Text consolidated by Valsts valodas centrs (State
Language Centre) with amending laws of:
18 June 2009 [shall come
into force on 23 July 2009];
1 December 2009 [shall come into force on 1 January
2010];
16 December 2010 [shall come into force on 1 January
2011];
21 June 2012 [shall come into force on 10 July
2012];
25 September 2014 [shall come into force on 22 October
2014];
18 June 2015 [shall come into force on 28 June
2015];
8 June 2017 [shall come into force on 6 July 2017];
24 October 2019 [shall come into force on 20 November
2019];
21 November 2019 [shall come into force on 12 December
2019].
If a whole or part of a section has been amended, the
date of the amending law appears in square brackets at
the end of the section. If a whole section, paragraph or
clause has been deleted, the date of the deletion appears
in square brackets beside the deleted section, paragraph
or clause.
|
The Saeima1 has adopted and
the President has proclaimed the following law:
Law on the
Circulation of Genetically Modified Organisms
Chapter I
General Provisions
Section 1. Terms Used in this
Law
The following terms are used in this Law:
1) organism - any biological entity replicable (capable
of replication) or capable of transferring genetic material;
11) genetically modified organism - an
organism, with the exception of human beings, in which the
genetic material has been altered using methods of genetic
modification referred to in Clause 2 of this Section in a way
that does not occur naturally by mating or natural
recombination;
12) micro-organism - any microbiological
entity, cellular or non-cellular, capable of replication or of
transferring genetic material, including viruses, viroids, and
animal and plant cells in culture;
13) genetically modified micro-organism - a
micro-organism in which the genetic material has been altered
using at least any of the methods referred to in Clause 2 of this
Section in a way that does not occur naturally by mating or
natural recombination;
2) methods of genetic modification:
a) recombinant nucleic acid techniques - the formation of new
combinations of genetic material by the insertion of nucleic acid
molecules produced by whatever means outside an organism, into
any virus, bacterial plasmid or other vector system and their
incorporation into a host organism in which they do not naturally
occur but in which they are capable of continued propagation;
b) methods involving the direct introduction into an organism
or micro-organism of genetic material formed outside the
organism, or micro-organism including micro-injection,
macro-injection, micro-encapsulation;
c) cell and protoplast fusion or hybridisation methods -
formation of cells with new genetic material combinations through
the fusion of two or more cells from systematically remote groups
of organisms and utilising techniques that do not occur
naturally;
3) circulation of genetically modified organisms -
activities related to the contained use of genetically modified
organisms and deliberate release of genetically modified
organisms;
4) contained use of genetically modified
micro-organisms - any activity performed in relation to
genetically modified micro-organisms that are controlled using
specific measures which effectively limit the contact of such
micro-organisms with the environment and their impact on it;
41) deliberate release of genetically modified
organisms - deliberate release into the environment of
genetically modified organisms for experiments or placing on the
market, not using specific measures to limit a direct contact of
the genetically modified organisms with the environment;
5) release into the environment of genetically modified
organisms for experiments - release into the environment of
genetically modified organisms for experiments related to their
further utilisation in agriculture or in other sectors of the
economy, or for any other specified purposes, not using specific
measures to limit a direct contact of the genetically modified
organisms with the environment, as well as the use in clinical
trials of such medicinal products which contain genetically
modified organisms, consist of or are produced from them;
6) placing on the market of genetically modified
organisms - making available genetically modified organisms
or the products containing thereof to the third parties in return
for payment or free of charge. Placing on the market includes
activities that are related to:
a) the circulation of such food which contains genetically
modified organisms, consists of or is produced from them;
b) the circulation of such feed which contains genetically
modified organisms, consists of or is produced from them;
c) the circulation of seeds of genetically modified crops and
of plant propagating material;
d) the cultivation of genetically modified crops;
e) the circulation of genetically modified animals;
f) the use of genetically modified organisms in other sectors
of the economy;
7) co-existence - an aggregate of such measures that
are used in order to prevent indirect presence of genetically
modified organisms in conventional and organic crops or
apiculture products;
8) risk assessment - a scientific evidence based set of
measures to identify the potential adverse direct or indirect,
short-term or long-term effects of the genetically modified
organisms on human and animal health and on the environment;
9) emergency situation - a situation that is related to
the escape of genetically modified organisms from control when
such escape may cause a short-term or long-term threat to human
and animal health or on the environment.
[18 June 2009; 21 June 2012]
Section 2. Purpose of this Law
The purpose of this Law is to achieve high level of safety in
all stages of circulation of genetically modified organisms in
order to prevent the negative impact on human and animal health
or the environment, to preserve biological diversity, to promote
the development of sustainable agriculture and biotechnology, as
well as the co-existence of genetically modified crops
concurrently with organic and conventional farming.
