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1 Animal health requirements for beef and beef products to be exported to Japan from the United States of America Animal health requirements for beef and beef products to be exported to Japan from the United States of America (United States) are as follows: 1 Definitions For the purpose of the animal health requirements: 1-(1) “Cattle” means domesticated bovine animals (Bos taurus and Bos indicus only) born and raised in the United States or legally imported into the United States from a country deemed eligible by the Japanese government to export beef or beef products to Japan. 1-(2) “Beef and beef products” means all edible parts of cattle and products derived from such parts of cattle, as described in the U.S. Federal Meat Inspection Act (FMIA) and specified in the U.S. Department of Agriculture (USDA) Food Safety and Inspection Service (FSIS) Export Library for Japan. The following tissues are removed from U.S. slaughtered cattle: - tonsils and distal ileum (two meters from connection to caecum) from cattle of all ages - brain, eyes, spinal cord, trigeminal ganglia, skull (including head meat, but excluding cheek meat), dorsal root ganglia, and vertebral column (excluding vertebrae of the tail, transverse processes of the thoracic and lumbar vertebrae, and wings of the sacrum) from cattle 30 months of age and older at the time of slaughter. 1-(3) “Designated facility” includes any slaughterhouses, meat cutting facilities, meat processing facilities, and storage facilities for beef and beef products that are designated by the competent authority of the United States (or the government authority of the third free countries or the specified countries. These facilities meet the requirements of Article 1 to 4 of Annex1. 1-(4) “the third free countries ” countries or areas approved by the Ministry of Agriculture, Forestry and Fisheries of Japan for the export of meat etc. derived from cloven-hoofed animals to Japan as listed in Article 1 to 3 in Annex 2. 1-(5) "the specified countries" countries approved by the Ministry of Agriculture, Forestry and Fisheries of Japan for the export of beef to Japan other than the third free countries as listed in Article 4 of Annex 2. 1-(6) “Outbreak” means detection of specific pathogen, antigen or antibody of a disease as well as appearance of animal showing clinical symptoms of the diseases. 1-(7) “The Japanese animal health authorities”

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Page 1: Animal health requirements for beef and beef …...The imported meat must be handled only at the facilities designated as eligible to export meat to Japan and be derived from cattle

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Animal health requirements for beef and beef products to be exported to Japan from the United

States of America

Animal health requirements for beef and beef products to be exported to Japan from the United States of

America (United States) are as follows:

1 Definitions

For the purpose of the animal health requirements:

1-(1) “Cattle”

means domesticated bovine animals (Bos taurus and Bos indicus only) born and raised in the United

States or legally imported into the United States from a country deemed eligible by the Japanese

government to export beef or beef products to Japan.

1-(2) “Beef and beef products”

means all edible parts of cattle and products derived from such parts of cattle, as described in the U.S.

Federal Meat Inspection Act (FMIA) and specified in the U.S. Department of Agriculture (USDA) Food

Safety and Inspection Service (FSIS) Export Library for Japan.

The following tissues are removed from U.S. slaughtered cattle:

- tonsils and distal ileum (two meters from connection to caecum) from cattle of all ages

- brain, eyes, spinal cord, trigeminal ganglia, skull (including head meat, but excluding cheek

meat), dorsal root ganglia, and vertebral column (excluding vertebrae of the tail, transverse

processes of the thoracic and lumbar vertebrae, and wings of the sacrum) from cattle 30 months

of age and older at the time of slaughter.

1-(3) “Designated facility”

includes any slaughterhouses, meat cutting facilities, meat processing facilities, and storage facilities for

beef and beef products that are designated by the competent authority of the United States (or the

government authority of the third free countries or the specified countries. These facilities meet the

requirements of Article 1 to 4 of Annex1.

1-(4) “the third free countries ”

countries or areas approved by the Ministry of Agriculture, Forestry and Fisheries of Japan for the export

of meat etc. derived from cloven-hoofed animals to Japan as listed in Article 1 to 3 in Annex 2.

