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Statutory Instrument 2002 No. 2443Genetically Modified Organisms (Deliberate Release) Regulations 2002(The document as of February, 2008) STATUTORY INSTRUMENTS2002 No. 2443ENVIRONMENTAL PROTECTIONGenetically Modified Organisms (Deliberate Release) Regulations 2002
The Secretary of State for Environment, Food and Rural Affairs in exercise of the powers conferred on her by section 2(2) of the European Communities Act 1972[1], being the Minister designated[2] for the purposes of that subsection in relation to the control and regulation of genetically modified organisms, and sections 108(7), 111(1), (4), (5), (7) and (11), 122(1) and (4), 123(7), and 156 of the Environmental Protection Act 1990[3], having consulted the Food Standards Agency in accordance with section 126(5) of that Act, hereby makes the following Regulations: - Citation, commencement, extent and application 1. - (1) These Regulations may be cited as the Genetically Modified Organisms (Deliberate Release) Regulations 2002 and shall come into force on 17 October 2002. (2) Except for this regulation, regulation 38, insofar as it relates to the continental shelf, and regulation 2, insofar as it defines "the Act" for the purposes of regulation 38, these Regulations shall extend only to England and Wales. (3) Except for this regulation, regulations 3, 4, 19(1), 29, 30, 33(2), 38 and 39 and regulation 2, insofar as it defines "the Act" for the purposes of the regulations referred to in this paragraph, these Regulations shall apply only to England. Interpretation 2.In these Regulations -
Purpose of Part VI of the Act and meaning of "genetically modified organisms" etc
(3) In subsection (4) (definition of organism which is genetically modified) for paragraph (a) (modification of prescribed artificial technique) substitute -
(4) After that subsection insert -
(4B) For the purposes of subsection (4) above -
(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 paragraph. (4C) An organism shall be taken not to be a genetically modified organism for the purposes of this Part if it is an organism of a prescribed description. (5) Subsections (5) and (6) are omitted.
(3) In subsection (3) (meaning of "damage to the environment") omit "to the living organisms supported by the environment".
(5) For subsection (9) (meaning of organism being under a person's "control") substitute -
(6) For subsection (11) (meaning of organism being "marketed") substitute -
Techniques of genetic modification
(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 force of the first regulations under section 106(4B)(b) of the Act, genes or other genetic material shall not be regarded, for the purposes of subsection (4) of that section, as artificially modified by reason only of being altered by the use of any of the following techniques: -
(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 -
(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 force of the first regulations under section 106(4C) of the Act, an organism shall be taken, for the purposes of Part VI of the Act, 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.
(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 bibliographic references 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. Requirement for consent to release 8.The cases and circumstances prescribed for the purposes of section 111(1)(a) of the Act 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 section 111(7) of the Act in which persons are exempt from the requirements of section 111(1)(a) of the Act, 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 section 111(1)(a) of the Act 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 - general provisions 10. - (1) An application for a consent to release genetically modified organisms must be made in writing to the Secretary of State. (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 -
(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, (2) The application may contain -
(b) any other information that the applicant considers relevant. Advertisement of applications for consent to release
(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 Secretary of State within twelve days of her receipt of the application, (f) the means by which that register can be inspected, (g) a statement that the Secretary of State will consider any representations made to her relating to risks of damage to the environment posed by the release of the genetically modified organisms within a period which she shall specify in accordance with these Regulations and shall immediately send a copy of the newspaper containing the advertisement to the Secretary of State.
(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 (Contained Use) Regulations 2000[15], (d) the Association of National Park Authorities, (e) English Nature[16], and (f) the Environment Agency, and shall immediately send to the Secretary of State copies of the notices.
(b) the applicant shall submit to the Secretary of State 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 17 January 2003, (c) the application shall be treated as having been sent to the Secretary of State for the purposes of regulations 12(1) and (4) and as having been received by the Secretary of State 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 17 January 2003, the Secretary of State may refuse to proceed with the application. Requirement for consent to market 14.The cases and circumstances prescribed for the purposes of section 111(1)(a) of the Act 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 sections 108(7) and 111(7) of the Act in which persons are exempt from the requirements of section 108(1)(a) of the Act (to carry out a risk assessment) and of section 111(1)(a) of the Act (to obtain consent), respectively, insofar as they relate to marketing genetically modified organisms, are all cases and circumstances in which -
(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[17], as amended by Commission Regulation EC No 649/98[18], 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[19] is marketed. Applications for consent to market
(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, (3) The application may in addition contain -
(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.
