Regulations on animal health conditions for the import and export of embryos of cattle


Date FOR-1998-12-31-1486


Ministry of Agriculture and Food


Published Dept. In 1998 2514


Commencement 01.01.1999

Edited
FOR-2014-09-17-1294

Changes
FOR 1994-06-23-693

For
Norway

Legal

LOV-2003-12-19-124-§12, LAW-2003-12-19-124-§15, LAW-2003-12-19-124-§19, LAW-2003-12-19- 124 §23, LAW-2003-12-19-124-§33, LAW-2003-12-19-124-§36, FOR-2003-12-19-1790, TO-2004-05-05-884

Promulgated


Short Title
Regulations on trade in embryos of cattle

Chapter Overview:

Chapter I. Purpose, scope and definitions (§§ 1-3)
Chapter II. Conditions for imports and exports within the EEA (§§ 4-10)
Chapter III. Conditions for imports from third countries (§§ 11-15)
Chapter IV. Final provisions (§§ 16-21)
Appendix A. List of third countries and regions in third countries from which embryos may be imported
Appendix B. Model of animal health certificate to accompany the embryos of cattle imported from or exported to countries in EEA
Appendix C. Model of animal health certificate to accompany the in vivo fertilized embryos on imports from third
Appendix D. Model of animal health certificate to accompany the in vitro fertilized embryos by imports from third countries, cf. § 14 first paragraph
Appendix E. Model of animal health certificate to accompany the in vitro fertilized embryos by imports from third countries, cf. § 14 subsection
Appendix F

Adopted by the Ministry of Agriculture (now Agriculture and Food) December 31, 1998 pursuant to the Act of 19 December 2003. 124 relating to food production and food safety. (Food Act) § 23 third paragraph, ref. § 12, § 15 and § 19, § 33, first paragraph, ref. § 36 second paragraph, cf.. Delegated Decision of 19 December 2003. 1790.
EEA Referrals: EEA agreement Annex I (Directive 89/556 / EEC, decision 2004/52 / EC, decision 2004/205 / EC, decision 2006/60 / EC, decision 2008/155 / EC, decision 2006/168 / EC (as amended by Regulation (EC) no. 1792/2006, decision 2009/873 / EC decision 2012/414 / EC, Regulation (EC). 519/2013 and decision 2013/309 / EC), Regulation (EC) no. 657 / 2006 and Directive 2008/73 / EC (as amended by decision 2009/436 / EC).
Changes: amended by regulations 9 January 2004 no. 61, June 9, 2004 No.. 897, 22 May 2007 No.. 531, May 9, 2008 No.. 551, February 13, 2009 no. 169, October 8, 2009 No.. 1257, 25 June 2010 No.. 1053, August 8, 2011 No.. 812, 19 Dec 2012 No.. 1349, 13 August 2013 No.. 976, 17 September 2014 No.. 1294.

Chapter I. purpose, scope and definitions

§ 1. purpose the purpose of this regulation is to prevent the spread of infectious animal diseases by the import and export of embryos of cattle.

§ 2. Scope These regulations apply import and export within the EU and imports from third countries or regions of third countries of fresh and frozen embryos of cattle.
Regulation does not apply import of embryos that have been the subject of nucleus transfer.

§ 3. Definitions In these regulations;
Embryo: the first step in the development of a bovine individual by fertilization of the egg cells, while it is suitable for transfer to a mottakerdyr.
Embryo-raising group, officially approved technician group, which is supervised by a team veterinarian and which is authorized to collect, process and store embryos.
Cattle: individuals of cattle (Bos spp.), Bison (Bison bison) and water buffalo (Bubalus bubalus).
Embryo-manufacturing group, officially approved technician group, which is supervised by a team veterinarian and which is authorized to perform in vitro fertilization.
Group Veterinary: the veterinarian responsible for the supervision of one embryo collection group.
Embryo Shipment: a plethora of embryos collected simultaneously from a single donor animals, which are covered by one health certificate.
Bull Drive: officially approved and supervised holding for the production of bull sperm for use in insemination.
Holding: an agricultural operation which regularly kept or bred breeding, production or slaughter, or a permitted activity for commercial sales of animals.
Crew: all animals with such contact that infection can be transmitted (hygienically contact) within the same holding.
Official veterinarian: a veterinarian given public authority by the competent central authority in the country concerned.
Government approved laboratory: a laboratory approved by the competent authority of the country of origin to carry out the diagnostic tests that are specified in these regulations.
Epizootifri zone: an area with a diameter of 20 km where it officially during the last 30 days prior to dispatch has not acted rinderpest (Rinderpest) and foot-and-mouth disease.

