation; c cell fusion (including protoplast fusion) or hybridisation techniques where live cells with new combinations of heritable genetic material are formed through the fusion of two or more cells by means of methods that do not occur naturally. 2 Until the coming into operation of the first regulations under Article 3(4B)(b) of the Order, genes or other genetic material shall not be regarded, for the purposes of paragraph (4) of that Article, as artificially modified by reason only of being altered by the use of any of the following techniques: – a in vitro fertilisation, b natural processes such as conjugation, transduction and transformation, c polyploidy induction. provided that such techniques do not involve the use of recombinant nucleic acid molecules or genetically modified organisms made by techniques or methods other than – i mutagenesis; ii cell fusion (including protoplast fusion) of plant cells of organisms which can exchange genetic material through traditional breeding methods. 3 Until the coming into operation of the first regulations under Article 4(4C) of the Order, an organism shall be taken, for the purposes of the Order, not to be a genetically modified organism if it is yielded from the techniques or methods listed in paragraph (2)(i) or (ii) provided that those techniques or methods did not involve the use of recombinant nucleic acid molecules or genetically modified organisms other than those made by techniques or methods listed in that paragraph. Environmental risk assessment 6 1 An environmental risk assessment contained in an application for consent to release or market genetically modified organisms shall – a identify and evaluate the potential damage to the environment, whether direct or indirect, immediate or delayed, which may arise from the release or marketing of genetically modified organisms, b be carried out in accordance with Annex II of the Deliberate Release Directive and contain the conclusions required in section D of that Annex, c include any bibliographic reference and indications of the methods used where applicable. 2 Where the genetically modified organisms contain antibiotic resistance markers, the environmental risk assessment shall include an examination of the particular risks of damage to the environment which may be posed by the deliberate release or marketing of those genetically modified organisms. Communication with applicant for consent 7 1 Wherever an applicant for consent or renewal of a consent to which these Regulations apply or a holder of such consent is required under these Regulations to submit any document in writing, he is required to submit that document in both a paper and in a commonly used electronic form. 2 Wherever these Regulations require any communication from the Department to the applicant for a consent or renewal of a consent to be in writing, “writing” shall include an electronic communication. 3 Any documents required by these Regulations to be in writing which do not fall within the provisions of paragraph (1) or (2) must be in paper form. PART II RELEASING ORGANISMS FOR ANY OTHER PURPOSE THAN MARKETING Requirement for consent to release 8 The cases and circumstances prescribed for the purposes of Article 8(1)(a) of the Order in relation to the release of any genetically modified organisms are all cases and circumstances in which genetically modified organisms are intended to be released. Exempt activities 9 The cases and circumstances prescribed for the purposes of Article 8(7) of the Order in which persons are exempt from the requirements of Article 8(1)(a) of the Order, insofar as those requirements apply to the release of genetically modified organisms, are all cases and circumstances in which the release is in accordance with a consent to market genetically modified organisms under Article 8(1)(a) of the Order or in which an approved product is released in accordance with the conditions and limitations to which the use of the product is subject. Applications for consent to release genetically modified organisms – general provisions 10 1 An application for a consent to release genetically modified organisms must be made in writing to the Department. 2 Proposed releases of the same genetically modified organism or of a combination of genetically modified organisms on the same site or on different sites for the same purpose and within a defined period may be notified in a single application. 3 Where an application for a consent to release genetically modified organisms is expressed to rely on the First Simplified Procedure (crop plants) Decision, in the event of any inconsistency in the requirements as to information to be provided under that Decision and the requirements as to information to be provided under these Regulations, the provisions of that Decision shall prevail. Information to be contained in applications for consent to release 11 1 An application for a consent to release genetically modified organisms must contain – a the information prescribed in – i Schedule 1, where the application is for consent to release any genetically modified higher plant, or ii Schedule 2 in any other case, to the extent and at the level of detail that such information is appropriate to the nature and scale of the release or application; b information on data or results from any previous release of the organisms, or of the same combination of organisms, which has been carried out by the applicant, and information from any previous application for the release of the organisms, or of the same combination of organisms, which the applicant has made to the Department pursuant to the Order or to another competent authority in accordance with Article 6 of the Deliberate Release Directive; c an environmental risk assessment prepared in accordance with regulation 6; d a summary, in the format established by the Commission under Article 11(1) of the Deliberate Release Directive, of the information contained in the application. 