The Genetically Modified Organisms (Deliberate Release) (Scotland) Regulations 2002
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The Scottish Ministers, in exercise of the powers conferred by section 2(2) of the European Communities Act 1972[1] and of all other powers enabling them in that behalf hereby make the following Regulations, a draft of which has, in accordance with paragraph 2(2) of Schedule 2 to that Act been laid before, and approved by resolution of, the Scottish Parliament: Citation, commencement and extent 1. - (1) These Regulations may be cited as the Genetically Modified Organisms (Deliberate Release) (Scotland) Regulations 2002 and shall come into force on the day after the day on which they are made. (2) These Regulations extend to Scotland only. Interpretation 2. - (1) In these Regulations, unless the context otherwise requires-
(2) Expressions used in these Regulations have,
unless the contrary intention appears, the meaning which they bear in Part
VI of the Act and in regulations 8, 9, 14, 15, 33 and 34 the prescribing
of cases, circumstances, descriptions and matters shall be treated as
being cases, circumstances, descriptions and matters prescribed in
accordance with and under the Act.
(b) a reference to a numbered paragraph is a reference to the paragraph so numbered in the regulation or Schedule to which that reference occurs. 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)-
(4) After subsection (4) 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) (techniques which may be
prescribed as genetic modification) and (6) (direct or indirect means of
modification immaterial) are omitted.
(3) In subsection (3) (meaning of "damage to
the environment") the words "to the living organisms supported by the
environment" are omitted.
(5) For subsection (9) (meaning of organism
being under a person's "control") substitute-
(6) For subsection (11) (meaning of "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 made by the Scottish Ministers under section 106(4B)(b) (power
to prescribe techniques, alteration by which shall not be taken to be
artificial modification) of the Act, genes or other genetic material shall
not be taken, for the purposes of subsection (4) of that section, to be
artificially modified by reason only of being altered by the use of any of
the following techniques:-
(b) natural processes including conjugation, transduction or 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-
(3) Until the coming into force of the first
regulations made by the Scottish Ministers under section 106(4C) (power to
prescribe organisms which shall be taken not to be genetically modified)
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):
(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; and (c) include any 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 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 submitted in writing to the Scottish Ministers. (2) The Scottish Ministers may accept that 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 application for consent to release 11. - (1) An application for a consent to release genetically modified organisms must contain-
(ii) Schedule 3 in any other case, to the extent that such information is appropriate to the nature and
scale of the release or application; (2) The application may contain-
(b) any other information which the applicant considers is 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 of the release; (e) a statement that information about the application will be placed on the register by the Scottish Ministers within 12 days of their receipt of the application; (f) the means by which the register can be inspected; and (g) a statement that the Scottish Ministers shall, within a period which they shall specify in accordance with these Regulations, have regard to any representations made to them in writing relating to risks of damage to the environment[18] posed by the release of the genetically modified organisms, and that person shall-
(ii) if requested to do so by the Scottish Ministers, send a copy of such newspaper containing the advertisement to them. (2) A notice published under paragraph (1) need
not contain the information referred to in subparagraphs (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.
(b) the owner of the site of each proposed release, if such person is not 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 2000[19] where relevant; (d) any National Park Authority designated under section 6 of the National Parks (Scotland) Act 2000[20] for the area of each proposed release; (e) Scottish Natural Heritage established under section 1 of the Natural Heritage (Scotland) Act 1991[21]; and (f) such other body as the Scottish Ministers may notify the applicant that they consider appropriate, and shall immediately send to the Scottish Ministers copies of the
notices given under this paragraph.
(b) the applicant shall submit in writing to the Scottish Ministers 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 the date occurring three months after the coming into force date of these Regulations; (c) the application shall, for the purposes of regulation 12(1) and (4), be treated as having been sent to the Scottish Ministers and shall, for the purposes of regulation 20, be treated as having been received by the Scottish Ministers on the date of submission of the information required by paragraph (b); and (d) if the information required by paragraph (b) has not been submitted in writing by the date occurring three months after the coming into force date of these Regulations, the Scottish Ministers 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 (including culture collections); (c) genetically modified organisms other than micro-organisms referred to in 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 Regulation 2309/93 is marketed; (f) a novel food or novel food ingredient within the scope of Regulation EC No. 258/1997 of the European Parliament and of the Council[22] as amended by Commission Regulation (EC) No. 1852/2001[23] is marketed. Applications for consent to market
(ii) Schedule 3 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
paragraph (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 data or results obtained from research and developmental releases
concerning the impact of the release on human health and the
environment.