Third country that is neither a member of the European Union or the EEA Agreement has entered into an agreement with the EU on trade in fresh and frozen embryos.
Region: an area of ​​a country that is at least 2,000 km², which is under official veterinary control.
Herd officially free of tuberculosis: herd which satisfies the requirements of Council Directive. 64/432 / EEC Annex A, Part I.
Herd officially free of brucellosis: herd which satisfies the requirements of Council Directive. 64/432 / EEC Annex A, Part II.
Herd free from infectious leukosis: herd which satisfies the requirements of Council Directive. 64/432 / EEC Annex G, Part I.

Chapter II. Conditions for imports and exports within the EEA

§ 4. General Within the EEA, it is only allowed to import and export embryos of cattle that have been collected and produced by embryoinnsamlings- and production groups approved by the competent authority of the country of dispatch, and which are exercised in accordance with the requirements enshrined in the regulation. The groups and their veterinary registration numbers shall be listed on a list published by the competent authority of that country.
Embryo imported or exported within the Community shall be collected, processed and stored:

1.
After 1 January 1991, if they originate from countries that were Member States before 1 May 2004.

2.
After 1 May 2004, if they originate from countries that were Member States from 1 May 2004.

§ 5. Conditions for approval of embryoinnsamlings- and embryo production group To be approved, each embryo collection team must meet the following conditions:

1)
collection, processing and storage of embryos shall be carried out by a group of veterinarians or on his responsibility by one or more competent technicians, who are adequately trained in hygiene methods and techniques

2)
group should be supervised by an official veterinarian

3)
group should have access on a permanent or mobile laboratory where embryos can be examined, processed and packed. The laboratory shall consist of at least a work bench, a microscope and refrigeration equipment

4)
group to the permanent laboratory have access to:

A)
local, where embryos can be handled. This will limit up to, but separate from the area used for managing donors during collection

B)
local area, which is equipped for cleaning and sterilization of the instruments and the equipment used for the collection and management of embryo

C)
if properly carried micromanipulation of the embryo which involves penetration of the zona pellucida, this shall be done in laminar flow facilities which are cleaned and disinfected properly between each batch

5)
properly when it concerns a mobile laboratory, have access to a specially equipped part of the vehicle consisting of two separate parts, of which

A)
one to study and handling of the embryo, called a clean department and

B)
one for the storage of equipment and materials used in contact with the donors.

A mobile laboratory shall always have contact with a permanently installed laboratory to ensure the sterilization of equipment and supply of fluids and other products necessary for the collection and handling of embryos.
To be approved as embryo production group, the following provisions must also be fulfilled:

1)
staff should be trained in appropriate disease control and laboratory techniques, particularly in procedures for working in sterile conditions

2)
staff must have access to permanent laboratory which shall:

A)
have adequate equipment and facilities, including special facilities for the extraction of oocytes from ovaries and separate areas or areas for processing oocytes and embryos and storage of embryos

B)
have laminar flow facilities which all oocytes, semen and embryos must be processed; centrifuging the sperm may be made outside the laminar flow facilities, provided that the hygienic conditions are guaranteed

3)
if oocytes and other tissues are collected at the slaughterhouse, the slaughterhouse have appropriate equipment available for hygienic and risk-free collection and transport of ovaries and other tissues to the processing laboratory.