(b) the applicant shall submit to the Secretary of State 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 17 January 2003, (c) the application shall be treated as having been received by the Secretary of State for the purposes of regulation 23 on submission of the information required by paragraph (b), (d) if, by 17 October 2002, the Secretary of State has forwarded to the Commission the information required by regulation 16(2) of the 1992 Regulations, she shall supplement it and, if she considers it to be necessary, revise it on receipt of the further information required by paragraph (b) in the light of her obligations under these Regulations, and (e) if the information required by paragraph (b) has not been submitted by 17 January 2003, the Secretary of State may refuse to proceed with the application. Applications for renewal of consent to market
(b) no later than nine months before the expiry of the consent in all other cases. (2) The application shall contain -
(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 Secretary of State under section 111(1) of the Act before 17 October 2002 for which no application for renewal under paragraph (1) has been received before 17 October 2006 shall be treated as having expired on that date. Duty of the applicant after applying for consent to release or to market 19. - (1) In section 111 of the Act (consents required by certain persons) in subsection (6) (power of Secretary of State or the National Assembly for Wales to require further information) insert as a second sentence -
(2) An applicant for a consent to release or to market genetically modified organisms who notifies the Secretary of State of any information in accordance with section 111(6A) of the Act (requirement for applicant to notify new information regarding risks of damage to the environment) shall submit in writing to the Secretary of State a revised version of the original application for consent amended to take account of the new information.
(b) invite any person by means of a request placed on the register, to make representations to her 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 60 days from the date the application was received by her; (c) within 30 days of the date the application was received by her 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 Act 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 her 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 Secretary of State on applications for consent to release
(b) any period of time during which the Secretary of State 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 Secretary of State as soon as reasonably practicable after completion of the release and thereafter, at such intervals as the Secretary of State shall consider appropriate on the basis of the results of the environmental risk assessment.
(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 Act 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 she received the application either -
(ii) refuse the application, stating reasons for her 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 she is satisfied it conforms to the requirements prescribed in regulation 16, and no later than when she sends her assessment report in accordance with paragraph (d), forward a copy of the application to the Commission. (2) The Secretary of State shall forward to the Commission -
(b) any further information she has received from the applicant pursuant to the service of a notice under section 111(6) of the Act, and (c) any additional information on which she has based her assessment report, in the circumstances described in regulation 23(d)(i), before the end of a period of 90 days beginning with the day on which she received the application and, in the circumstances described in regulation 23(d)(ii), no sooner than 15 days from the date she sent the assessment report to the applicant and no later than 105 days from the date she received the application.
(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 15(1) 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(1) of the Deliberate Release Directive in favour of granting consent. (2) The Secretary of State shall inform the competent authority or authorities of each member State and the Commission of her decision to grant consent to market genetically modified organisms within 30 days of its grant.
(b) examine the application for its conformity with the requirements of the Act and of these Regulations and, if necessary, request the applicant to supply additional information, (c) either -
(ii) refuse the application, stating reasons for her 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 her assessment report. (2) Where the Secretary of State 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, she shall first consult the Health and Safety Executive and shall not forward her favourable opinion on the application as it relates to the protection of human health where the Health and Safety Executive has informed her that it does not fulfil the requirements of the Act and of these Regulations.
(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(1) of the Deliberate Release Directive in favour of granting consent. (2) The Secretary of State shall inform the competent authority or authorities of each member State and the Commission of her decision to renew consent to market genetically modified organisms within 30 days of its renewal.
