Regulation (2000:271) On The Contained Use Of Genetically Modified Organisms

Original Language Title: Förordning (2000:271) om innesluten användning av genetiskt modifierade organismer

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Definitions



Article 1 terms and expressions used in this regulation has the same

meaning as in chapter 13. the environmental code. Regulation (2011:32).



paragraph 2 of this regulation,



"micro-organism" shall mean any microbiological entity, cellular or non-

cellular, capable of replication or of transferring genetic material;

including viruses, viroids and cell cultures of plants and animals,



genetically modified micro-organism: a micro-organism in which the

the genetic material has been altered in a way that does not occur

naturally by mating and/or natural recombination;



protective measure: a containment measures or precautions

otherwise, taken to prevent, hinder or discourage

activities involve harm to human health or the environment,



supervisory authority: an authority referred to in Chapter 2. 4, 12, 13

or section 18 of the environmental protection Decree (2011:13) has responsibility for

supervision in the case of contained use,



F-activities: the contained use of genetically modified

microorganisms with negligible or no risk of harm to

human health or the environment,



L-activities: the contained use of genetically modified

microorganisms with a low risk of harm to human health

or the environment,



R-activities: the contained use of genetically modified

microorganisms with moderate or high risk of damage to the

human health or the environment,



new use: a the contained use of genetically modified

organisms in an already registered and is compared to the

notified operation on a non-negligible way differ in

the case of the genetically modified organisms used

or in respect of the methods for the manufacture or

the use of the organisms,



accident: any incident involving a significant and unintended

the release of genetically modified organisms in contained

use and that may pose an immediate or delayed danger

to human health or the environment. Regulation (2011:32).



2 a of for the purposes of this regulation,



Directive 90/220/EEC: Council Directive 90/220/EEC of 23 april

1990 on the deliberate release into the environment of genetically modified

organisms in the environment, as last amended by Commission directive

97/35/EC,



Directive 2001/18/EC: European Parliament and Council directive

2001/18/EC of 12 March 2001 on the deliberate release into the environment of

genetically modified organisms and repealing

Council Directive 90/220/EEC, as last amended by

European Parliament and Council Directive 2008/27/EC, and



Directive 2009/41/EC: European Parliament and Council directive

2009/41/EC of 6 May 2009 on the contained use of

genetically modified micro-organisms (recast).

Regulation (2011:125).



Exemptions for certain activities



the provisions of paragraph 3 of 8-11 and 13-34 paragraphs shall not apply in

question on the contained use of



1. organisms that are produced or obtained through

mutagenesis,



2. plants that are produced or obtained by cell fusion

(including protoplast fusion) of plant cells where the plant

can also be produced by traditional breeding methods,



3. micro-organisms that are produced or obtained through

cell fusion (including protoplast fusion) of prokaryotic species that

Exchange genetic material by known physiological processes,

If it is unlikely that the micro-organism is harmful to

human health or the environment,



4. micro-organisms that are produced or obtained through

cell fusion (including protoplast fusion) of cells of any eukaryotic

species, including production of hybridomas and mergers

of plant cells,



5. micro-organisms that are produced or obtained through

self cloning of cells of the same species or into cells of

phylogenetically closely related species which can exchange genetic

material by natural physiological processes, if it is

unlikely that the micro-organism is harmful to human health

or the environment.



Self-cloning consisting in the removal of nucleic acid sequencing

a cell in an organism and, possibly, to all or part of the

nucleic acid or a synthetic equivalent since reinstatement

with or without prior enzymic or mechanical steps.

Self-cloning referred to in the first subparagraph 5 shall include

the use of such for a long time proven recombinant

vectors that have been shown to lead to the use of the

individual organisms are safe.



The opt-out in the first subparagraph shall not apply if the

the operations involve the use of recombinant

-nucleic acid molecules or in addition to such

contained uses referred to in the first paragraph also covers

the use of genetically modified organisms obtained

or obtained otherwise than as mentioned in the first

paragraph 1-5.



section 4 provisions of Chapter 13. section 8 environmental code and 7-11 and 13-34 of this Regulation shall not apply to contained

use only such genetically modified

micro-organisms that are safe for human health and the environment

According to Directive 2009/41/EC.



The work environment authority shall draw up a list of the types of

genetically modified microorganisms referred to in the first

paragraph. The list should correspond to the list in part C of the

Annex II to Directive 2009/41/EC. Regulation (2011:125).



