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United States
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Canada
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New Zealand
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EU
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United Kingdom
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Relevant
legislation
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Federal Plant Pest
Act and Federal Insecticide, Fungicide and Rodenticide Act
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Canadian Environmental
Protection Act
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The Hazardous Substances and New Organisms Act
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Council Directive
90/220/EEC
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Environment
Protection Act 1990 Part VI, the Genetically Modified Organisms (Deliberate
Release) Regulations 1992 (SI 1992/3280) and the Genetically Modified
Organisms (Deliberate Release) Regulations 1995 (SI 1995/304).
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Relevant Regulatory
authority
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The
US Department of Agriculture Animal and Plant Health Inspection Service (for
plant pests, plants and veterinary biologics)
The
U.S. Environmental Protection Agency (for microbial/plant pesticides, new
uses of existing pesticides and novel micro-organisms).
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Environment Canada
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Environmental Risk
Management Authority (ERMA)
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The Council of the
European Communities
Member states must
designate a competent authority responsible for carrying out the requirements
of the Directive.
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The Department of
the Environment, Transport and Regions
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Coverage
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Field testing,
moving, importing and commercial release of
organisms and products altered or produced through genetic engineering
which are plant pests or may become plant pests
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Manufacture
or import of new substances (i.e. that are not on the list of Domestic
Substances). Substances include living organisms that are an animate product
of biotechnology.
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Importation,
development, field testing and release of new organisms. All GMOs are considered to be new
organisms.
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The deliberate
release of GM micro-organisms into the environment
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The culturing
storage, use, transport, destruction, disposal, release (field trials for
research purposes and commercial releases) into the environment or marketing of
GMOs.
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Assessment process
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Developer
submits data to the USDA Animal and Plant Health Inspection Service
Data
must demonstrate that the plant is safe to release and is not itself a plant
pest or potential noxious weed.
The
USDA conducts an assessment in accordance with the National Environmental Protection Act.
If the GMO is also
a plant pesticide then EPA approval is also required under the Federal Insecticide, Fungicide and
Rodenticide Act as pesticide is
broadly defined to include plants modified by biotechnology to resist
disease.
The EPA may also
treat micro-organisms as subject to the Toxic Substances Control Act
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The Minister must be notified if someone wishes to
manufacture or import a new substance that is not on the Domestic Substances
List (if it is on the list no approval is necessary).
Information relevant to the assessment must be provided
to the Minister.
Assessment is undertaken by Environment Canada who may
utilise external advice
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Any person
importing or releasing a ‘new organism’ into the environment must apply to
the ERMA for approval.
The organism is
assessed according to whether it is likley to cause:
- any
significant displacement of any native species within its natural habitat;
- any
significant deterioration of natural habitats;
- any
significant adverse effects on New Zealand’s inherent genetic diversity; and
- disease,
become parasitic or become a vector for human, animal or plant disease.
The positive
effects of the organism must outweigh the adverse effects of the organism and
any inseparable organism.
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A person must
submit notification about the proposed release including all of the information required by the Directive and
an evaluation of the impacts.
The competent
authority must examine the application for compliance with the directive and
evaluate the risks posed by the release - this must be a science based
consideration.
The competent
authority may consult on any aspect of the proposed deliberate release.
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Application must
be made to the Department of the Environment.
Application must
include a risk assessment prepared by the applicant.
The Advisory
Committee on Releases to the Environment (ACRE) carries out an assessment of
the application and advises on the risks posed to human health and the
environment, whether a consent should be granted and whether any risk
management of the release should be required as a condition of consent.
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Approvals
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A
“determination of non-regulated” status is issued by APHIS if the crop is not
a plant pest allowing the crop to be released without restriction. EPA would also issue approval.
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Minister decides whether the substance is toxic or
capable of becoming toxic.
If the organism is not toxic or capable of becoming
toxic, the Minister can place the organism on the Domestic Substance Register
but cannot impose any conditions.
If the organism is
toxic or capable of becoming toxic, the Minister can permit its manufacture
or importation subject to conditions or can prohibit its import or
manufacture.
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Approval for
release can only be granted without conditions.
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Consent to release
may be granted with conditions
The competent
authority must send to the commission the results of the decision and the
Commission must forward summaries to
other Member States.
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Release may only
take place with the consent of the Secretary of State for the Environment and
the Minister of Agriculture, Fisheries and Food.
Consent may be
subject to risk management conditions.
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Enforcement
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Once permission
for the cultivation of their transgenic crops has been granted, progress is
monitored. The system does not rely on significant enforcement powers as the
regulatory system is based on
‘permits, testing and tolerance setting’.
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The Minister can
appoint enforcement officers to investigate alleged offences against the
Act.
The enforcement
officers have broad powers including to search, seize etc.
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Considerable
powers of enforcement and inspection including search and seizure powers.
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Member states
shall ensure that the competently authority organises inspections and other
control measures as appropriate to ensure compliance with the Directive.
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Specialist
inspectors may be appointed on behalf of DETR.
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