1-(5) "the specified countries"

countries approved by the Ministry of Agriculture, Forestry and Fisheries of Japan for the export of beef

to Japan other than the third free countries as listed in Article 4 of Annex 2.

1-(6) “Outbreak”

means detection of specific pathogen, antigen or antibody of a disease as well as appearance of animal

showing clinical symptoms of the diseases.

1-(7) “The Japanese animal health authorities”

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

Forestry and Fisheries of Japan.

1-(8) “the competent authorities of the United States”

means United States Department of Agriculture Food Safety and Inspection Service, United States

Department of Agriculture Animal and Plant Health Inspection Service, and United States Department of

Agriculture Agricultural Marketing Service.

2 General requirements

2.1 The United States is free from foot-and-mouth disease (FMD) and rinderpest, and vaccination

against FMD and rinderpest is prohibited in the United States.

2.2 Importation into the United States of cloven-hoofed animals that have been vaccinated against FMD

or rinderpest is prohibited.

2.3 The U.S. Government will continue to maintain measures to prevent introduction, to control spread,

and to detect bovine spongiform encephalopathy (BSE). These measures meet or exceed World

Organization for Animal Health (OIE) guidelines for a negligible risk country and include appropriate

specified risk material (SRM) removal, a feed ban, and a surveillance program. The United States,

consistent with its World Trade Organization (WTO) obligations, provides notice to all trading

partners, including Japan, regarding the repeal or modification of any BSE-related measure.

3 Requirements for designated facilities

3.1 To be eligible to export beef and beef products to Japan, a designated facility must implement a

QAD 1030J Procedure that is approved by USDA’s Agricultural Marketing Service (AMS).

3.2 USDA must inform the Japanese animal health authorities of the name, address, and establishment

number of each eligible designated facility in advance of that facility exporting beef or beef product to

Japan by providing access to the approved list of eligible designated facilities on the Internet at

https://www.ams.usda.gov/services/imports-exports . This list will be maintained and updated

by AMS.

3.3 A system-wide problem such as repeated serious noncompliance may result in the suspension of the

animal health requirements.

4 Requirements for shipment

4.1 The beef and beef products will be produced and handled in a manner to prevent contamination with

any causative agents of animal infectious diseases. Clean and sanitary wrappings and/or containers

such as cardboard boxes must be used to pack the exported beef to Japan.

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4.2 If an outbreak of FMD or rinderpest is confirmed in the United States, USDA must immediately

stop certification of beef and beef products to be exported to Japan and report the outbreak to the

Japanese animal health authorities. If beef and beef products exported to Japan have been certified and

are in transit to Japan at the time of the outbreak, the shipment will be prohibited entry into Japan,

except where the USDA can demonstrate that the shipment definitely bears no relation (such as, time

of shipment, region of origin, route of transit) to the outbreak of the said diseases.

4.3 If a BSE case is detected in United States and it is discovered to have epidemiological relevance to

any beef and beef product exported to Japan, USDA must notify immediately the Japanese animal

health authority with the relevant information.

4.4 In the case where exported beef and beef product is transported to Japan by way of third countries,

that product must be stored in an enclosed ocean/air vessel container. USDA must close the container

with an official seal. The seal must be apparently distinguishable from those of the other

countries/regions than the United States. A copy of the official seal must be provided in advance to the

Japanese animal health authority. In case the official seal with the container had been broken or

removed prior to the time of import inspection after the container’s arrival in Japan, Japan may

prohibit the import into Japan of the beef contained in that container.

5 Requirements for beef and beef products exported to Japan

5.1 Beef and beef products from the United States (the fifty states, the District of Columbia and Guam)

for export to Japan must be products which Japan and the United States recognize as eligible to export

to Japan.

