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Porcine Semen (the Netherlands) As of 10 th November 2015 ANIMAL HEALTH REQUIREMENTS FOR PORCINE SEMEN TO BE EXPORTED TO JAPAN FROM THE NETHERLANDS This document defines Animal health requirements for porcine semen to be exported to Japan from the Netherlands. (Definitions) For the purpose of this document, the definitions of terms are as follows: “Artificial insemination center (hereinafter referred to as ‘the AI center’)” means a facility approved by the animal health authorities of the Netherlands and which meets the conditions set out in Article 6 to 13 of this document for the collection, processing and/or storage of semen. Donor boar” means a boar whose semen is collected for export to Japan. E xported semen” means porcine semen to be exported or which was exported to Japan from the Netherlands. Notifiable disease” means a disease listed by the animal health authorities of the Netherlands, and that, as soon as detected or suspected, must be brought to the attention of the government authorities of the Netherlands, in accordance with national regulations. “OIE code” means OIE Terrestrial Animal Health Code which is effective at the time of collection. Quarantine stationmeans a premise under the control of the animal health authorities of the Netherlands where animals are maintained in isolation with no direct or indirect contact with other animals, to prevent the transmission of specified pathogen(s) while the animals are undergoing observation for a specified length of time and, if appropriate, testing and treatment. The animal health authorities of Japanmeans Animal Health Division, Food Safety and Consumer Affairs Bureau, Ministry of Agriculture, Forestry and Fisheries of Japan. The animal health authorities of the Netherlandsmeans the Ministry of Economic Affairs.

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Page 1: ANIMAL HEALTH REQUIREMENTS FOR PORCINE SEMEN ...Porcine Semen (the Netherlands) As of 10 th November 2015 (8) While staying at the AI center the donor boars are not used for natural

Porcine Semen (the Netherlands)

As of 10th

November 2015

ANIMAL HEALTH REQUIREMENTS FOR PORCINE SEMEN TO BE

EXPORTED TO JAPAN FROM THE NETHERLANDS

This document defines Animal health requirements for porcine semen to be exported to

Japan from the Netherlands.

(Definitions)

For the purpose of this document, the definitions of terms are as follows:

“Artificial insemination center (hereinafter referred to as ‘the AI center’)”

means a facility approved by the animal health authorities of the Netherlands and

which meets the conditions set out in Article 6 to 13 of this document for the

collection, processing and/or storage of semen.

“Donor boar”

means a boar whose semen is collected for export to Japan.

“Exported semen”

means porcine semen to be exported or which was exported to Japan from the

Netherlands.

“Notifiable disease”

means a disease listed by the animal health authorities of the Netherlands, and that,

as soon as detected or suspected, must be brought to the attention of the government

authorities of the Netherlands, in accordance with national regulations.

“OIE code”

means OIE Terrestrial Animal Health Code which is effective at the time of

collection.

“Quarantine station”

means a premise under the control of the animal health authorities of the

Netherlands where animals are maintained in isolation with no direct or

indirect contact with other animals, to prevent the transmission of specified

pathogen(s) while the animals are undergoing observation for a specified

length of time and, if appropriate, testing and treatment.

“The animal health authorities of Japan”

means Animal Health Division, Food Safety and Consumer Affairs Bureau, Ministry

of Agriculture, Forestry and Fisheries of Japan.

“The animal health authorities of the Netherlands”

means the Ministry of Economic Affairs.

okazakita
テキスト ボックス
(平成27年11月10日付け27動検第782号)
Page 2: ANIMAL HEALTH REQUIREMENTS FOR PORCINE SEMEN ...Porcine Semen (the Netherlands) As of 10 th November 2015 (8) While staying at the AI center the donor boars are not used for natural

Porcine Semen (the Netherlands)

As of 10th

November 2015

(General Requirments) 1. The Netherlands is free from Vesicular stomatitis, African swine fever (ASF),

Aujeszky’s disease, classical swine fever (CSF), enterovirus encephalomyelitis,

foot-and-mouth disease (FMD), rinderpest and swine vesicular disease.

