The Genetically Modified Organisms (Deliberate Release) (Wales) Regulations 2002
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The National Assembly for Wales, being designated[1]for the purposes of section 2(2) of the European Communities Act 1972[2] in relation to the control and regulation of the deliberate release of genetically modified organisms, acting in exercise of the powers conferred on it by the said section 2(2) and by sections 106(4) and (5), 107(8), 111(1), (4), (5), (7) and (11), 122(1) and (4), 123(7), and 126(1) of the Environmental Protection Act 1990[3], having consulted the Food Standards Agency in accordance with section 126(5) of that Act and of all other powers enabling it in that behalf, makes the following Regulations: - Citation, commencement and application 1. - (1) These Regulations may be cited as the Genetically Modified Organisms (Deliberate Release) (Wales) Regulations 2002 and shall come into force on 31st December 2002. (2) These Regulations apply in relation to Wales. Interpretation 2. - (1) In these Regulations -
(2) In these Regulations -
(b) a reference to a numbered paragraph is a reference to the paragraph so numbered in the regulation or Schedule in which that reference occurs. Designation of competent authority
(3) The amendment of subsection (4) made by
regulation 3(3) of those Regulations, which substitutes for paragraph (a)
the following -
(4) The amendment made by regulation 3(4) of
those Regulations (which inserts subsections (4A) to (4D)) is modified by
paragraph (5) and, as so modified, also has effect in relation to
Wales.
(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. (7) The amendment made by regulation 3(5) of
those Regulations (which omits subsections (5) and (6)) also has effect in
relation to Wales.
(c) substitute for subsection (6) (meaning of "harm") -
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; and (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 or 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
paragraphs (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; and (c) include any bibliographic reference and indications of the methods used where applicable. (2) Where the genetically modified organisms
contain antibiotic resistance markers, the environmental risk assessment
shall include an examination of the particular risks of damage to the
environment which may be posed by the deliberate release or marketing of
those genetically modified organisms. Requirement for consent to release 9. 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 10. 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 release is in accordance with a consent to market genetically modified organisms given by the National Assembly for Wales 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 11. - (1) An application for a consent to release genetically modified organisms must be made in writing to the National Assembly for Wales. (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 application for consent to release 12. - (1) An application for a consent to release genetically modified organisms must contain -
(ii) Schedule 2 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) an indication of the information submitted in the application, the disclosure of which might harm the competitive position of the applicant and which should therefore be treated as confidential, and (c) any other information which the applicant considers is relevant. (3) Any indication in accordance with paragraph
(2)(b) must be accompanied by verifiable
justification.
(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 National Assembly for Wales within twelve days of the receipt of the application, (f) the means by which that register can be inspected, (g) a statement that the National Assembly for Wales will consider any representations made to it relating to risks of damage to the environment posed by the release of the genetically modified organisms within a period which it shall specify in accordance with these Regulations, and shall immediately send a copy of the publications containing the
advertisement to the National Assembly for
Wales.
(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[14], (d) the Association of National Park Authorities, (e) the Countryside Council for Wales[15], (f) the Environment Agency; and shall immediately send to the National Assembly for Wales copies of
the notices.
(b) the applicant shall submit to the National Assembly for Wales such further information, additional to that already provided in connection with the application, as is necessary in order to comply with the requirements of these Regulations by 17th January 2003; (c) the application shall be treated as having been sent to the National Assembly for Wales for the purposes of regulations 13(1) and (4) and as having been received by the National Assembly for Wales for the purpose of regulation 21 on submission of the information required by paragraph (b); and (d) if the information required by paragraph (b) has not been submitted by 17th January 2003, the National Assembly for Wales may refuse to proceed with the application.
