Regulations relating to the transport and import of genetically modified organisms

Chapter 1 General provisions

Section 1 Purpose

The purpose of these Regulations is to establish conditions enabling the transport and import of genetically modified organisms without the general approval required by section 10, first paragraph, of the Gene Technology Act.

Section 2 Scope

The Regulations apply to the transport and import of genetically modified organisms, which, pursuant to section 10 of the Gene Technology Act, are approved for deliberate release as mentioned in section 9, second paragraph, ae, of the Act, or which, pursuant to section 7 of the Act, are approved or notified for contained use as defined in section 5 of the Act. No further approval for transport and import is required for products that are approved for placing on the market pursuant to section 10 of the Act.

Section 3 Definitions

Genetically modified organisms: microorganisms, plants and animals whose genetic composition has been modified by the use of gene or cell technology.

Reproductive genetically modified plants: genetically modified plants or parts of plants, including seeds, pollen, corms and spores, which are in a phase of life where sexual or asexual reproduction occurs, or which are otherwise capable of spreading or surviving in the environment.

Risk classes: Microorganisms are classified according to section 1-4 of the Regulations of 11 February 1994 concerning approval of or the duty to report contained use of genetically modified organisms. The risk classes are I, II-2, II-3 and II-4.

Section 4 General precautions

Persons responsible for transport and import of genetically modified organisms shall ensure that the conditions stated in these Regulations are complied with, and otherwise show due care and take reasonable measures to ensure that transport and import are carried out without adverse effects on health and the environment.

Section 5 Other regulations

These Regulations in no way limit any requirements pursuant to other regulations concerning transport or import of plants, animals or micoorganisms.

Chapter 2 Transport and import

Section 6 General rule for transport and import

Unless otherwise stated in section 7, transport and import of genetically modified organisms subject to these Regulations may be carried out without special approval when the requirements regarding labelling and packaging laid down in chapter 3 are fulfilled.

The first import of genetically modified organisms that may be carried out without approval pursuant to section 7 shall however be reported, cf. section 9. The duty to report shall not however apply to microorganisms in risk class I and II-2 under 10 litres of culture.

Section 7 Transport and import for which approval is required

Approval is required for transport and import of the following genetically modified organisms on the basis of a simplified application:

1) Genetically modified microorganisms classes II-3 and II-4.

2) Volume of culture exceeding 10 litres of genetically modified microorganisms class II-2.

3) Live animals and plants used as host organisms for genetically modified microorganisms.

4) All genetically modified animals, except

a) traditional livestock that have no wild relatives in Norwegian fauna that they can cross with,

b) laboratory animals, e.g. mice, rats, hamsters intended for use in laboratories approved for contained use of genetically modified organisms,

c) embryos, eggs, semen, and cell and tissue cultures.

5) Transport where it is not possible to satisfy the requirements regarding packaging and labelling laid down in chapter 3.

Section 8 Contents of the application

Simplified applications for transport and import shall include the following information:

1) Name, address, telephone number and telefax number of the following: applicant, person responsible pursuant to section 4, sender, recipient and carrier.

2) Information concerning packaging, means of transport, transport route and date of dispatch and delivery.

3) Information concerning the organism: Ordinary and scientific name, description of the genetically modified organism and donor, recipient or (if applicable) parent organisms.

4) Amount: Number of organisms or litre of culture and number of packages to be transported.

5) Assessment of the risks to health and the environment associated with the transportation.

6) Information concerning when and by which authority the genetically modified organism was approved or reported for contained use or deliberate release pursuant to sections 7 and 10 of the Gene Technology Act.

7) Precautions to be taken in connection with handling of the organism.

8) Safety routines in connection with accidents.

9) Signature.

Section 9 Contents of the Notification

The notification of the first import shall include the following information:

1) Name, address, telephone number and telefax number of the person responsible for the report and of the person responsible pursuant to section 4.

2) Date of import.

3) Information concerning the organism: Ordinary and scientific name, description of the genetically modified organism and donor, recipient or (if applicable) parent organisms.

4) Amount: Number of organisms per litre of culture to be imported.

5) Information concerning when and by which authority the genetically modified organism was approved or reported for contained use or deliberate release pursuant to sections 7 and 10 of the Gene Technology Act.

6) Signature.

Section 10 Request for further information

If necessary, the authority responsible for granting approval or receiving notification may request further information.

Chapter 3 Labelling and packaging

Section 11 Labelling

During transport, each package shall be clearly labelled in Norwegian and/or English as containing genetically modified organisms.

The labelling shall also state the species of organism and the name, address and telephone number of both the sender and the recipient.