(ii) 31 December 2008 in the case of release. (2) Where prior to 31 December 2004 in the case of marketing and 31 December 2008 in the case of release, an application is made for consent to release or market genetically modified organisms containing antibiotic resistance markers, the Secretary of State 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 marketing of the genetically modified organisms referred to in paragraph (1) within the time limits specified in that paragraph. General provisions of consents to market 28.A consent to market genetically modified organisms granted by the Secretary of State under section 111(1) of the Act shall specify -
(b) the period of validity of the consent, (c) the conditions for marketing 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 Secretary of State on request, (e) the labelling requirements, in accordance with paragraph 8 of Schedule 3, which shall include a requirement to notify the Secretary of State 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 information at an appropriate level on the location of the genetically modified organisms that are grown. General conditions in consents to release or market
(ii) omit sub-paragraph (ii), and (iii) after that sub-paragraph insert -
(b) for paragraph (c) (duty as regards preventing damage to environment) substitute -
(c) after that paragraph insert -
(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 Secretary of State.". Proof of compliance with consent conditions
(1A) The matters referred to in subsection (1) above are -
(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
(b) an objection or objections have been raised by a member State or by the Commission but all outstanding issues have been resolved in accordance with Article 20(3) of the Deliberate Release Directive, she shall vary or revoke the consent as proposed and inform the applicant, the competent authority or authorities of each member State and the Commission that she has done so within 30 days thereof.
(b) in accordance with a decision adopted by the Commission under Article 18(1) or Article 23(2) of the Deliberate Release Directive. Safeguard 32. - (1) The Secretary of State may serve a prohibition notice under section 110 of the Act to prohibit an act which is authorised by a consent granted by her under section 111(1) of the Act or by a consent granted in respect of an approved product only if her opinion that doing such an act would involve a risk of causing damage to the environment is based on detailed grounds as the result of either -
(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 Secretary of State considers that the risk of damage being caused to the environment is severe she shall serve a prohibition notice requiring such measures to be taken as she may consider appropriate and once any work required by the notice has been carried out she shall enter details of it on the register.
(b) the results of her review of the environmental risk assessment, (c) her 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 her decision to take action was based. (4) A prohibition notice served under section 110 of the Act 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. Confidentiality 33. - (1) For the purposes of section 123(7) of the Act 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 -
(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 section 123 of the Act (exclusion from register of certain information) in subsection (7) (particulars included even if commercially confidential) -
(b) in paragraph (b) for "the description" substitute "the general description", and (c) paragraphs (c) and (e) are omitted. 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 Secretary of State under section 110 of the Act -
(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 marketed, (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 section 111(1) of the Act -
(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 Secretary of State, (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 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 Secretary of State 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 -
(ii) a summary of the reasons why that committee has advised that the consent should not be granted. (4) Where the Secretary of State 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), she shall enter so much of that more detailed information on the register as she shall consider appropriate.
(b) any information supplied to the Secretary of State 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 Secretary of State 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 the risk of damage being caused to the environment by genetically modified organisms -
(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 Secretary of State in accordance with section 112(5)(b)(iii) of the Act. (7) A copy of any consent to market genetically modified organisms granted by a competent authority of another member State.
(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 section 120 of the Act. Keeping the register Revocations 37.The regulations set out in Schedule 5 are revoked in respect of England to the extent specified in that Schedule. Application of Part VI of the Act to territorial sea and continental shelf 38.In section 127(2) of the Act (definitions etc) in subsection (2) (application to territorial sea and continental shelf) -
(b) for the words from "to any" to the end substitute "applies to any area for the time being designated under section 1(7) of the Continental Shelf Act 1964[25] as it applies in England". Application of Part VI of the Act: England and Wales
(1) The amendments made to the provisions of Part VI by the 2002 Regulations, other than the amendment of section 127(2) as it relates to the continental shelf, have effect in relation to England only, and accordingly, in the application of that Part in relation to Wales, the provisions listed in subsection (2) below continue to have effect without the amendments made by the 2002 Regulations. (2) The provisions referred to in subsection (1) above are -
(b) section 107(2), (3), (6), (9) and (11); (c) section 111(6); (d) section 112(1) and (5); (e) section 119(1); (f) section 123(7); (g) section 127(2) in so far as it relates to the territorial sea. (3) In this section "the 2002 Regulations" means the Genetically Modified Organisms (Deliberate Release) Regulations 2002.".