5.2 The exported beef and beef product to Japan must be derived from (A) animals that were born and

raised only in the United States, or from animals legally imported into the United States from a country

recognized by the Japanese animal health authorities as the third free countries for cloven-hoofed

animals and meat,etc(Annex2-1) or the specified countries(Annex2-4), or (B) meat legally imported

into the United States from a country recognized by the Japanese animal health authorities as eligible

to export cattle meat to Japan under the following requirements:

1. The imported meat must be derived from the cloven-hoofed animals (cattle) that were born and

raised only in the exporting country.

2. The imported meat must be handled only at the facilities designated as eligible to export meat to

Japan and be derived from cattle found to be sound and healthy as a result of ante- and post-mortem

inspection conducted by the competent authority of the exporting country.

3. The imported meat must be accompanied with an official inspection certificate issued by the

competent authority of the exporting country and must be shipped directly to the United States. If

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transported through countries other than the third free countries or the eligible countries, the imported

meat must be transported in an officially sealed container.

4. The meat products shall have been free from any evidence of animal infectious diseases as a result

of import inspection conducted by the government authorities of the United States, and must be moved

directly into the designated facilities in the United States after the said inspection.

5.3 Slaughtered cattle that are known to be suspect or confirmed BSE cases or their birth cohorts may

not be utilized in the United States for the production of materials for human or animal consumption.

5.4 The slaughtered cattle were found to be sound and healthy as a result of ante- and post-mortem

inspections conducted by veterinary inspectors of the competent authority of the U.S. in the designated

facilities at the time of slaughter, or if the exported meat is derived from imported meat, the imported

meat must meet the requirements delineated in Article 5.2 (B).

5.5 The exported meat derived from cattle to Japan must be slaughtered, processed and stored only in the

designated facilities, or if the exported meat is derived from meat imported from a third country, the

imported meat must be handled and stored only in the designated facilities in the United States.

5.6 The exported meat derived from cattle to Japan has been handled at the designated facilities in such a

way as to prevent contamination with any causative agents of animal infectious diseases until shipment

to Japan.

6 Audit by the Japanese Government, and U.S. monitoring

6.1 The Japanese government may conduct on-site audits of the U.S. inspection system through

representative samples of designated facilities that export beef or beef product to Japan to ensure they

comply with the relevant requirements set out in this document and U.S. regulations. This audit of

USDA’s regulatory requirements may include an analysis of the facility’s hazard analysis critical

control points (HACCP), sanitation standard operating procedures (SSOP), and prerequisite programs.

The audit may also include review of the additional requirements set out in this protocol and

established in QAD 1030J Procedure. In the event a non-compliance with the requirements set out in

this document is found as a result of the on-site audit, the Japanese government will inform the U.S.

government on-site of the finding.

6.2 FSIS also must verify though ordinary monitoring that establishments are in compliance with U.S.

food safety regulations, and through export verification tasks, that product exported to Japan meets

relevant required conditions of section 3 of this document. AMS must confirm, through periodic audit,

that establishments meet the required conditions of section 3 of this document that are addressed by the

establishment’s QSA Program.

6.3 If non-compliance is found as a result of an on-site audit by the Japanese government, ordinary

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monitoring by FSIS, or periodic audit by AMS, FSIS would issue a Non-compliance Record (NR) for

findings related to U.S. regulations and AMS would cite the non-conformance for findings related to

the QAD 1030J Procedure for Japan. Non-compliant and/or non-conformance product would be

controlled immediately. If the process that resulted in the non-compliant and/or non-conformance

product is ongoing, USDA would immediately stop the process until it determines the appropriate

corrective and preventative measures have been taken. Only when USDA determines that corrective

actions are adequate will it permit production to resume.

6.4 USDA may revoke the designation of the non-compliant and/or non-conformant facility and must

inform the Japanese government of the contents of the non-compliance including name, address, and

establishment number of that facility. After verifying that acceptable corrective actions have been

taken, USDA may re-designate the revoked facility.