[21 June 2012]
Section 3. Circulation Principles of
Genetically Modified Organisms
A decision related to the circulation of genetically modified
organisms shall be taken by observing the following
principles:
1) a risk assessment principle which provides for the
assessment of risk prior to the activities related to the
circulation of genetically modified organisms, including in
relation to the particular ecosystem which may be affected by
deliberate release of genetically modified organisms;
2) a principle of sustainable development which provides that
the circulation of genetically modified organisms may be
permitted if the relevant activity is aimed at promotion of the
national economic development and the basic principles of
sustainable development and preservation of biological diversity
specified in the laws and regulation governing environmental
protection are being observed;
3) a principle of precaution which provides for the relevant
temporary risk management measures for reduction of danger until
the assessment of risk and the development of risk management, if
an uncertainty is present at the risk assessment process related
to the possible negative impact on human and animal health or the
environment when genetically modified organisms are deliberately
released;
4) a principle of public information and participation which
provides that authorities promote public education and informing,
hear out and evaluate public opinion regarding issues related to
the circulation of genetically modified organisms;
5) a principle of ensuring supervisory and control measures
which provides that the deliberate release of genetically
modified organisms is authorised only if for the relevant
genetically modified organism a method of determination and
traceability is ensured.
[18 June 2009; 21 June 2012]
Section 4. Scope of Application of
the Law
(1) This Law prescribes the competence of State authorities,
the rights and obligations of natural and legal persons
(hereinafter - the person), the principles, supervision and
control for the circulation of genetically modified organisms
including those for the co-existence of modified crops, public
participation, liability and legal protection of persons, as well
as security measures and circulation of information for the
prevention of any possible emergency situation.
(2) This Law shall not apply to:
1) the medicinal use of gene therapy;
2) the use of such medicinal products in clinical trials which
contain genetically modified organisms, consist of or are
produced from them, except for the risk assessment in accordance
with the laws and regulations regarding deliberate release of
genetically modified organisms, the procedures for monitoring and
issuance of a permit, as well as the procedures for the provision
of information on the circulation of genetically modified
organisms and public involvement in the decision-making
process;
3) organisms and micro-organisms, which occur when using the
following methods [on condition that the referred to methods do
not involve the use of recombinant-nucleic acid molecules or
genetically modified organisms (micro-organisms)]:
a) mutagenesis;
b) cell fusion, including protoplast fusion, as the result of
which the exchange of genetic material occurs, even when the
traditional cultivation methods are used (applies only to
organisms);
c) in vitro fertilisation;
d) conjugation, transduction, transformation and similar
natural processes;
e) polyploidy induction;
f) cell fusion, including protoplast fusion, of prokaryotic
species, as a result of which the exchange of genetic material by
known physiological processes may occur (applies only to
micro-organisms);
g) cell fusion, including protoplast fusion, of any eukaryotic
species, production of hybridomas and plant cell fusions (applies
only to micro-organisms);
h) self-cloning, as a result of which micro-organisms acquired
are not dangerous to humans, animals or plants and cannot cause
diseases thereof - separation of nucleic acid from the cells of
such organisms followed or not followed by all the relevant
nucleic acids, fermentative or mechanical processing of parts
thereof or synthetic equivalent thereof, in order to cause the
modification of genetic material, and administration of the
acquired genetic material in the cells of organisms of the same
species or phylogenetically closely related species, using which
the exchange of genetic information is possible also in natural
physiological conditions (applies only to micro-organisms);
4) contained use of such genetically modified organisms which
conform to the harmlessness criteria specified in the laws and
regulations regarding the procedures for contained use of
genetically modified organisms and issuance of a permit.
[18 June 2009; 21 June 2012]
Chapter
II
Competence of Bodies
Section 5. Competence of the
Cabinet
(1) The Cabinet shall:
1) determine the procedures for contained use of genetically
modified organisms, the procedures for issuance, amending and
cancelling of a permit;
2) determine the procedures for deliberate release of
genetically modified organisms and the procedures for monitoring
and issuance, extending, amending and cancelling of a permit, as
well as the procedures for providing information regarding
circulation of genetically modified organisms and the public
involvement in the decision-making process, and the procedures
for restricting or prohibiting the growing of genetically
modified crops;
3) determine the methodology for the risk assessment of
genetically modified organisms;
4) issue regulations regarding co-existence of genetically
modified crops governing the requirements for co-existence of
genetically modified crops and the procedures for the
supervision, control and registration of growers of genetically
modified crops, deletion thereof from the Register of Growers of
Genetically Modified Crops and exchange of information included
in the Register of Growers of Genetically Modified Crops;
5) determine a fee for the preparation of an opinion on the
risk assessment of genetically modified organisms;
6) [8 June 2017].
(2) The Cabinet shall approve the plan for the development of
the national system of biosafety at least once in every seven
years.
(3) The Cabinet may specify provisional prohibitions and
containment for the placing on the market of genetically modified
organisms permitted in the European Union in Latvia or in
particular territory thereof, if in accordance with new or
additional scientific data, the release of the particular
genetically modified organism may cause harm to human and animal
health or to the environment. The European Commission and Member
States of the European Union shall be notified without delay of
the referred to prohibition or containment.
(4) The Cabinet may specify restrictions or prohibitions on
growing of genetically modified crops permitted in the European
Union:
1) in especially protected nature territories in order to
prevent threats to the biological diversity of the particular
territory;
2) for a particular genetically modified crop in Latvia or
separate territory thereof, in conformity with the environmental
policy objectives, agricultural policy objectives, land use
policy, spatial development planning documents, socio-economic
considerations, attempts to avoid the presence of genetically
modified organisms in other products, or other reasons arising
from the State policy.