§ 6. Requirements for the collection, preparation and processing embryos must be collected, prepared and processed in accordance with the following requirements:

1)
embryos must be collected and processed by an approved embryo collection group. Embryo must not come into contact with other consignments of embryos than those that meet the requirements of this regulation.

2)
embryos must be collected at a place separated from other parts of the premises or holding. The place should be well maintained and easy to clean and disinfect.

3)

Embryo be examined, washed, treated and placed in labeled sterile containers in a permanent or mobile laboratory. The laboratory must not be located in an area subject to government restrictions because of contagious animal diseases or quarantine regulations.

4)
All equipment that comes into contact with the embryo or donor animal during collection and processing shall be either disposable equipment or be sterilized or disinfected before use.

5)
Animal products used during collection of the embryo and in transport media must be taken from sources that do not pose any health hazards, or prior to use treated in such a way that the risk is removed. All media and solutions shall be sterilized by approved methods according to the manual IETS (International Embryo Transfer Society). Antibiotics may be added to the medium according to IETS manual.

6)
Storage and transport containers should be disinfected or sterilized before filling starts.

7)
refrigerant must not previously have been used for products of animal origin.

8)
Each embryo container and the container where the embryos are stored and transported shall be clearly code marked so that the collection date and donoroksens and donorkuas race and identity, as well as collecting the group's registration immediately be ascertained.

9)
Each embryo shall be washed at least ten times a embryonæringssubstrat, each time replaced and that will contain trypsin in accordance with internationally approved procedures, (unless it made another decision in accordance with paragraph 13). When washing should the transferred liquid is diluted 100 times, and each time used a sterile micropipette to transfer embryos.

10)
entire embryo surface will after the last wash is examined under a microscope at a magnification of at least 50X to determine whether the zona pellucida is intact and free of extraneous material. Micro manipulation which involves penetration of the zona pellucida shall be after the last wash and examination carried out in facilities which are approved for this purpose. Micro manipulation must be performed on embryos where the zona pellucida is intact.

11)
Each group embryos removed in one operation from a donor and who have achieved a satisfactory result in the survey in point no. 10), to be placed in a sterile container marked in accordance with Section 8) . The container shall be immediately sealed.

12)
Each embryo shall, if necessary immediately frozen and stored in a place which is under the supervision of team veterinarian and regularly inspected by an official veterinarian.

13)
When washing the embryo must be used approved rinsing and washing liquids, washing procedure, and optionally enzymatic treatments and storage conditions approved for transport.

14)
Each embryo collection team shall routinely submit samples of flushing fluids, washing liquids, damaged embryos, infertile eggs etc. In connection with the group's activities with respect to public examination for bacterial and viral contamination. If the current standards are not met, the competent authority has approved embryo collection team, withdraw the approval.

15)
Each collection team shall keep a record of their embryo collection work. The record shall be kept for twelve months after the acquisition, stating:

A)
donor animals breed, age and identity

B)
place for the collection, processing and storage of embryos

C)
embryo 'identity, together with details of their destination if known

D)
details of micromanipulation techniques, which involves penetration of the zona pellucida or other methods as in vitro fertilization and / or in vitro culture, which was performed on the embryo. Embryos fertilized in vitro, can be identified on the basis of a batch, but must include details of the date and place of collection of ovaries and / or oocytes. It should also be possible to identify the donor animals originating crew.

The provisions of paragraph 1 point 1) through 15) shall to the extent applicable, apply to the collection, processing, storage and transport of ovaries, oocytes and other tissues for use in in vitro fertilization and / or in vitro culture . Moreover, the following additional requirements:

1)
ovaries and other tissues can only be collected by local authorities slaughterhouse, under the supervision of an official veterinarian who has the responsibility to carry out ante- and post-mortem inspection of donor animals.

2)
materials and equipment coming into direct contact with ovaries and other tissues shall be sterilized before use and after sterilization only used for this purpose. Handling of oocytes from donor animals originating from different holdings should be kept separate.