(b) the applicant shall submit in writing to the Scottish Ministers 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 the date occurring three months after the coming into force date of these Regulations; (c) the application shall be treated as having been received by the Scottish Ministers for the purposes of regulation 23 on the date of submission of the information required by paragraph (b); (d) if, by the coming into force date of these Regulations, the information required by regulation 16(2) of the 1992 Regulations has been forwarded to the Commission, the Scottish Ministers shall ensure that the information is supplemented and, if they consider it necessary, revised on the receipt by the Scottish Ministers of the further information required by paragraph (b) in the light of their obligations under these Regulations; and (e) if the information required by paragraph (b) has not been submitted in writing by the date occurring three months after the coming into force date of these Regulations, the Scottish Ministers 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 the consent to market was granted-
(ii) before that date, a report on the results of any monitoring carried out on the relevant product; (c) any other new information which has become available with regard
to the risks of the product causing damage to the environment;
and (3) Any consent to market genetically modified
organisms first marketed in Scotland which was granted under section
111(1) of the Act before the coming into force date of these Regulations
and for which no application for renewal under paragraph (1) has been
received by the Scottish Ministers before 17th 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) Section 111 of the Act (consents required by certain persons) is amended as follows:-
(ii) after the word "period" where it appears for the second time insert "and in the specified form and manner"; and (b) after subsection (6) (power of Scottish Ministers to require
further information) insert-
(2) An applicant for a consent to release or to
market genetically modified organisms who notifies the Scottish Ministers
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)[24]
shall submit in writing to the Scottish Ministers 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 in writing to the Scottish Ministers relating to any risks of damage being caused to the environment[25] 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 the Scottish Ministers; (c) ensure that within thirty days of the date that the application was received by them a summary of that application in the format established by the Commission under Articles 11(1) and 30(2) of the Deliberate Release Directive is forwarded to the Commission; (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 prepared in accordance with regulation 6; and (f) take into account and give due weight to-
(ii) any comments made by the 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 Scottish Ministers on applications for consent to
release
(b) ensure that the Commission is informed of their decision, before the end of a period of ninety days beginning with the day on
which the application was received and shall include in any refusal of
consent the reason for the decision.
(b) any period of time during which the Scottish Ministers are considering representations submitted by any persons in accordance with regulation 20(b), provided that this consideration shall not prolong the ninety day period referred to in paragraph (3) by more than thirty 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 Scottish Ministers as
soon as reasonably practicable after completion of the release and
thereafter, at such intervals as the Scottish Ministers shall consider
appropriate on the basis of the results of the environmental risk
assessment.
(b) ensure that a summary of that application in the format established by the Commission under Articles 13(2)(h) and 30(2) of the Deliberate Release Directive is forwarded immediately to the Commission and to the competent authorities of the other Member States; (c) without delay 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 ninety days beginning with the day on which they received the application either-
(ii) refuse the application, stating reasons for their decision, supported by an assessment report prepared in accordance with Schedule 5 which indicates that the genetically modified organisms should not be marketed; and (e) once they are satisfied the application conforms to the
requirements prescribed in regulation 16 and in any event no later than
when they send their assessment report in accordance with subparagraph
(d), ensure that a copy of the application is forwarded to the
Commission. (2) The Scottish Ministers shall ensure
that-
(b) any further information they have received from the applicant pursuant to the service of a notice under section 111(6) of the Act[26]; and (c) any additional information on which they have based their assessment report, are forwarded to the Commission-
(ii) in the circumstances described in paragraph (1)(d)(ii), no sooner than fifteen days from the date the Scottish Ministers sent the assessment report to the applicant and no later than 105 days from the date they received the application. (3) The ninety day periods prescribed in
paragraphs (1) and (2) shall not include any period beginning with the day
on which the Scottish Ministers give notice in writing under section
111(6) of the Act that further information in respect of the application
is required and ending on the day on which that information is received by
the Scottish Ministers.