Section 12 Packaging of microorganisms class I and of non-reproductive plants or parts of plants

The packaging shall be watertight, sealed and fracture proof, etc. so as to prevent any unintentional leakage of the contents.

Section 13 Packaging of microorganisms class II-2, II-3 and II-4

There shall always be an inner and an outer container, which shall both be waterproof.

Between the inner and the outer container, there shall be fluid-absorbent material capable of absorbing a quantity of fluid equivalent to that in the container. If two or more inner containers are carried in the same outer container, each inner container shall be separately packaged in shock-absorbent and fluid-absorbent material.

The outer container shall be watertight, sealed, fracture proof, etc. so as to prevent any unintentional leakage of the contents.

Section 14 Packaging of reproductive plants and parts of plants

There shall always be an inner and an outer container, which shall impervious to both spores and pollen. The outer container shall be sealed and fracture proof, etc. so as to prevent any unintentional leakage of the contents.

Section 15 Packaging of animals

The packaging shall consist of either a cage or a container that ensures that the animals are not able to escape or cross with other animals outside the packaging.

Packaging of embryos, eggs and semen, cell and tissue cultures, and insects and other invertebrates shall be carried out in accordance with the provisions laid down in section 12.

Section 16 Other requirements regarding packaging

The authority responsible for granting approval may make additional requirements in relation to packaging as conditions for approval.

In connection with the transport of greater volumes, other forms of packaging than those required pursuant to sections 12 to 15 may be approved on application.

Chapter 4 Records and transport documents

Section 17 Records

All transport and import of genetically modified organisms shall be recorded by the recipient in Norway, and also by the sender when both are located in Norway. The record shall describe the genetically modified organisms in question, give the date of dispatch and delivery and the result of the check that all the material reached its destination.

The record shall at all times be available for inspection by the surveillance authority.

Section 18 Transport documents

Transport documents shall accompany all consignments of genetically modified organisms from sender to recipient. The documents shall contain the information required by section 8, subsections 1) to 9).

A copy of the approval shall accompany all consignments of genetically modified organisms for which approval is required pursuant to section 7. An acknowledgment proving receipt of notification shall be enclosed with all consignments for which notification is required pursuant to section 6.

Chapter 5 Accidents

Section 19 Obligation to report

Accidents during transport that have resulted in or could result in the release of genetically modified organisms shall without undue delay be reported to the Norwegian Pollution Control Authority in Horten.

In cases where genetically modified organisms are classified as dangerous goods, accidents shall also be reported to the local fire and rescue services.

Section 20 Duties in connection with accidents

The person responsible pursuant to section 4 of the present Regulations shall, pursuant to section 21 of the Gene Technology Act, take responsible measures to prevent and limit damage.

Chapter 6 Enforcement provisions

Section 21 Approval and inspection

The Directorate for Nature Management is responsible for approval of applications to transport or import genetically modified plants and animals. The Norwegian Pollution Control Authority is responsible for approval of applications to transport or import genetically modified microorganisms.

The authorities shall deal with the application as rapidly as possible. If the matter is not decided within one month of the authorities receipt of the application, the applicant shall be informed of this in writing and shall be notified of when the result may be anticipated.

The Norwegian Pollution Control Authority is responsible for ensuring that the provisions concerning genetically modified microorganisms laid down in these Regulations are complied with. The Directorate for Nature Management is similarly responsible for ensuring that the provisions concerning genetically modified plants and animals are complied with.

Section 22 Exceptions

The surveillance authorities may, if special grounds so indicate, either by means of individual decisions or by issuing regulations, make exceptions from the provisions laid down in these Regulations.

Section 23 Contraventions

Contravention of these Regulations is subject to penalties in accordance with section 25 of the Gene Technology Act.

Section 24 Coercive fines

To ensure the implementation of the provisions laid down in these Regulations and of decisions made pursuant to the Regulations, the surveillance authority may impose coercive fines, cf. Section 24 of the Gene Technology Act.

Section 25 Appeals

Appeals in relation to decisions made pursuant to these Regulations shall be addressed to the Ministry of the Environment.

Section 26 Entry into force

These Regulations enter into force 1 January 1999.

