LegalizeThe Genetically Modified Organisms (Deliberate Release) Regulations 1992
The Secretary of State for the Environment and the Minister of Agriculture, Fisheries and Food, acting jointly, as respects England, the Secretary of State for Wales, as respects Wales, and the Secretary of State for Scotland, as respects Scotland, in exercise of the powers conferred on them by section 2(2) of the European Communities Act 1972[^f00001], being the Ministers designated[^f00002] for the purposes of that subsection in relation to the control and regulation of genetically modified organisms, and sections 106(4) and (5), 107(8), 111(1), (4), (5), (7) and (11), 122(1) and (4) and 126(1) of the Environmental Protection Act 1990[^f00003], and the Secretary of State for the Environment, as respects England, the Secretary of State for Wales, as respects Wales, and the Secretary of State for Scotland, as respects Scotland, in exercise of the powers conferred on them by section 156 of the Environmental Protection Act 1990, hereby make the following Regulations:—
PART I — GENERAL
Citation and commencement
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Interpretation
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Artificial techniques of genetic modification
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Capacity of organisms for causing harm
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PART II — RELEASING ORGANISMS
Consent to release organisms
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Information to be contained in application for consent to release
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Exemptions from regulation 6
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Advertisement of application for consent to release
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General condition on consents to release organisms
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In section 112 of the Act (Consents: limitations and conditions) there shall be substituted for paragraph (b) of subsection (5) the following paragraph—
(b) notify the Secretary of State of— (i) any new information which becomes available with regard to any risks there are of damage to the environment being so caused, and (ii) the effects of any releases by him for the assessment of any risks there are of damage to the environment being so caused by such organisms being released or marketed;
PART III — MARKETING ORGANISMS
Consent to market products
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Information to be contained in application for consent to market
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Transitional provision for marketing
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PART IV — DUTIES AFTER THE MAKING OF APPLICATIONS
Duty of the applicant after applying for consent
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- (1) In section 111 of the Act (Consents required by certain persons), after subsection (6) there shall be inserted the following subsection—
(6A) Where an applicant for consent for releasing or marketing genetically modified organisms becomes aware, before his application is either granted or rejected, of any new information with regard to any risks there are of damage to the environment being caused as a result of the organisms being released or marketed, he shall notify the Secretary of State of that new information forthwith.
- (2) In section 118(1)(e) of the Act (Offences), after the words “section 108(5) or (6)” there shall be inserted the words “or section 111(6A)”.
Duties of the Secretary of State on receiving applications for consent to release
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Decisions by the Secretary of State on applications for consent to release
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Duties of the Secretary of State in relation to applications for consent to market
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PART V — REGISTER OF INFORMATION
Information to be included in register
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Keeping of the register
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SCHEDULE 1 — APPLICATIONS FOR CONSENT TO RELEASE OR MARKET GENETICALLY MODIFIED HIGHER PLANTS
PART I — GENERAL INFORMATION
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PART II — INFORMATION RELATING TO THE PARENTAL OR RECIPIENT PLANT
Characteristics of donor, parental and recipient organisms
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Characteristics of the vector
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Characteristics of the modified organisms
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Characteristics of the genetically modified organisms
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The method by which the genetically modified plants will be released.
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PART III — INFORMATION RELATING TO THE GENETIC MODIFICATION
The release
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Information on results of previous releases of those organisms, or of organisms of the same type as those which are to be released, and in particular releases on a different scale or into different ecosystems.
The environment (both on the site and in the wider environment)
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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.
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The physical or biological proximity of the site of the organisms to humans and other significant biota.
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The proximity to significant biotopes or protected areas.
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The size of the local human population.
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The local economic activities which are based on the natural resources of the area.
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The distance to the nearest drinking water supply zone and/or areas protected for environmental purposes.
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The climatic characteristics of the region or regions likely to be affected.
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The geographical, geological and pedological characteristics.
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The flora and fauna, including crops, livestock and migratory species.
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The description of the target and non-target ecosystems likely to be affected.
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The comparison of the natural habitat of the recipient organisms with the proposed site or sites of release.
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Any known planned developments or changes in land use in the region which could influence the environmental impact of the release.
PART IV — INFORMATION RELATING TO THE GENETICALLY MODIFIED PLANT
Characteristics affecting survival etc
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The biological features which affect survival, multiplication and dispersal.
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The known or predicted environmental conditions which may affect survival, multiplication and dissemination, including wind, water, soil, temperature and pH.
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The sensitivity to specific agents.
Interactions with the environment
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The predicted habitat of the organisms.
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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.
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The capability of post-release transfer of genetic material—
- (a) from the genetically modified organisms into organisms in affected ecosystems,
- (b) from indigenous organisms to the genetically modified organisms.
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The likelihood of post-release selection leading to the expression of unexpected or undesirable traits in the genetically modified organisms.
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The measures employed to ensure and to verify genetic stability, the description of genetic traits which may prevent or minimise dispersal of genetic material, and methods to verify genetic stability.
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The routes of biological dispersal, known or potential modes of interaction with the disseminating agent, including inhalation, ingestion, surface contact and burrowing.
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The description of ecosystems to which the organisms could be disseminated.
Potential environmental impact
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The potential for excessive population increase of the organisms in the environment.
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The competitive advantage of the organisms in relation to the unmodified recipient or parental organisms.
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The identification and description of the target organisms.
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The anticipated mechanism and result of interaction between the released organisms and the target organisms.
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The identification and description of non-target organisms which may be affected.
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The likelihood of post release shifts in biological interactions or in the host range.
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The known or predicted effects on plants and animals and non-target organisms in the environment, impact on population levels of competitors, prey, hosts, symbionts, predators, parasites and pathogens.
