Regulation No 1/1999. (I. 14.) FVM of the Minister of
Agriculture and Regional Policy
on the execution of the Act XXVII of 1998 on Gene
Technology Activity on the fields of the agriculture and the food industry
According to the authorisation given by the paragraphs
(3), (6) and (8) of Article 34 of the Act XXVII of 1998 on Gene Technology
Activity (hereinafter: the Act) - in agreement with the affected Ministers and
the Hungarian Academy of Sciences - I decree the followings:
The force of the regulation
Article
1
(1) The force of the regulation covers:
a) the modification of natural organisms
by gene technology, the closed system usage, the release to the environment,
the distribution, as well as the importing to Hungary and the exporting to abroad
and the transportation of the genetically modified organisms and the products
made from them (hereinafter together: gene technological activity) on the field
of the agriculture and the food industry;
b) the natural entities, the legal
entities, and the economic companies without legal entities (hereinafter:
companies) performing gene technological activity on the field of the
agriculture and the food industry;
(2) The regulation's force does not covers
the below genetic modifying procedures, if there is no use of any genetically
modified organisms as recipient or donor organisms during the process:
a) mutagenesis
b) cell fusion (including the protoplast
fusion)
(3) In the case of raw foods, processed foods
and food raw materials qualified as new food to be applied the prescriptions
specified in the Act XC of 1995 on Foods and in the common regulation No 1/1996
(I. 9.) FM-NM-IKM on the execution of the above-mentioned Act of Foods.
Explanatory provisions
Article
2
In the application of
this regulation:
a) emergency:
that kind of event, in the course of which or in consequence of which the
genetically modified organism or the product made from that means immediate or
undoubtedly happening danger to the human health or to the environment;
b) organism:
any biological entity, which is capable to replication or transfer genetic
material, excluding the human being;
c) product
made from genetically modified organism: a preparation consisting of, or
containing genetically modified organism or a combination of genetically
modified organisms, and is placed on the market.
Genetic
modification
Article
3
(1) In the application of this regulation
among others especially the followings are qualified as genetic modifications:
a) recombinant
deoxyribonucleic acid (hereinafter: DNA) procedures using vector systems;
b) techniques involving the direct
introduction into an organism of heritable material prepared outside the
organism including any kind of technical introduction into the cell, especially
micro-injection, macro-injection, micro-encapsulation, electroporation and
electrofusion;
(2) In the application of this regulation the
following techniques are not considered as genetic modifications:
a) in-vitro fertilization,
b) conjugation, transduction,
transformation or any other natural process,
c) polyploidy induction
d) gynogenesis and androgenesis,
if recombinant DNA
molecules or genetically modified organisms are not used during the operation.
Article
4
It is possible to
perform gene modification technique only under the conditions specified in this
regulation. The material and personal conditions of the performance of genetic
modifications are contained in the Annex 1.
Constitution and functioning of the Gene Technology
Advisory Committee
Article
5
(1) The secretary duties of the Gene
Technology Advisory Committee (hereinafter: Gene Technology Committee) are
managed by the National Agricultural Qualification Institute (hereinafter:
OMMI).
(2) The dates of the Gene Technology
Committee's sessions must be determined so that let the permanent report on the
applications for gene technological activity (hereinafter: application) be
guaranteed.
(3) Fee is due for the president and the
members of the Gene Technology Committee. The level of the fee and the
frequency of its payment are determined by the Minister of Agriculture and
Regional Policy (hereinafter: Minister). The fee is paid from the budget of the
Ministry of Agriculture and Regional Policy (hereinafter: Ministry).
(4) The rules concerning the constitution and
functioning of the Gene Technology Committee are contained in Annex 2.
Competent authorities
Article
6
(1) On the fields of agriculture and food
industry the permissions specified in the Article 3 paragraph (1) of the act
are issued in the official jurisdiction of the first degree by the departments
of the Ministry responsible for agriculture, plant animal health and food
industry (hereinafter: agricultural gene technology authority).
(2) The agricultural gene technology
authority permits according to the opinion of the Gene Technology Committee
a) the establishment of a laboratory
performing genetic modifications if the genetically modified organism is used
for plant growing, animal breeding, plant protection, food processing or feed
production purpose;
b) the genetic modification of a natural
organism in the cases of plants, plant protection products, seeds and plant
reproduction materials, as well as micro-organisms, animals and animal
reproduction materials, respectively feeds, feed raw materials, feed
supplements and feed additives, except the experimental modification;
c) the usage in closed system, the release
or circulation of genetically modified organisms and products made from them -
according to the special acts relevant to the given product type - in the cases
of plants, plant protection products, seeds and plant reproduction materials,
as well as micro-organisms, animals and animal reproduction materials,
respectively feeds, feed raw materials, feed supplements and feed additives,
except the experimental closed system usage;
d) the importing and exporting of
genetically modified organisms and products made from them in the cases of
plants, plant protection products, seeds and plant reproduction materials, as
well as micro-organisms, animals and animal reproduction materials, respectively
feeds, feed raw materials, feed supplements and feed additives, except the
experimental import and export.
(3) The authorities supervised by the
Minister of Environmental Protection (hereinafter: environmental- and nature
protection authority) and the authorities supervised by the Minister of Health
are participating in the issuing of permissions as professional authorities.
Article
7
(1) The application should be submitted in
three copies by the natural entity, legal entity or economic companies without
legal entity
a) establishing gene technology
laboratory,
b) modifying natural organisms by gene
technology,
c) using the genetically modified
organisms and the products made from them in closed system,
d) releasing genetically modified
organisms and products made from them into the free environment,
e) - regarding as stated in Article 11
paragraph (4) - placing on the market genetically modified organisms and
products made from them,
f) importing genetically modified
organisms and products made from them,
g) exporting genetically modified
organisms and products made from them
to the agricultural gene
technology authority, which sends it to the Gene Technology Committee for
expressing an opinion on it.
(2) The documentation specified in the
Annexes 3 and 4 should be enclosed to the application, and also should be
submitted in six copies to the agricultural gene technology authority.
(3) The agricultural gene technology
authority and the Gene Technology Committee are obligatory to manage the data
coming to its knowledge from the application and the enclosed documentation as
an official secret. This direction remains valid if the user withdraws his
submitted application.
(4) The agricultural gene technology
authority controls the content of the documentation enclosed to the application
by an official laboratory if it is necessary.
Gene technology licensing fee
Article
8
The
fees to be paid for the licensing of gene technology activity are determined by
a special Act.
Testing obligation
Article
9
(1) In case of importing the importer
declares to the agricultural gene technology authority thereof, whether the
consignment contains genetically modified organism or a product made from
that. The importer must enclose to the
declaration the certification of the examiner centre specified in Annex 5.
(2) The examiner centre finds by instrumental
analysis, whether the provided sample contains genetically modified organism or
a product made from that or in which proportion it contains of these.
(3) The import licence specified in the
Article 6 paragraph (2) point d) (hereinafter: import licence) deliverable only
in case of the presence of the examiner centre certificate.
(4) Should be attached to the import licence
application - after the application purpose of the import object - the
requested data in case of the different gene technology activities as it is
specified in the Annex 3 and 4.
(5) In case of importing breeding animals,
plant- or animal reproduction material, the import licence does not substitute
the execution of the prescriptions specified in the special Act.
Genetic protective zone
Article
10
(1) The agricultural gene technology
authority - on the grounds of the suggestion of the Gene Technology Committee
respectively the environmental- and nature protection authority or as needed -
can order the establishment of genetic protective zone. The establishment
conditions of the genetic protective zone must be determined in the gene
technology permission according to the expertise of the environmental- and
nature protection authority.
(2) At examining the necessity of the
establishment of the genetic protective zone - beside others – should be
considered the flowering-biological features of the genetically modified and
the affected plant species, the environmental and climate relations, the other
features of the genetically modified and the affected plant species and
environmental- and nature protection considerations.
Release, placing on the market
Article
11
(1) It is possible to submit the application
for the breed registration procedure of the genetically modified animal breeds
and the application for the state registration procedure of the genetically
modified plant lines only after the receipt of the release permission specified
in the Article 11 of the Act. Should be enclosed to this application the
release permission provided by the agricultural gene technology authority.
(2) The agricultural gene technology
authority orders in the release permission the conditions of the release -
especially in case of the conditions of the breed examination and the breed
testing. In these conditions determines - beside others - the possible
dimension of the release, the place and the number of the places of the breed
examination or the breed testing, the isolation distance, the size of the
genetic protective zone as well as limited area use, pollen control, waste
material management and the subsequent observation of the area as needed.
(3) In case of genetically modified animal
breeds or plant lines the marketing permission - specified in the Article 11 of
the Act - is necessary for the placing on the market. The application for this
marketing licence can be submitted to the agricultural gene technology
authority only after completing the breed registration or the state
registration. Should be enclosed to the application the decision thereof the
breed registration or the state registration had been taken place.