7 Export certificate

7.1 USDA must be responsible for issuing the Export Certificate of Wholesomeness and the Certificate

for Export of Beef and Beef Products to Japan, stating the following items in detail in English, after

confirming the beef and beef product exported to Japan complies with the animal health requirements:

a) Name, address, and establishment number of each designated facility where a relevant procedure,

such as slaughtering or processing, occurred;

b) Slaughtering and processing date period (dd/mm/yy-dd/mm/yy);

c) Date, authority’s name and place of issue of the inspection certificate, and name and title of signer;

d) Identification number of the seal applied to the container (in case the container is sealed by the

official seal in line with the paragraph 11); and

e) Each required condition of the paragraphs 5-2 to 5-6.

7.2 The application of these Animal health requirements for beef and beef products to be exported to

Japan from the United States will be effective on May 17, 2019.

8 References

http://www.fsis.usda.gov/wps/portal/fsis/topics/international-affairs/exporting-products/export-library-

requirements-by-country/Japan

https://www.ams.usda.gov/services/imports-exports

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Annex 1 – Requirements for the designated facilities

1 Cloven-hoofed animals which can be handled at the designated facilities must be born and

raised only in the United States (except for cervid animals epidemiologically related to the

outbreak of Chronic wasting disease (CWD), and except for pigs epidemiologically related

to the outbreak of African swine fever (ASF) or Classical swine fever (CSF)), or must be

directly imported to the United States from the third free countries or the specified

countries listed in Annex 2 and meet all of the following requirements 1.1 to 1.5.

1.1 The said animals must be born and raised only in the third free countries or the specified

countries.

1.2 Slaughtered cattle that are known to be suspect or confirmed BSE cases or their birth

cohorts may not be utilized in the United States for the production of materials for human

or animal consumption.

1.3 The said animals must be free from any evidence of animal infectious diseases as a result

of export inspection conducted by the government authorities of the third free countries or

the specified countries.

1.4 The said animals must be directly and legally imported to the United States from the third

free countries or the specified countries without transiting through countries other than

the said countries, and must be accompanied by inspection certificates issued by the

government authorities of the said country.

1.5 The said animals must be free from any evidence of animal infectious diseases as a result

of import inspection conducted by the competent authority of the United States.

2 The meat etc. for export to Japan must originate from cloven-hoofed animals that were

born and raised only in the United States (except for deer meat etc. epidemiologically

related to the outbreak of CWD, and except for pig meat etc. epidemiologically related to

the outbreak of ASF or CSF), and in the United States can be handled only at the

designated facilities, or must be directly imported to The United States from the third free

countries or the specified countries listed in Annex 2 and meet all of the following

requirements 2.1 to 2.5.

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2.1 The imported meat etc. must be derived from cloven-hoofed animals that were born and

raised only in the third free countries or the specified countries.

2.2 The imported meat etc. must meet relevant U.S. requirements. Slaughtered cattle that

are known to be suspect or confirmed BSE cases or their birth cohorts may not be utilized

in the United States for the production of materials for human or animal consumption.

2.3 The imported meat etc. must be handled only at the designated facilities in the third free

countries or the specified countries and be derived from cloven-hoofed animals that were

free from any evidence of animal infectious diseases as a result of ante- and post-mortem

inspections conducted by official veterinarians of the third free countries or the specified

countries.

2.4 The imported meat etc. must be directly and legally imported to the United States from the

third free countries or the specified countries without transiting through countries other

than the said third free countries or the specified countries, and must be accompanied by

inspection certificates issued by the government authorities of the third free countries or

the specified countries.

2.5 The imported meat etc. must be free from any evidence of animal infectious diseases as a

result of import inspection conducted by the competent authority of the United States, and

must be directly carried into the designated facilities in the United States after the said

inspection.

3 If the designated facilities are storage facilities and satisfy the following conditions, they

can be designated as storage facilities to handle the exported beef to Japan. In this case the

said designated facilities may be used only for the temporary storage of final products until

shipment.

3.1 The exported beef to Japan which is handled in the storage facilities must be completely

wrapped and boxed, and must be effectively segregated from any meat etc. other than

products complying with Article 2 above.