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The known or predicted involvement of the organisms in biogeochemical processes.
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Any other potentially significant interactions of the organisms with the environment.
PART V — INFORMATION RELATING TO THE SITE OF RELEASE (Applications for consent to release only)
Monitoring techniques
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Methods for tracing the organisms, and for monitoring their effects.
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Specificity (to identify the organisms, and to distinguish them from the donor, recipient or the parental organisms), sensitivity and reliability of the monitoring techniques.
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Techniques for detecting transfer of the donated genetic material to other organisms.
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Duration and frequency of the monitoring.
Control of the release
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Methods and procedures to avoid and/or minimise the spread of the organisms beyond the site of release or the designated area for use.
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Methods and procedures to protect the site from intrusion by unauthorised individuals.
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Methods and procedures to prevent other organisms from entering the site.
Waste treatment
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Type of waste generated
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Expected amount of waste.
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Possible risks.
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Description of treatment envisaged.
Emergency response plans
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Methods and procedures for controlling the organisms in case of unexpected spread.
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Methods, such as eradication of the organisms, for decontamination of the areas affected.
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Methods for disposal or sanitation of plants, animals, soils, and any other thing exposed during or after the spread.
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Methods for the isolation of the area affected by the spread.
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Plans for protecting human health and the environment in case of the occurrence of an undesirable effect.
SCHEDULE 2 — INFORMATION TO BE CONTAINED IN AN APPLICATION FOR CONSENT TO MARKET GENETICALLY MODIFIED ORGANISMS
PART I — GENERAL INFORMATION
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PART II — ADDITIONAL RELEVANT INFORMATION
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Signed
Michael Howard — Secretary of State for the Environment — 1992-12-18
In witness whereof the Official Seal of the Ministry of Agriculture, Fisheries and Food is hereunto affixed on 21st December 1992.
John Selwyn Gummer — Minister of Agriculture, Fisheries and Food
David Hunt — Secretary of State for Wales — 1992-12-17
Hector Monro — Parliamentary Under Secretary of State, Scottish Office — 1992-12-18
Explanatory note
(This note is not part of the Regulations)
These Regulations, together with Part VI of the Environmental Protection Act 1990 (“the Act”), give effect to Council Directive 90/220/EEC (OJ No. L117, 8.5.90, p. 15) on the deliberate release into the environment of genetically modified organisms.
Part I of the Regulations makes provision as to interpretation of the Regulations and as to the application of the definitions of “artificial techniques” and “harm” in the Act.
Part II of the Regulations makes provision as to the circumstances in which consents for the release of genetically modified organisms to the environment are required, and makes provision as to applications for consents and the conditions on which consents are held.
Part III of the Regulations makes provision as to the circumstances in which consents for the marketing of genetically modified organisms are required, and makes provision as to applications for consents to market.
Part IV of the Regulations places duties on applicants and the Secretary of State following the making of applications for consents.
Part V makes provision as to the registers of information required to be kept by the Secretary of State under section 122 of the Act.
Footnotes
[^f00001]: 1972 c. 68.
[^f00002]: S.I. 1991/775.
[^f00003]: 1990 c. 43.
Editorial notes
[^key-53e61c83c0df2b36ae1e3b2466fc27e8]: Reg. 9 in force at 1.2.1993, see reg. 1
[^key-15d03e991f62539ba4fb62a1df82ea26]: Reg. 13 in force at 1.2.1993, see reg. 1
[^key-b1cc857da3ec6d872a0dea97a1b3f599]: Regulations revoked (E.) (17.10.2002) by Genetically Modified Organisms (Deliberate Release) Regulations 2002 (S.I. 2002/2443), reg. 1(1), Sch. 5; revoked (except for the purposes of regs. 9, 13 (S.) (5.12.2002) by The Genetically Modified Organisms (Deliberate Release) (Scotland) Regulations 2002 (S.S.I. 2002/541), reg. 1(1), sch. 7; and revoked (W.) (31.12.2002) by The Genetically Modified Organisms (Deliberate Release) (Wales) Regulations 2002 (S.I. 2002/3188), reg. 1(1), Sch. 5
PART VI — INFORMATION RELATING TO THE RELEASE (Applications for consent to release only)
PART VII — INFORMATION ON CONTROL, MONITORING, POST-RELEASE PLANS AND WASTE TREATMENT PLANS(Applications for consent to release only)
PART VIII — INFORMATION ON THE POTENTIAL ENVIRONMENTAL IMPACT OF THE RELEASE OF THE GENETICALLY MODIFIED PLANTS
SCHEDULE 1A — APPLICATIONS FOR CONSENT TO RELEASE OR MARKET ORGANISMS OTHER THAN GENETICALLY MODIFIED HIGHER PLANTS
PART I — GENERAL INFORMATION
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PART II — INFORMATION RELATING TO THE ORGANISMS
Characteristics of the donor, parental and recipient organisms
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Characteristics of the vector
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Characteristics of the modified organisms
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Characteristics of the genetically modified organisms
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PART III — CONDITIONS OF RELEASE
The release
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The environment (both on the site and in the wider environment)
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PART IV — THE ORGANISMS AND THE ENVIRONMENT
Characteristics affecting survival etc
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Interactions with the environment
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Potential environmental impact
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74
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PART V — MONITORING, CONTROL WASTE TREATMENT AND EMERGENCY RESPONSE PLANS
Monitoring Techniques
75
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
76
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
77
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
78
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Control of the release
79
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
80
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
81
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Waste treatment
82
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
83
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
84
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
85
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Emergency response plans
86
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
87
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
88
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
89
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
90
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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