Requirement for consent to market 15. 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 16. 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[16], as amended by Commission Regulation EC No. 649/98[17], 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[18] is marketed in accordance with that Regulation. Application 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) an indication of the information submitted in the application, the disclosure of which might harm the competitive position of the applicant and which should therefore be treated as confidential, and (c) 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 organism 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 National Assembly for Wales 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 Regulation by 17th January 2003; (c) the application shall be treated as having been received by the National Assembly for Wales for the purposes of regulation 24 on submission of the information required by paragraph (b) above; (d) if, by 31st December 2002, the National Assembly for Wales has forwarded to the Commission the information required by regulation 16(2) of the 1992 Regulations, it shall supplement it and, if it considers it to be necessary, revise it on receipt of the further information required by paragraph (b) above in the light of its obligations under these Regulations; and (e) if the information required by paragraph (b) above has not been submitted by 17th January 2003, the National Assembly for Wales 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 29(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 original consent, including the conditions concerning future monitoring and the time limitation of the new consent. (3) Any consent to market genetically modified
organisms granted by the National Assembly for Wales under section 111(1)
of the Act before 17th October 2002 for which no application for renewal
under paragraph (1) above has been received 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 20. - (1) The amendment of section 111 of the Act (consents required by certain persons) made by regulation 19(1) of the Genetically Modified Organisms (Deliberate Release) Regulations 2002, which inserts as a second sentence in subsection (6) the following -
also has effect in relation to
Wales.
(b) invite any person by means of a request placed on the register, to make representations to it relating to the release before the end of a period to be specified which shall not be less than sixty days from the date the application was received by it; (c) ensure that within 30 days a summary of that application in the format established by the Commission under Article 11(1) 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; and (f) take into account any representations relating to risks of damage being caused to the environment by the release made to it before the end of the period specified in accordance with paragraph (b) and any comments made by a competent authority or authorities of other Member States following the circulation to them by the Commission of the summary referred to in paragraph (c). Decisions by the National Assembly for Wales on applications for
consent to release
(b) a period of time during which the National Assembly for Wales is considering representations submitted by any persons in accordance with regulation 21(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 National Assembly for
Wales after completion of the release and thereafter, at such intervals as
the National Assembly for Wales 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 Article 13(2)(h) of the Deliberate Release Directive is forwarded immediately to the Commission and to the competent authorities of the Member States; (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 it received the application either -
(ii) refuse the application, stating reasons for its decision, supported by an assessment report prepared in accordance with Schedule 4 which indicates that the genetically modified organisms should not be marketed; (e) ensure that a copy of the application is forwarded to the
Commission when satisfied it conforms to the requirements prescribed in
regulation 15 and no later than when it sends its assessment report in
accordance with paragraph (d). (2) The National Assembly for Wales shall
ensure that -
(ii) any further information it has received from the applicant pursuant to the service of a notice under section 111(6) of the Act, (iii) any additional information on which it has based its assessment report, are forwarded to the Commission in the circumstances described in
regulation 24(1)(d)(i), before the end of a period of ninety days
beginning with the day on which it received the application and, in the
circumstances described in regulation 24(1)(d)(ii), no sooner than
fifteen days from the date it sent the assessment report to the
applicant and no later than one hundred and five days from the date it
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 National Assembly for Wales gives 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 National Assembly for
Wales.
(b) an objection or objections have been raised by either a competent authority of 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 competent authority of 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 National Assembly for Wales shall
inform the competent authority or authorities of each Member State and the
Commission of its decision to grant consent to market genetically modified
organisms within thirty days of its
grant.
(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 its decision, supported by an assessment report which indicates that the genetically modified organisms should not continue to be marketed; (d) ensure that a copy of the application and its assessment report
is forwarded to the Commission. (2) Where the National Assembly for Wales
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, the National Assembly for Wales shall
first consult the Health and Safety Executive and not forward a favourable
opinion on the application as it relates to the protection of human health
where the Health and Safety Executive has informed the National Assembly
for Wales 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 competent authority of any 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 competent authority of any 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 National Assembly for Wales shall
ensure that the competent authority or authorities of each Member State
and the Commission are informed of its decision to renew 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 National Assembly
for Wales shall evaluate the information in the environmental 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 genetically modified organisms 29. A consent to market genetically modified organisms granted by the National Assembly for Wales under section 111(1) of the Act shall specify -
(b) the period of validity of the consent; (c) the conditions for the marketing of 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 National Assembly for Wales on request; (e) the labelling requirements, in accordance with paragraph 8 of Schedule 3, which shall include a requirement to notify the National Assembly for Wales of any new commercial name of the product after consent has been given; (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 to provide information at an appropriate level on the location of the genetically modified organisms. General conditions in consents to release or market genetically
modified organisms
(ii) omit sub-paragraph (ii), and (iii) after that sub-paragraph insert -
(b) substitute for subsection (5)(c) -
(5) The amendment of subsection (5) made by
regulation 29(3)(c) of those Regulations, which inserts paragraphs (d) and
(e), is modified by paragraph (6) and, as so modified, also has effect in
relation to Wales.