2. Vesicular stomatitis, ASF, Aujeszky’s disease, CSF, enterovirus encephalomyelitis,

FMD, rinderpest and swine vesicular disease are designated as notifiable diseases in

the Netherlands.

3. Vaccination against CSF, FMD and rinderpest has been prohibited in the

Netherlands.

4. Donor boar should come from the herds in the premises where Aujeszky’s disease,

brucellosis (B. abortus, B. suis), porcine reproductive and respiratory syndrome

(PRRS) and transmissible gastroenteritis (TGE) have not been reported for 6

months prior to start of the isolation stated in article 8.

5. The donor boar must not be vaccinated against Aujeszky’s disease, brucellosis and

PRRS.

(Requirements for the AI center)

6. The AI center is composed of semen collection facilities, a semen laboratory and

semen storage areas, and administration offices. A quarantine station may also be

attached to the AI center.

The AI center should meet the following conditions:

(1) The AI center is under the direct supervision and sanitary control of an official

veterinarian of the animal health authorities of the Netherlands.

(2) The AI center is inspected every 6 month by an official veterinarian of the

animal health authorities of the Netherlands.

(3) The semen collection facilities should include separate and distinct areas for

accommodating resident animals, for semen collection, for feed storage, for

manure storage, and for the isolation of animals suspected of being infected.

(4) The AI center should have semen laboratory which complies with

“Conditions applicable to semen laboratories” of OIE code.

(5) The semen collection area is cleaned daily after collection. The animals ’

accommodation, semen collection and storage areas are cleaned and

disinfected at least once a year.

(6) Only swine associated with semen production should be permitted to enter the

AI center. Other species of livestock may be exceptionally permitted their

residence on the AI center, provided that they are kept physically apart from the

swine. Donor boars in the AI center should be isolated from animals, materials,

feeds and vehicles which are not under the control of the AI center.

(7) Entry of visitors is strictly controlled under the supervision of the AI center.

Personnel at the AI center should be technically competent and observe high

standards of personal hygiene to preclude the introduction of pathogenic

organisms. Protective clothing and footwear for use only on the AI center

should be provided.

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Porcine Semen (the Netherlands)

As of 10th

November 2015

(8) While staying at the AI center the donor boars are not used for natural breeding.

(9) Vehicles used for transport of animals to and from the semen collection

facilities should not be allowed to enter the facilities.

(10)Fodder introduction and manure removal should be done in a manner which

poses no significant animal health risk.

(11)At the AI center, there have been no confirmed clinical, microbiological and

serological cases of brucellosis, PRRS, and TGE for at least 6 months

immediately before commencement of the collection of the exported semen.

(Requirements for the donor boar) 7. The donor boar should comply with the following requirements within 30 days prior

to entry into isolation in the quarantine station.

(1) The donor boars should be clinically healthy within 30 days prior to entry into

isolation in the quarantine station.

(2) The donor boars should be tested negative for the following disease.

Brucellosis (B. abortus, B. suis) : Tube agglutination test (less than 50 IU/ml) or

Buffered Brucella antigen tests or

ELISA or

Fluorescence polarisation assay

8. The donor boar should be kept isolated at the quarantine station for at least 30 days

before entering the AI center. The donor boars may only enter the AI center on the

successful completion of the following requirements

(1) The donor boar should be clinically healthy in this period.