1.The name and address of the applicant, and the name, qualifications and experience of the scientist and of every other person who will be responsible for planning and carrying out the release of the organisms, and for the supervision, monitoring and safety of the release. 2.The title of the project. 3.The full name of the plant -
(b) genus, (c) species, (d) subspecies, (e) cultivar/breeding line, (f) common name. 4.Information concerning -
(ii) any specific factors affecting reproduction, (iii) generation time; and (b) the sexual compatibility of the plant with other cultivated or wild plant species, including the distribution in Europe of the compatible species. 5.Information concerning the survivability of the plant:
(b) any specific factors affecting survivability. 6.Information concerning the dissemination of the plant:
(b) any specific factors affecting dissemination. 7.The geographical distribution of the plant. 10.A description of the methods used for the genetic modification. 11.The nature and source of the vector used. 12.The size, intended function and name of the donor organism or organisms of each constituent fragment of the region intended for insertion. 13.A description of the trait or traits and characteristics of the genetically modified plant which have been introduced or modified. 14.The following information on the sequences actually inserted or deleted:
(b) the size and function of the deleted region or regions, (c) the copy number of the insert, and (d) the location or locations of the insert or inserts in the plant cells (whether it is integrated in the chromosome, chloroplasts, mitochondria, or maintained in a non-integrated form) and the methods for its determination. 15.The following information on the expression of the insert -
(b) the parts of the plant where the insert is expressed, such as roots, stem or pollen. 16.Information on how the genetically modified plant differs from the parental or recipient plant in the following respects -
(b) dissemination, (c) survivability. 17.The genetic stability of the insert and phenotypic stability of the genetically modified plant. 26.The location and size of the release site or sites. 27.A description of the release site ecosystem, including climate, flora and fauna. 28.Details of any sexually compatible wild relatives or cultivated plant species present at the release sites. 29.The proximity of the release sites to officially recognised biotopes or protected areas which may be affected. 30.The purpose of the release of the genetically modified plant, including its initial use and any intention to use it as or in a product in the future. 31.The foreseen date or dates and duration of the release. 32.The method by which the genetically modified plants will be released. 33.The method for preparing and managing the release site, prior to, during and after the release, including cultivation practices and harvesting methods. 34.The approximate number of genetically modified plants (or plants per square metre) to be released. 35.A description of any precautions to -
(b) any measures to minimise or prevent dispersal of any reproductive organ of the genetically modified plant (such as pollen, seeds, tuber). 36.A description of the methods for post-release treatment of the site or sites. 41.A description of the methods used or a reference to standardised or internationally recognised methods used to compile the information required by this Schedule, and the name of the body or bodies responsible for carrying out the studies. 1.The name and address of the applicant, and the name, qualifications and experience of the scientist and of every other person who will be responsible for planning and carrying out the release of the organisms, and for the supervision, monitoring and safety of the release. 2.The title of the project. 3.Scientific name and taxonomy. 4.Usual strain, cultivar or other name. 5.Phenotypic and genetic markers. 6.The degree of relatedness between donor and recipient or between parental organisms. 7.The description of identification and detection techniques. 8.The sensitivity, reliability (in quantitative terms) and specificity of detection and identification techniques. 9.The description of the geographic distribution and of the natural habitat of the organisms including information on natural predators, prey, parasites and competitors, symbionts and hosts. 10.The organisms with which transfer of genetic material is known to occur under natural conditions. 11.Verification of the genetic stability of the organisms and factors affecting that stability. 12.The following pathological, ecological and physiological traits -
(b) the generation time in natural ecosystems and the sexual and asexual reproductive cycle; (c) information on survivability, including seasonability and the ability to form survival structures, including seeds, spores and sclerotia; (d) pathogenicity, including infectivity, toxigenicity, virulence, allergenicity, ability to act as a carrier (vector) of pathogen, possible vectors, host range including non-target organisms and possible activation of latent viruses (proviruses) and ability to colonise other organisms; (e) antibiotic resistance, and potential use of these antibiotics in humans and domestic organisms for prophylaxis and therapy; (f) involvement in environmental processes, including primary production, nutrient turnover, decomposition of organic matter and respiration. 13.The sequence, frequency of mobilisation and specificity of indigenous vectors, and the presence in those vectors of genes which confer resistance to environmental stresses. 15.The nature and source of the vector. 16.The sequence of transposons, vectors and other non-coding genetic segments used to construct the genetically modified organisms and to make the introduced vector and insert functions in those organisms. 17.The frequency of mobilisation, genetic transfer capabilities and/or methods of determination of the inserted vector. 18.The degree to which the vector is limited to the DNA required to perform the intended function. 19.The methods used for the modification. 20.The methods used -