3.2 The exported beef to Japan must be handled to prevent cross contamination with any meat

etc. other than products complying with Article 2 above.

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4 The species, quantities, production areas and date of handling (and, in case of handling

animals or meat imported from the third free countries or the specified countries, the name

of the country/area of origin and date of import for imported meat) must be recorded on the

original records at the designated facilities. The original records must be kept for at least

two years at the designated facilities.

4.1 If the exported beef to Japan has been certified and in transit to Japan at the time when

outbreak of FMD or Rinderpest is confirmed in the United States, the shipment will be

prohibited entry into Japan, except where the competent authority of the United States can

demonstrate that the shipment definitely bears no relation (such as, time of shipment,

region of origin, route of transit) to the outbreak of the said diseases.

4.2 The shipping prohibition of the exported beef to Japan described above may be resumed

either in the case that the Japanese animal health authority has confirmed that the third

free countries or the specified countries concerned are free from the said diseases or it may

be avoided in the case that the competent authority of the United States suspended the

entrance of cloven-hoofed animals and their meat etc. into the designated facilities from the

said third free countries or the specified countries and informed the Japanese animal

health authority of the said prohibition. (In any case, no shipment must be permitted of

beef that is epidemiologically related to the outbreak of the said diseases.)

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Annex 2. The third free countries and the specified countries

1.) The third free countries in respect of cloven-hoofed animals (other than cervid animals and

pigs) and their meat etc. (other than deer meat etc. and pig meat etc.) (Countries or areas

approved as free from Rinderpest, FMD and BSE and eligible to export to Japan by the

Minister of Agriculture, Forestry and Fisheries of Japan or the Japanese animal health

authority)

Update information on the MAFF official website at the following URL:

http://www.maff.go.jp/aqs/english/news/third-free.html

2.) The third free countries in respect of cervid animals and deer meat etc. (countries or areas

approved as free from Rinderpest, FMD and CWD and eligible to export to Japan by the

Minister of Agriculture, Forestry and Fisheries of Japan or the Japanese animal health

authority)

Update information on the MAFF official website at the following URL:

http://www.maff.go.jp/aqs/english/news/third-free.html

3.) The third free countries in respect of pigs and pig meat etc. (countries or areas approved as

free from Rinderpest, FMD, ASF and CSF and eligible to export to Japan by the Minister of

Agriculture, Forestry and Fisheries of Japan or the Japanese animal health authority)

Update information on the MAFF official website at the following URL:

http://www.maff.go.jp/aqs/english/news/third-free.html

4.) The specified countries for export beef, sheep meat etc. or goat meat etc. to Japan other than

the third free countries

Update information on the MAFF official website at the following URL:

http://www.maff.go.jp/aqs/english/news/eligible-bse-country.html

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米国から日本向けに輸出される牛肉及び牛肉製品の家畜衛生条件(仮訳)

米国から日本向けに輸出される牛肉及び牛肉製品に適用される家畜衛生条件は以下のとおり。

1.(定義)

1 -(1)「牛」 家畜化された牛科の動物(Bos taurus 、Bos indicus のみ。) 米国で出生し飼養された又は牛肉若しくは牛肉製品の日本向け輸出が日本政府により可

能とされている国から米国に合法的に輸入されたもの。

1 -(2)「牛肉及び牛肉製品」

米国連邦食肉検査法に記載され、「米国農務省(USDA)食品安全検査局(FSIS)

日本向け輸出条件」に規定されたとおり、牛のすべての可食部分及び牛のこれら可食部分

から製造された製品を示す。

以下の組織は除く;

― 全ての月齢の扁桃及び回腸(盲腸との接合部分から2メートル)

― と畜時点で 30 か月超の牛の脳、眼球、脊髄、三叉神経節、頭蓋(頬以外の頭部の肉

を含む)、背根神経節、脊柱(尾椎、胸腰椎横突起、仙骨翼を除く)