(2) The donor boars should be tested negative for the following diseases

(i) Brucellosis (B. abortus, B. suis) :

Tube agglutination test (less than 50 IU/ml) or

Buffered Brucella antigen tests or

ELISA or

Fluorescence polarisation assay

(ii) PRRS:

ELISA or

Indirect fluorescent antibody test or

Immunoperoxidase monolayer assay

9. The donor boar in the AI center should be tested negative for the following diseases.

(1) Brucellosis (B. abortus, B. suis) (annually):

Tube agglutination test (less than 50 IU/ml) or

Buffered Brucella antigen tests or

ELISA or

Fluorescence polarisation assay

(2) PRRS (annually)

ELISA or

Indirect fluorescent antibody test or

Immunoperoxidase monolayer assay

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Porcine Semen (the Netherlands)

As of 10th

November 2015

10. The donor boar should be subjected to ELISA or Virus neutralisation test for TGE

(1) with negative result within 30 days prior to semen collection for fresh semen,

or

(2) with negative results at least 14 days after semen collection for frozen semen.

11. The donor boar should be isolated from all other animals that are not the same

health status.

12. The donor boar showed no sign of infectious diseases at the time of semen

collection.

13. The donor boar should have been kept for at least 4 months prior to semen

collection in the AI center.

(Requirements for handling and shipment of semen)

14. The exported semen should be handled for the packing and storage according to

“Conditions applicable to the packing and storage of semen” of the OIE Code.

15. Ampoules or straws used for packaging the exported semen should be marked with

numbers, etc. by each of the donor boar and with the date of each collection so as to

be checked with the health certificate prescribed stated in article 18.

16. The ampoules or straws should be stored with semen of equivalent health status in

the storage tank at a storage facility designated by the animal health authorities of

the Netherlands and be maintained there under the supervision of a veterinarian

approved by the animal health authorities of the Netherlands until they are placed in

the shipping tank. The shipping tank should be sealed with the official seal of the

government authorities of the Netherlands.

17. The shipping tank is either new or cleaned and disinfected under the supervision of

a veterinarian approved by the animal health authorities of the Netherlands and only

fresh liquid nitrogen has been used to charge the tank.

(Issue of the health certificate)

18. The animal health authorities of the Netherlands are responsible for issuing a health

certificate stating the following articles in English by each of the donor boar on

shipping of the exported semen to Japan.

(1) Each of articles 1 to 17.

(2) Sampling dates, methods and results of examinations for each disease stated in

article 7, 8 and 10.

(3) Latest sampling dates, methods and results of recent examinations for each

disease stated in article 9.

(4) If any vaccines are applied to the donor boar, date of vaccination, type,

manufacture, manufacturing lot numbers of vaccine and inoculation dose.

(5) Name and breed of the donor boar, collection date, quantity of straws or

ampoules, identification number, etc. marked on straws or ampoules.

(6) Name and address of the premises of origin of donor boar.

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Porcine Semen (the Netherlands)

As of 10th

November 2015

(7) Name and address of the quarantine station.

(8) Name and address of the AI center.

(9) Isolation period with starting and ending dates stated in article 8.

(10) Date of entering the AI center

(11) The number of official seal used to seal the shipping tank stated in article 16.

(12) Date of issue, name and title of signer, and authorities’ name and address of

the health certificate.

(Other)

19. In the case of an outbreak of Vesicular stomatitis, ASF, Aujeszky’s disease, CSF,

enterovirus encephalomyelitis, FMD, and swine vesicular disease in the

Netherlands, the animal health authorities of the Netherlands must immediately

suspend the shipment of the porcine semen to Japan. The animal health authorities

of the Netherlands must inform the animal health authorities of Japan of the

outbreak as soon as possible and the completion of the necessary measures for the

last case.

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Additional requirements for porcine epidemic diarrhea (PED) As of 10th November 2015

<Additional requirements for swine semen

from the Netherlands to Japan>

(Additional requirements for PED)

1. There were no clinical signs of PED on all the boars in the AI center during the 12

months prior to collection of semen to be exported to Japan.

2. For fresh semen;

Individual donor boar which produces semen for export to Japan was tested by PCR

using fresh feces for PED within 30 days prior to semen collection with negative

results.