§ 5 the provisions of paragraphs 7 to 34 do not apply to the storage, culture,

transport, destruction, disposal or use of the

GMOs which have been placed on the

market in accordance with



1. Directive 90/220/EEC or Directive 2001/18/EC,



2. other EU legislation that provides for a

specific environmental risk assessment similar to that laid down in

Directive 2001/18/EC,



3. Ordinance (1994:901) on genetically modified organisms

or Ordinance (2002:1086) on release of genetically

modified organisms in the environment.



The exemption provisions in the first subparagraph shall not apply if the

the contained use differs from the permit conditions

placing the organisms on the market. Regulation (2011:125).



the provisions of paragraph 6 of the 8-11 and 13-29 sections do not apply to the transport of

genetically modified organisms by road, rail or

inland waterway, sea or air.



Risk assessment



section 7 of the operator or intends to operate with

the contained use of genetically modified organisms shall

do the investigation for the assessment of risks referred to in 13

Cape. section 8 of the environmental code.



The supervisory authority may, within its regulatory area Info

the methods of investigation and what it should include.



section 8 a business with the contained use of genetically

modified micro-organisms shall be classified as an F-

activities, L-R-business activities. The risk assessment

referred to in section 7 shall be the basis for classification.



The work environment authority may, within its regulatory area Info

the details about the meaning of F, L-

activity and R-activities and rating. Before

The work environment authority will notify such provisions, the

consult the gene technology Committee, and Naturvårdsverket.

Regulation (2000:968).



Protection measures



§ 9 The carrying on or intending to carry on business with

the contained use of genetically modified organisms

shall, in the context of the risk assessment referred to in section 7, judge

the protective measures are needed. In Chapter 2. section 3 of the environmental code, see

a provision on the obligation to perform such safeguards.



The supervisory authority may, within its regulatory area Info

regulations on how the need for protective measures shall

be identified and assessed.



section 10 of the contained use of genetically modified

organisms, physical barriers, or a combination of physical

and other barriers used to limit the organism

contact with the general population and the environment.



section 11 of the supervisory authority may, within its regulatory area Info

regulations about the doing business with enclosed

the use of genetically modified organisms shall

maintain a certain level of protection for human health and the

the environment (protection level). Such rules may mean that a

particular circumstance in risk assessment or to the need for a

some protective action is decisive for the choice of the level of protection of

all or part of the business.



section 12 of the supervisory authority may, within its regulatory area Info

the additional regulations on protective measures needed for

the contained use of genetically modified organisms.



The regulatory authority shall consult the Authority for

civil contingencies Agency, the environmental protection agency and

The gene technology Committee before it announces regulations on transport

of genetically modified organisms (GMOs) or that otherwise relate to

measures for the protection of the environment or to people outside the

establishments where activities with genetically modified

organisms are conducted. Regulation (2008:1032).



Update of estimates



paragraph 13 of the assessments referred to in paragraphs 7 and 9 shall be reviewed and

updated on a regular basis.



Such a review shall be made immediately if



1. classification under section 8 is no longer real,



2. the selected level of protection within the meaning of section 10 is no longer sufficient,



3. the safeguard measures are no longer sufficient,

or



4. in the light of new scientific or technical knowledge

There is reason to suspect that the assessment is no longer

real.



Documentation



section 14 of the supervisory authority may, within its regulatory area Info

provisions on the obligation to document the assessments

made under sections 7 and 9, to keep the documentation available

and submitting it to the regulatory authority.




Notification and authorisation obligation, etc.



15 § a business with the contained use of genetically

modified organisms may be carried out only if the notification has

completed or permission has been granted in accordance with the provisions

in §§ 16-29.



section 16 of the notification shall be made to the supervisory authority which is

responsible supervisory developments. The Authority also

questions about permits.



section 17 A notification or application for authorisation shall be

include a summary of such risk assessment referred to

in section 7 and an explanation of the need for protective measures pursuant to

the assessment referred to in section 9.



The supervisory authority may, within its regulatory area Info

additional regulations on what a notification or application shall

contain.



section 18 When the regulator has received a notification or

the application, it shall examine whether



1. the requirements under section 17 are met and if the information

submitted may be accepted as correct and complete,



2. risk assessment can be considered real,



3. the proposed protection measures are adequate.



The supervisory authority may submit to the notifier or the applicant to

provide the additional information needed

trial.