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Guidelines on the regulations pursuant to the Gene Technology Act, concerning transport and import of genetically modified organisms

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Chapter 1 General provisions

Section 1 Purpose

In Act no. 38 of 2 April 1993 relating to the production and use of genetically modified organisms, the Gene Technology Act, transport and import of genetically modified organisms is defined as deliberate release cf. section 9 litrae g) and h). This is primarily because, when the organism during transport and import is removed from the approved laboratories and installations for contained use, the risk of spreading is increased. There is therefore a need for different requirements in connection with the handling of genetically modified organisms during transport and import than those applying to handling in connection with contained use. At the same time, there is general agreement that it is unnecessary and impractical to place equally strict requirements on approval for transport in general as on the deliberate release of genetically modified organisms. It has therefore been made possible to exempt the transport and import of genetically modified organisms from the main provisions concerning approval pursuant to section 10 of the Gene Technology Act.

Section 2 Scope

Only genetically modified organisms that have been approved for contained use or deliberate release other than transport or import may be transported pursuant to the provisions of these Regulations. If an organism has not been approved for other deliberate release or contained use, approval must be applied for pursuant to section 10 of the Act, or notification or an application for approval must be submitted pursuant to section 7 of the Act before transport and import may be carried out.

Products that have been approved for placing on the market pursuant to section 10, first and final paragraph, of the Gene Technology Act (cf. EEA directive 90/220 Part C) may freely be transported and imported. Such products are therefore not subject to the provisions of these Regulations.

Internal transport

Transport of genetically modified organisms within the area of a laboratory or installation approved pursuant to the Gene Technology Act section 6 is regarded as contained use and is not included within the scope of these Regulations. The same applies to transport between approved laboratories that both lie within a geographical location restricted to the activity concerned. Transport between laboratories where two or more units are located within an area where other types of activity are also located will be regarded as deliberate release and will be subject to these Regulations.

Internal transport of microorganisms shall however be carried out in accordance with good microbiological practice and taking security measures pursuant to section 6, third paragraph, of the Gene Technology Act. In the case of plants and animals, transport shall also be carried out in such a way as to hinder unintentional release.

In cases of doubt as to whether transport may be regarded as internal transport, and thus fall outside of the scope of these Regulations, the matter shall be decided by the surveillance authority on the basis of information concerning the transport area in question.

Section 4 General precautions

Any person who arranges for the transport or import of genetically modified organisms is responsible for compliance with the requirements of these Regulations. The surveillance authority may according to the circumstances hold either the sender or the recipient responsible. The deciding factor will in most cases be whether it was the sender or the recipient who had control of the transport and import (date, choice of means of transport/carrier, etc.). As a general rule, it will be appropriate to regard the sender as responsible for ensuring that the provisions concerning packaging and labelling are complied with.

The name, address and telephone number of the person responsible shall be given in the simplified application for approval and in the transport document, among other reasons, as part of the accident preparedness. The duty to show due care involves, among other factors, that the responsible person shall ensure that the personnel responsible for transportation have a knowledge of the consignment and of the measures that shall be implemented in the event of accidents, and that persons importing genetically modified organisms into Norway notify the sender of the requirements regarding packaging and labelling.

Section 5 Other regulations

These Regulations apply in addition to other regulations which may contain further requirements regarding transport and import of genetically modified organisms. In the following, an overview is given of relevant regulations.

Transport of genetically modified organisms as dangerous goods

Certain types of genetically modified organisms will be classified as dangerous goods pursuant to the regulations for transport of dangerous goods. The provisions for packaging laid down in the present Regulations have to a great extent been harmonized with the regulations listed below, but all consignments that are also classified as dangerous goods must be labelled in accordance with the provisions for transport of dangerous goods.

Table 1 shows which regulations apply to the transport of dangerous goods, and to which authorities one can apply for further information.

Table 1.

Directorate for Fire and Explosion Prevention	Regulations of 20 December 1996 relating to the carriage of dangerous goods by road and rail. ADR 1> and RID 2> shall be regarded as integrated parts of the Regulations.
Norwegian Maritime Directorate	Regulations of 21 May 1987 relating to transport by sea of special or dangerous freight in bulk or as packed goods. Refers to IMDG code 3>.
Coast Directorate	Regulations of 21 July 1992 relating to loading, unloading, storage and transport of dangerous substances and goods within the harbour district.
Civil Aviation Administration	Regulations of 15 May 1979 relating to transport of goods by air. Refers to ICAO-TI. 4>

¹> ADR (The European Agreement on the Carriage of dangerous Goods by Road) is the version valid at any time of the European agreement on international road transport of dangerous goods, concluded in Geneva on 30 September 1957.

²> RID (the version valid at any time of the international regulations for transport of dangerous goods by rail) is contained in Supplement 1 Annex B to the Convention on international railway goods traffic.

³> The IMDG code (International Maritime Dangerous Goods Code) is the International Maritime Organization?s (IMO) classification codes for transport of dangerous goods by sea, and is regarded as part of International Convention for the Safety of Life at Sea (SOLAS).