2 The application may contain – a data or results from an application for consent to release genetically modified organisms previously made by some other person, provided that a copy of that person’s agreement in writing is contained in the application; and b any other information which the applicant considers is relevant. Advertisement of applications for consent to release 12 1 Subject to paragraphs (2) and (3), a person who makes an application for a consent to release genetically modified organisms shall, not more than ten days after he sends that application to the Department, cause to be published in at least three newspapers to be specified by the Department a notice containing the following information – a the name and address of the applicant, b the general description of the organisms to be released, c the location and purpose of the release, d the intended date or dates of the release, e a statement that information about the application will be placed on the register by the Department within twelve days of its receipt of the application, f the means by which that register can be inspected, g a statement that the Department will consider any representations made to it relating to risks of damage to the environment posed by the release of the genetically modified organisms within a period which it shall specify in accordance with these Regulations and shall immediately send copies of the newspapers containing the advertisement to the Department. 2 A notice published under paragraph (1) need not contain the information referred to in sub-paragraphs (c) and (d) of that paragraph insofar as the First Simplified Procedure (crop plants) Decision does not require that information to be submitted with the application and that information is not submitted with the application. 3 An applicant for consent shall ascertain from the Department the level of detail on the location of the release which will be placed on the register and shall include the same level of detail in the notice to be published under paragraph (1). 4 A person who makes an application for a consent to release genetically modified organisms shall, not more than ten days after he sends that application to the Department, give to the following persons notice in writing that he has made the application and shall include in such notice the information prescribed in paragraph (1)(a) to (g), save in so far as paragraph (2) permits such information to be excluded from the notice referred to in paragraph (1) – a the district council for the area or areas of each proposed release, b the owner or owners of the site or sites of each proposed release, if a person other than the applicant, c each member of the genetic modification safety committee established by the applicant under regulation 16 of the Genetically Modified Organisms (Contained Use) Regulations (Northern Ireland) 2001 , d the Department of Agriculture and Rural Development, and shall immediately send to the Department copies of the notices. Transitional provisions for release 13 Where the Department has received an application for consent to release genetically modified organisms before 15th April 2003 pursuant to the 1994 Regulations and has not yet determined the application – a the application shall be subject to the provisions of these Regulations, b the applicant shall submit to the Department such further information, additional to that already provided in connection with the application, as is necessary in order to comply with the requirements of these Regulations by 17th July 2003, c the application shall be treated as having been sent to the Department for the purposes of regulations 12(1) and (4) and as having been received by the Department for the purpose of regulation 20 on submission of the information required by paragraph (b), and d if the information required by paragraph (b) has not been submitted by 17th July 2003, the Department may refuse to proceed with the application. PART III MARKETING ORGANISMS Requirement for consent to market 14 The cases and circumstances prescribed for the purposes of Article 8(1)(a) of the Order in relation to marketing genetically modified organisms are all cases and circumstances in relation to the marketing of genetically modified organisms. Exempt activities 15 The cases and circumstances prescribed for the purposes of Article 5(7) and Article 8(7) of the Order in which persons are exempt from the requirements of Article 5(1)(a) of the Order (to carry out a risk assessment) and of Article 8(1)(a) of the Order (to obtain consent), insofar as they relate to marketing genetically modified organisms, are all cases and circumstances in which – a an approved product is marketed for a use for which it has approval; b genetically modified micro-organisms are made available for activities regulated under the Contained Use Directive; c genetically modified organisms other than micro-organisms falling within paragraph (b) are made available to be used exclusively for activities where appropriate stringent containment measures based on the same principles of containment as laid down in the Contained Use Directive are used to limit their contact with and to provide a high level of safety for the general population and the environment; d genetically modified organisms are made available to be used exclusively for deliberate releases complying with the requirements laid down in Part II; e a genetically modified organism authorised under Council Regulation (EEC) No. 2309/93 , as amended by Commission Regulation EC No 649/98 , is marketed; or f a novel food or novel food ingredient within the scope of Regulation EC No. 258/97 of the European Parliament and of the Council is marketed. Applications for consent to market 16 1 An application for a consent to market genetically modified organisms under Article 8(1) of the Order must be made in writing to the Department. 