(4) The permission issued on placing on the
market the genetically modified animal breed or plant line is also valid for
placing on the market the products made from the registered animal breed or
plant line as it is specified in this permission
(5) The agricultural gene technology
authority - on the grounds of the suggestion of the Gene Technology Committee
or as needed - determines in the marketing permission the maximal sowing area
percentage of the registered genetically modified plant line from the total
domestic sowing area of the traditional plant line, or the maximal stock
percentage of the registered genetically modified animal breed from the total
domestic stock of the traditional animal breed.
Registration of animal breeds
Article
12
(1) Should be applied the prescriptions of
the special Act on Animal Breeding and the order of the breed registration
together with the prescription of the paragraph (2) during the breed
registration process.
(2) The OMMI executes the examinations
necessary for the breed registration using the method approved by the National
Agricultural Breed Qualification Council, according to the suggestion of the
Gene Technology Committee and the prescriptions determined by the agricultural
gene technology authority.
Registration of plant lines
Article
13
(1) Should be applied the prescriptions of
the special Act on State Registration of Plant Lines and the production and
placing on the market seeds and vegetative reproduction materials together with
the prescription of the paragraph (2) during the state registration process.
(2) The OMMI executes the examinations
necessary for the state registration using the method approved by the National
Agricultural Breed Qualification Council, according to the suggestion of the
Gene Technology Committee and the prescriptions determined by the agricultural
gene technology authority.
Special commodity production licence
Article
14
(1) It is possible to perform manufacturing
products which origins from genetically modified animal organism in closed
system for the purpose of agricultural commodity production (hereinafter:
special product manufacturing) with the special commodity production licence,
without licensing the genetically modified animal breed.
(2) It is possible to issue special commodity
production licence for the production of live animal and product of animal
origin in closed system only if the genetically modified animal or its
reproductive material is not used in the common breeding, there is no use of
this for propagation and no breeding animal production.
(3) Should be withdrawn the special commodity
production licence if in the case of the live animal or the product of animal
origin the genetically modified animal or its reproduction material gets into
common breeding, propagation or breeding animal production happens.
(4) The agricultural gene technology
authority determines the conditions of the special commodity production in the
special commodity production licence and controls the keeping of these
conditions on the scene.
(5) The agricultural gene technology
authority keeps records of the special commodity production licences.
Marking the product
Article
15
(1) The manufacturer or the distributor -
with the exception of which specified in the Article 16 - is required to
indicate on the packaging of the product consisting of genetically modified
organism or containing of this kind of organism completely or partly and also
on the quality certification documents, that the product is containing
genetically modified organism. Should be indicated on the mark the type of the
genetically modified organism.
(2) If the product made from genetically
modified organism, but it does not contain genetically modified organism, the
manufacturer or the distributor - with the exception of which specified in the
Article 16 - is obliged to indicate on the packaging of the product and also on
the quality certification documents the fact of the genetic modification.
Should be indicated on the mark that which type of the genetically modified
organism was used for the production.
(3) Should be used the mark specified in the
paragraph (1) if only protein or DNA of genetic modification origin is present.
(4) The manufacturer, the distributor is
required to provide the necessary information on the mark for the use of
product and to notify the danger of the use different from the included
instructions.
(5) The manufacturer, the distributor is
required to provide information on the packaging of the product and also on the
quality certification documents about that the product, or the use of it could
mean risk to the health or to the environment. Should be unambiguously
indicated on the mark the type of the risk - especially the allergic effects,
and the effects concerning the digestibility and feeding which origins from the
composition.
(6) The mark must be well visible, clear,
unambiguous and true. Should be used on the mark the text and figure specified
in the Annex 6.
(7) In case of genetically modified animal -
especially at a registered animal – should be indicated - with a distinctive
note - on the certificate of origin and in the breeding registers the fact of
the genetic modification so that let the register be suitable for the
determination of the whole circle of the individuals containing the determined
gene.
Article
16
(1) For marking a new food should be used
only the prescriptions specified in the Act XC of 1995 and in the common
regulation No 1/1996 (I. 9.) FM-NM-IKM on the execution of the above-mentioned
Act.
(2) For marking the feeds, feed raw
materials, feed supplements and feed additives should be used only the
prescriptions specified in the Act XCII 1995 on Production and Marketing Feeds
and in the regulation No 25/1996. (IX. 4.) FM on the execution of the above-mentioned
Act.
Transportability
Article
17
The agricultural gene technology authority make decision
on the transportability of the genetically modified organisms and the products
made from them and on the conditions of the transportability according to the
data specified in Annex 7. The applicant or the authorized entity of the
permission submits the data.
Gene technology register
Article
18
(1) The Agricultural Biotechnology Center
(hereinafter: registering institution) keeps the records of the genetic
modifications used in plant growing, in plant protection, in animal breeding,
in food processing, in feed production, in industry and in any other use, the
data concerning the use in closed systems, the release and the placing on the
market of the genetically modified organisms and the products made from them
and the list of the laboratories performing genetic modifications and the
responsible leaders of these laboratories.
(2) The registering institution keeps records
of only those data, which was provided for the institution by the agricultural
gene technology authority as it is specified in the paragraph (4). The data
provided for keeping records of them cannot contain that kind of information,
that the acquaintance of which by a third party breaks the business interest or
the rights of the user, related to any patent or breed registration.
(3) The data provided for keeping records of
them neither can contain that kind of information which is asked by the user
from the Gene Technology Committee or the agricultural gene technology authority
to handle as a secret, supposing that these information is not belonging to the
information specified in the paragraph (4).
(4) The registry institution keeps the
records of the below data:
a) description of the genetically modified
organism;
b) name (company name) of the user
submitting the application;
c) purpose and the geographical site of
the gene technological activity;
d) methods and plans to be used in case of
emergency, which suitable for controlling and following of the genetically modified
organisms;
e) Assessment of the impact study and
impact estimation surveying the predictable effects - especially the
pathogenity and the ecological damage - of the gene technological activity.
(5) It is prohibited to keep records of the
data contained in the application and the enclosed documentation withdrawn by
the user.
(6) The registry institution performs the
data management and the data supply in separated organizational unit according
to the prescriptions of the Act on the protection of the personal data and the
publicity of the data of public interest.
(7) The registry institution supplies data in
printed form in return for paying the fee determined in Annex 8.
(8) The data supply is free of charge if it
is performed through computing-telecommunication system.
Article
19
This regulation is coming into force on the day of its
issue, but it is obligatory to apply the prescriptions of the regulation's
Article 15 concerning the product's marking only after the 1st of July 1999.
Altering acts
Article
20
(1) Simultaneously with the coming into force
of this regulation the Article 5 paragraph (3) of the regulation No 31/1994.
(VI. 28.) on the order of the breed registration is completed with the below f)
paragraph, and simultaneously the letter signs of the f)-j) paragraphs are
changing to g)-k) paragraphs:
(The announcement must contain)
"f) that, whether the species or the breed
is modified by gene technology, or whether it contains genetically modified
organism;"
(2) Simultaneously with the coming into force
of this regulation the Act XCII of 1995 on Production and Marketing Feeds and
in the regulation No 25/1996 (IX. 4.) FM on the execution of the
above-mentioned Act is changing according to the followings
a)
in Annex 9 the "food health quarantine period" is substituted by
"nutritional health quarantine period:"
b) Annex 9 is completed with the below text:
(Quality control
period)
"Genetically modified organism
or the product made from that
- Name:
- Stirring
proportion:
- the
certification of the examiner centre or the number of the permission issued by
the agricultural gene technology authority:
- suggestion on the proper use of the
feed:
c)
Annex 12 is completed following the first French paragraph with the below
French paragraph:
"-
the declaration thereof whether the feed contains genetically modified organism
or a product made from that (enclosed the certification of the examiner centre
on the genetically modified organism or the product made from that, or the
permission of the agricultural gene technology authority)"
d)
in Annex 13 the paragraph 2 is substituted by:
"2.
Its composition [proportion of agents, whether it contains genetically modified
organism or a product made from that (enclosed the certification of the
examiner centre on the genetically modified organism or the product made from
that, or the permission of the agricultural gene technology authority)]:"
e)
Annex 14 is completed following the first French paragraph with the below
French paragraph:
"-
the declaration thereof whether the feed contains genetically modified organism
or a product made from that (enclosed the certification of the examiner centre
on the genetically modified organism or the product made from that, or the
permission of the agricultural gene technology authority)"
f)
Annex 15 is completed after the first French paragraph which follows the
"should be attached to the application" text, with the below French
paragraph:
"-
the declaration thereof whether the feed contains genetically modified organism
or a product made from that (enclosed the certification of the examiner centre
on the genetically modified organism or the product made from that, or the
permission of the agricultural gene technology authority)"
g)
Annex 16 is completed after the first French paragraph which follows the
"should be attached to the application" text, with the below French
paragraph:
"-
the declaration thereof whether the feed contains genetically modified organism
or a product made from that (enclosed the certification of the examiner centre
on the genetically modified organism or the product made from that, or the
permission of the agricultural gene technology authority)"
h)
Annex 17 is completed after the first French paragraph with the below French
paragraph:
"-
the declaration thereof whether the feed contains genetically modified organism
or a product made from that (enclosed the certification of the examiner centre
on the genetically modified organism or the product made from that, or the
permission of the agricultural gene technology authority)"
i)
point 1.4. of Annex 18 is substituted by the below direction:
"1.4.