(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 or, in relation to Wales, the National Assembly for Wales.". Proof of compliance with consent
conditions
(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 to the
environment
(b) an objection or objections have been raised by a competent authority of any Member State or by the Commission but all outstanding issues have been resolved in accordance with Article 20(3) of the Deliberate Release Directive, it 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 it has done so within 30 days
thereof.
(ii) in accordance with a decision adopted by the Commission in accordance with Articles 18(1) or 23(2) of the Deliberate Release Directive.
Safeguard 33. - (1) The National Assembly for Wales may serve a prohibition notice under section 110 of the Act to prohibit an act which is authorised by a consent granted by it under section 111 of the Act or by a consent granted in respect of an approved product only if its opinion that doing such an act would involve a risk of causing damage to the environment is based on detailed grounds as 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) above, the National Assembly for Wales considers that the
risk of damage being caused to the environment is severe it shall serve a
prohibition notice requiring such measures to be taken as it may consider
appropriate and once any work required by the notice has been carried out
it shall enter details of it on the
register.
(b) the results of its review of the environmental risk assessment, (c) its opinion as to whether the conditions of the consent should be varied, and, if so, how, or whether the consent should be revoked, and (d) where appropriate, the new or additional information on which its decision to take action was based. (4) A prohibition notice served under 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 34. - (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 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 organism 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) The amendments of section 123(7) of the Act
(exclusion from register of certain information: particulars included even
if commercially confidential) made by regulation 33(2) of the Genetically
Modified Organisms (Deliberate Release) Regulations 2002,
which -
(b) in paragraph (b) for "the description" substitutes "the general description", and (c) omits paragraphs (c) and (e), also have effect in relation to Wales. Information to be included on the register 35. - (1) The register shall contain the particulars set out in paragraphs (2) to (10). (2) In relation to a prohibition notice served by the National Assembly for Wales 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 National Assembly for Wales, (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 environment 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 National Assembly for Wales 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 National Assembly for Wales 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) above, it shall enter so much of that more
detailed information on the register as it shall consider
appropriate.
(b) any information supplied to the National Assembly for Wales 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 National Assembly for Wales 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 National Assembly for Wales 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 Precautionary principle 38. In carrying out its functions under Part VI of the Act and these Regulations, the National Assembly for Wales is to take into account the precautionary principle. Revocations 39. The regulations set out in Schedule 5 are revoked in respect of Wales to the extent specified in that Schedule. Application of Part VI of the Act to the territorial sea 40. - (1) The amendment of section 127(2) of the Act (definitions etc: application to territorial sea) made by regulation 38(a) of the Genetically Modified Organisms (Deliberate Release) Regulations 2002 also has effect in relation to Wales. (2) In section 127(2), as so amended, after "as it applies in England" insert "and applies to the territorial sea adjacent to Wales as it applies in Wales". Application of Part VI of the Act to Wales 41. In consequence of the provision made by regulations 4, 5, 20(1), 30, 31, 34(2) and 40, section 163A of the Act ceases to have effect. Signed on behalf of the National Assembly for Wales under section 66(1) of the Government of Wales Act 1998[24] D. Elis-Thomas The Presiding Officer of the National Assembly 18th December 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 m2) 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 genetically modified 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, 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; (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, (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; and (e) the other product hazards.
34. The description of the proposed deliberate release, including the 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 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, 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 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 genetically modified organisms, and in particular, releases on a different scale or into different ecosystems. 45. The geographical location and national grid reference of the site onto 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 genetically modified 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 genetically modified 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 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. 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. 80. Type of waste generated. 81. Expected amount of waste. 82. Description of treatment envisaged. 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 areas 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 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 National Assembly for Wales, 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 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 National Assembly for Wales, 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 product 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 change 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 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. 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 specified aspects of the environmental risk assessment and what those aspects are.