2 An application for a consent to market genetically modified organisms which is not an application for renewal of a consent must contain the following information – a the information prescribed in – i Schedule 1 where the application is for consent to market any genetically modified higher plant, or ii Schedule 2 in any other case, to the extent that such information is appropriate to the nature and scale of the release which may result from the marketing, b information on data or results from any previous release of the organisms, or of the same combination of organisms, which has been carried out by the applicant either inside or outside the European Community, and information from any previous application for consent to release the organisms, or the same combination of organisms, which the applicant has made to the Department in accordance with the Order and these Regulations or to another competent authority in accordance with Article 6 of the Deliberate Release Directive, c an environmental risk assessment prepared in accordance with regulation 6, d the information prescribed in Schedule 3, e the proposed conditions for the marketing of the product, including specific conditions of use and handling, f a proposed period for the consent which shall not exceed ten years, g a monitoring plan prepared in accordance with Annex VII of the Deliberate Release Directive which shall include a proposal for the time period of the plan which may differ from the proposed period for the consent, h a proposal for labelling which shall comply with the requirements laid down in Schedule 3, i a proposal for packaging, j a summary of the application in the format established by the Commission under Article 13(2)(h) of the Deliberate Release Directive. 3 The application may in addition contain – a data or results from an application for consent to release genetically modified organisms previously made by some other person, provided that a copy of that person’s agreement in writing is contained in the application, and b any other information which the applicant considers relevant. 4 The information provided in accordance with sub-paragraphs (2)(a) and (d) shall take into account the diversity of sites of use of the genetically modified organisms and shall include information on any results obtained from research and developmental releases concerning the impact of the release on human health and the environment. 5 Where the applicant can demonstrate in his application to the satisfaction of the Department, that, on the basis of the results of any release in pursuance of and in accordance with a consent under Article 8(1) of the Order or under Part B of either the Deliberate Release Directive or the 1990 Directive, or on other substantive, reasoned scientific grounds, the marketing and use of the product do not pose a risk of damage to the environment, he may omit from the application part or all of the information prescribed in Part II of Schedule 3. Transitional provision of marketing 17 Where the Department has received an application for consent to market genetically modified organisms before 15th April 2003 pursuant to the 1994 Regulations and has not yet determined that application, or, in a case where the Commission is required to take a decision in accordance with Article 13(3) of the 1990 Directive, that decision has not yet been taken – a the application shall be subject to the provisions of these Regulations; b the applicant shall submit to the Department such further information, additional to that already provided in connection with the application, as is necessary in order to comply with the requirements of these Regulations by 17th July 2003; c the application shall be treated as having been received by the Department for the purposes of regulation 23 on submission of the information required by paragraph (b); d if, by 15th April 2003, the Department has forwarded to the Commission the information required by regulation 16(2) of the 1994 Regulations, it shall supplement it and, if it considers it to be necessary, revise it on receipt of the further information required by paragraph (b) in the light of its obligations under these Regulations, and e if the information required by paragraph (b) has not been submitted by 17th July 2003, the Department may refuse to proceed with the application. Applications for renewal of consent to market 18 1 Where the Department has granted a consent to market genetically modified organisms under Article 8(1) of the Order, any application to renew that consent shall be made in writing to the Department – a before 17th October 2006 where the consent was granted before 15th April 2003; and b no later than nine months before the expiry of the consent in all other cases. 2 The application shall contain – a a copy of the consent to market the genetically modified organisms; b where applicable, a report on the results of the monitoring carried out in accordance with the requirements of regulation 28(f); c any other new information which has become available with regard to the risks of the product causing damage to the environment; d as appropriate, a proposal for amending or adding to the conditions of the existing consent, including the conditions concerning future monitoring, and a proposal for the time limitation of the new consent. 3 Any consent to market genetically modified organisms granted by the Department under Article 8(1) of the Order before 15th April 2003 for which no application for renewal under paragraph (1) has been received before 17th October 2006 shall be treated as having expired on that date. PART IV DUTIES AFTER THE MAKING OF APPLICATIONS Duty of the applicant after applying for consent to release or to market 19 1 In Article 8 of the Order (consents required by certain persons) in paragraph (6) (power of Department to require further information) insert as a second sentence – A notice under this paragraph must state the reasons for requiring the further information specified in the notice. . 