[18 June 2009; 16 December 2010; 21 June 2012; 25 September
2014; 18 June 2015; 8 June 2017]
Section 6. Competence of the
Ministry of Agriculture
(1) The Ministry of Agriculture in co-operation with
scientific organisations, associations and foundations shall
develop and shall, jointly with the State authorities responsible
for the control and supervision of genetically modified organism
circulation, implement a unitary policy in the following
fields:
1) circulation of genetically modified organisms;
2) co-existence;
3) development of the national system of biosafety.
(2) The Ministry of Agriculture shall prepare and during the
process of granting a permit for growing a specific genetically
modified crop submit to the European Commission a request to
exclude Latvia or separate territory thereof from the territory
of geographical operation of the permit for growing the
respective genetically modified crop.
[18 June 2015]
Section 7. Competence of the State
Plant Protection Service
The State Plant Protection Service shall:
1) organise and conduct the development and operation of the
State information system accessible to the public - Register of
Growers of Genetically Modified Crops;
2) examine notifications and take decisions regarding the
inclusion of genetically modified crop growers within the
Register of Growers of Genetically Modified Crops;
3) ensure the supervision and control of co-existence of
genetically modified crops;
4) ensure the supervision and control for the circulation of
seeds of genetically modified crop varieties and plant
propagating material;
5) [8 June 2017];
6) [8 June 2017];
7) [8 June 2017];
8) [8 June 2017];
9) take samples of seeds and plant propagating material in
order to establish presence of genetically modified
organisms.
[18 June 2009; 25 September 2014; 8 June 2017; 24 October
2019]
Section 8. Competence of the Food
and Veterinary Service
Food and Veterinary Service shall organise and perform the
supervision and control of the circulation of genetically
modified food, animal feed and animals and shall be the competent
authority which performs tasks in relation to the circulation of
genetically modified organisms in the areas laid down in Article
1(2)(a), (b) and (c) of Regulation (EU) No 2017/625 of the
European Parliament and of the Council of 15 March 2017 on
official controls and other official activities performed to
ensure the application of food and feed law, rules on animal
health and welfare, plant health and plant protection products,
amending Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) No
1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No
652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European
Parliament and of the Council, Council Regulations (EC) No 1/2005
and (EC) No 1099/2009 and Council Directives 98/58/EC,
1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and
repealing Regulations (EC) No 854/2004 and (EC) No 882/2004 of
the European Parliament and of the Council, Council Directives
89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC,
96/93/EC and 97/78/EC and Council Decision 92/438/EEC (Official
Controls Regulation).
[21 November 2019 / The new wording of Section shall
come into force on 14 December 2019. See Paragraph 9 of
the Transitional Provisions]
Section 9. Competence of the State
Scientific Institute Institute of Food Safety, Animal Health and
Environment "BIOR"
The State scientific institute Institute of Food Safety,
Animal Health and Environment "BIOR" shall:
1) on the basis of the laws and regulations regarding the
circulation of genetically modified organisms and considering the
binding opinion of the Scientific Expert Commission on the risk
assessment and monitoring programme of genetically modified
organisms, issue a permit for:
a) the contained use of genetically modified
micro-organisms;
b) the release into the environment of genetically modified
organisms for experiments;
c) the placing on the market of genetically modified
organisms, with the exception of a permit for the activities
specified in Regulation (EC) No 1829/2003 of the European
Parliament and of the Council of 22 September 2003 regarding
genetically modified food and feed (Text with EEA relevance)
(hereinafter - Regulation No 1829/2003 of the European Parliament
and of the Council);
2) amend or cancel a permit for the contained use of
genetically modified organisms, as well as release into the
environment for trials and placing on the market, if there are
threats that the respective genetically modified organism may
cause harm to human and animal health or the environment;
3) examine the opinions of the European Food Safety Authority,
the European Medicines Agency and other competent authorities of
other Member States of the European Union regarding the risk
assessment related to deliberate release of genetically modified
organisms, and prepare an opinion in accordance with Regulation
No 1829/2003 of the European Parliament and of the Council and
Regulation (EC) No 726/2004 of the European Parliament and of the
Council of 31 March 2004 laying down Community procedures for the
authorisation and supervision of medicinal products for human and
veterinary use and establishing a European Medicines Agency, as
well as the laws and regulations regarding deliberate release of
genetically modified organisms, the procedures for monitoring and
issuance of permit, and the procedures for the provision of
information regarding the circulation of genetically modified
organisms and the public involvement in the decision-making
process;
4) organise and conduct the development and operation of the
State information system accessible to the public - the Register
of Genetically Modified Organism Circulation;
5) determine genetically modified organisms in food and animal
feed samples, genetically modified animals, and also in seeds and
plant propagating material;
6) perform the functions of a reference laboratory in
identifying genetically modified organisms;
7) participate in the interlaboratory testing programmes
organised by international organisations;
8) introduce internationally recognised methods for the
identification of genetically modified organisms;
9) ensure the examination of genetically modified organism
samples in foreign laboratories if the performance thereof is not
possible in Latvia.