⁴> ICAO-TI (Technical Instructions for the safe transport of dangerous goods by air) has been prepared by the International Civil Aviation Organisation (ICAO), on the basis of the Convention on International Civil Aviation Annex 18 (Chicago Convention)

Microorganisms

Consignments of microorganisms class II-2, II-3 and II-4 shall be packaged and labelled in accordance with international regulations concerning the transport of dangerous goods. However, genetically modified microorganisms class I will not be subject to the provisions concerning transport of dangerous goods in addition to the provisions laid down in the Regulations relating to the transport and import of genetically modified organisms.

Table 2.

Labelling of microorganisms pursuant to provisions concerning transport of dangerous goods

Risk class	FN class	FN ID number	Comments
II-4 5>, II-3 and II-2	6.2	2814 Pathogenic agent, afflicts human beings	Used both for genetically modified and non-genetically modified microorganisms.
		2900 Pathogenic agent, only afflicts animals
I 6>	9	3245 Genetically modified microorganisms	Used for genetically modified microorganisms not defined as pathogenic, but which may be harmful in other ways to animals and plants or to other microorganisms

⁵> Risk classes II-4, II-3 and II-2 correspond to risk groups IV, III and II of the international regulations concerning risk classification of microorganisms cf. WHO "Laboratory Safety Manual" and directive 90/679/EØF. I n the international regulations concerning the transport of dangerous goods, these risk groups are classified in class 6.2 Pathogenic or infectious substances.

⁶> Corresponds to risk group I in international regulations concerning risk classification of microorganisms, cf. footnote 1. The risk group is characterized as follows: "microorganisms that are probably not capable of causing disease in human beings or animals." In international regulations concerning the transport of dangerous goods, this risk group is placed in class 9: "Various hazardous substances and objects."

All packages shall be clearly and permanently labelled "UN" followed by the ID number of the goods. The packaging shall also labelled as dangerous pursuant to the Regulations relating to the transport of dangerous goods.

In connection with the transport of microorganisms, in addition to the provisions described above, the Regulations of 12 September 1996 relating to the import, transport or other handling of material that is infectious for human beings must be complied with.

Animals

In connection with the transport of animals, the following regulations must be complied with:

Regulations of 27 May 1990 relating to the transport of freshwater fish.

Regulations of 29 June 1994 relating to import and export of aquatic organisms, products and infectious objects.

Regulations relating to the transport of live animals pursuant to section 30 of the Welfare of Animals Act of 20 December 1974 and the Act of 8 June 1962 relating to measures to combat livestock diseases.

Regulations of 2 July 1991 relating to prohibition against the import of animals and infectious objects.

Instructions to District Veterinary Officers concerning private quarantine of animals.

Plants

In connection with the transport of plants, the following regulations must be complied with:

Regulations of 12 September 1983 relating to the import of plants and parts of plants, etc. to Norway.

Regulations of 23 December 1993 relating to horticultural seed.

Regulations of 23 December 1993 relating to agricultural seed.

Regulations of 23 December 1993 relating to cereal seed.

Regulations of 2 July 1996 relating to agricultural seed.

These lists are not necessarily exhaustive.

Chapter 2 Transport and import

Section 6 General rule for transport and import

The general rule laid down in these Regulations is that all organisms notified or approved for contained use or deliberate release pursuant to sections 7 and 10 of the Gene Technology Act may be transported and imported without special approval. Instead of the special approval, conditions have been introduced for approval on the basis of a simplified application, notification in the case of first import, labelling, packaging, the keeping of records and transport documents. The conditions laid down differ from one organism to another according to an assessment of risk and the needs of the public administration to exercise control, see table 3.

With the exception of microorganisms in risk classes I and II-2 under 10 litres of culture, the first import of organisms subject to these Regulations shall be notified. In the cases where approval is required on the basis of a simplified application, cf. section 7, this application will replace the notification. This means that, in the following cases, notification is only required in relation to the first import:

• Plants.
• Traditional livestock that has no wild relatives in Norwegian fauna with which it may cross, e.g. cattle, sheep, horses, pigs, goats, poultry.
• Laboratory animals intended for use in laboratories approved for contained use.
• Embryos, eggs, and semen, and cell and tissue cultures.

By first import is meant import of a specific genetically modified organism for a specific use that has not previously been imported to Norway for this use. Information concerning this may be obtained from the appropriate surveillance authority.