(b) a comment or a reasoned objection has 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 date the Commission circulated the assessment report; or (c) an objection has been raised and maintained by a competent authority of any Member State or the Commission in accordance with Articles 15 or 20 of the Deliberate Release Directive 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 Scottish Ministers shall-
(b) ensure that the other Member States and the Commission are informed, of any decision by the Scottish Ministers to grant consent to market
genetically modified organisms within thirty 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 their decision, supported by an assessment report which indicates that the genetically modified organisms should not continue to be marketed; and (d) ensure that a copy of the application and their assessment report
is forwarded to the Commission. (2) Where the Scottish Ministers intend to
arrange for an assessment report which indicates that the genetically
modified organisms to which an application relates should be permitted to
be marketed to be forwarded to the Commission, they shall first consult
the Health and Safety Executive and shall not arrange for their favourable
opinion on the application as it relates to the protection of human health
to be forwarded to the Commission where the Health and Safety Executive
has informed them that it does not fulfil the requirements of the Act and
of these Regulations.
(b) a reasoned objection has been raised by either a competent authority of any Member State or by the Commission but all outstanding issues have been resolved in accordance with Article 17(7) and (8) of the Deliberate Release Directive within a seventy-five day period beginning on the day the Commission circulated the assessment report; or (c) an objection has been raised and maintained by a competent authority of any Member State or the Commission in accordance with Articles 17 or 20 of the Deliberate Release Directive 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 Scottish Ministers shall-
(b) ensure that the other Member States and the Commission are informed, of any decision by the Scottish Ministers to renew the consent to
market genetically modified organisms within thirty days of its
renewal.
(ii) 31st December 2008 in the case of release. (2) Where prior to 31st December 2004 in the
case of marketing and 31st 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 Scottish Ministers
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 Scottish Ministers 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 Scottish Ministers on request; (e) the labelling requirements, in accordance with paragraph 8 of Schedule 4, which shall include a requirement to notify the Scottish Ministers 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 of it, 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 on consents to release or market genetically
modified organisms
(ii) omit subparagraph (ii); and (iii) after that subparagraph 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 Scottish Ministers in such form and manner as they may specify.". 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) a reasoned objection has 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, they shall vary or revoke the consent as proposed and they shall inform
the applicant, and ensure that the other Member States and the Commission
are informed, that they have done so within thirty days of the sixty day
period specified in subparagraph (a) or of the resolution referred to in
subparagraph (b), as the case may be.
(b) in accordance with a decision adopted by the Commission under Articles 18(1) or 23(2) of the Deliberate Release Directive.
Safeguard 32. - (1) The Scottish Ministers may serve a prohibition notice under section 110 of the Act to prohibit an act which is authorised by a consent granted in respect of an approved product only if their 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 Scottish Ministers consider that the risk of damage
being caused to the environment is severe they shall serve a prohibition
notice requiring such measures to be taken as they may consider
appropriate and once any work required by the notice has been carried out
they shall enter details of that work on the
register.
(b) the results of the review by the Scottish Ministers of the environmental risk assessment; (c) the opinion of the Scottish Ministers 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 information on which their decision to take action was based, are provided to the Commission and the other Member
States. Confidentiality 33. - (1) For the purposes of section 123(7) of the Act (exclusion from the register of certain information) 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 organism 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; and (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), after the word "the" where it appears for the first time insert "general"; 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 Scottish Ministers 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; and (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 Scottish Ministers; (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 Scottish Ministers have 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 Scottish Ministers are or become
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), they shall enter so much of that more detailed information
on the register as they consider
appropriate.