Genetic stability, description of genetic modifications compared to the
international nomenclature index."
j)
Annex 18 is completed with the below direction:
"1.9.
whether the product contains genetically modified organism or a product made
from that (enclosed the certification of the examiner centre on the genetically
modified organism or the product made from that, or the permission of the
agricultural gene technology authority)"
k)
1.2. point of Annex 19 is substituted by the following direction:
"1.2.
Active agent content, composition [whether it contains genetically modified
organism or a product made from that (enclosed the certification of the
examiner centre on the genetically modified organism or the product made from
that, or the permission of the agricultural gene technology authority)]."
Harmonisation
with the Acts of the European Communities
Article
21
This regulation - in harmony with the relevant directions
of the European Agreement signed in Brussels on the 16 December 1991 and
published with the Act I of 1994 on Establishment the Association between the
Hungarian Republic and the European Communities as well as their Member States
- is containing a regulation compatible with the below acts of the European
Communities:
a) the directive No 90/219/EGK of the
Council on the use of the genetically modified micro-organisms in closed
systems, and
b) the directive No 90/220/EGK - completed
with the decision No 92/146/EGK of the Committee and modified with the
directive No 94/15/EK and the decision No 94/211/EK of the Committee - on the
release of the genetically modified organisms into the free environment.
Dr.
József Torgyán m.p.
Minister
of Agriculture and Regional Policy
Annex 1
of the FVM regulation No 1/1999. (I. 14.)
Conditions
necessary for performing genetic modification
1. Material conditions
Existence of such technical equipment, which provide
the defence of the employee’s health, and in addition prevents the escape of
the genetically modified organism from the site of the gene technology
technique.
2. Personal conditions
a) Special university graduation in case
of the persons performing and participating in relation to the genetic
modification.
b) In case of the project leader directing
the genetic modification besides the provision specified in paragraph a) the
further requirement is at least three years special practice.
Annex 2
of the FVM regulation No 1/1999. (I. 14.)
The
constitutional and functional order of the Gene Technology Committee
1. Each of the members of the Gene
Technology Committee has one vote at every decision. The Gene Technology
Committee makes its decisions on closed sessions (i.e. exclusively with the
presence of the members entitled for voting) with simple majority (i.e. with
the votes of the fifty percent of the members + one member; in case of the
presence of the whole committee it means nine votes), excluding the decisions
on the applications concerning the placing on the market and the importing of
genetically modified organisms or the products made of them, which decisions
are made with qualified majority (i.e. with the votes of the two-third part of
the members; in case of the presence of the whole committee it means eleven
votes. All the present members are obliged for voting. The voting is invalid if
at least the two-third part of the members is not present.
2. The Gene Technology Committee is
obligatory excludes that member, which is missing the participation in the
decision process at least for six months. The president and the secretary sign
the decision on the exclusion, and three members countersigns it.
3. The institution or person specified in
the Article 5 paragraph (2) of the Act chooses or delegates a new member
instead of the excluded member as its representative into the Gene Technology
Committee in 15 days on the receipt of the notice on the exclusion. This
direction should be used if the member resigns or dies.
4. The president chairs the sessions of
the Gene Technology Committee, in case of his prevention the secretary chairs
the session.
5. Under his duties the president:
a) co-ordinates the work of the Gene
Technology Committee;
b) determines the agenda, the date and the
site of the Gene Technology Committee sessions;
c) calls together for a session the Gene
Technology Committee if needed or for the written request of at least eight
members;
d) invites the representative of the
user's professional business federation to the sessions;
e) orders voting during the sessions;
f) represents the viewpoint of the Gene
Technology Committee outside its sessions.
6. Under his duties the secretary:
a) performs the president's jobs if the
president is being prevented;
b) on the sessions submits the
applications for permission (hereinafter: application) and the documents
necessary for the work of the Gene Technology Committee, or sends these to the
members before the decision process providing the necessary period for
expressing an opinion;
c) at least fourteen days prior to the
sessions informs the members about the agenda, the date and the site of the
sessions;
d) takes the minutes of the sessions, and
provides it for the members if it is required, or provides the copy of that;
e) controls the authenticity of the
written votes and takes care on the secrecy of the votes given by this way
until the statement of the result of the voting;
f) settles the result of the voting;
g) provides the conditions for the work of
the Gene Technology Committee;
h) informs the gene technology authority
about the viewpoint of the Gene Technology Committee concerning the
application.
7. Under his duties the member:
a) expresses his opinion, takes a stand,
puts forward a proposal, participates in the elaboration of the viewpoint of
the Gene Technology Committee;
b) expresses his opinion by voting;
c) suggests to the Gene Technology
Committee about asking the opinion of external expert, if it is necessary for
the elaboration of the viewpoint concerning the application.
8. The Gene Technology Committee
determines the constitutional and functional orders not controlled in this
Annex according to the rules specified in the paragraph 1.
Annex 3
of the FVM regulation No 1/1999. (I. 14.)
Information to be submitted together with the
application on the gene technological modification or on the usage in closed
system together
I. MICRO-ORGANISMS
1. General
information
1.1 Did the user previously get permission
for the same gene technology activity?
1.1.1. In which country?
1.1.2. When?
1.1.3. Name of the competent authority, number of the
decision:
1.2. Did it occur previously that the
application concerning the same gene technology activity was refused or the
issued permission was withdrawn?
1.2.1. In which country?
1.2.2. When?
1.2.3. Name of the competent authority, number of the
decision:
Characteristics of
the genetically modified micro-organisms in the closed system of Category 1.
a) The recipient or parental micro-organism
- is
non-pathogenic,
- will not
become pathogenic;
- has
detailed examination, demonstrating experiment on the safe use;
- is carrying built-in biological
barriers, which, without interfering with optimal growth in the reactor or
fermentor, confer limited survivability and replicability, without adverse
consequences in the environment.
b) The vector/insert
- is well characterized and free from
known harmful sequences;
- is poorly mobilizable after the
modification;
- is limited in size as much as
possible to the genetic sequences required to perform the intended function;
- do not increase the stability of the
construct in the environment (unless that is the required function)
- do not transfer any resistance by the
modification (if such insertion could compromise the effectiveness of the use
of the drugs controlling disease agents).
c) The genetically modified micro-organism
- is non-pathogenic
- as
safe in the reactor or fermentor as the recipient or the parental
micro-organism;
- has no adverse consequences in the
environment because of its limited survivability and replicability.
d) Other genetically modified
micro-organisms could be included in Category 1. if they suit the requirements
specified in paragraph c) above
- those constructed entirely from a
single prokaryotic recipient (including its indigenous plasmids and phages) or
from a single eukaryotic recipient (including its mitochondria, plasmids, but
excluding its viruses);
- those that consist entirely of
genetic sequences from different species, which sequences are exchanging by
known physiological processes.