(b) to delete a sequence. 21.The description of any insert and/or vector construction. 25.The description of genetic trait or traits or phenotypic characteristics and in particular any new traits and characteristics which may be expressed or no longer expressed. 26.The structure and amount of any vector or donor nucleic acid remaining in the final construction of the modified organisms. 27.The stability of the organisms in terms of genetic traits. 28.The rate and level of expression of the new genetic material in the organisms, and the method and sensitivity of measurement of that rate and level. 29.The activity of the gene product. 30.The description of identification and detection techniques, including techniques for the identification and detection of the inserted sequence and vector. 31.The sensitivity, reliability (in quantitative terms), and specificity of detection and identification techniques. 32.The history of previous releases or uses of the organisms. 33.In relation to human health, animal health and plant health -
(b) the comparison of the organisms to the donor, recipient or (where appropriate) parental organisms regarding pathogenicity, (c) the capacity of the organisms for colonisation, and (d) if the organisms are pathogenic to humans who are immunocompetent -
(ii) communicability, (iii) infective dose, (iv) host range and possibility of alteration, (v) possibility of survival outside of human host, (vi) presence of vectors or means of dissemination, (vii) biological stability, (viii) antibiotic resistance patterns, (ix) allergenicity, and (x) availability of appropriate therapies. (e) the other product hazards. 34.The description of the proposed deliberate release, including the initial purpose or purposes of the release and any intention to use the genetically modified organism as or in a product in the future. 35.The intended dates of the release and time planning of the experiment including frequency and duration of releases. 36.The preparation of the site before the release. 37.The size of the site. 38.The method or methods to be used for the release. 39.The quantity of organisms to be released. 40.The disturbance on the site, including the type and method of cultivation, and mining, irrigation or other activities. 41.The worker protection measures taken during the release. 42.The post-release treatment of the site. 43.The techniques foreseen for elimination or inactivation of the organisms at the end of the experiment or other purpose of the release. 44.Information on, and the results of, previous releases of the organisms, and in particular, releases on a different scale or into different ecosystems. 45.The geographical location and national grid reference of the site or sites on to which the release will be made, or the foreseen areas of use of the product. 46.The physical or biological proximity of the site of the organisms to humans and other significant biota. 47.The proximity to significant biotopes, protected areas or drinking water supplies. 48.The climatic characteristics of the region or regions likely to be affected. 49.The geographical, geological and pedological characteristics. 50.The flora and fauna, including crops, livestock and migratory species. 51.The description of the target and non-target ecosystems likely to be affected. 52.The comparison of the natural habitat of the recipient organisms with the proposed site or sites of release. 53.Any known planned developments or changes in land use in the region which could influence the environmental impact of the release. 54.The biological features which affect survival, multiplication and dispersal. 55.The known or predicted environmental conditions which may affect survival, multiplication and dissemination, including wind, water, soil, temperature and pH. 56.The sensitivity to specific agents. 57.The predicted habitat of the organisms. 58.The studies on the behaviour and characteristics of the organisms and their ecological impact carried out in simulated natural environments, such as microcosms, growth rooms and greenhouses. 59.The capability of post-release transfer of genetic material -