3)

Ovaries and other tissues should not be introduced into the processing laboratory until post-mortem examination of all donor animals from the same animal husbandry is completed. If it is discovered relevant disease in animal husbandry or in any animals slaughtered in the slaughterhouse concerned that day, everything must tissues derived from these animals traced and destroyed.

4)
procedure for washing and inspection laid down under section 1 point 9) and 10) shall be carried out after the culture procedure has been completed.

5)
micro manipulations that involve penetration of the zona pellucida shall be carried out in accordance with paragraph 1 point 10) after the procedure under paragraph 2 point 4) is performed.

6)
embryos stored in the same ampoule / straw, should come from the same animal husbandry.

§ 7. Storage Each embryoinnsamlings- or production group shall ensure that the embryos are stored at suitable temperatures place approved by the competent authority of the country of origin.
To be approved, these locations:

1)
comprise at least one lockable room intended exclusively for the storage of embryos

2)
be easy to clean and disinfect

3)
have permanent records of all incoming and outgoing embryo. Embryo The final destination is noted in the minutes

4)
be inspected by an official veterinarian.

The competent authority may allow semen that fulfills the conditions for the import and export of bovine semen, kept at the approved storage places.
Embryos to be imported or exported must be transported under satisfactory hygienic conditions in sealed containers from the approved storage places to their destinations.
The containers must be marked in such a way that it is consistent with the number of the health certificate.

§ 8. Requirements for donor embryo donor animals must meet the following requirements:

1)
They must have stayed in the EEA or in a third country or region of a third country for at least the previous six months.

2)
They must have stayed in the herd of origin for at least 30 days before the gathering takes place.

3)
They must come from herds which are:

A)
officially free of tuberculosis

B)
officially free of brucellosis or free of brucellosis

C)
free of contagious leukosis or in which it is confirmed that it is not occurring clinical cases of communicable leukosis the last 3 years.

4)
During the past year, they must not have stayed in herds where there have been any clinical signs of IBR / IPV.

Donor animals shall on collection day:

1)
Sustaining himself on a holding that is not compulsory veterinary restrictions or quarantine regulations.

2)
Not showing clinical symptoms of the disease.

The above requirement shall also apply to live animals shall be oocytdonordyr after withdrawing eggs or ovariectomy.
Donors of ovaries or other tissue to be collected at the slaughterhouse, must be from animals slaughtered in the context of a disease control program or that come from holdings that are imposed restrictions because of animal disease.
Ovary and other tissues may not be collected in slaughterhouses located in areas that are imposed restrictions or quarantine regulations.

§ 9. Requirements for donor sperm embryos must be the result of artificial insemination or in vitro fertilization using semen from a bull standing in an approved semen collection center or semen imported in accordance with current regulations on animal health conditions for production, import and export of bovine semen.

§ 10. Health Certificate With each embryo shipment shall be accompanied by a health certificate.
When importing from or exporting to countries in the EEA, the health certificate issued by an official veterinarian in the country of origin on a form prepared by the competent authority of the country of origin on the model shown in Annex B.
Health Certificates should be written in at least one of the official languages ​​of the country of origin and one of the official languages ​​of the recipient country.
Healt foreseen original, accompany the consignment to the final destination, consist of one sheet and be issued to a single recipient.

Chapter III. Conditions for imports from third

§ 11. Approved third embryos can only be imported if they are collected or produced in third countries or region of a third country listed in Annex A.

§ 12. Approved collection and production groups embryos can only be imported from the embryo collection team or embryo production team approved by the competent national competent authority and listed on a list published by the European Commission.


§ 13. In vivo fertilized embryos Embryos fertilized in vivo can be imported if the conditions set out in the health certificate the model of Annex C is met and every embryo shipment is accompanied by such a health certificate duly completed.