1 -(3)「指定施設」

別添 1 の1から4の条件を満たすものとして、米国農務省(又は 3 清浄国又は特定国の政

府機関)により指定されたと畜及び加工施設

1-(4)「第 3 清浄国」

日本国農林水産省が偶蹄類の食肉等の日本への輸出を認めている別添 2 の 1 から 3 に 掲げる国/地域。

1-(5)「特定国」 日本国農林水産省が日本への牛肉の輸出を認めている別添 2 の 4 に掲げる第 3 清浄国 以外の国

1 -(6)「発生」 当該疾病の臨床症状を示した動物の出現、当該疾病の病原体、抗原又は抗体の検出。

1 -(7)「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。

1-(8)「米国家畜衛生当局」 米国農務省 食品安全検査部、動植物検査部及び商務部

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2.(一般条件)

2.1 米国においては、口蹄疫及び牛疫の発生がなく、かつ、口蹄疫及び牛疫のワクチン接

種が禁止されていること。

2.2 米国においては、口蹄疫及び牛疫のワクチン接種を受けた偶蹄類動物の輸入が禁止さ

れていること。

2.3 米国政府はBSEの侵入防止、まん延防止及び摘発のための措置を継続する。これら

措置には、適切なSRM除去、飼料規制及びサーベイランスプログラムを含む無視できるリ

スクの国のための国際獣疫事務局(OIE)のガイドラインを満している又は上回っているこ

と。世界貿易機関(WTO)の義務に整合し、米国政府は、日本を含むすべての貿易対象国に、

すべてのBSE関連措置の廃止又は変更に係る通知を提供する。

3.(指定施設の条件)

3.1 日本向け牛肉及び牛肉製品輸出について適格であるために、指定施設は、米国農務省

農業販売促進局(AMS)により認証された「QAD1030J Procedure」を満たさなければなら

ない。

3.2 米国農務省は、適合する各指定施設の名称、所在地及び施設番号を、当該施設が日本

に牛肉及び牛肉製品を輸出する前に、インターネット

(https://www.ams.usda.gov/services/imports-exports)に適合する指定施設の認定リスト

を掲載することにより日本国家畜衛生当局に通知すること。当該リストは米国農務省農業販

売促進局により維持され、施設の資格に変更があれば更新される。

3.3 重大な遵守違反が繰り返されるようなシステム全般に係る問題により本家畜衛生条件

は停止され得る。

4.(船積みの条件)

4.1 牛肉及び牛肉製品は、家畜の伝染性疾病の病原体による汚染を防止する方法で取り扱

われること。日本向け輸出牛肉は清潔かつ衛生的な包装、カードボード等の容器で梱包され

ること。

4.2 米国において口蹄疫及び牛疫の発生があった場合は、米国農務省は日本向け輸出牛肉

及び牛肉製品の証明書発行を直ちに停止し、日本国家畜衛生当局に報告すること。当該疾病

の発生時に日本向け輸出牛肉及び牛肉製品の証明書発行がなされ日本向け輸送の途中の場合

には、当該船積みが当該疾病の発生と明らかに関連しないことを米国農務省が示すことがで

きる場合を除き、当該船積みは日本への持ち込みを禁止される。

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4.3 米国農務省は、米国でBSEが摘発され、この発生が日本向けに輸出される、いかな

る牛肉及び牛肉製品についても疫学的に関連性があることが判明した場合には、このことを

関連情報とともに直ちに日本国家畜衛生当局に通報すること。

4.4 日本向け輸出牛肉及び牛肉製品が第3国を経由して輸送される場合には、製品は、密

閉式の海上又は航空コンテナに収容されること。米国農務省は当該コンテナを米国政府の公

式封印で封印すること。なお、封印様式については、輸出国以外の封印と明確に識別できる

ものであること。公式封印の写しは、事前に日本国家畜衛生当局に提供されること。当該コ

ンテナの日本国到着時の輸入検査において、当該コンテナに取り付けられた公式封印の破損

又は脱落がある場合には、日本は当該コンテナに積載された牛肉の日本への持ち込みを禁止

できる。

5.(日本向け輸出牛肉及び牛肉製品の条件)