(b) from indigenous organisms to the genetically modified organisms. 60.The likelihood of post-release selection leading to the expression of unexpected and/or undesirable traits in the genetically modified organisms. 73.Methods for tracing the organisms and for monitoring their effects. 74.Specificity (to identify the organisms, and to distinguish them from the donor, recipient or, where appropriate, the parental organisms), sensitivity and reliability of the monitoring techniques. 75.Techniques for detecting transfer of the donated genetic material to other organisms. 76.Duration and frequency of the monitoring. 77.Methods and procedures to avoid and/or minimise the spread of the organisms beyond the site of release or the designated area for use. 78.Methods and procedures to protect the site from intrusion by unauthorised individuals. 79.Methods and procedures to prevent other organisms from entering the site. 80.Type of waste generated. 81.Expected amount of waste. 82.Description of treatment envisaged. 83.Methods and procedures for controlling the organisms in case of unexpected spread. 84.Methods, such as eradication of the organisms, for decontamination of the areas affected. 85.Methods for disposal or sanitation of plants, animals, soils, and any other thing exposed during or after the spread. 86.Methods for the isolation of the areas affected by the spread. 87.Plans for protecting human health and the environment in case of the occurrence of an undesirable effect. A description of the methods used or a reference to standardised or internationally recognised methods used to compile the information required by this Schedule, and the name of the body or bodies responsible for carrying out the studies. 1.The proposed commercial name of the product and names of the genetically modified organisms in the product, and any specific identification, name or code used by the applicant to identify the genetically modified organism. 2.The name and address in the Community of the person who is responsible for the marketing, whether it be the manufacturer, importer or distributor. 3.The name and address of the supplier or suppliers of control samples. 4.A description of how the product and the genetically modified organism are intended to be used, highlighting any differences in use or management of the genetically modified organism compared to similar non-genetically modified products. 5.A description of the geographical area or areas and types of environment where the product is intended to be used within the Community, including, where possible, an estimate of the scale of use in each area. 6.A description of the intended categories of users of the product, such as industry, agriculture or consumer use by the public. 7.Information on the genetic modification for the purposes of placing on one or several registers modifications in organisms, which can be used for the detection and identification of particular products to facilitate post marketing control and inspection. This information should include where appropriate the lodging of samples of the genetically modified organism or its genetic material with the Secretary of State, and details of nucleotide sequences or other type of information which is necessary to identify the product and its progeny, for example the methodology for detecting and identifying the product, including experimental data demonstrating the specificity of the methodology. Information that cannot be placed, for confidentiality reasons, in the publicly accessible part of the register should be identified. 8.The proposed labelling, which must include, in a label or an accompanying document, at least in summarised form, a commercial name of the product, a statement that "This product contains genetically modified organisms", the name of the genetically modified organism and the name and address of the person established in the Community who is responsible for marketing the product, and how to access the information in the publicly accessible part of the register. 9.The measures to be taken in the event of the escape of the organisms in the product or misuse of the product. 10.Specific instructions or recommendations for storage and handling of the product. 11.Specific instructions for carrying out monitoring and reporting to the applicant and, if required, the Secretary of State, which are consistent with Part C of Annex VII of the Deliberate Release Directive. 12.The proposed restrictions in the approved use of the genetically modified organism, such as where the product may be used and for what purposes. 13.The proposed packaging. 14.The estimated production in and/or imports to the Community. 15.Any proposed additional labelling, which may include, at least in summarised form, the information referred to in paragraphs 4 and 5 of Part I of this Schedule, or paragraphs 9 to 12 of this Part. 1.An identification of the characteristics of the recipient organism which are relevant to the assessment of the relevant genetically modified organisms. 2.A description of the way in which the characteristics of the organisms have been affected by genetic modification. 3.An identification of any known risks of damage to the environment resulting from the release into the environment of the recipient non-modified organism. 4.An assessment of whether the genetic modification has been characterised sufficiently for the purpose of evaluating any risks of damage to the environment. 5.An identification of any new risks of damage to the environment that may arise from the release of the relevant genetically modified organisms as compared to the release of the corresponding non-modified organism, based on the environmental risk assessment. 6.A conclusion which addresses the proposed use of the product, risk management and the proposed monitoring plan, and states whether the relevant genetically modified organisms should be marketed and under which conditions, or should not be marketed, including reasons for that conclusion, and whether the views of the competent authorities of the other member States and the Commission are being sought on specific aspects of the environmental risk assessment and what those aspects are.