2. Safety
assessment parameters
2.1. Characteristics of the donor, the recipient and the
parental micro-organism
2.1.1. Names and designation:
2.1.2. Degree of relatedness:
2.1.3. Source of the organism:
2.1.4. Description of the reproductive cycle (sexual,
asexual) of the parental or the recipient micro-organism:
2.1.5. History of prior genetic manipulations:
2.1.6. Stability of parental or recipient organism in
terms of relevant genetic traits:
2.1.7. Nature of pathogenity and virulence, infectivity,
toxicity and vectors of disease transmission:
2.1.8. Nature of the indigenous vectors: sequence,
frequency of mobilization, specificity, presence of resistance genes:
2.1.9. Host range:
2.1.10. Other potentially significant physiological
traits and the stability of these traits:
2.1.11. Natural habitat and geographic distribution,
climatic characteristics of the original habitats:
2.1.12. Significant involvement in environmental
processes (such as nitrogen fixation or pH regulation):
2.1.13. Interaction with, and effects on, other organisms
in the environment (including the antagonism, the competition and the
symbiosis):
2.1.14. Ability to form survival structures (such as
spores or sclerotia)
2.2. Characteristics of the genetically modified
micro-organism
2.2.1. Description of the modification including the
method for introducing the vector/insert into the recipient organism or the
method used for achieving the genetic modification involved:
2.2.2. Function of the genetic manipulation and/or of the
new nucleic acid:
2.2.3. Nature and source of the vector:
2.2.4. Structure and amount of any vector and/or donor
nucleic acid remaining in the final construction of the modified
micro-organism:
2.2.5. Stability of the micro-organism in terms of
genetic traits:
2.2.6. Frequency of mobilization of the inserted vector
and the genetic transfer capability:
2.2.7. Rate and level of expression of the new genetic
material, method and sensitivity of the measurement:
2.2.8. Activity of the expressed protein:
2.3. Health considerations
2.3.1. Toxic or allergic effects of the non-viable
organisms and/or of their metabolic products:
2.3.2. Hazards of the product:
2.3.3. Comparison of the modified micro-organism to the
donor, recipient or the parental organism regarding pathogenity:
2.3.4. Capacity for colonization:
2.3.5. Tests to be performed in
bacteriological/virological model system, if the micro-organism is pathogenic
to humans (immunocompetents):
2.3.5.1. Diseases caused and mechanism of pathogenity
including invasiveness and virulency:
2.3.5.2. Communicability:
2.3.5.3. Infective dose:
2.3.5.4. Host range, possibility of alteration:
2.3.5.5. Possibility of survival outside of human host:
2.3.5.6. Presence of vectors or means of dissemination:
2.3.5.7. Biological stability:
2.3.5.8. Antibiotic-resistance patterns:
2.3.5.9. Allergic trait:
2.3.5.10. Availability of appropriate therapies:
2.3.6. Tests to be performed in
bacteriological/virological model system, if the micro-organism is
non-pathogenic to humans (assessment of the opportunist infections):
2.4. Environmental considerations
2.4.1. Factors affecting survival, multiplication and
dissemination of the modified micro-organism in the environment:
2.4.2. Available techniques for detection, identification
and monitoring of the modified micro-organism:
2.4.3. Available techniques for detecting transfer of the
new genetic material to other organisms:
2.4.4. Known and predicted habitats of the modified
micro-organism:
2.4.5. Description of ecosystems to which the
micro-organism could be accidentally spread:
2.4.6. Anticipated mechanism and result of interaction
between the modified micro-organism and the organisms or micro-organisms which
might be exposed in case of release into the environment:
2.4.7. Known or predicted effects on plants and animals
such as pathogenity, infectivity, toxicity, virulence, vector of pathogen,
allergic trait, colonization:
2.4.8. Known or predicted participation in biogeochemical
processes:
2.4.9.
Availability of methods for decontamination of the area in case of release to
the environment:
2.4.10.
Predictable changes in the micro-organism in case of release to the environment
and determination its hazards:
Characteristics of the
genetically modified micro-organisms in the closed system of Category 2.
During the use of micro-organisms in the closed system of
Category 2. the safety conditions must be determined according to the character
of the used micro-organism and method so that these conditions could ensure the
success of the health and environmental requirements.
The character of the certain methods determines the
conditions to be applied. The suitable method, the factory and the operational
process should be chosen according to it. Two important factors should be
considered following the breakdown of the factory equipment: the risk and the
consequences.
The characteristics of the closed system of Category 2.:
a) Viable micro-organisms
should be reared in a system, which physically separates the process from the
environment.
b) Gases exhausted should be treated so as
to minimize or prevent the releasing from the closed system.
c) Sample collection, addition of
materials to a closed system and transfer of viable micro-organisms to another
closed systems, should be performed so as to minimize or prevent release from
the closed system.
d) Bulk culture fluids are not allowed to
remove from the closed system unless the viable micro-organisms have been
inactivated by validated chemical or physical means.
e) Seals should be designed so as to
minimize or prevent release.
f) Closed systems should be located
within a controlled area:
fa) biohazard signs should be posted on the
closed area;
fb) access should be restricted to nominated
personnel only;
fc) personnel should wear protective
clothing, which should be completely changed if it is expended and the
pollution attached to the clothes should be decontaminated;
fd) decontamination and washing facilities
should be provided for personnel;
fe) personnel should shower before leaving
the controlled area;
ff) effluent from the sinks and showers
should be collected and inactivated before release;
fg) the controlled area should be adequately
ventilated to minimize air contamination;
fh) the controlled area should be maintained
at an air pressure negative to atmosphere;
fi) input air and extract air to the
controlled area should be HEPA filtered;
fj )the controlled area should be
designed to contain spillage of the entire contents of the closed system;
fk) the
controlled area should be sealable to permit fumigation.
g) The expended material should be
decontaminated, inactivated by validated chemical or physical means before the
final release.
h) Should be prevented the release of
genetically modified organisms able to reproduce from the closed system.
3) Other
information to be submitted
3.1) Name of person responsible for
carrying out the closed system usage including the persons responsible for
supervision, monitoring and safety, and information on their training and
qualifications;
3.2) The activity, in which the micro-organism is used:
3.3) The maximum number of persons working in the
installation and the number of the persons working directly with the
micro-organism:
3.4) Address of the site of the closed system,
description of the sections of the installation:
3.5) Description of the nature of work which will be
undertaken, and in particular the classification of the micro-organisms to be
used and the likely scale of the operation:
3.6) A summary of the risk assessment (summary of the
environmental and biological risk assessment):
3.7) The used parental micro-organism, or the host-vector
system desired to use:
3.8) The source and the intended function of the genetic
material involved in the manipulation:
3.9) The identification and the characteristics of the
genetically modified micro-organism, the purpose of the planned application and
the expected result:
3.10) The used culture volumes:
3.11) The used technology:
3.12) Description of predominant meteorological
conditions, and specific hazards arising from the location of the installation:
3.13) The protective and supervisory measures to be used
during the closed system use:
3.14) Description of sources of hazards and conditions
under which accidents might occur:
3.15) The equipment of prevention, such as safety
equipment, alarm systems, isolation methods and the available resources for
these:
3.16) Description of the information provided to workers:
3.17) The information necessary for the competent
authority to enable them to establish the necessary emergency response plan to
be used outside the installation:
3.18) The comprehensive assessment of the risks to human
health and environment arising from the planned closed system usage:
3.19) The stated containment category, simultaneously
determined the waste management method and the security measurements necessary
for this:
3.20) The names, types, quantities and potential hazards
of wastes arising from the use of the micro-organism:
3.21) The used waste management techniques, including the
inactivation of the wastes and the possible utilisation of them:
3.22) The ultimate form and the destination of the
inactivated wastes:
3.23) Behaviour and characteristics of the micro-organism
in case of the change of containment category or the releasing to the
environment:
3.24) Overview of the potential hazards associated with
the release of the micro-organism to the environment:
3.25) The description of the substances other than the
intended product, which are produced, originated or formed in the course of the
use of the micro-organism:
3.26) The type of the intended product:
3.27) Summary of the environmental and biological impact
assessment:
4. Plans
worked out for emergency
Note:
If it is technically impossible to produce the information to be submitted
together with the application, the applicant should be described its detailed
reasons.
II. PLANTS
1. General
information
1.1. Did the user previously get permission for the same
gene technology activity?
1.1.1. In which country?
1.1.2. When?
1.1.3. Name of the competent authority, number of the
decision:
1.2. Did it occur previously that the application
concerning the same gene technology activity was refused or the issued
permission was withdrawn?
1.2.1. In which country?
1.2.2. When?
1.2.3. Name of the competent authority, number of the
decision:
2. Methods
used during the genetic modification
3. Characteristics
of the vector
3.1. Nature and source of the vector:
3.2. Description of the vector construction:
3.3. Genetic map and/or restriction map of the vector:
3.4. Sequence data:
3.5. Information on the degree to which the vector
contains sequences whose product or function is not known:
3.6. Genetic transfer capabilities of the vector:
3.7. Frequency of the mobilization of the vector:
3.8. Part of the vector that remains in the genetically
modified organism:
4. Information
on the insert
4.1. Methods used to construct the insert:
4.2. Restriction sites:
4.3. Sequence of the insert:
4.4. Origin and function of each constituent part of the
insert in the genetically modified organism:
4.5. Information on the degree to which the insert is
limited to the required function:
4.6. Location of the insert in the genetically modified
organism:
5. Information
on the organism from which the insert is derived (donor)
5.1. Scientific and other names:
5.2.1. Pathogenic characteristics of the donor organism:
5.2.2. Other harmful characteristics of the organism
whether living or dead (including its extracellular products):
5.3. If the donor has any pathogenic or harmful
characteristic, indicate whether the donated sequences are in any way involved
in them:
5.4. Classification of the donor according to the
existing Community rules relating to the protection of human health and the
environment:
5.5. Potential for exchange of natural genetic material
between the donor and recipient organism:
6. The
characteristics of the genetically modified organism
(Information relating to
the recipient or parental organisms from which the genetically modified
organism is derived.)
6.1. Scientific name and other names
6.1.1. Whole name:
6.1.2. Family name:
6.1.3. Genus:
6.1.4. Species:
6.1.5. Subspecies:
6.1.6. Cultivar:
6.1.7. Common name:
6.2. Phenotypic and genetic traits:
6.3. Geographical distribution and natural habitat:
6.4. Genetic stability of the organism and factors
affecting it:
6.5. Potential for genetic transfer and exchange with
other organisms:
6.6. Information concerning reproduction and factors
affecting it:
6.7. Information on survival and factors affecting it:
6.8. Possibilities of its expansion and the factors
affecting them:
6.9. Interactions with the environment:
6.10.1. Detection techniques:
6.10.2. Identification techniques:
6.11. Classification under existing Community rules
concerning the protection of human health and the environment:
6.12.1. Pathogenity characteristics:
6.12.2. Other harmful characteristics of the organism
whether living or dead, including its extracellular products:
6.13. Nature and description of known extrachromosomal
genetic elements:
6.14. History of previous genetic modifications:
7. Interactions
between the environment and the genetically modified organism
7.1. Expansion, survival and reproduction of the
genetically modified organism in the environment:
7.2. Interactions between the environment and the
genetically modified organism:
7.3. Effect of the genetically modified organism to the
environment:
Note:
If it is technically impossible to produce the information to be submitted
together with the application, the applicant should be described its detailed
reasons.