2 An applicant for a consent to release or to market genetically modified organisms who notifies the Department of any information in accordance with Article 8(6A) of the Order (requirement for applicant to notify new information regarding risks of damage to the environment) shall submit in writing to the Department a revised version of the original application for consent amended to take account of the new information. Duties of the Department in relation to applications for consent to release 20 Following receipt of an application for consent to release genetically modified organisms the Department shall – a inform the applicant in writing of the date of receipt of the application; b invite any person by means of a request placed on the register, to make representations to it relating to any risks of damage being caused to the environment by the release before the end of a period to be specified which shall not be less than sixty days from the date the application was received by it; c within 30 days of the date the application was received by it forward to the Commission a summary of that application in the format established by the Commission under Article 11(1) of the Deliberate Release Directive; d examine the application for its conformity with the requirements of the Order and of these Regulations; e evaluate the risks of damage being caused to the environment by the proposed release having regard to the environmental risk assessment; and f take into account any representations relating to risks of damage being caused to the environment by the release made to it before the end of the period specified in accordance with paragraph (b) and any comments made by a competent authority or authorities of other Member States following the circulation to them by the Commission of the summary referred to in paragraph (c). Decisions by the Department on applications for consent to release 21 1 The Department shall not grant a consent to release genetically modified organisms under Article 8(1) of the Order as it relates to the protection of human health without the agreement of the Executive. 2 The Department shall not grant or refuse consent to release genetically modified organisms before the end of a period of 60 days beginning on the day on which the application for consent was received. 3 The Department shall communicate its decision on an application for a consent to release genetically modified organisms to the applicant and to the Commission before the end of a period of 90 days beginning with the day on which the application was received and shall include in any refusal of consent the reasons for the decision. 4 The period prescribed in paragraph (3) shall not include – a any period beginning with the day on which the Department gives notice in writing under Article 8(6) of the Order that further information in respect of the application is required and ending on the day on which that information is received by the Department; or b any period of time during which the Department is considering representations submitted by any persons in accordance with regulation 20(b), provided that this consideration shall not prolong the 90 day period referred to in paragraph (3) by more than 30 days. 5 A consent to release genetically modified organisms shall require the applicant to send any information which might be relevant to assessing the risk of damage being caused to the environment, with, where appropriate, particular reference to any product which it is intended to market in the future, to the Department as soon as reasonably practicable after completion of the release and thereafter, at such intervals as the Department shall consider appropriate on the basis of the results of the environmental risk assessment. 6 The Department shall send to the Commission the information submitted to it in accordance with paragraph (5). Variation or revocation of a consent to release genetically modified organisms 22 1 The Department shall only vary or revoke a consent to release genetically modified organisms under Article 8(10) of the Order without the agreement of the holder of the consent where new information has become available to it which it considers would affect the assessment of the risk of damage being caused to the environment by the release. 2 The Department shall not revoke or vary a consent to release genetically modified organisms under Article 8(10) of the Order as it relates to the protection of human health without the agreement of the Executive. Duties of the Department in relation to applications for consent to market 23 1 Following receipt of an application for a consent to market genetically modified organisms the Department shall – a inform the applicant in writing of the date of receipt of the application; b forward to the Commission and to the competent authorities of the other Member States a summary of that application in the format established by the Commission under Article 13(2)(h) of the Deliberate Release Directive; c examine the application for its conformity with the requirements of the Order and of these Regulations and, if necessary, request the applicant to supply additional information; d before the end of a period of 90 days beginning with the day on which it received the application either – i send to the applicant an assessment report prepared in accordance with Schedule 4 which indicates that the genetically modified organisms should be permitted to be marketed and under which conditions, or ii refuse the application, stating reasons for its decision, supported by an assessment report prepared in accordance with Schedule 4 which indicates that the genetically modified organisms should not be marketed, and e once it is satisfied it conforms to the requirements prescribed in regulation 16, and no later than when it sends its assessment report in accordance with paragraph (d), forward a copy of the application to the Commission. 2 The Department shall forward to the Commission – i its assessment report, ii any further information it has received from the applicant pursuant to the service of a notice under Article 8(6) of the Order, iii any additional information on which it has based its assessment report, in the circumstances described in paragraph (1)(d)(i), before the end of a period of 90 days beginning with the day on which it received the application and, in the circumstances described in paragraph (1)(d)(ii), no sooner than 15 days from the date it sent the assessment report to the applicant and no later than 105 days from the date it received the application. 3 The 90 day periods prescribed in paragraphs (1) and (2) shall not include any period beginning with the day on which the Department gives notice in writing under Article 8(6) of the Order that further information in respect of the application is required and ending on the day on which that information is received by the Department. 