3. For frozen semen;

(1) individual donor boar which produces semen for export to Japan was tested by

PCR using fresh feces for PED within 30 days prior to semen collection with

negative results.

OR

(2) a sample of frozen semen was tested for PED with negative by PCR

OR

(3) the semen was collected prior to November 2014.

(Issue of an additional health certificate)

4. The animal health authorities of the Netherlands should be responsible for issuing

an additional health certificate stating the following items for each donor boar on

shipping the exported semen to Japan.

(1) Item 1.

(2) Item 2 or 3 with dates, methods and results of each examination.

(3) Collection date and identification number.

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Porcine Semen (Netherlands)

(仮訳)

As of 10th

November 2015

オランダから日本向けに輸出される豚精液の家畜衛生条件(案)

本文書において、オランダから日本向けに輸出される豚精液の家畜衛生条件を

定める。

(定義)

本条件の適用において、以下のとおり定義する。

「人工授精場(AIセンター)」

オランダ家畜衛生当局に認可され、精液の採取、加工及び/又は保管について、

本条件の6から 13に記載されている条件に適合している施設をいう。

「供与豚」

精液を採取するための雄豚をいう。

「輸出精液」

オランダから日本向けに輸出される、又は輸出された豚精液をいう。

「届出対象疾病」

オランダ家畜衛生当局によりリスト化されており、オランダ内で発生例や疑い

例が見られた場合、国の法令に基づき、届出しなければならない疾病をいう。

「OIE コード」

採取時に有効である OIE Terrestrial Animal Health Codeをいう。

「隔離検疫施設」

一定期間動物を観察し、及び必要があれば、検査や処置を実施する間、特定の

病原体の伝染を防止するために、その他の動物との直接又は間接的な接触がな

いよう隔離状態が保たれている、オランダ家畜衛生当局の管理下にある施設を

いう。

「日本国家畜衛生当局」

日本国農林水産省消費・安全局動物衛生課をいう。

「オランダ家畜衛生当局」

経済省をいう。

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Porcine Semen (Netherlands)

(仮訳)

As of 10th

November 2015

(一般条件)

1. オランダでは、水胞性口炎、アフリカ豚コレラ、オーエスキー病、豚コレラ、

豚エンテロウイルス性脳脊髄炎、口蹄疫、牛疫及び豚水胞病が存在しないこ

と。

2. オランダでは、水胞性口炎、アフリカ豚コレラ、オーエスキー病、豚コレラ、

豚エンテロウイルス性脳脊髄炎、口蹄疫、牛疫及び豚水胞病が届出対象疾病

に指定されていること。

3. オランダでは、豚コレラ、口蹄疫及び牛疫のワクチン接種が禁止されている

こと。

4. 供与豚は、条件8で記載される隔離開始前6ヶ月間、オーエスキー病、ブル

セラ病(B. abortus, B.suis)、豚繁殖・呼吸障害症候群(PRRS)及び伝染

性胃腸炎について報告のない群由来であること。

5. 供与豚はオーエスキー病、ブルセラ病及びPRRSに対するワクチン接種を

受けていないこと。

(AIセンターの条件)