III. ANIMALS
(FARM ANIMALS AND breeding
animals)
1. General
information
1.1. Name, address, type of organization of the
applicant:
1.2. Names, graduation, practice period of the scientists
responsible for the release:
1.3. The title of the project:
1.4. Did the user previously get permission for the same
gene technology activity?
1.4.1. In which country?
1.4.2. When?
1.4.3. Name of the competent authority, number of the
decision:
1.5. Did it occur previously that the application
concerning the same gene technology activity was refused or the issued
permission was withdrawn?
1.5.1. In which country?
1.5.2. When?
1.5.3. Name of the competent authority, number of the
decision:
2. Information
relating to the recipient or (where necessary) parental organism
2.1.1. Species:
2.1.2. Name of the breed:
2.2. Further information to be submitted in case of
pedigree animals:
2.2.1. Female
2.2.1.1. Number of the stock-farm:
2.2.1.2. Sexual condition (virgin, after giving birth):
2.2.1.3. Place of origin:
2.2.1.4. Place of residence:
2.2.1.5. Individual identification No:
2.2.2. Male
2.2.2.1. Breeding permission:
2.2.2.2. Place of residence:
2.2.2.3. Individual identification No (Kpl. Number):
2.2.2.4. Type of the participation in the reproduction (e.g.
natural or artificial getting of sperm, IVF, ICSI):
3. Marking
the animals
All the genetically modified animals and the other
animals involved in the experiment (e.g. the animals, in which the gene
transfer was unsuccessful or did not provide the required result) should have
clear, well detectable and registered identification number. Description of the
method and system of the marking.
4. Documentation
of experiments
The clear, well followable and
registered documentation on the experimental methods during the breeding, and
on the creation, transportation, release from the closed system of the lines,
and the method of the waste (carcass) treatment.
The experimentally worthless animals
are forbidden to use any further as breeding animals or for food processing.
5. Methods
used during the genetic modification
6. Characteristics
of the vector
6.1. Nature and source of the vector:
6.2. Description of the vector construction:
6.3. Genetic map and/or restriction map of the vector:
6.4. Sequence data:
6.5. Information on the degree to which the vector
contains sequences whose product or function is not known:
6.6. Genetic transfer capabilities of the vector:
6.7. Frequency of the mobilization of the vector:
6.8. Part of the vector that remains in the genetically
modified organism:
7. Information
on the insert
7.1. Methods used to construct the insert:
7.2. Restriction sites:
7.3. Sequence of the insert:
7.4. Origin and function of each constituent part of the
insert in the genetically modified organism:
7.5. Information on the degree to which the insert is
limited to the required function:
7.6. Location of the insert in the genetically modified
organism:
8. The
characteristics of the genetically modified organism
(Information on the genetically modified organism of
final structure.)
8.1. Description of genetic traits or phenotypic
characteristics and in particular any new traits and characteristics which may
be expressed or no longer expressed.
8.2. Structure and quantity of any vector and/or donor
nucleic acid remaining in the genetically modified organism of final structure.
8.3. The stability of the organism in terms of the
genetic characteristics.
8.4. Proportion and level of the appearance of the new
genetic material, the method of its measurement and the sensitivity of the
measurement.
8.5. The activity of the appearing proteins.
8.6. The description of the identification and detection
methods is including the methods of the identification and detection of the
inserted part and vector.
8.7. The sensitivity reliability (with quantitative
measurement) and specificity of the identification and detection methods.
8.8. Information on the former use and release of the
genetically modified organism.
9. Other
information to be submitted
9.1. Information on the keeping of
prescriptions concerning the protection of animals. (All kind of genetic
modification is forbidden, which causes long-lasting pain to the animal or it
is proven that harmful to the health.)
9.2. Information on the circumstances of the release of
genetically modified animals into the environment:
9.2.1. Solution of the questions related to the physical
or etologic changes of the genetically modified animal (e.g. in case of animals
of improved growth capacity the avoiding of the overgrazing should be solved,
or the deposition of the improved quantity of excreta).
9.2.2. The probable consequences of the accidental escape
of the animal, the possibility of the transmission of the genetically modified
gene to other farmed or wild (especially protected wild) animal species, or the
probable consequences of the transmission.
10. Information
concerning the genetically modified farm animals and breeding animals in the
Category 1. of the closed system
10.1. Content of the information
concerning the rearing genetically modified farm animals
10.1.1. Only animal tenders of
qualified and well informed about the specific requirements of the gene
technological experiments are employable in the animal house. The documentation
of the qualification of the veterinary surgeon making keep and supervising the
animal health guidelines and the animal tenders.
10.1.2. Information concerning the
animal house.
10.1.2.1.Description of the cleaning
and aeration of the animal rearing rooms.
10.1.2.2. Information concerning the
autoclave necessary for the sterilization installed into the same settlement
together with the animal house.
10.1.2.3.Descripction of the
equipment used for the sterilization of cages and boxes and the destruction of
wastes.
10.1.2.4. Safety equipment and
prescriptions.
10.1.2.4.1. Description of the
equipment preventing the escape of genetically modified animals and the
equipment serving for the indication of the escape.
10.1.2.4.2. In case of outdoor
rearing double fence system and permanent supervision is required, its
documentation.
10.1.2.4.3. Description of the
safety prescriptions concerning the keeping out unauthorized persons.
10.1.2.4.4. Description of the
protective clothing of the animal tenders and other personnel participating in
the experiments and the notification method of the accidents occurring during
the contact with the animals.
10.1.2.4.5. In case of animal
individuals which are not distinguishable according to their phenotypic traits
from the domestic useful animals should be used two different type markings
which is also serving as distinctive sign (e.g. plastic ear mark + special
tattooing or implanted microchip e.t.c.). Description of these marks.
10.2.Content of the information
concerning the rearing of genetically modified aquatic vertebrate animals:
In case of aquatic vertebrate
animals necessary to use that kind of safety system which provides that the
experimental animals or their gametes cannot get out of the closed system,
neither through the water inlet- or the outlet channels nor in consequence of
the damage of the tank. Description of the type and covering of the rearing
tank:
11. Information
concerning the genetically modified useful animals and breeding animals in the
Category 2. of the closed system
If there is the possibility of the
horizontal transmission of the modified DNA into other domestic animals or any
wild animals, the permission must be issued for use of Category 2. Should be
classified into this category some of the transgenic animals probably used as
disease-model in the medical biology research (Among the existing laboratory
experiments such is the polio-mouse used for testing the poliovirus vaccines,
which could cause epidemic in case of its escaping.)
11.1. Content of the information
concerning the rearing genetically modified useful animals
11.1.1. The information required at
the Category 1. permissions.
11.1.2. Other information (besides
the data contained in the point 11.1.1. should be described the performance of
the below conditions).
11.1.2.1. The rearing of the animals
can be performed only in entirely closed system. Stepping in and out into the
closed system should be taken trough a sluice system which conforms to the
international standards. Description of the corresponding measures.
11.1.2.2. The closed system should
be settled on area, which is controlled and assigned for this purpose, its
documentation.
11.1.2.3. The closed system
(controlled area) should be maintained at an air pressure negative to
atmosphere, its documentation.
11.1.2.4. The safety equipment
should be suitable for preventing the escape of the experimental animals and
the entrance of unauthorized persons into the animal house, its documentation.
11.1.2.5. All wastes, including the
excreta of the animals and the used litter should be disinfected in autoclave
or destroyed in refuse burner. Animal carcasses should be destroyed locally.
Documentation of the execution possibilities of the concerning measures.
11.1.2.6. Inside the closed system
should be developed a double defence system for the isolation of the male and
female animals, preventing the vertical transmission - by reproductive way - of
the modified gene if it is not involved in the program. Documentation of this
measure.
11.2. Content of the information concerning the rearing of genetically
modified aquatic vertebrate animals:
11.2.1. The information required at
the Category 1. permissions.
11.1.2. Other information (besides
the data contained in the point 11.2.1. should be described the performance of
the below conditions).
11.2.2.1. Should be solved that in
case of technical defect (tank defect, overflow) the escaped animals or their
gametes will not be able to get into the outflow system of the building, its
documentation.
11.2.2.2. The closed system should
be maintained at an air pressure negative to atmosphere, its documentation.
11.2.2.3. The safety equipment
should be suitable for preventing the getting in of unauthorized persons into
the animal house, its documentation.