4 Where the Department intends to submit to the Commission an assessment report which indicates that the genetically modified organisms to which an application relates should be permitted to be marketed, it shall first consult the Executive and shall not forward its favourable opinion on the application as it relates to the protection of human health where the Executive has informed it that it does not fulfil the requirements of the Order and of these Regulations. Decisions by the Department on applications for consents to market genetically modified organisms 24 1 The Department may grant an application for consent to market genetically modified organisms only where it has prepared an assessment report which indicates that the genetically modified organisms should be marketed and – a no objection has been raised by a Member State or by the Commission during a 60 day period beginning on the day the Commission circulated the assessment report, or b an objection or objections have been raised by either a Member State or by the Commission but outstanding issues have been resolved in accordance with Article 15(l) of the Deliberate Release Directive within a 105 day period beginning on the day the Commission circulated the assessment report; or c an objection has been raised by a Member State or the Commission and the Commission has adopted a decision in accordance with Article 18(l) of the Deliberate Release Directive in favour of granting consent. 2 The Department shall inform the competent authority or authorities of each Member State and the Commission of its decision to grant consent to market genetically modified organisms within thirty days of its grant. 3 For the purpose of calculating the final 45 day period of 105 days in paragraph (1)(b) no period during which further information is awaited from the applicant shall be taken into account. 4 Subject to paragraphs (5) and (6), a consent to market genetically modified organisms shall be given for a maximum period of ten years beginning with the day on which the consent is issued. 5 For the purpose of granting consent to market a genetically modified organism or any progeny of that genetically modified organism contained in a plant variety where that plant variety is intended only for the marketing of its seeds under the relevant Community provisions the period of the first consent shall end at the latest ten years after the date of the first inclusion of the first plant variety containing the genetically modified organism on an official national catalogue of plant varieties in accordance with Directives 2002/53/EC and 2002/55/EC . 6 For the purpose of granting consent to market a genetically modified organism contained in forest reproductive material, the period of any first consent shall end at the latest ten years after the date of the first inclusion of basic material containing the genetically modified organism on an official national register of basic material in accordance with Council Directive 1999/105/EC . Duties of the Department on receiving applications for renewal of consent to market 25 1 On receipt of an application for renewal of consent to market genetically modified organisms the Department shall – a inform the applicant in writing of the date of receipt of the application; b examine the application for its conformity with the requirements of the Order and of these regulations and, if necessary, request the applicant to supply additional information; c either – i send to the applicant an assessment report prepared in accordance with Schedule 4 which indicates that the genetically modified organisms should continue to be permitted to be marketed and under which conditions, or ii refuse the application, stating reasons for its decision, supported by an assessment report which indicates that the genetically modified organisms should not continue to be marketed, d forward to the Commission a copy of the application and its assessment report. 2 Where the Department intends to submit to the Commission an assessment report which indicates that the genetically modified organisms to which an application relates should be permitted to be marketed, it shall first consult the Executive and shall not forward its favourable opinion on the application as it relates to the protection of human health where the Executive has informed it that it does not fulfil the requirements of the Order and of these Regulations. Decisions by the Department on applications for renewal of consent to market genetically modified organisms 26 1 The Department may grant an application to renew a consent to market genetically modified organisms only where it has prepared an assessment report which indicates that the genetically modified organisms should continue to be permitted to be marketed and – a no objection has been raised by a Member State or by the Commission during a 60 day period beginning on the day the Commission circulated the assessment report; or b an objection or objections have been raised by either a Member State or by the Commission but all outstanding issues have been resolved in accordance with Article 17(8) of the Deliberate Release Directive within a 75 day period beginning on the day the Commission circulated the assessment report; or c an objection has been raised by a Member State or the Commission and the Commission has adopted a decision in accordance with Article 18(l) of the Deliberate Release Directive in favour of granting consent. 2 The Department shall inform the competent authority or authorities of each Member State and the Commission of its decision to renew consent to market genetically modified organisms within 30 days of its renewal. 3 The consent to market genetically modified organisms shall be given for a period of ten years unless the Department considers that a shorter or longer period is justified, in which case it shall give its reasons in writing. 