6. AIセンターは精液採取施設、精液検査室及び精液保管場所及び管理事務所

で構成されている。隔離検疫施設はAIセンター付属の場合もある。

AIセンターは以下の条件を満たすこと。

(1) AIセンターはオランダ家畜衛生当局獣医官の直接の監視下、及び衛

生管理下にあること。

(2) AIセンターは、オランダ家畜衛生当局獣医官により 6 ヵ月毎に検査

されていること。

(3) 精液採取施設は、センター内にいる動物の居住区域、精液採取、飼料

保管、堆肥保管、及び感染の疑いのある動物を隔離するための、明確

に分離された区域を持つこと。

(4) AIセンター内の精液検査所は、OIE コードの「精液検査室の条件」

に合致していること。

(5) 精液採取場所は、採取後、毎日清掃されること。動物の居住区域、精

液採取及び精液保管場所は年に1回清掃及び消毒されること。

(6) 精液の生産に関連した豚のみがAIセンターへの入場が許可されるこ

と。その他の種類の家畜は、豚から物理的に隔離されているという条

件下で例外的に居住を許可されること。AIセンター内の供与豚は、

AIセンターの管理下にない動物、物資、飼料及び車両から隔離され

ていること。

(7) AIセンターへの訪問者はAIセンターの監視下で厳しく管理されて

いること。AIセンター内の職員は技術的な能力を有し、病原体の侵

入を防ぐために個々に高い衛生基準を遵守すること。保護着及び保護

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Porcine Semen (Netherlands)

(仮訳)

As of 10th

November 2015

靴はセンター内専用のものが提供されること。

(8) AIセンター内に滞在の間、供与豚は自然交配に供されていないこと。

(9) 精液採取場所への動物の輸送に使用される車両は精液採取場所への入

場が許可されないこと。

(10) 飼料の搬入及び堆肥の搬出は家畜衛生上の明確な危険性のない方法で

行うこと。

(11) 日本向け輸出精液採取前少なくとも 6 カ月間、AIセンターでは、ブ

ルセラ病、PRRS及び伝染性胃腸炎が臨床的、微生物学的又は血清学的

に摘発されなかったこと。

(供与豚の条件)

7. 供与豚はAIセンター入場前の隔離検疫に入る前 30 日以内に以下の条件を

満たすこと。

(1) 供与豚は、当該期間中、臨床的に健康であること。

(2) 供与豚は、下記の疾病に対し、検査陰性であること。

ブルセラ病(B. abortus, B. suis):

試験管凝集反応(50IU/ml未満)又は

緩衝ブルセラ抗原試験又は

ELISA 又は

蛍光偏光法

8. 供与豚は、AIセンター入場前にオランダ家畜衛生当局の監視下で少なくと

も 30 日間の隔離を行うこと。以下の条件に合致した供与豚のみAIセンタ

ーに入所できる。

(1) 供与豚は、当該期間中、臨床的に健康であること。

(2) 供与豚は、下記の疾病に対し、検査陰性であること。

(i) ブルセラ病(B. abortus, B. suis):

試験管凝集反応(50IU/ml未満)又は

緩衝ブルセラ抗原試験又は

ELISA 又は

蛍光偏光法

(ii) PRRS:ELISA又は

間接蛍光抗体法又は

免疫ペルオキシダーセ単層分析法

9. AIセンター内の供与豚は、下記の疾病に対し検査陰性であること。

(1) ブルセラ病(B. abortus, B. suis)(毎年):

試験管凝集反応(50IU/ml未満)又は

緩衝ブルセラ抗原試験又は

ELISA 又は

蛍光偏光法

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Porcine Semen (Netherlands)

(仮訳)

As of 10th

November 2015

(2) PRRS(毎年):ELISA又は

間接蛍光抗体法又は

免疫ペルオキシダーセ単層分析法

10. 供与豚は伝染性胃腸炎について

(1) 生鮮精液の場合、精液採取前 30日以内に ELISA又はウイルス中和試験を

行い、陰性であること、又は

(2) 凍結精液の場合、精液採取後 14日以降に ELISA又はウイルス中和試験を

行い、陰性であること。

11. 供与豚は、同等の衛生状態の動物以外から隔離されていること。

12. 供与豚は採精時にいかなる伝染性疾病の徴候も確認されないこと。

13. 供与豚は、精液採取前少なくとも 4ヶ月間はAIセンターで飼養されていた

こと。

(精液の取扱い及び輸送等の条件)