(This note is not part of the Regulations) These Regulations, which apply only to Wales, implement Directive 2001/18/EC of the European Parliament and of the Council on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC ("the Deliberate Release Directive"). They revoke the Genetically Modified Organisms (Deliberate Release) Regulations 1992 (S.I. 1992/3280) and make amendments to Part VI of the Environmental Protection Act 1990 ("the 1990 Act"). The Regulations are divided into nine parts and have five Schedules. 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 Act and partly by the Genetically Modified Organisms (Deliberate Release) Regulations 1992. These Regulations apply in relation to Wales the amendments made to the Act by the Genetically Modified Organisms (Deliberate Release) Regulations 2002 which are required to implement the Directive. They also revoke 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 9 (for release) and regulation 15 (for marketing). This general requirement is subject to the exemptions provided for in regulations 10 (for release) and 16 (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 4 and 5 amend a number of these definitions to reflect the Directive. Regulation 4 also amends the power in section 106 for the National Assembly for Wales 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 6. 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 National Assembly for Wales under section 122 of the Act. Part IX includes a requirement for the National Assembly for Wales to take the precautionary principle into account in carrying out its functions under the Act and these Regulations. The "precautionary principle" is a term derived from Article 174 of the Treaty Establishing the European Community. The preamble to the Directive states that the principle must be taken into account in the implementation of the Directive. Schedule 1 sets out the information to be included in applications for consent to release or market genetically modified higher plants. Schedule 2 sets out the information to be included in applications for consent to release or market genetically modified organisms other than genetically modified higher plants. Schedule 3 sets out the information to be included in an application for consent to market genetically modified organisms. Schedule 4 sets out the information to be included in an assessment report. Schedule 5 specifies the Regulations revoked by these regulations. A regulatory appraisal has been prepared for these regulations and is available on the National Assembly for Wales web-site (www.wales.gov.uk). Copies can be obtained from the Welsh Assembly Government, Plant Health and Biotechnology Branch, Crown Buildings, Cathays Park, Cardiff, CF10 3NQ. Notes: [1] S.I. 2001/3495.back [3] 1990 c. 43. The functions of the Secretary of State under these provisions (with the exception of section 156) were transferred to the National Assembly for Wales under Article 2 of and Schedule 1 to the National Assembly for Wales (Transfer of Functions) Order 1999 (S.I. 1999/672). The functions of the Minister of Agriculture, Fisheries and Food under these provisions were transferred to the National Assembly for Wales under Article 2 of and Schedule 1 to the National Assembly for Wales (Transfer of Functions) Order 2000 (S.I. 2000/253).back [4] OJ No. L117, 8.5.1990, p.1.back [5] OJ No. L73 ,15.03.2001, p.32 - 34back [6] OJ No. L106, 17.4.2001, p.1.back [7] OJ No. L117, 8.5.90, p.15.back [8] OJ No. L103, 22.4.94, p.20.back [9] OJ No. L169, 27.6.97, p.72.back [11] OJ No. L292, 12.11.1994, p.31.back [12] S.I. 1992/3280. The functions of the Secretary of State under these regulations were transferred to the National Assembly for Wales under Article 3 and Schedule 1 to the National Assembly for Wales (Transfer of Functions) Order 2000 (S.I. 2000/253).back [13] Section 106(4) is amended by regulation 3(3) and section 106(4A) to 106(4D) is inserted by regulation 3(4) of the Genetically Modified Organisms (Deliberate Release) Regulations 2002, and are given effect in Wales subject to further modification by regulation 4 of these Regulations.back [15] See section 128 Environmental Act 1990 (c.43).back [16] OJ No. L214, 24.8.1993, p.1.back [17] OJ No. L88, 24.3.1998, p.7.back [18] OJ No. L43, 14.2.1997, p.1.back [19] See section 10 of the Health and Safety at Work etc. Act 1974 (c.37).back [20] OJ No. L193, 20.7.2002, p.1.back [21] OJ No. L193, 20.7.2002 p.33.back [22] Council Directive 1999/105/EC on the marketing of forest reproductive material OJ No. L11, 15.1.2000, p. 17.back [23] See section 1of the Food Standards Act 1999 (c.28).back
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