(b) any information supplied to the Scottish Ministers 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, where applicable, a copy of the varied consent; and (d) a summary of any advice the Scottish Ministers have 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, or
proposed to be released or grown pursuant to a consent, as the case may
be:-
(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 Scottish Ministers in accordance with section 112(5)(b)(iii)[30] 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 date on which the offence was committed; (e) the date on which the person was convicted; and (f) the penalty imposed and any order made by the court under section 120 of the Act (power of the court to order cause of offence to be remedied). Keeping the register Consequential and other amendments - agency arrangements 37. The Scotland Act 1998 (Agency Arrangements) (Specification) (No. 2) Order 2002[32] shall be amended in accordance with Schedule 6. Revocations 38. The Regulations set out in column 1 of Schedule 7 are revoked to the extent specified in the corresponding entry in relation to those Regulations in column 3 of that Schedule. ROSS FINNIE A member of the Scottish Executive St Andrew's House, Edinburgh 4th December 2002 "Regulation 2309/93" means Council Regulation (EEC) No. 2309/1993[33] laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products as amended by-
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, that is-
(b) genus; (c) species; (d) subspecies; (e) cultivar/breeding line; and (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, that is-
(b) any specific factors affecting survivability. 6. Information concerning the
dissemination of the plant, that is-
(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 source (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 of the insert 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 recipient plant in the following
respects:-
(b) dissemination; and (c) survivability. 17. The genetic stability of the insert
and phenotypic stability of the genetically modified higher
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 site or sites. 29. The proximity of the release site or sites to officially recognised biotopes or protected areas which may be affected. 30. The purpose of the release. 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-
(b) any measures to minimise or prevent dispersal of any reproductive organ of the genetically modified higher 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. 1. Characteristics of donor, parental and recipient organisms 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, sexual and asexual reproductive cycle; (c) information on survivability, including seasonability and the ability to form survival structures, including seeds, spores and sclerotia; (d) pathogencity, including infectivity, toxigenicity, virulence, allergenicity, 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; and (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.
(b) to delete a sequence. 21. The description of any insert
and/or vector construction.
(b) the comparison of the modified organism to the donor, recipient or (where appropriate) parental organism regarding pathogenicity; (c) the capacity of the organisms for colonisation; (d) if the organism is 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; and (e) the other product hazards.
5. The release 34. The description of the proposed deliberate release, including the purpose of the release and the foreseen products of the release. 35. The foreseen 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 methods to be used for the release. 39. The quantity of organisms to be released. 40. The disturbance of the site, including the type and method of cultivation, 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 genetically modified 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. 6. The environment (both on the site and in the wider environment) 45. The geographical location and national grid reference of the site onto which the release will be made, or in the case of applications for consent to market or renewed consent to market 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. A comparison of the natural habitat of the recipient organism 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. 7. Characteristics affecting survival, multiplication and dissemination 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. 8. Interactions with the environment 57. The predicted habitat of the genetically modified organisms. 58. The studies on the behaviour and characteristics of the genetically modified 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
organism. 9. Monitoring techniques 73. Methods for tracing the genetically modified organisms and for monitoring their effects. 74. Specificity (to identify the genetically modified 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. 10. Control of the release 77. Methods and procedures to avoid and/or minimise the spread of the genetically modified 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. 11. Waste treatment 80. Type of waste generated. 81. Expected amount of waste. 82. Description of treatment envisaged. 12. Emergency response plans 83. Methods and procedures for controlling the genetically modified organisms in case of unexpected spread. 84. Methods, such as eradication of the genetically modified 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 area affected by the spread. 87. Plans for protecting human health and the environment in case of the occurrence of an undesirable effect. 88. 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 placing on the market, whether it be the manufacturer, importer or distributor. 3. The name and address of the supplier of control samples. 4. A description of how the product and the genetically modified organism as or in the product 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 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, skilled trades or consumer use by the public at large. 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 genetically modified organism 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 Scottish Ministers, and details of nucleotide sequences or other type of information which is necessary to identify the genetically modified organism product and its progeny, for example the methodology for detecting and identifying the genetically modified organism 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. Information regarding 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 the placing on the market, 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 Scottish Ministers, which are consistent with Part C of Annex VII of the Deliberate Release Directive, so that the Scottish Ministers can be effectively informed of any adverse effect. 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. An identification of any known risks to human health and the environment resulting from the release into the environment of the recipient non-modified organism. 3. A description of the result of the genetic modification in the modified organism. 4. An assessment of whether the genetic modification has been characterised sufficiently for the purpose of evaluating any risks to human health and the environment. 5. An identification of any new risks to human health and 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 carried out in accordance with regulation 6. 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 placed on the market on its own or in a product and under which conditions, or not placed on the market for reasons which are specified, or whether the views of other competent authorities and the Commission are sought for on specified aspects of the environmental risk assessment carried out in accordance with regulation 6. Where it is concluded that the genetically modified organisms should not be placed on the market the Scottish Ministers shall give reasons for their conclusion. For paragraphs (d) and (e) of the Schedule to the Scotland Act 1998 (Agency Arrangements) (Specification) (No. 2) Order 2002[34] substitute-
(cb) Regulation 16(5) of the Genetically Modified Organisms (Deliberate Release) (Scotland) Regulations 2002 (function of consideration whether applicant may omit certain information from an application for consent to market genetically modified organisms). (cc) Regulation 20 of the Genetically Modified Organisms (Deliberate Release) (Scotland) Regulations 2002 (functions on receiving applications for consent to release genetically modified organisms). (cd) Regulation 23(1) of the Genetically Modified Organisms (Deliberate Release) (Scotland) Regulations 2002 (functions on receipt of applications for consent to market genetically modified organisms). (ce) Regulations 23(4) and 31(4) of the Genetically Modified Organisms (Deliberate Release) (Scotland) Regulations 2002 (function of consulting the Health and Safety Executive). (cf) Regulation 27(2) of the Genetically Modified Organisms (Deliberate Release) (Scotland) Regulations 2002 (function of evaluating information in environmental risk assessments). (cg) Regulation 35 of the Genetically Modified Organisms (Deliberate Release) (Scotland) Regulations 2002 (function of maintaining the register).".