[25 September 2014; 8 June 2017; 21 November 2019]
Section 10. Competence of the State
Agency of Medicines
[21 June 2012]
Section 11. Competence of the State
Limited Liability Company Latvian Environment, Geology and
Meteorology Centre
Having received an application from the person who
deliberately releases genetically modified organisms, the State
limited liability company Latvian Environment, Geology and
Meteorology Centre shall prepare a monitoring programme. On the
basis of the results of the performed monitoring, the persons who
deliberately release genetically modified organisms, shall inform
the Ministry of Agriculture about the risk management and
environmental protection measures to be implemented when
performing activities with genetically modified organisms and
deliberately releasing them.
[21 June 2012]
Section 12. Competence of the State
Environmental Service
The State Environmental Service, in accordance with the laws
and regulations regarding environmental protection and
environmental impact assessment, shall control the conformity
with the environmental protection conditions while the release
into the environment of genetically modified organisms for
experiments takes place and during cultivation of genetically
modified crops.
[21 June 2012]
Section 13. Competence of the Nature
Protection Board
The Nature Protection Board shall prepare and submit to the
Environment State Bureau recommendations to be included in the
conditions regarding the impact assessment on the protected
territories of European significance (Natura 2000) in conformity
with the procedures laid down in the laws and regulations
regarding environmental impact.
Section 14. Competence of the State
Labour Inspectorate
The State Labour Inspectorate, in conformity with the laws and
regulations regarding labour protection when coming into contact
with biological substances, shall ensure the supervision and
control of such safety and labour protection measures which are
related to the contained use of genetically modified
micro-organisms.
[21 June 2012]
Section 15. Scientific Expert
Commission
(1) The Scientific Expert Commission is a group of experts,
which examines risk assessment documents submitted by the
persons, as well as prepares and submits to the State scientific
institute Institute of Food Safety, Animal Health and Environment
"BIOR" a scientifically substantiated opinion on the risk
assessment of genetically modified organisms and a monitoring
program. On the basis of its opinion, a decision to issue the
permit referred to in Section 9, Clauses 1 and 2 of this Law, to
refuse to issue it and to amend or cancel the permit is
taken.
(2) The Scientific Expert Commission shall prepare and submit
proposals to the State scientific institute Institute of Food
Safety, Animal Health and Environment "BIOR" on the improvement
of the development strategy of the national biological safety
system and promote the public involvement in the decision-making
process on circulation of genetically modified organisms.
(3) The Scientific Expert Commission shall prepare and submit
to the State scientific institute Institute of Food Safety,
Animal Health and Environment "BIOR" a scientifically
substantiated opinion regarding opinions of the risk assessment
of genetically modified organisms referred to in Section 9,
Clause 3 of this Law.
(31) The Scientific Expert Commission shall, not
later than within 30 working days after receipt of a request of
the supervisory and control authorities referred to in Section
33, Paragraph two of the Law, submit to the State scientific
institute Institute of Food Safety, Animal Health and
Environment "BIOR" an opinion on the level of threat caused
by the genetically modified organisms to the human and animal
health or the environment.
(4) The operation of the Scientific Expert Commission
according to the resources granted from the State budget shall be
ensured by the State scientific institute Institute of Food
Safety, Animal Health and Environment "BIOR".
[25 September 2014; 21 November 2019]
Section 16. Monitoring Council of
Genetically Modified Organisms
[8 June 2017]
Chapter
III
Contained Use of Genetically Modified Micro-organisms
[21 June 2012]
Section 17. Activities Related to
the Contained Use of Genetically Modified Micro-organisms
The activities related to the contained use of genetically
modified micro-organisms may be performed by a scientific
establishment which has been registered in the Register of
Science Establishments (hereinafter - the scientific
establishment).
[21 June 2012]
Section 18. Containment Levels for
Use of Genetically Modified Micro-organisms
(1) For each activity related to the contained use of
genetically modified micro-organisms in conformity with the laws
and regulations regarding the procedures for contained use of
genetically modified micro-organisms and issuance of a permit, on
the basis of the risk assessment performed and the laws and
regulations regarding the labour protection requirements when
coming into contact with biological substances, a containment
level shall be determined.
(2) The activities related to the contained use of genetically
modified micro-organisms are divided into four safety
classes:
1) activities, which do not cause any risk or cause an
insignificant risk, shall comply with the first safety class.
Such activities conform to the containment of the first level,
which is determined in order to protect human health or the
environment;
2) activities, which cause a small risk, shall comply with the
second safety class. Such activities conform to the containment
of the second level, which is determined in order to protect
human health or the environment;
3) activities, which cause a moderate risk, shall comply with
the third safety class. Such activities conform to the
containment of the third level, which is determined in order to
protect human health or the environment;
4) activities, which cause a huge risk, shall comply with the
fourth safety class. Such activities conform to the containment
of the fourth level, which is determined in order to protect
human health or the environment.
(3) Safety measures shall be performed in conformity with the
relevant containment level in accordance with the laws and
regulations regarding the procedures for the contained use of
genetically modified micro-organisms and issuance of a permit and
laws and regulations regarding the labour protection when coming
into contact with biological substances.
[21 June 2012]
Section 19. Rights and Obligations
when Performing Activities Related to the Contained Use of
Genetically Modified Micro-organisms
(1) The contained use of genetically modified micro-organisms
may be commenced if, in accordance with the laws and regulations
regarding the procedures for contained use of genetically
modified micro-organisms and issuance of permit, the following
conditions are observed:
1) the scientific establishment is provided with equipment and
installations;
2) the risk assessment of a genetically modified
micro-organism has been performed and the containment level has
been determined;
3) a notification to the State scientific institute Institute
of Food Safety, Animal Health and Environment "BIOR" on
commencement of operation has been provided in accordance with
specific procedures.