Note:
1. If it is technically impossible to
produce the information to be submitted together with the application, the
applicant should be described its detailed reasons.
2. The prescriptions and questions
determined in this Annex should not be applied generally in case of all the
applications. The recommended principle is that those requirements should be
fulfilled and those questions should be answered in the certain applications
which are applicable in the given case.
The prescripted elaboration is also
depending on the nature and size of the planned gene technology activity.
Annex 4
of the FVM regulation No 1/1999. (I. 14.)
Information
to be submitted together the applications for permission on release and
commercial circulation
I. MICRO-ORGANISMS
Information
to be submitted together the applications for permission on release of the
genetically modified micro-organisms
1. General
information
1.1. Name, address, of the applicant (economic
organization or institute):
1.2. Names, graduation, practice period of the scientists
responsible for the genetic modification and for the release of the genetically
modified organism:
1.3. Names, graduation and scientific degree of persons
responsible for the planning and the execution (including especially the
revision, monitoring, safety):
1.4. The qualification of the experts participating in
the genetic modification and in the release:
1.5. Did the user previously get permission for the same
gene technology activity?
1.5.1. In which country?
1.5.2. When?
1.5.3. Name of the competent authority, number of the
decision:
1.6. Did it occur previously that the application
concerning the same gene technology activity was refused or the issued
permission was withdrawn?
1.6.1. In which country?
1.6.2. When?
1.6.3. Name of the competent authority, number of the
decision:
2. Information
concerning the genetically modified organism
2.1. The donor, the recipient and the parental
micro-organisms
2.1.1. Scientific name:
2.1.2. Classification (taxonomy):
2.1.3. Other name:
2.1.4. Phenotypic and genetic traits:
2.1.5. Degree of relatedness between the donor and the
recipient or the parental organisms:
2.1.6. Description of the identification and isolation
techniques, sensitivity and reliability of these techniques:
2.1.7. Description of the geographical distribution and
natural habitat of the micro-organisms:
2.1.8 Occasional gene transfer or gene exchange with
other organisms:
2.1.9. Control/examination of the genetic stability of
the micro-organism and the factors affecting it:
2.1.10. Pathogenic, ecological and physiological traits:
2.1.10.1. Risk assessment, with special interest to the
human health and the environment:
2.1.10.2. Reproduction/generation period in the natural
ecosystems:
2.1.10.3. Information on the survival, including the
forming of survival structures (spores, sclerotia):
2.1.10.4. Pathogenity: infectiousness, toxicity,
virulency, allergic character, possible vector of pathogens, host range.
Occasional activation of inactive viruses (proviruses), colonization of other
micro-organisms:
2.1.10.5. Antibiotic resistance, which influences the
effectiveness of the antibiotics used for healing or preventing:
2.1.10.6. Participation in environmental processes:
production, nutrient circulation, and organic material decomposition:
2.1.11. The nature of the inserted vector:
2.1.11.1. Connected nucleotide sequences:
2.1.11.2. Frequency of mobilization:
2.1.11.3. Specific characteristics:
2.1.11.4. Connected resistance genes:
2.1.12. History of prior genetic
modifications:
2.2. Characteristics of the used vector/insertion
2.2.1. Nature and source of the vector:
2.2.2. Nucleotide sequences of the vectors/transposons
which are inserted into the recipient organism during the genetic modification:
2.2.3. Occasional change of the mobilizationability
and/or inheredity of the used vector, the methods of the insertion into the
recipient:
2.2.4. Information on the interaction between the vector
and the DNA necessary for the required genetic modification:
2.3. Characteristics of the genetically modified organism
2.3.1. Information concerning the genetic modification:
2.3.1.1. Methods used during the genetic modification:
2.3.1.2. The source of the genetic material to be inserted,
and the method used for inserting it into the recipient:
2.3.1.3. Description of the composition of the genetic
material and/or vector to be inserted:
2.3.1.4. The genetic material to be inserted is free from
other, unknown recombinant nucleotide sequence and the information concerning
the limited DNA necessary for reaching the required modification after the
insertion:
2.3.1.5. Functional characterization of the nucleotide
sequence insertion, the effect of the gene exchange or gene substitution to other
genes in the recipient.
2.3.2. The information concerning the final character of
the genetically modified micro-organisms:
2.3.2.1. Description of the genetic traits or the
phenotypic features, report on new trait and feature, probable or temporary
changes:
2.3.2.2. The structure and quantity of the vector and/or
donor nucleic acid remained in the genetically modified micro-organism:
2.3.2.3. Stability of the micro-organism according to the
identification of the genotype:
2.3.2.4. Proportion and level of the expression of the
new genetic material, the method of its measurement, the sensibility of the
measurement:
2.3.2.5. The activity of the appearing proteins:
2.3.2.6. Description of the identification and detection
methods, including the identification and detection methods of the inserted
nucleotide sequence and vector:
2.3.2.7. The sensibility, reliability and specificity of
the identification and detection methods:
2.3.2.8. Description of the former use and release of the
genetically modified micro-organism:
2.3.2.9. Health considerations:
2.3.2.9.1. Toxic or allergic effect of the non-viable
genetically modified micro-organisms and/or their excreta:
2.3.2.9.2. Hazard of the product:
2.3.2.9.3. Comparison of the modified micro-organism and
the donor, recipient or parental organism from the viewpoint of pathogenity:
2.3.2.9.4. Possibility of the infection or transmission:
2.3.2.9.5. If the micro-organism is pathogen to humans,
immunologically hardly defendable:
2.3.2.9.5.1. Description of the disease caused by the
micro-organism, mechanism of the pathogenity, its expansion and viulency:
2.3.2.9.5.2. The way of the transmittance:
2.3.2.9.5.3. The infectious dose:
2.3.2.9.5.4. The distribution of the host organisms:
2.3.2.9.5.5. Possibility of change:
2.3.2.9.5.6. Survival possibility outside the infected
host organism:
2.3.2.9.5.7. Presence of vectors or the method of the
expansion:
2.3.2.9.5.8.
Biological stability:
2.3.2.9.5.9. Antibiotic resistance pattern, the allergic
effect:
2.3.2.9.5.10. Availability of suitable healing therapies:
3. Information
concerning the release and the receiving environment:
3.1. Information concerning the
release of the organism
3.1.1. Description of the suggested release, including
its purpose and the probable originating product:
3.1.2. The predictable date of the release and the
planned period of the experiment, including the frequency and period of the
releases:
3.1.3. The preparation of the scene prior to the release:
3.2.4. The size of the area used for the release:
3.1.5. Methods should be used for the release:
3.1.6. The quantity of the genetically modified
micro-organisms to be released:
3.1.7. The existing disturbing factors on the area used
for the release:
3.1.8. The labour-safety measurements should be kept
during the release:
3.1.9. Treatment of the used area following the release:
3.1.10. Methods to be used for destruction or
inactivation of genetically modified micro-organisms following the completion
of the experiments:
3.1.11. Results of the former releases of genetically
modified micro-organisms, or the information related to these, so thus
especially the experiences of experiments of different sizes executed in
various ecosystems:
3.2. Information concerning the environment (both the
area of the release and the wider environment)
3.2.1. The geographical site, map of the area (in case of
the use of the part IV. of this Annex the area of the release is simultaneously
the area of the probable usage):
3.2.2. The physical or biological closeness to humans and
other important living organisms:
3.2.3. Closeness to important biotopes or natural- or
protected natural areas:
3.2.4. The size of the local human population:
3.2.5. The economic activity of the local human
population using the natural sources of the area:
3.2.6. The distance form the areas protected because of
drinking water bases and/or environmental purposes:
3.2.7. Possibly changing climate traits of the area on
releasing the genetically modified micro-organism:
3.2.8. Geographical, geological and child-health traits:
3.2.9. Flora and fauna, including the crop, the animal
stock and the migrating species:
3.2.10. Changing ecosystems probably targeted and
non-targeted with the release of the genetically modified micro-organism:
3.2.11. Comparison of the natural habitat of the
recipient organism with the suggested area of the release:
3.2.12. All kind of previously planned development and
change in the area, which can influence the environmental effect of the release:
3.2.1.3. List of the related species and races, which the
released genetically modified organisms can get into interaction with.
4. Information
concerning the interaction of the genetically modified micro-organism and the
environment
4.1. Characteristics effecting the survival, reproduction
and spreading:
4.1.1. Biological features influencing the survival,
reproduction and spreading:
4.1.2. Known or expected environmental conditions, which
can influence the survival, reproduction and spreading (wind, water, soil,
temperature, pH value e.t.c.)