4 The applicant may continue to market the genetically modified organisms under the conditions specified in the original consent until a final decision has been taken on the application. Genetically modified organisms containing antibiotic resistance markers 27 1 The Department shall not grant a consent to an application for the release or marketing of genetically modified organisms containing antibiotic resistance markers which may have adverse effects on human health and the environment after – i 31st December 2004 in the case of placing on the market; and ii 31st December 2008 in the case of release. 2 Where prior to 31st December 2004 in the case of placing on the market and 31st December 2008 in the case of release, an application is made for consent to release or place on the market genetically modified organisms containing antibiotic resistance markers, the Department shall evaluate the information in the environmental risk assessment accompanying the application, taking into particular consideration those antibiotic resistance markers in use for medical or veterinary treatment, with a view to identifying and phasing out the release or placing on the market of the genetically modified organisms referred to in paragraph (1) within the time limits specified in that paragraph. PART V GENERAL PROVISION FOR CONSENTS TO MARKET General provisions of consents to market genetically modified organisms 28 A consent to market genetically modified organisms granted by the Department under Article 8(1) of the Order shall specify – a the scope of the consent, including the identity of the genetically modified organisms to be placed on the market, and their unique identifier; b the period of validity of the consent; c the conditions for the placing on the market the product, including any specific conditions of use, handling and packaging of the genetically modified organisms, and conditions for the protection of particular ecosystems or environments or geographical areas as applicable; d that the applicant shall make control samples available to the Department on request; e the labelling requirements, in accordance with paragraph 8 of Schedule 3, which shall include a requirement to notify the Department of any new commercial name of the product after consent has been given; and f monitoring requirements which shall be in accordance with the monitoring plan, and shall include the time period of the monitoring plan, an obligation that the applicant shall submit the reports of monitoring to the Commission and the competent authorities of the Member States and, where appropriate, any obligations on any person selling the product or any user, which may include an obligation to provide the information at an appropriate level on the location of the genetically modified organisms that are grown. General conditions in consents to release or market genetically modified organisms 29 1 Article 9 of the Order (consents: limitations and conditions) is amended as follows. 2 In paragraph (1) (power of Department to impose limitations and conditions) after the words “as he may think fit” insert “for the purpose of ensuring that all appropriate measures are taken to avoid damage to the environment which may arise from the activity permitted by the consent.”. 3 In paragraph (5) (implied condition when releasing or marketing) – a in sub-paragraph (b) (obligation to notify Department of new information etc) – i after “Department” insert “forthwith”, ii omit head (ii), and iii after that head insert – iii any unforeseen event, occurring in connection with a release by him, which might affect the risks there are of damage to the environment being caused as a result of their being released. , b for sub-paragraph (c) (duty as regards preventing damage to environment) substitute – c take such measures as are necessary to prevent any damage to the environment being caused as a result of the release or, as the case may be, the placing on the market of the organisms; , and c after that sub-paragraph insert – d notify the Department of the measures (if any) taken as a result of new information becoming available or an unforeseen event occurring as described in sub-paragraph (b)(iii); and e in a case where new information becomes available or an unforeseen event so occurs, revise the information contained in his application for a consent accordingly and supply the revised information to the Department. . Proof of compliance with consent condition 30 In Article 16 of the Order (onus of proof as regards techniques and evidence) in paragraph (1) (accused to prove use of best available techniques) after “the accused to prove” insert the matters described in paragraph (1A). 1A The matters referred to in paragraph (1) are – a in the case of an offence under Article 15(1)(c) consisting in a failure to comply with the general condition implied by Article 9(5)(c) – i that no measures, other than the measures taken by him, were necessary to prevent damage being caused to the environment from the release or, as the case may be, placing on the market of the organisms, or ii in a case where he took no measures, that no measures were necessary; and b in any other case, . New information on risks of damage from marketing genetically modified organisms 31 1 The Department shall immediately forward to the Commission and the competent authority or authorities of each Member State any new information which becomes available to it which it considers could affect the assessment of the risk of the damage being caused to the environment by releasing or placing on the market genetically modified organisms. 2 Where an application for consent or for renewal of consent to place on the market genetically modified organisms has been made and the information referred to in paragraph (1) becomes available to the Department before the consent has been granted or renewed, the Department may seek to reach agreement with the Commission and other Member States pursuant to Articles 15(1) or 17(7) of the Deliberate Release Directive as applicable. 3 Where an application for consent or for renewal of consent to place on the market genetically modified organisms has been made and the information referred to in paragraph (1) becomes available to the Department after the consent has been granted or renewed, it shall within 60 days after receipt of the new information, forward to the Commission an assessment report indicating whether the conditions of the consent should be varied, and, if so, how, or whether the consent should be revoked. 