Table 3. The general rules can be schematized as follows:

	Approval on the basis of a simplified application for transport and import	Packaging of first import	Notification
Microorganisms
Class I	No	Section 12	No
Class II-2 under 10 litres of culture	No	Section 13	No
Class II-2 over 10 litres of culture	Yes, see section 7, subsection 2	Section 13	No, simplified application, see section 6 (section 7)
Class II-3 and II-4	Yes, see section 7, subsection 1	Section 13	No, simplified application section 6 (section 7)
Genetically modified microorganisms transported in plants or animals	Yes, see section 7, subsection 3	Sections 15 and 16	No, simplified application section 6 (section 7)
Plants
Not reproductive	No	Section 12	Yes, see second sentence of section 6
Reproductive, including pollen, spores, seeds, etc.	No	Section 14	Yes, see second sentence of section 6
Animals
All animals (for exceptions, see below)	Yes, see section 7, subsection 4	Section 15 (Insects, section 12)	No, simplified application section 6 (section 7)
Livestock and Laboratory animals	No	Section 15	Yes, see second sentence of section 6
Embryos, eggs and semen, and cell and tissue cultures	No	Section 12 (section 15)	Yes, see second sentence of section 6

Section 7 Transport and import for which approval is required

In the case of transport and import of organisms as referred to in section 7, approval is required on the basis of a simplified application in addition to the requirements concerning packaging and labelling.

All transport of genetically modified organisms where it is not possible to satisfy the requirements regarding packaging and labelling shall be approved on the basis of a simplified application. The application shall give the reasons why it is not possible to comply with the Regulations? requirements regarding packaging and labelling.

Sections 8 and 9 Contents of the application and notification of first import

Applications and notifications concerning transport and import of genetically modified microorganisms shall be addressed to different authorities depending on the types of organism concerned.

Applications and notifications concerning genetically modified plants and animals shall be addressed to:

Directorate for Nature Management.
Tungasletta 2
7004 Trondheim
Tel.: 73 58 05 00
Fax: 73 91 54 33

Applications concerning genetically modified micoorganisms shall be addressed to:

Norwegian Pollution Control Authority
Postboks 8100 Dep
0032 Oslo

Tel.: 22 57 34 00
Fax: 22 67 67 06

Application forms and notification forms can be obtained from both directorates.

Chapter 3 Labelling and packaging

Section 11 Labelling

There are no requirements stipulating the use of specific symbols or texts, but the packaging shall be clearly labelled as containing genetically modified organisms. The intention of the labelling requirement is to ensure that it is easy to identify the consignment during transport as containing genetically modified organisms. It is therefore primarily the transport packaging that shall be labelled. If the organism is classified as dangerous goods, the packaging shall also be labelled pursuant to the provisions concerning transport of dangerous goods (see chapter 1).

Sections 12, 13, 14, 15 and 16 Packaging

In cases where the packaging fails to satisfy the requirements laid down in these Regulations, approval for the transport shall be applied for in accordance with section 7. If the organism is classified as dangerous goods, see chapter 1, the packaging must also satisfy the appropriate requirements concerning transport of dangerous goods.

Chapter 4 Records and transport documents

Section 17 Records

All import and transport shall be recorded, These records will be an aid to surveillance and accident preparedness. The recorded information may also be used by the surveillance authorities as basic data in connection with the control ofthe number of times goods are transported and imported. This applies especially to transport that shall neither be approved nor notified.

Section 18 Transport documents

A copy of the approval on the basis of a simplified application for transport and import may be used as a transport document.

Chapter 5 Accidents

Section 19 Obligation to report

Accidents during transport that have resulted in, or may result in, the release of genetically modified organisms shall be reported immediately to the Oil Pollution Control Department of the Norwegian Pollution Control Authority (Horten) Tel 33 03 48 00. This telephone is continually manned, day and night.

In the event of accidents involving genetically modified organisms classified as dangerous goods, a report shall also be made to the local fire and rescue services on emergency number 110, pursuant to the regulations of 20 December 1996 relating to the transport of dangerous goods by road and rail.

In cases where notification may result in delays in the implementation of safety measures necessary for the prevention or limitation of possible adverse effects, such safety measures must be implemented before notifying the surveillance authority.

Section 20 Responsibility in connection with accidents

In the event of accidental releases, the person responsible for the release is obliged to take reasonable measures to prevent or limit damage and inconvenience. The surveillance authority may order the person responsible to carry out retrieval measures or other measures to render the organism harmless or to restore the natural state of the environment as far as possible.

If such orders are not complied with, the authorities may themselves implement measures, and demand that the cost of such measures be covered by the person responsible.

This page was last updated February 15th 1999 by the editors