§ 14. In vitro produced embryos Embryo produced by in vitro fertilization using semen that fulfills the animal health conditions for imports and exports of bovine semen may be imported if the conditions in Annex D is met and every embryo shipment is accompanied by such a health certificate in duly completed.
Embryos produced by in vitro fertilization using semen produced in approved semen collection or storage sædlager in third countries as it is permitted to import bovine semen from, can be imported if the conditions set out in Annex E is fulfilled and each embryo shipment is accompanied by a such health certificate duly completed.

§ 15. Restrictions on the sale of imported embryos in vitro produced embryos referred to in § 14 subsection shall not be imported or exported within the EEA, but solely implanted in animals, which are kept in the Member State of destination indicated in the animal health certificate that came with embryo shipment.

Chapter IV. Final provisions

§ 16. Approval, control and decisions of the Authority to approve embryo collection groups, embryo production groups and repositories for embryo in Norway. Approved embryo collection groups and embryo production groups assigned a veterinary registration number.
FSA may withdraw the approval if the embryo collection team, embryo production team or storage site no longer meets the conditions for approval or activities take place in violation of this regulation.
Approved embryo collection groups and embryo production groups shall notify the FSA of any significant changes in the composition of the group. When replacing group veterinary or significant changes of the group, the laboratories or equipment group must apply for approval.
FSA supervises that this regulation is complied with and can make the decisions necessary to ensure this.
When importing and exporting of embryos coming applicable regulatory supervision and inspection to anvendelse.1

§ 17. Expenses All expenses in connection with the import and export of fresh and frozen embryos are the responsibility.

§ 18. Safety regulations FSA at short notice and without compensation for the importer, stop the importation or exportation of fresh and frozen embryos if special conditions concerning the sending zoosanitære situation or other circumstances indicate this.

§ 19. Exemption FSA may in special cases grant exemptions from the provisions of this regulation, provided that it does not conflict with Norway's international obligations, including the EEA agreement.

§ 20. Penalties Deliberate or negligent violation of these regulations or provisions and decisions issued pursuant thereto is punishable under the Food Act § 28

§ 21. Commencement and transitional arrangements This Regulation shall enter into force on 1 January 1999.
From the same date, the Regulations on 23 June 1994 no. 693 on animal health conditions for importation and exportation of fresh and deep-frozen embryos of cattle within the EEA .
To September 1st, 2013, cattle embryos referred to in § 13, § 14 first paragraph and § 14 subsection imported if the terms of the respective health model certificates in Annex F Part 1, Part 2 and Part 3 are met and shipments followed by such health certificates issued before August 1, 2013.

Appendix A. List of third countries and regions in third countries from which embryos may be imported

ISO code
Land
Relevant health certificate model


AR Argentina
Appendix C Appendix D

Appendix E


AU Australia
Appendix C Appendix D

Appendix E


CA Canada
Appendix C Appendix D

Appendix E


CH Switzerland *

Appendix C Appendix D

Appendix E


IL Israel
Appendix C Appendix D

Appendix E


MK Macedonia **

Appendix C Appendix D

Appendix E


NZ New Zealand ***

Appendix C Appendix D

Appendix E


US United States
Appendix C Appendix D

Appendix E

Appendix B. Model of animal health certificate to accompany the embryos of cattle imported from or exported to countries in the European Economic



Appendix C. Model of animal health certificate to accompany the in vivo fertilized embryos on imports from third



Appendix D. Model of animal health certificate to accompany the in vitro fertilized embryos by imports from third countries, cf. § 14 subsection



Appendix E. Model of animal health certificate to accompany the in vitro fertilized embryos by imports from third countries, cf. § 14 subsection



Appendix F


Part 1. Transitional: Model of health certificate to be used when importing vivo fertilized embryos from third countries to and including 1 September 2013

Part 2. Transitional: Model of health certificate to be used for imports of in vitro fertilized embryos from third countries, cf. § 14 first paragraph, the 1st September 2013

Part 3. Transitional: Model of health certificate to be used for imports of in vitro fertilized embryos from third countries, cf. § 14, second paragraph, of the 1st September 2013