4.1.3. Sensitivity to the different medium materials:
4.2. Interaction with the environment
4.2.1. Predicted habitat of the genetically modified
micro-organisms:
4.2.2. Study on the behaviour and characteristics of the
genetically modified micro-organisms, or the survey on the ecological impact of
the organisms in simulated natural environment, thus in microcosmos, plant
growing room, plant house:
4.2.3. Gene transfer capacity:
4.2.3.1. Gene transfer of genetically modified
micro-organisms into other organisms in the ecosystem changed following the
release:
4.2.3.2. Gene transfer of native organisms into
genetically modified micro-organisms following the release:
4.2.4. Possibility of selection of unexpected and/or
undesired traits in the genetically modified micro-organisms following the
release:
4.2.5. Methods used for demonstration, verification of
genetic stability. Description of genetic characteristics, which inhibit the
segregation. Methods providing genetic stability:
4.2.6. Ways of biological dispersal, known or possible
ways of the interaction with the mediating agent, including the cases of
inhalation, swallowing, surface contact and digging into the soil:
4.2.7. Description of those ecosystems, in which the
genetically modified organisms can spread:
4.3. Possible environmental effect:
4.3.1. Possibility of the overpopulation in the
environment:
4.3.2. The competitive advance of the genetically
modified micro-organisms against the non-modified recipient or parental
organisms:
4.3.3. Identification and description of target
organisms:
4.3.4. Expected function and result of the interaction
between the released genetically modified micro-organisms and the target
organism.
4.3.5. Identification and description of non-targeted
organisms, which can accidentally effect:
4.3.6. Possibility of changes following the release in
the biological interactions or on the distribution area of the phage carrier:
4.3.7. Known or predictable effects on the non-targeted
organisms in the environment through the food chain, in symbiotic connections
or in parasitic condition:
4.3.8. Known or predictable participation in
biogeographical processes:
4.3.9. Other predictable important interactions with the
nature:
4.3.10. Examination of the possibility of niche
re-organization: [In every living communities the actual populations of
occurring species are filling up certain places more or less steadily, namely
the present living entities are dividing the available place and sources (niche
pattern). A steady niche pattern can change if the individuals of a new species
can steadily fill up certain places. The genetically modified organisms can get
into certain living communities and can change the patterns developed in them;
namely it can occur a niche re-organization. Because of this should be examined
in relation the released genetically modified organism, that which kind of
natural living community this organism can get in relationship with, and how
far can it change the developed pattern.]
5. Information
concerning the monitoring, controlling, waste treatment and the emergency plan
5.1. Monitoring techniques
5.1.1. Methods used for monitoring the genetically
modified micro-organisms and their effects:
5.1.2. Selectivity (to identify the genetically modified
organisms and to distinguish them from the donor-, recipient- and parental
organisms), sensibility and reliability of the monitoring methods:
5.1.3. Techniques serving for the isolation of forwarding
the inserted genetic material into other organisms:
5.1.4. The period and frequency of the monitoring:
5.2. Control of the release
5.2.1. Procedures and methods for preventing and/or
reducing the spreading of the genetically modified micro-organisms outside the
release area or the area assigned for usage:
5.2.2. Procedures and methods used for keeping away the
unauthorized persons from the release and usage area of the genetically
modified micro-organisms:
5.2.3. Procedures and methods for preventing other
organisms from getting into the release and usage area of the genetically
modified micro-organisms:
5.3. Waste treatment
5.3.1. Nomination and hazard level of the produced wastes
5.3.2. Probable amount of the wastes:
5.3.3. Possible environment protection and environment
health hazards:
5.3.4. Description of the planned waste treatment:
5.4. Emergency plans
5.4.1. Procedures and methods used for controlling the
unexpected spreading of the genetically modified organisms:
5.4.2. Methods to be used for the decontamination,
cleaning of emergency areas (for the elimination of the of the genetically
modified micro-organisms):
5.4.3. Methods to be used for elimination or sanitary
cleaning of plants, animals, soil, objects contaminated during or following the
expansion of the genetically modified micro-organisms:
5.4.4. Methods to be used for the isolation of area
affected by the expansion of the genetically modified organisms:
5.4.5. Plans for the protection of human health and
environment in case of appearance of undesired impact:
Note:
If it is technically impossible to produce the information to be submitted
together with the application, the applicant should be described its detailed
reasons.
II.
PLANTS
Information
to be submitted together the applications for permission on release of the
genetically modified higher plants (gymnospermae and angiospermae)
1. General
information
1.1. Name and address of the applicant (economic
organization or institute):
1.2. Names, graduation, practice period of the scientists
responsible for the release:
1.3. The title of the project:
1.4. Did the user previously get permission for the same
gene technology activity?
1.4.1. In which country?
1.4.2. When?
1.4.3. Name of the competent authority, number of the
decision:
1.5. Did it occur previously that the application
concerning the same gene technology activity was refused or the issued
permission was withdrawn?
1.5.1. In which country?
1.5.2. When?
1.5.3. Name of the competent authority, number of the decision:
2. Information concerning the recipient organism or
(where necessary) the parental organism
2.1. Whole name:
2.1.1. Family name:
2.1.2. Genus:
2.1.3. Species:
2.1.4. Subspecies:
2.1.5. Cultivar:
2.1.6. Common name:
3. Information
concerning the reproduction
3.1. Methods of reproduction:
3.2. Specific factors affecting the reproduction, if
there is any:
3.3. The period of the reproductive cycle:
3.4. Ability of cross-pollinating with individuals of
other cultured or wild plant species:
4. Survival
ability
4.1. Ability to produce structures necessary for the
survival or the standstill:
4.2. Specific factors affecting the survival capacity, if
there is any:
5. Dispersion,
spreading
5.1. Methods and dimension of the dispersion:
5.2. Specific factors affecting the dispersion, if there
is any:
5.3. Geographical distribution of the plant:
5.4. If the plant is not present in the nature, the
description of the natural habitat of the plant, including the information
concerning the predators, parasites, competitors and symbionts:
5.5. Probably occurring important interactions of the
plant with non-plant organisms in such ecosystems where the plant
generally/normally is presented, including the information concerning the
traits of the toxicity to other organisms:
6. Information
concerning the genetic modification
6.1. Description of the methods used for genetic
modification:
6.2. Nature and source of the used vector:
6.3. Size, source (names of donor organisms) and planned
function of every important part of the area/region which is planned for the
use the genetically modified plant:
7. Information
concerning the genetically modified organism
7.1. Description of the newly created or modified traits
and features:
7.2. Information concerning the inserted or deleted
sequences:
7.2.1. Size and structure of the part inserted by the
genetic modification, and the methods used for the characterization of this
part, including the information concerning any part of the vector inserted into
the genetically modified higher plant or any mediating agent remained in the
genetically modified higher plant, and the foreign DNA:
7.2.2. In case of deletion, the size and function of the
deleted part:
7.2.3. Position of the inserted part in the plant cells
(settled in chromosome, chloroplast, mithocondry, or stayed up without settled
in), and the methods used for its direction:
7.2.4. Number of copies of the inserted part:
7.3. Information concerning the appearance of the
inserted part:
7.3.1. Information concerning the appearance of the
inserted part, and the methods used for the characterization of the part:
7.3.2. Information concerning those parts of the plant,
in which the inserted part appears (root system, stem, leaves, pollen, other
parts):
7.4. Information concerning that the genetically modified
plant how far differs from the recipient plant:
7.4.1. in the method and/or the rate of the reproduction:
7.4.2. in the spreading:
7.4.3.in the survival capacity:
7.5. Genetic stability of the inserted part:
7.6. Possibility of forwarding the genetic material from
the genetically modified plant into other organism:
7.7. Information concerning the materials toxic to the
human health or to the environment and the harmful effects which are
originating from or caused by the genetic modification:
7.8. The functioning of the interaction between the
genetically modified plant and the target organisms (if measurable):
7.9. Probably happening important interactions with
non-targeted organisms:
7.10. Description of techniques used for the isolation
and identification of the genetically modified plant:
7.11. Information concerning the former release of the
genetically modified plant into the environment:
8. Information
concerning the place of the release*
8.1. Geographical position and size of the release area:
8.2. Description of the ecosystem of the release area,
including the climate, the flora and fauna:
8.3. Presence of wild and cultivated related plants able
to cross-pollinating with the genetically modified plant:
8.4. Closeness to officially registered biotopes or
protected areas:
8.5. Information concerning the release
8.5.1. The purpose of the release:
8.5.2. The predictable date and period:
8.5.3. Method of release of the genetically modified
plant:
8.5.4. Methods used for the preparation and
maintenance/treatment of the release area before, during and following the
release, including the cultivation practice and harvesting methods:
8.5.5. The number of plants approximately (or determined
in plants/sq. metre):
9. Plans
concerning the control, the monitoring, the situation following the release,
and the waste treatment*
9.1. Preventive measures taken:
9.1.1. Distance from cross-pollinating plant species:
9.1.2. Measurements which preventing or decreasing to the
lowest level the dispersal of pollen or seeds:
9.2. Description of methods to be used for the treatment
of the area following the release:
9.3. Description of methods to be used for the treatment
of the genetically modified plant material following the release, including the
wastes:
9.4. Description of monitoring plans and techniques:
9.5. Emergency plans:
10. Possible
effect of the release of genetically modified plants to the environment
10.1. Possibility of that the genetically modified higher
plants will be more resistant on the cultivated areas, or will have much higher
reproductivity on the natural habitats than the recipient or parental plants.