19 § When the regulatory authority has received the information necessary

to the data and assessments shall be accepted as

complete and correct, the authority shall inform the

the notifier or applicant that a complete notification or

the application has been received.



section 20 on the content of a complaint raises, or if

the supervisory authority is aware of circumstances that may have

substantial importance to the risk associated with the activity,

authority may decide



1. the specific conditions shall apply for the business,



2. the activity must not commence or be operated without

special permit,



3. the activity may be carried out only for a limited time,

or



4. that the business may no longer be operated.



section 21 Of the business changed in a way that can have a significant

importance of risk associated with the activity, the operator

activities as soon as possible inform the supervisory authority.

The notification obligation also applies if the operator

business becomes aware of circumstances that may have such

importance.



section 22 if the information previously filed in a declaration or

the application is no longer accurate or has become outdated,

the program operates to ensure that the previously

made notification or application changed or updated in

the relevant parts. This obligation also applies if the activity

has been discontinued.



The supervisory authority may, within its regulatory area Info

details relating to the revision and update.



Specific provisions relating to the activities of microorganisms



section 23 where the supervisory authority does not decide otherwise, gets an F

activities or L-activities commence at the earliest 45 days after the

the full report has been made under the provisions

in paragraphs 16 to 19.



section 24 without a special registration needs to be done, get a new

use in a business carried on in a place or in a

facility that is already covered by a complete notification pursuant to

16-19 sections. The provisions of §§ 21 and 22 on the obligation to

inform the supervisory authority as well as to modify and update the

previous notification shall, however, apply.



section 25 A new use of an L-activity must not be operated without

that the use has been notified pursuant to the provisions of §§ 16-19.



Where the supervisory authority does not decide otherwise, the new

the use is begun immediately after a complete

notification has been made, if it intends to engage in the use of a

location or in a facility that is already covered by a

full registration, or a permit for a L-activities

or R-activity and the conditions attached to the

the business has been met.



paragraph 26 of A R-activity or a new use of an R-activities

must not be carried out without the authorisation of the supervisory authority.



If the new use means a use according to section 25 of the other

the paragraph that is conducted within the framework of a State for a R-

activities, it is sufficient that a notification is made in accordance with section 25 of the

the first paragraph. Regulation (2011:125).



section 27 Of the supervisory authority decides otherwise on the basis of section 20,

It shall notify its State



1. within 90 days after the date of a complete application

received,



2. within 45 days after the date of a complete application

received, if the application relates to a new use, provided that

be conducted in a location or in a facility that is already covered

a permit for a R-activity and the conditions

the activities have been met.



Specific provisions on activities with other organisms than

micro-organisms



section 28 A second plant for the contained use of genetically

modified organisms other than micro-organisms must not be used for

such activities without the authorisation of the supervisory authority.



Permission may be granted only if the plant is acceptable from

health and environmental protection point of view.



The authority shall notify its decision in

licensing question within 90 days of a complete

application has been made.



29 § a business with contained use of other genetically

modified organisms other than micro-organisms may be carried out only

If the business has been notified pursuant to the provisions of §§ 16-19.

If the supervisory authority within its regulatory area not

provides otherwise, the notification obligation applies also to each

new use.



Where the supervisory authority does not decide otherwise, the activities

or the new use commences no earlier than 45 days after the

a full report has been made.



The regulatory authority may, in the particular case, decide on the

exemption from the notification requirement, the

construction and circumstances otherwise make to the protection of

human health and the environment can be considered to be sufficiently

met.



Contingency plans



section 30 of the supervisory authority may, within its regulatory area Info

provisions on the obligation of the doing business with

the contained use of genetically modified organisms to

draw up a contingency plan for the business.



section 31 of the supervisory authority shall ensure that emergency plans

established for operations with the contained use of

genetically modified micro-organisms, if

containment measures are not working, may result in immediate

or delayed serious danger to people outside the

establishments where activities are carried on or for the environment.



A contingency plan should mean that the operator

the business provides information on planned security measures.

The information shall be submitted to the relevant authorities and other

may be affected by an accident. It should be provided as appropriate and

without the recipients need to request that it be submitted.

The information should be kept updated and available for

members of the public. Regulation (in 2008:52).



32 § At handling cases on contingency plans and

regulations on such plans, regulators

consult the Swedish civil contingencies Agency.

Regulatory authorities shall inform the authority of

civil contingencies Agency on the contingency plans

be established. Regulation (2008:1032).



Accidents, etc.



33 of the Act (2003:778) the accident prevention provisions

If obligations at hazardous activities etc.