4 The Department shall not forward an assessment report indicating that the consent to place on the market genetically modified organisms as it relates to the protection of human health should be varied without the agreement of the Executive. 5 Where the Department has indicated that the consent should be varied and either – a no objection has been raised by a Member State or by the Commission during a 60 day period beginning on the day the Commission circulated the assessment report, or b an objection or objections have been raised by a Member State or by the Commission but outstanding issues have been resolved in accordance with Article 20(3) of the Deliberate Release Directive; it shall vary the consent as proposed and inform the applicant, the competent authority or authorities of each Member State and the Commission that it has done so within 30 days thereof. 6 The Department shall only vary or revoke a consent to market genetically modified organisms under Article 8(10) of the Order – a where the information referred to in paragraph (1) has become available to it, and the procedure referred to in paragraphs (3) and (5) has been complied with, or b in accordance with a decision by the Commission under Article 18(1) or Article 23(2) of the Deliberate Release Directive. PART VI SAFEGUARD Safeguard 32 1 The Department may serve a prohibition notice under Article 7 of the Order to prohibit an act which is authorised by the consent granted by it under Article 8(1) of the Order or by a consent granted in respect of an approved product only if its opinion that doing such an act would involve a risk of causing damage to the environment is based on detailed grounds as a result of either – a new or additional information made available since the date of the consent which affects the environmental risk assessment in respect of that product; or b a reassessment of existing information in respect of that product on the basis of new or additional scientific information. 2 Where, in the circumstances described in paragraph (1), the Department considers that the risk of damage being caused to the environment is severe it shall serve a prohibition notice requiring such measures to be taken as it may consider appropriate and once any work required by the notice has been carried out it shall enter details of it on the register. 3 In cases to which paragraphs (1) and (2) apply, the Department shall immediately inform the Commission and the other Member States of its actions and shall at the same time provide them with – a its reasons for taking such actions; b the results of its review of the environmental risk assessment; c its opinion as to whether the conditions of the consent should be varied, and if so, how, or whether the consent should be revoked; and d where appropriate, the new or additional information on which its decision to take action was based. 4 A prohibition notice served under Article 7 of the Order in accordance with this regulation shall be subject to any decision adopted by the Commission in accordance with Article 23(2) of the Deliberate Release Directive. 5 Upon receipt of notification of a decision by the Commission to which paragraph (4) refers the Department shall send a copy of it to the holder of the consent to which the decision relates and shall at the same time withdraw any prohibition notice which is inconsistent with that decision. 6 References in this regulation to the Department exercising a function under Article 7 of the Order shall, in any case to which Article 22(3) of the Order applies, be treated as references to the Department and the Food Standards Agency acting jointly. PART VII CONFIDENTIALITY Confidentiality 33 1 For the purposes of Article 20(7) of the Order, the following descriptions of information are also information which the public interest requires to be included in the register notwithstanding that it may be commercially confidential – a the location of the release of the genetically modified organisms to which the information relates; b the intended use of the genetically modified organisms to which the information relates; c the environmental risk assessment; d the methods and plans for monitoring and for responding to an emergency in relation to the genetically modified organisms to which the information relates; e the name and address of the holder of a consent to which a prohibition notice or other information relates. 2 In Article 20 of the Order (exclusion from register of certain information) in paragraph (7) (particulars included even if commercially confidential) – a after “Article 19(1)(a),” insert “(c)”, b in sub-paragraph (b) for “the description” substitute “the general description”, and c sub-paragraphs (c) and (e) are omitted. PART VIII REGISTER OF INFORMATION Information to be included in the register 34 1 The register shall contain the particulars set out in paragraphs (2) to (10). 2 In relation to a prohibition notice served by the Department under Article 7 of the Order – a the name and address of the person on whom the notice is served, b the description of the genetically modified organisms in relation to which the notice is served, c the location at which the genetically modified organisms are proposed to be released, d the purpose for which the genetically modified organisms are proposed to be released or placed on the market, e the reason for the service of the notice, f any date specified in the notice as the date on which the prohibition is to take effect. 