(This note is not part of the Regulations) These Regulations implement, in respect of Scotland, Directive 2001/18/EC of the European Parliament and of the Council 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 (as subsequently amended). These Regulations include amendments to the Act, applicable only to Scotland, required to implement the Directive and revoke, subject to exceptions, the 1992 Regulations. 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 provisions of the Directive. Regulation 3 also amends the power in section 106 for the Scottish Ministers to prescribe techniques which result in organisms becoming "genetically modified". However under regulation 5, until the coming into force of the first regulations made by the Scottish Ministers prescribing such techniques, references in the Act to "genetically modified organisms" will be interpreted by reference to the modification techniques described in that regulation. 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 Scottish Ministers under section 122 of the Act. Part IX and Schedule 6 principally update the Scotland Act 1998 (Agency Arrangements) (Specification) (No. 2) Order 2002 in consequence of the implementation of the Directive, which permits the Scottish Ministers to enter into agency arrangements with the Secretary of State to allow her to carry out specified functions on behalf of the Scottish Ministers. It also corrects an omission from that Order. Such agency arrangements will not affect the Scottish Ministers' powers or responsibilities in relation to these functions. Schedule 7 provides for certain revocations of the Genetically Modified Organisms (Deliberate Release) Regulations 1992 and amending instruments. Notes: [1] 1972 c.68; section 2(2) was amended by the Scotland Act 1998 (c.46), Schedule 8, paragraph 15(3). The function conferred upon the Minister of the Crown under section 2(2) of the European Communities Act 1972, insofar as within devolved competence, was transferred to the Scottish Ministers by virtue of section 53 of the Scotland Act 1998.back [4] O.J. No. L 117, 8.5.90, p.1.back [5] O.J. No. L 297, 18.11.94, p.29.back [6] O.J. No. L 330, 5.12.98, p.13.back [7] O.J. No. L 106, 17.4.01, p.1.back [8] O.J. No. L 117, 8.5.90, p.15.back [9] O.J. No. L 103, 22.4.94, p.20.back [10] O.J. No. L 169, 27.6.97, p.72.back [12] O.J. No. L 292, 12.11.94, p.31.back [16] S.I. 1992/3280, as amended by S.I. 1993/152, 1995/304, 1997/1900 and 2000/2831.back [17] Section 106(4) is amended by regulation 3(3) and section 106(4A) to (4D) is inserted by regulation 3(4).back [18] As defined in section 107(2), (3) and (6) of the Act as amended by regulation 4(2) to (4).back [22] O.J. No. L 43, 14.2.97, p.1back [23] O.J. No. L 253, 21.9.01, p.17.back [24] Section 111(6A) was added by S.I. 1992/3280.back [25] As defined in section 107(2), (3) and (6) of the Act as amended by regulation 4(2) to (4).back [26] Section 111(6) of the Act is amended by regulation 19(1).back [27] O.J. No. L 193, 20.7.02, p.1.back [28] O.J. No. L 193, 20.7.02, p.33.back [29] O.J. No. L 11, 15.1.00, p.17.back [30] Section 112(5)(b)(iii) has been inserted by regulation 29(3)(iii).back [33] O.J. No. L 214, 24.8.93, p.1.back
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