The supervisory authority may, within its regulatory area Info

further provisions on the obligation of the operator of a

activities involving the contained use of genetically modified

organisms that in the event of an accident, incident or illness

that can be associated with the use of the organisms in the correct

the relevant authorities. In addition, to provide for

obligation for students engaged in operations to leave the

information needed to take the necessary protection measures should

able to be taken. Regulation (2003:799).



34 section about it in a business with the use of genetically

modified organisms occurs, an accident should

the supervisory authority



1. ensure that the necessary protective measures are taken,



2. immediately warn the Member States of the European Union

can be affected by the accident,



3. If possible, collect the information necessary for a

full analysis of the accident, and



4. issue the recommendations needed to prevent

similar accidents in the future and limit such accidents

effects.



If there is an immediate serious danger to the environment or for

people outside the premises where the activities are carried out,

the supervisory authority shall immediately notify the municipal

the Organization of emergency services and the Agency for

public safety and emergency preparedness. Regulation (2008:1032).



35 § Working Environment Authority to respond to the consultation and

the notifications referred to in article 15 of Directive 2009/41/EC.

Regulation (2011:125).



Reporting



36 § Working Environment Authority supposed to fulfill the reporting to

The European Commission referred to in article 17 of Directive

2009/41/EC. Regulation (2011:125).



Transboundary movement of genetically modified

organisms



36 a of the environmental protection agency to coordinate the national work

with Sweden's participation in the international

the information procedure pursuant to European Parliament and Council

Regulation (EC) no 1946/2003 of 15 July 2003 on

transboundary movement of genetically modified

organisms.



The supervisory authorities shall communicate to the

The environmental protection agency in accordance with article 15(1) of that regulation.

Regulatory authorities shall consult with the environmental protection agency on how

data shall be provided. Regulation (2006:1503).




Appeal and penalty and forfeiture



section 37 of chapter 19. § 1 and 29. the environmental code includes provisions

on appeal, and on penalties and forfeiture.



Entry into force and transitional provisions



2000:271



1. This Regulation shall enter into force on 5 June 2000. In the case of

activities with genetically modified organisms other than

micro-organisms applied, however, the provisions of 3-7, 9, 11-22,

28-30 and 32-34 §§ until 1 May 2001.



2. The following apply to a business with GM

microorganisms that were started before 5 June 2000 and

is registered or subject to authorisation in accordance with regulation

(1994:901) on genetically modified organisms. Activities

may continue to be conducted as if the notification were completed or

the permit has been issued under this regulation. In addition to what

resulting from the 20 or 21 of this regulation, the

operates to ensure that information about changes or

updates under section 22 shall be submitted to the supervisory authority

by 30 september 2000. The regulatory authority may, in the

each case shall decide on a later date.



3. The following apply to a business with GM

microorganisms that were started before 5 June 2000 and

is the registration or permit under this regulation

but that has not been reported or subject to authorisation in accordance with

Ordinance (1994:901) on genetically modified organisms.

The operator business shall, not later than 5 June 2000

inform the supervisory authority of the activities are carried out and

provide the information as requested by the supervisory authority to

tentatively assess whether the business is a F-business, L-

activities or R-business. If it is likely that

the business is a business, it may continue to be carried out

Notwithstanding that the notification is not completed in accordance with §§ 16-19

This regulation. In other cases, the supervisory authority

decide on the conditions under which operations can be carried out despite

that notification is not completed or permission granted

According to this regulation. Operations can be carried out pending

on the supervisory authority's decision. The provisions of §§ 20 and 22 shall

apply as if the notice were a completion notification. If

the supervisory authority does not decide otherwise, the activity is not

be conducted with the aid of this transitional provision after 30

September 2000. An operation must not be carried out under cover

of this transitional provision, if the operations before the June 5

2000 has been carried out in violation of the provisions on permit requirements

in the Ordinance (1994:901) on genetically modified organisms.



4. The following apply to an activity with other genetically

modified organisms other than micro-organisms if the business has

started before 1 May 2001. The business may continue to

be conducted as if the notification is completed or permission has

granted under this regulation until

the supervisory authority decides otherwise. This applies during

condition that the notification under section 29 shall be submitted to

the supervisory authority by 1 June 2001, and that the application for

authorization under section 28 shall be submitted to the regulatory authority no later

on 1 september 2001. The regulatory authority may in the individual

the case decide on a later date. Regulation (2001:19).

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