(2) In order to perform activities related to the contained
use of genetically modified micro-organisms complying to the
third and fourth safety class, a permit of the State scientific
institute Institute of Food Safety, Animal Health and Environment
"BIOR" shall, in accordance with the laws and regulations
regarding the procedures for the contained use of genetically
modified micro-organisms and issuance of permit, be received.
Without a permit it is allowed to perform activities related to
the contained use of genetically modified micro-organisms which
conform to the first and second safety class if the conditions of
Paragraph one of this Section are observed.
(3) The scientific establishment, when performing activities
related to the contained use of genetically modified
micro-organisms, has the following obligations:
1) to evaluate the performed measures of control and safety in
conformity with the laws and regulations regarding the procedures
for the contained use of genetically modified micro-organisms and
issuance of a permit;
2) to take appropriate measures of control and safety without
delay, if there is a reason to believe that these genetically
modified micro-organisms no longer conform to the latest
scientific knowledge;
3) to ensure the observance of the work safety and hygiene
requirements of the contained use of genetically modified
micro-organisms in conformity with the laws and regulations
regarding labour protection when coming into contact with
biological substances;
4) to suspend the activity with genetically modified
micro-organisms, if taking into account the latest scientific
knowledge, there is a reason to believe that it threatens human
and animal health or the environment, and to inform regarding
that the relevant competent authorities and the public.
[21 June 2012; 25 September 2014]
Chapter
IV
Deliberate Release of Genetically Modified Organisms
[21 June 2012]
Section 20. Rights and Obligations
Related to Deliberate Release of Genetically Modified
Organisms
(1) In order to release genetically modified organisms into
the environment for experiments it is necessary for the person
who has created genetically modified organisms to receive a
permit of the State scientific institute Institute of Food
Safety, Animal Health and Environment "BIOR" in accordance with
the laws and regulations regarding the procedures for deliberate
release of genetically modified organisms, the procedures for
monitoring and issuance of a permit, as well as the procedures
for the provision of information regarding the circulation of
genetically modified organisms and the public involvement in the
decision-making process.
(2) In order to place genetically modified organisms on the
market it is necessary for the person who has created genetically
modified organisms to receive one of the following permits:
1) a permit in accordance with the laws and regulations
regarding the procedures for deliberate release of genetically
modified organisms, the procedures for monitoring and issuance of
permit, as well as the procedures for the provision of
information regarding the circulation of genetically modified
organisms and the public involvement in the decision-making
process;
2) a relevant permit of the competent authority of another
European Union Member State;
3) a permit specified in Regulation No 1829/2003 of the
European Parliament and of the Council.
(3) The person registered in the Register of Growers of
Genetically Modified Crops has the right to cultivate genetically
modified crops, if the appropriate permit referred to in
Paragraph two of this Section has been issued to the creator of
the relevant genetically modified organism. A grower of
genetically modified crops shall ensure the observation of
co-existence provisions in accordance with the laws and
regulations regarding co-existence of genetically modified
crops.
[21 June 2012]
Section 21. Receipt of a Permit for
Conducting a Clinical Trial
[21 June 2012]
Section 22. Containment in
Cultivation of Genetically Modified Crops
(1) The Cabinet may determine a prohibition for the
cultivation of genetically modified crops in Latvia or in a
particular territory thereof in accordance with Section 5,
Paragraphs three and four of this Law.
(2) A local government may, by taking into account the
socio-economic, climatic or environmental circumstances or upon
evaluation of the methods of agricultural activity, specify a
prohibition by issuing binding rules for the cultivation of
genetically modified crops in the relevant administrative
territory or in a particular territory thereof upon its own
initiative or on the basis of a proposal of the person.
(3) The prohibition referred to in Paragraph two of this
Section shall be determined for a period of time which is not
less than five years.
(4) Prior to taking of the binding rules referred to in
Paragraph two of this Section, the local government shall inform
the public and publish a notification regarding the intention to
determine such prohibition in the newspaper issued by the local
government, but, if there is no such newspaper - in another local
newspaper, as well as place the notification referred to on the
Internet website thereof and send information regarding the
notification to the Ministry of Agriculture and the Ministry of
Environmental Protection and Regional Development, which shall
place this information on their Internet websites. The territory
where the determination of the prohibition for cultivation of
genetically modified crops is intended, as well as the place and
term for the submission of public opinions, proposals and
objections shall be indicated. The term for the submission of
proposals and objections may not be less than 30 days from the
day of publication of the notification. Non-submission of
objections within the term specified by the local government
shall be considered as the consent for determination of
prohibition.
(5) If a local government has received a written objection
against the prohibition for cultivation of genetically modified
crops, it shall evaluate the submitted objection and decide upon
exclusion of the particular territory, against inclusion of which
the objection was expressed, from the intended prohibition zone
or retaining therein, taking into account the opinion of majority
of the public, the principles of proportionality and sustainable
development.