14. 輸出精液は、包装及び保管に関して、OIEコードの「精液の包装及び保管に

関する条件」に基づき取り扱われていること。

15. 輸出精液のアンプル又はストローには、下記 18 の検査証明書と照合できる

供与豚ごと及び採取年月日ごとの番号を付すこと。

16. 輸出精液を充填するアンプル又はストローは、オランダ家畜衛生当局に指定

された精液保管場所において同等の衛生状態の精液と一緒に貯蔵し、また、

輸送用タンクに収容するまでオランダ家畜衛生当局認定獣医師の監督下で

維持管理されること。輸送タンクはオランダ家畜衛生当局のシールで封印さ

れること。

17. 輸送タンクは、新品又はオランダ家畜衛生当局により認定された獣医師の監

督の下で、清掃・消毒されたものであること。また、使用する液体窒素は新

しいものであること。

(証明書記載事項)

18. オランダ家畜衛生当局は、豚精液の日本向け輸出に際し、供与豚毎に次の各

事項を英語で記載した検査証明書を発行すること。

(1) 1~17の各事項

(2) 7、8及び 10に掲げる疾病ごとの採材実施年月日、検査方法及び検査結果

(3) 9に掲げる疾病ごとの直近に実施した採材実施年月日、検査方法及び検査

結果

(4) ワクチン接種を行なっている場合、接種年月日、種類、製造会社名、ロ

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Porcine Semen (Netherlands)

(仮訳)

As of 10th

November 2015

ット番号及び接種量

(5) 供与豚の名称及び品種、精液採取年月日、アンプル又はストローの本数

並びにアンプル又はストローに付した番号等

(6) 供与豚の生産農場の名称及び住所

(7) 隔離検疫施設の名称及び住所

(8) AIセンターの名称及び住所

(9) 8 に掲げる隔離検疫の期間(開始年月日及び終了年月日を含む)

(10) AIセンターへの入所日

(11) 16に掲げる輸送タンクの封印に用いたシールの番号

(12) 検査証明書の発行年月日、発行者の氏名及び所属機関名称及び住所

(その他)

19. オランダ家畜衛生当局は、オランダにおいて水胞性口炎、アフリカ豚コレ

ラ、オーエスキー病、豚コレラ、豚エンテロウイルス性脳脊髄炎、口蹄疫、

及び豚水胞病が発生した場合は、直ちに、日本向け精液の輸出を中止する

こと。なお、オランダ家畜衛生当局は発生状況及び最終発生における必要

な措置が完了したことを日本国家畜衛生当局あて通報すること。

Page 12: ANIMAL HEALTH REQUIREMENTS FOR PORCINE SEMEN ...Porcine Semen (the Netherlands) As of 10 th November 2015 (8) While staying at the AI center the donor boars are not used for natural

Additional requirements for porcine epidemic diarrhea (PED)

(仮訳)

As of 10th November 2015

<オランダから日本向けに輸出される豚精液に関する追加条件>

(PEDに関する追加条件)

1. 日本向け精液採精前 12ヶ月間、AIセンターにいる全ての種豚は PEDの臨

床的症状を呈していないこと。

2. 新鮮精液について;

日本向け精液を生産する個々の供与豚は採精前 30日以内の間に、PEDにつ

いて、新鮮糞便を用いた PCR法による検査を行い、陰性であること。

3. 凍結精液について;

(1) 日本向け精液を生産する個々の供与豚は採精前 30 日以内の間に、PED

について、新鮮糞便を用いた PCR 法による検査を行い、陰性であるこ

と。

又は

(2) 凍結精液のサンプルについてPCR法によるPEDの検査で陰性であるこ

と。

又は

(3) 精液は、2014年 11月より前に採精されたこと。

(追加衛生証明書の発行)

4. オランダ家畜衛生当局は、日本向け精液輸出の際に、それぞれの供与豚につ

いて次の各事項を記載した追加衛生証明書の発行に責任を有する。

(1) 項目1

(2) 項目2又は3及びその検査日、検査方法及び検査結果

(3) 採精日及び個体識別番号