3 Subject to paragraph (4), in relation to an application for a consent under Article 8(1) of the Order – a the name and address of the applicant, b a general description of the genetically modified organisms in relation to which the application is being made, c the location at which the genetically modified organisms are proposed to be released, to the extent that this information is notified to the Department, d the purpose for which the genetically modified organisms are proposed to be released (including any future use to which they are intended to be put) or, in relation to a consent to place on the market, the purpose for which they will be marketed, e the intended dates of the release, f the environmental risk assessment, g the methods and plans for monitoring the genetically modified organisms and for responding to an emergency, and h a summary of any advice the Department has received from the Advisory Committee on Releases to the Environment as to whether an application for release of genetically modified organisms should be granted or rejected, and either – i the conditions or limitations in accordance with which that committee has advised that the consent should be granted, or ii a summary of the reasons why that committee has advised that the consent should not be granted. 4 Where the Department is or becomes aware that information regarding the genetically modified organisms or the purpose for which they will be released or marketed has been published which is more detailed than that which would satisfy the requirements of paragraph (3), it shall enter so much of that more detailed information on the register as it shall consider appropriate. 5 In relation to consents granted under Article 8(1) of the Order – a a copy of the consent, and a reference to the application in respect of which it was granted, b any information supplied to the Department in accordance with conditions imposed on the consent, c the fact that the consent has been varied or revoked, the contents of the notice by which the consent was varied or revoked, and a copy of the varied consent, d a summary of any advice the Department has received from the Advisory Committee on Releases to the Environment as to whether a consent to release genetically modified organisms should be varied or revoked. 6 The following information concerning genetically modified organisms released or grown pursuant to a consent – a any information provided to the Department in accordance with Article 8(6A) or Article 9(5)(b)(i) of the Order, b any information relating to an unforeseen event occurring in connection with a release of a genetically modified organism which might affect the risks there are of damage being caused to the environment notified to the Department in accordance with Article 9(5)(b)(ii) of the Order. 7 A copy of any consent to market genetically modified organisms granted by a competent authority of another Member State. 8 The location of any genetically modified organisms grown in Northern Ireland pursuant to a consent to market insofar as that information is supplied to the Department in accordance with the monitoring requirements imposed on the consent. 9 Any decision adopted by the Commission in accordance with Article 18 of the Deliberate Release Directive. 10 In relation to convictions for any offence under Article 15 of the Order – a the name and address of the person convicted, b the description of any genetically modified organisms in relation to which the conviction was obtained, c the offence which was committed, d the penalty imposed and any order made by the court under Article 17 of the Order. Keeping the register 35 1 The information prescribed in regulation 34(2) shall be placed on the register within 12 days of the prohibition notice being served. 2 The information prescribed in paragraphs (a) to (g) of regulation 34(3) shall be placed on the register within 12 days of the receipt by the Department of the application for consent to release or to place on the market. 3 The information prescribed in regulation 34(3)(h) shall be placed on the register within 12 days of the consent being granted or refused. 4 The information prescribed in regulation 34(5)(a) shall be placed on the register within 12 days of the consent being granted. 5 The information prescribed in regulation 34(5)(b) and (d) shall be placed on the register within 12 days of its receipt by the Department. 6 The information prescribed in regulation 34(5)(c) shall be placed on the register within 14 days of the consent being revoked or varied. 7 The information prescribed in regulations 34(6) and 34(10) shall be placed on the register within 14 days of its receipt by the Department. 8 The information prescribed in regulation 34(7) shall be placed on the register within 14 days of its receipt by the Department. 9 The information prescribed in regulation 34(8) shall be placed on the register within 14 days of its receipt by the Department. 10 The information prescribed in regulation 34(9) shall be placed on the register within 14 days of the decision having been notified to the Department. Publication of representations 36 1 The Department shall, within a period of 28 days after granting consent to or rejecting an application for the release of genetically modified organisms, make available to the public by whatever means it shall consider appropriate, details of where and when paper copies of representations received may be inspected. 2 Paragraph (1) shall not require copies of representations to be made publicly available where they contain confidential information and the person making the representations has asked the Department to treat that information as confidential. PART IX MISCELLANEOUS Advisory Committee for the purposes of the Order 37 After Article 22 of the Order there shall be inserted – Advisory Committee 22A 1 The Department shall appoint a Committee to provide it with advice – a on the exercise of its powers under Articles 8, 9 and 10; b on the exercise of any power under this Order to make regulations, and on such other matters concerning the Department’s functions under this Order as the Department may from time to time direct. 2 The Department shall pay to the members of the Committee such remuneration (if any) and such allowances as it may determine. 3 The “Committee” means the Committee appointed by the Secretary of State under section 124 of the Environmental Protection Act 1990 . . Revocations 38 The Regulations set out in Schedule 5 are revoked to the extent set out in that Schedule. Sealed with the Official Seal of the Department of the Environment on 12th March 2003. Judena Goldring A senior officer of the Department of the Environment