(6) A local government shall notify those local governments
regarding the prohibition referred to in Paragraph two of this
Section, the administrative territory of which borders on the
territory where the determination of the prohibition for
cultivation of genetically modified crops is intended, as well as
the Ministry of Agriculture, the relevant regional environmental
board of the State Environment Service, as well as the State
Plant Protection Service, which includes the referred to
information in the Register of Growers of Genetically Modified
Crops.
[18 June 2009, 1 December 2009; 16 December 2010; 21 June
2012; 18 June 2015]
Section 23. Use of Antibiotic
Resistance Marker Genes
It is prohibited to release deliberately genetically modified
organisms containing genes, which code resistance to antibiotics
used in medicine or veterinary, if in the risk assessment of
potential effect of gene transfer of the particular genetically
modified organism, it is determined that they have an adverse
effect on human and animal health or the environment.
[21 June 2012]
Section 24. Obligations of the
Persons
The person who has obtained a permit for the deliberate
release of genetically modified organisms has the following
obligations:
1) to comply with the conditions of the permit regarding
deliberate release of genetically modified organisms;
2) to ensure the implementation of monitoring measures and
notification of the competent authorities regarding the results
thereof in accordance with the laws and regulations regarding
deliberate release of genetically modified organisms, the
procedures for monitoring and issuance of a permit, as well as
the procedures for the provision of information regarding the
circulation of genetically modified organisms and the public
involvement in the decision-making process;
3) to take relevant measures and to suspend deliberate release
of genetically modified organisms, as well as to inform thereof
the relevant competent authorities and the public if new
information has become available, and there is a reason to
believe in the existence of a risk to human and animal health or
the environment.
[21 June 2012]
Section 25. Provision of
Monitoring
In order to ensure the implementation of the monitoring
referred to in Section 24, Clause 2 of this Law; the person has
the right to make an agreement with the competent authority for
the adjustment of environmental monitoring to the monitoring
referred to in Section 24, Clause 2 of this Law, providing
accordingly the financing necessary for the implementation
thereof.
Section 26. Placing on the Market of
such Food and Feed, which Contains Genetically Modified
Organisms, Consist of or is Produced From Them
Placing on the market of such food and feed, which contains
genetically modified organisms, consist of or is produced from
them, shall comply with Regulation No. 1829/2003 of the European
Parliament and of the Council and Regulation (EC) No. 1830/2003
of the European Parliament and of the Council of 22 September
2003 concerning the traceability and labelling of genetically
modified organisms and the traceability of food and feed products
produced from genetically modified organisms and amending
Directive 2001/18/EC.
[18 June 2009]
Section 26.1 Restrictions on the Release
of Genetically Modified Organisms
(1) The food products the labelling of which includes an
indication that these food products contain genetically modified
organisms, consist of or is produced from them shall be placed
for sale separately from other food products at sales points so
that they could be easily identifiable.
(2) Seeds in which an admixture of genetically modified
organisms is found may not be released.
[8 June 2017; 21 November 2019]
Chapter V
Availability of Information and Public Participation Section 27.
Openness and Availability of Information
Competent authorities shall provide the public with
information regarding the circulation of genetically modified
organisms in accordance with the requirements of the laws and
regulations governing the circulation of genetically modified
organisms.
Section 28. Public Involvement in
the Decision-making Process
(1) The public - any natural person, as well as associations
and foundations - have the right to submit proposals or express
an opinion to the competent authority prior to its issuing a
permit for the circulation of genetically modified organisms.
(2) The procedures for the public involvement and organisation
of public consultation with regard to the circulation of
genetically modified organisms shall be specified by the laws and
regulations regarding the deliberate release of genetically
modified organisms, the procedures for monitoring and issuance of
a permit, as well as the procedures for the provision of
information regarding the circulation of genetically modified
organisms and the public involvement in the decision-making
process.
(3) The competent authority shall involve the public in the
decision-making process prior to taking the decision on
circulation of genetically modified organisms.
[21 June 2012]
Section 29. Functions of Local
Governments, Associations and Foundations
[18 June 2009]
Section 30. Obligation to Provide
Information
(1) The person performing activities with genetically modified
organisms shall arrange and keep information on the circulation
of genetically modified organisms, and present it when requested
by the competent authorities.
(2) The person who performs activities with genetically
modified organisms shall, in conformity with the laws and
regulations regarding circulation of genetically modified
organisms, inform the relevant competent authorities and the
public, without delay, about the cases when scientifically
substantiated opinions on the possible adverse effects of
genetically modified organisms on human and animal health or the
environment have been received, as well as when the harm has
already been caused to human and animal health or the environment
or there are direct hazards that such harm could be caused, or
the negative changes in the environment have been observed in
connection with deliberate release of the genetically modified
organism.
[18 June 2009; 21 June 2012]
Section 31. Circulation of
Information
The competent authorities shall ensure the exchange of
information with the persons, the Member States of the European
Union, the European Commission, the European Food Safety
Authority, the European Medicines Agency and other authorities on
the circulation of genetically modified organisms.
Chapter
VI
Supervision and Control
Section 32. Supervisory and Control
Authorities
The implementation of the laws and regulations regarding the
circulation of genetically modified organisms shall be supervised
and controlled by the Food and Veterinary Service, the State
Environmental Service, the State Plant Protection Service and the
State Labour Inspectorate, in accordance with their
competence.