(This note is not part of the Regulations) These Regulations implement, in respect of England and the United Kingdom sector of the continental shelf, Council Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms ("the Directive") which replaced Council Directive 1990/220/EEC (as amended) of the same title. The subject matter of the Directive and its predecessor is the control of the deliberate release into the environment and the marketing of genetically modified organisms by means of the imposition of a requirement to obtain consent for those activities and to comply with the conditions imposed on the consent. The changes introduced by the Directive strengthen the existing control regime, particularly in respect of post marketing monitoring. Directive 1990/220/EEC was implemented partly by the (pre-existing) provisions of Part VI of the Environmental Protection Act 1990 ("the Act") and partly by the Genetically Modified Organisms (Deliberate Release) Regulations 1992 (subsequently amended). These Regulations include amendments to the Act required to implement the Directive and revoke the 1992 Regulations. Except in relation to the continental shelf, they apply only to England. The statutory basis for the requirement to obtain consent for the release or marketing of genetically modified organisms is section 111(1) of the Act. The cases and circumstances in which consent is required are prescribed in these Regulations. A general requirement to obtain consent for the release or marketing of genetically modified organisms is imposed by regulation 8 (for release) and regulation 14 (for marketing). This general requirement is subject to the exemptions provided for in regulations 9 (for release) and 15 (for marketing). The definitions used in the provisions relating to the control regime are contained in sections 106, 107 and 127(1) of the Act. Regulations 3 and 4 amend a number of these definitions to reflect the Directive. Regulation 3 also amends the power in section 106 for the Secretary of State to prescribe techniques which result in organisms becoming "genetically modified". However, on coming into force of these Regulations, references in the Act to "genetically modified organisms" will be interpreted by reference to the modification techniques described in regulation 5. Parts II and III of the Regulations impose requirements for applications for consent to release and market, respectively, genetically modified organisms (including transitional provisions). Part IV lays down the procedure for dealing with applications from their receipt to their determination (and, in the case of consents to release, their subsequent variation or revocation). For release consents this includes provisions for public consultation and for marketing consents (and renewals of such consents) their agreement at European Community level. Part V includes general requirements for marketing consents and amends section 112 of the Act (which imposes conditions on consents). It also provides for what should happen when new information becomes available which affects the risk assessment for the marketing of a genetically modified organism. Part VI supplements section 110 of the Act insofar as it allows action to be taken to prohibit the marketing of a genetically modified organism which has consent so as to bring it into line with the taking of "safeguard action" under the Directive. Part VII prescribes additional categories of information to be made public, notwithstanding that they may be commercially confidential, for the purposes of section 123(7) of the Act. Part VIII includes the requirement for different categories of information to be included in the public register to be kept by the Secretary of State under section 122 of the Act. A Transposition Note has been prepared for these Regulations and a copy has been placed in the library of each House of Parliament. Copies of the Transposition Note can be obtained from GM Controls Unit, DEFRA, Zone G/9, Ashdown House, 123 Victoria Street, London SW1E 6DE. Notes: [1] 1972 c. 68.back [2] SI 1991/755.back [3] 1990 c. 43.back [4] OJ No L117, 8.5.1990, p. 1.back [5] OJ No L297, 18.11.1994, p. 29.back [6] OJ No L330, 5.12.1998, p. 13.back [7] OJ No L106, 17.4.2001, p. 1.back [8] OJ No L117, 8.5.1990, p. 15.back [9] OJ No L103, 22.4.1994, p. 20.back [10] OJ No L169, 27.6.1997, p. 72.back [11] 2000 c. 7.back [12] OJ No L292, 12.11.1994, p. 31.back [13] SI 1992/3280 as amended by the Genetically Modified Organisms (Deliberate Release) Regulations 1993 (SI 1993/152), the Genetically Modified Organisms (Deliberate Release) Regulations 1995 (SI 1995/304), the Genetically Modified Organisms (Deliberate Release and Risk Assessment) (Amendment) Regulations 1997 (SI 1997/1900) and the Genetically Modified Organisms (Contained Use) Regulations 2000 (SI 2000/2831).back [14] Section 106(4) is amended by regulation 3(3) and section 106(4A) to 106(4D) is inserted by regulation 3(4).back [15] S.I. 2000/2831.back [16] See section 128 of the Environmental Protection Act 1990 (c.43) and section 73 of the Countryside and Rights of Way Act 2000 (c.37).back [17] OJ No L214, 24.8.1993, p. 1.back [18] OJ No L88, 24.3.1998, p. 7.back [19] OJ No L43, 14.2.1997, p. 1.back [20] See section 10 of the Health and Safety at Work etc Act 1974 (c. 37).back [21] OJ L193, 20.7.2002, p.1.back [22] OJ L193, 20.7.2002, p.33.back [23] Council Directive 1999/105/EC on the marketing of forest reproductive material OJ L11 15.1.2000 p. 17.back [24] See section 1 of the Food Standards Act 1999 (c.28).back [25] 1964 c. 29.back ISBN 0 11 042858 7 -- Back --
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