10.2. Improvement advance or disadvantage given to other
plant species able to cross-pollinate, which is derived from forwarding the
gene originating from the genetically modified plant.
10.3. Possible important impact of the interaction
between the genetically modified plant and the target organism (if measurable):
10.4. Examination of the possibility of niche
re-organization: [In every living communities the actual populations of
occurring species are filling up certain places more or less steadily, namely
the present living entities are dividing the available place and sources (niche
pattern). A steady niche pattern can change if the individuals of a new species
can steadily fill up certain places. The genetically modified organisms can get
into certain living communities and can change the patterns developed in them;
namely it can occur a niche re-organization. Because of this should be examined
in relation the released genetically modified organism, that which kind of
natural living community this organism can get in relationship with, and how
far can it change the developed pattern.]
10.5. Possible environmental effects originating from
interactions with non-targeted organisms.
Note:
1. It is possible to enclose the answers
concerning the line examination determined in the part marked with * later, if
the necessary data (sowing area, information concerning the methods to be used
for the release) are not available on the day of the submission.
2. If it
is technically impossible to produce the information to be submitted together
with the application, the applicant should be described its detailed reasons.
III. ANIMALS
(FARM ANIMALS AND breeding
animals)
Information
to be submitted together with the application for permission on release and
commercial circulation*, transportation, exporting and importing of genetically
modified animals
1. General
information
1.1. Did the user previously get permission for the same
gene technology activity?
1.1.1. In which country?
1.1.2. When?
1.1.3. Name of the competent authority, number of the
decision:
1.2. Did it occur previously that the application
concerning the same gene technology activity was refused or the issued
permission was withdrawn?
1.2.1. In which country?
1.2.2. When?
1.2.3. Name of the competent authority, number of the
decision:
2. Those individuals - registered and
marked according to the prescriptions - are considered as registered
genetically modified animals, of which the method of production, the modified
gene and the structure of the vector used for the modification is known.
Besides, it is certified that there was not possible to reveal health damage or
fertility reduction in the offspring, during the two-generation breeding.
Description of these facts:
3. The same legal and health rules are
also apply to the release, transportation, circulation, exporting and importing
of registered, genetically modified farm animals as in case of other laboratory
or farm animal of the same category. Documentation on keeping these
requirements:
4. In case of those genetically modified
farm animals, where the genetically modified farm animal or its product is used
as food, should be certified, that the animal product cannot cause health
damage to the consumer (e.g. genetically modified farm animals of disease
resistant, reduced stress sensitivity, improved muscularity). Other permissions
should be obtained - according to other
acts - for the genetically modified animals produced or marketed in order to
use as food. Products of genetically modified animal origin, which intended for
animal consumption, should be considered as they were intended for human
consumption. The concerned certification and enclosed the copies of the
permissions:
5. In case of the domestic marketing of
genetically modified farm animals which are producing protein applicable in
medicine (e.g. VIII. and IX. blood coagulation factors, alpha1-antitrypsine,
albumin produced in the milk of genetically modified sheep and cattle), the
collection of the permissions concerning the medicines and products of healing
power and the keeping of the concerning prescriptions is obligatory.
Note:
1. *In case of commercial circulation
should be enclosed the data specified in the chapter "IV. Putting into
market" of this Annex.
2. If it is technically impossible to
produce the information to be submitted together with the application, the
applicant should be described its detailed reasons.
IV. COMMERCIAL CIRCULATION
Additional information to be submitted together with
the application for permission on commercial circulation
1. General
information
1.1. Did the user previously get permission for the same
gene technology activity?
1.1.1. In which country?
1.1.2. When?
1.1.3. Name of the competent authority, number of the
decision:
1.2. Did it occur previously that the application
concerning the same gene technology activity was refused or the issued
permission was withdrawn?
1.2.1. In which country?
1.2.2. When?
1.2.3. Name of the competent authority, number of the
decision:
2. In
case of commercial circulation - in addition to the information specified in
the chapters "II. Plants" and "III. Animals" - the below
information should be submitted for the authority
2.1. Name of the product and the name of the contained
genetically modified organisms.
2.2. Name and Hungarian address of the producer or
distributor (in case of agency or branch office the address of the agency or
the branch office).
2.2.1. Domestic Producer:
2.2.2. Importer:
2.2.2.1. In case of import
2.2.2.1.1. Name of the producer:
2.2.2.1.2. Address of the producer:
2.3. Specification of the product
2.3.1. Characterization of the genetically modified
organism contained by the product (name and nature of each genetically modified
organisms contained by the product):
2.3.2. General description of the product:
2.3.2.1. Type of the product:
2.3.2.2. Composition of the product:
2.3.2.3. Specificity of the product:
2.3.2.4. Types of the users:
2.3.2.5. Exact using and handling circumstances:
2.3.2.6. Geographical area where the product can be used:
2.3.2.7. Type of the environment where the product can be
used:
2.3.2.8. Expected field of the usage: industry,
agriculture, commerce, public consumption:
3. The below information should be
submitted to the authority in addition to the information specified in point 2.
3.1. Measures to be done in case of non-intended release
or mistaken use:
3.2. Special prescriptions and suggestions for storing
and handling:
3.3. The estimated quantity of the domestic production or
the volume of the expected import:
3.4. Was the composition of the product containing
genetically modified organism reported for experimental use in the European
Union or outside that:
3.4.1. If yes, give the name of the country and the
registration number:
3.4.2. If not, refer to the risk assessment information:
3.5. Inform about the release of the product specified in
the point 3.4. or about the release of same composition genetically modified
organism which was earlier or simultaneously reported by the user in the
European Union or outside that:
3.6. Information on
the deposition and treatment of the wastes connected to the product:
Note:
1. The prescriptions and questions
determined in this Annex not to be applied generally in case of all
application. The principle to be followed is, that should be fulfilled only
those prescriptions or answer those questions in the certain applications, which
are valid in the given case.
2. The prescripted elaboration is also
depending on the nature and dimension of the planned gene technology activity.
3. The "I. Micro-organism" part
of the Annex is concerning the release of all other kind of genetically
modified organisms except the higher plants. The "II. Plants" of the
Annex is concerning the release of the genetically modified higher plants.
4. In the application of this regulation,
the plants belonging to the Gymnospermae and Angiospermae taxonomic groups are
qualified as higher plants.
5. If it is technically impossible to
produce the information to be submitted together with the application, the
applicant should be described its detailed reasons.
Annex 5
of the FVM regulation No 1/1999. (I. 14.)
The list of the official centres authorized for
determining the gene technology origin
1. Micro-organism,
seed, vegetative plant reproduction material, raw feed
Agricultural Biotechnology Center
2100 Gödöllő, Szent-Györgyi Albert u. 4.
Postal address: 2101 Gödöllő, P.O.Box 411
2. Micro-organism,
meat industry product, animal
National Animal Health Institute
1149 Budapest, Tábornok u. 2.
Postal address: 1581 Budapest, P.O.Box 2
3. Meat
industry product, product of plant origin
National Fodor József Public Health Centre
National Institute of Feeding- and Nutrition Sciences
1097 Budapest, Gyáli út 3/A
Postal address: 1476 Budapest 100, P.O.Box 52
Annex 6
of the FVM regulation No 1/1999. (I. 14.)
Gene technology marking
1. Text and figure to be indicated in case
of the Article 15 paragraph (1) of the regulation:
"Contains gene
technologically produced component"
The first fourth part of
the DNA chain is of national colours (red-white-green).
2. Text and figure to be indicated in case
of the Article 15 paragraph (1) of the regulation:
"Produced using
gene technology method, but do not contain gene technologically produced
component"
The last fourth part of
the DNA chain and the triangle is of green colour.
Annex 7
of the FVM regulation No 1/1999. (I. 14.)
Information necessary for the determination of the
transportability
1. Information specified in the Annexes 3
and 4 of the regulation:
2. Havaria-plan [Havaria is an unexpected,
of important effect, non intended event, resulted by the human activity, which
endangers the human health or the environment. The institution performing
genetic modification or gene technology activity should be prepared for the
averting of these kind of unexpected events. The concerning measures altogether
are the havaria-plan, which must be adjusted to the specific activity of the
institution and must contain itemized all of the important elements necessary
for the averting of the happened event (e.g. evacuation of the infected area,
decontamination of the infected area, treatment of the prompt health damages
etc.)]:
3. If the genetically modified organisms
or the products made from them are coming under the ruling of the regulations
on the transportation of dangerous products (ADR, RID, ADN etc.):
a) UN number and name of the material to
be transported according to the concerning regulations;
b) class, serial number and name of the
material to be transported according to the concerning regulations;
c) written order necessary for the
adequate transportation of the material to be transported, if it is prescripted
by the concerning regulations.
Annex 8
of the FVM regulation No 1/1999. (I. 14.)
Fee of the data supply
In case of print of A/4
format the fee is 40 HUF/page.
In case of print of A/3
format the fee is 80 HUF/page.