[21 June 2012]
Section 33. Rights of Supervisory
and Control Authorities
(1) The inspector of the supervisory and control authority has
the right to:
1) control and to become acquainted with documents to ensure
the implementation of the conditions specified in the permit;
2) take samples for the identification of the presence of
genetically modified organisms in the food, feed, animals, seeds
and plant propagating material, as well as in other environmental
sites;
3) immediately determine restrictions or prohibitions by
informing the public thereof if serious threats to human and
animal health or the environment have arisen or the requirements
of the laws and regulations governing the circulation of
genetically modified organisms have been violated.
(2) If serious threats to human and animal health or the
environment are caused or the requirements of the laws and
regulations governing the circulation of genetically modified
organisms have been violated, the following bodies have the right
to specify restrictions or prohibitions for the circulation of
genetically modified organisms:
1) the Food and Veterinary Service - for the contained use of
genetically modified micro-organisms and the circulation of
genetically modified food, animal feed and animals;
2) the State Labour Inspectorate - for the contained use of
genetically modified micro-organisms;
3) the State Environmental Service - for the release into the
environment of genetically modified organisms for experiments and
the cultivation of genetically modified crops;
4) the State Plant Protection Service - for the release on the
market of genetically modified organisms in relation to:
a) the circulation of seeds of genetically modified crops and
plant propagating material;
b) the cultivation of genetically modified crops.
(3) The State Plant Protection Service has the right:
1) to cancel the registration with the Register of Growers of
Genetically Modified Crops, if the requirements of the laws and
regulations regarding the cultivation and co-existence of
genetically modified crops have been violated;
2) in accordance with the laws and regulations regarding the
co-existence of genetically modified crops take a decision that
sowings or plantations should be destroyed using mechanical or
chemical methods within a specific time period. A decision of an
inspector of the State Plant Protection Service to destroy
sowings or plantations may be contested by submitting a
respective submission to the director of the State Plant
Protection Service. The decision of the director of the State
Plant Protection Service may be appeal to the court. Contesting
and appeal of a decision shall not suspend its operation;
3) to destroy sowings and plantations by force, if the
decision referred to in Clause 2 of this Paragraph has not been
executed within a specific time period.
(4) [25 September 2014]
[18 June 2009; 21 June 2012; 25 September 2014; 21 November
2019]
Section 34. Action in Emergency
Situations
(1) The Food and Veterinary Service shall develop and the
Director-General thereof shall approve the plan for action in
emergency situations, shall be liable for action in emergency
situations and shall comply with the requirements of the laws and
regulations governing the civil protection and those of the laws
and regulations governing the circulation of genetically modified
organisms.
(2) In emergency situations the Director-General of the Food
and Veterinary Service shall:
1) ensure and co-ordinate the implementation of the plan of
emergency situations;
2) ensure the circulation of information in accordance with
the laws and regulations regarding food circulation and the
circulation of genetically modified organisms;
3) perform the emergency situation analysis and in accordance
with the laws and regulations regarding the circulation of
genetically modified organisms prepare recommendations for the
avoidance of similar situations.
Chapter
VII
Administrative Offences in the Field of the Circulation of
Genetically Modified Organisms and Competence in the
Administrative Offence Proceedings
[24 October 2019 / The
new wording of the Chapter shall come into force on 1 July
2020. See Paragraph 8 of the Transitional
Provisions]
Section 35. Administrative Liability
for the Violation of the Regulations Regarding the Contained Use
of Genetically Modified Micro-organisms
For the violation of the regulations regarding the contained
use of genetically modified micro-organisms, a fine from
twenty-eight to one hundred units of fine shall be imposed on a
natural person, but a fine from seventy to two hundred and eighty
units of fine - on a legal person.
[24 October 2019 / The new wording of Section shall
come into force on 1 July 2020. See Paragraph 8 of the
Transitional Provisions]
Section 36. Administrative Liability
for the Violations of the Requirements of Laws and Regulations in
the Deliberate Release of Genetically Modified Organisms
(1) For the violation of the requirements laid down in laws
and regulations by releasing genetically modified organisms into
the environment for experiments, a fine from one hundred and
forty to four hundred units of fine shall be imposed on a natural
person, but from eight hundred and sixty to two thousand and
eight hundred units of fine - on a legal person.
(2) For the violation of the requirements laid down in laws
and regulations by releasing genetically modified organisms on
the market, a fine from one hundred and forty to two hundred and
eighty units of fine shall be imposed on a natural person, but
from one hundred and forty to two thousand and eight hundred
units of fine - on a legal person.
[24 October 2019 / The new wording of Section shall
come into force on 1 July 2020. See Paragraph 8 of the
Transitional Provisions]
Section 37. Administrative Liability
for the Violations of the Regulations Regarding the Co-existence
of Genetically Modified Crops
(1) For the cultivation of genetically modified crops without
registering with the State Plant Protection Service, a fine from
fourteen to one hundred and eight units of fine shall be imposed
on a natural person, but a fine from one hundred and forty to one
thousand four hundred and twenty units of fine - on a legal
person.
(2) For the cultivation of genetically modified crops without
complying with the requirements laid down for co-existence, a
fine from twenty-eight to one hundred and twenty-eight units of
fine shall be imposed on a natural person, but a fine from
fifty-six to two hundred and eighty units of fine - on a legal
person.
(3) For the violation of the requirements for the circulation
of seeds of genetically modified crop varieties, a fine from
fourteen to one hundred and twenty-eight units of fine shall be
imposed on a natural person, but a fine from twenty-eight to two
hundred and eighty units of fine - on a legal person.
[24 October 2019 / This Section shall come into
force on 1 July 2020. See Paragraph 8 of the Transitional
Provisions]
Section 38. Competence in
Administrative Offence Proceedings
(1) The administrative offence proceedings for the offences
referred to in Sections 35 and 36 of this Law shall be conducted
by the Food and Veterinary Service.
(2) Administrative offence proceedings for the offences
referred to in Section 36, Paragraph two, and Section 37 of this
Law shall be conducted by the State Plant Protection Service.
(3) Administrative offence proceedings for the offences
referred to in Section 36 and Section 37, Paragraph two of this
Law shall be conducted by the State Environmental Service.
(4) Administrative offence proceedings for the offences
referred to in Section 35 of this Law shall be conducted by the
State Labour Inspection.
[24 October 2019; 21 November 2019 / This Section
shall come into force on 1 July 2020. See Paragraphs 8 and
10 of the Transitional Provisions]
Transitional
provisions
1. The Cabinet shall issue the Cabinet regulations referred to
in Section 5, Paragraph one of this Law by 1 December 2008.
2. Until the day of coming into force of the new Cabinet
regulations, but not later than until 1 December 2008, Cabinet
Regulation No. 333 of 20 April 2004, Regulations Regarding the
Contained Use and Deliberate Release into the Environment and
Placing on the Market of Genetically Modified Organisms, as well
as Procedures for the Monitoring Thereof, shall be applied,
insofar as it is not in contradiction with this Law.
3. Section 5, Clause 5 of this Law comes into force
concurrently with the relevant amendments to the law On Taxes and
Fees.
4. Until the day of coming into force of the Cabinet
regulation referred to in Section 5, Paragraph one, Clause 4 of
this Law governing the requirements for co-existence, as well as
the procedures for supervision and control of genetically
modified crops, but not later than until 1 July 2010, the Cabinet
Regulation No. 30 of 15 January 2008, Regulations Regarding the
Requirements for Co-existence of Genetically Modified Crops, as
well as the Procedures for Supervision and Control, shall be
applied, insofar as they comply with this Law.
[18 June 2009]
5. Until 1 July 2013 the Cabinet shall issue the Cabinet
regulations referred to in Section 5, Paragraph one, Clause 4 of
this Regulation.
[21 June 2012]
6. Amendments to Section 5, Paragraph one, Clause 5 of this
Law in relation to determination of fee for the preparation of an
opinion on risk assessment of genetically modified organisms
shall come into force concurrently with respective amendments to
the Law On Taxes and Fees.
[25 September 2014]
7. The Cabinet shall make amendments to Cabinet Regulation No.
457 of 26 May 2009, Regulations Regarding Deliberate Release of
Genetically Modified Organisms, by 30 September 2015.
[18 June 2015]
8. Amendment regarding the rewording of Chapter VII of this
Law shall come into force concurrently with the Law on
Administrative Liability.
[24 October 2019]
9. Amendments to Section 8 of this Law regarding its rewording
which provides for a reference to Regulation (EU) 2017/625 of the
European Parliament and of the Council of 15 March 2017 on
official controls and other official activities performed to
ensure the application of food and feed law, rules on animal
health and welfare, plant health and plant protection products,
amending Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) No
1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No
652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European
Parliament and of the Council, Council Regulations (EC) No 1/2005
and (EC) No 1099/2009 and Council Directives 98/58/EC,
1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and
repealing Regulations (EC) No 854/2004 and (EC) No 882/2004 of
the European Parliament and of the Council, Council Directives
89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC,
96/93/EC and 97/78/EC and Council Decision 92/438/EEC (Official
Controls Regulation) shall come into force on 14 December
2019.
[21 November 2019]
10. Amendment to Section 38, Paragraph two of this Law by
which the competence of the State Plant Protection Service is
extended shall come into force concurrently with the Law on
Administrative Liability.
[21 November 2019]
Informative
Reference to European Union Directives
[21 June 2012; 18 June
2015]
This Law contains legal norms arising from:
1) Directive 2001/18/EC of the European Parliament and of the
Council of 12 March 2001 on the deliberate release into the
environment of genetically modified organisms and repealing
Council Directive 90/220/EEC;
2) Directive 2009/41/EC of the European Parliament and of the
Council of 6 May 2009 on the contained use of genetically
modified micro-organisms (Recast) (Text with EEA relevance);
3) Directive (EU) 2015/412 of the European Parliament and of
the Council of 11 March 2015 amending Directive 2001/18/EC as
regards the possibility for the Member States to restrict or
prohibit the cultivation of genetically modified organisms (GMOs)
in their territory.
This Law has been adopted by the Saeima on 15 November
2007.
President V. Zatlers
Rīga, 5 December 2007
1 The Parliament of the Republic of
Latvia
Translation © 2021 Valsts valodas centrs (State
Language Centre)