5.1 米国(50 州、コロンビア特別区及びグアム)から日本へ輸出される牛肉及び牛肉製品

は、日本と米国が対日輸出に適格と判断した製品でなければならない。

5.2 日本向け輸出牛肉は、(A)米国で出生し飼養されていた動物又は日本国家畜衛生当局

が認めた偶蹄類の動物及びその肉等の第3清浄国若しくは牛肉等の対日輸出が可能なBSE

発生国から合法的に米国に輸入された動物に由来すること、又は(B)日本向けに牛肉を輸

出することが適当であるとして日本国家畜衛生当局により認定された国から以下の条件を満

たし合法的に米国に輸入された肉に由来すること。

① 輸出国で出生し飼養されていた偶蹄類動物(牛)に由来すること。

② 日本向け輸出が適当であるとして指定を受けた施設でのみ取り扱われ、輸出国当局によると

畜前後の検査において、異常がなく健康であった牛に由来すること。

③ 輸出国当局発行の検査証明書が添付され、直接米国に輸入されたものであること。第3清浄

国又は輸出することが適当であると認定された国以外の国を経由して輸送される場合は、公

的に封印されたコンテナに収容されて輸送されること。

④ 米国政府機関による輸入検査において、家畜の伝染性疾病のいかなる徴候も認められなかっ

たものであり、かつ当該検査後、直接米国の指定施設に搬入されたものであること。

5.3 と畜牛は、BSEの疑いのある牛若しくはBSEと確認された牛、又は国際獣疫事務

局の陸生動物衛生規約に定義されたBSE牛のコホート(同居牛)でないこと。

5.4 と畜牛は、指定施設におけると畜時の米国当局検査官によると畜前後の検査にお

いて、異常が無く健康であったこと、又は日本向け輸出牛肉が輸入肉由来の場合、5.1(B)を満たすこと。

5.5 日本向け輸出牛肉は、指定施設においてと畜、加工及び保管されたものであるこ

と、又は日本向け輸出牛肉が第三国由来の場合、米国において指定施設で取扱及び保管

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されたものであること。

5.6 日本向け輸出牛肉は、日本への船積みまでの間、指定施設において家畜の伝染性

疾病の病原体による汚染を防止する方法で取り扱われること。

6.(日本政府による査察および米国モニタリング)

6.1 日本政府は、牛肉又は牛肉製品を日本向けに輸出する指定施設の代表的なサンプルを

通して、これら施設が本文書で定められた条件及び米国の国内規則の関連規定を確実に遵守し

ていることを確認するため、米国の検査システムの現地査察を実施することができる。米国農

務省の規制の条件の査察は、施設の危害分析重要管理点法(HACCP)、衛生標準作業手順

(SSOP)及び前提条件プログラムの分析を含む。査察はまた、本条件や QAD1030J Procedureの追加条件の見直しを含む。当該現地査察の結果、本衛生条件に対する違反が発見された場合

には、日本政府は現地で米国政府に報告する。

6.2 FSIS は日常のモニタリングにて当該施設が米国食品安全規則を遵守していること、

また、輸出確認タスクにて、日本向け製品が本条件の第3条を満たすことを検証しなければな

らない。また、AMS は定期的な査察を通し、当該施設が、QSA プログラムの対象となる本条

件の第3条を満たすこと確認しなければならない。

6.3 日本政府による現地査察、FSIS による日常的モニタリング又はAMS による定期査察

にて遵守違反が発見された場合は、FSIS は違反記録(NR)を発行する。違反品の生産は直ち

に管理されること。違反品の生産が続いている場合、USDA は直ちに生産を中止させ、改善及

び防止措置がとられたと判断されるまでの間生産を中止させる。USDAは適切な改善措置がとら

れたと判断した場合のみ生産再開を許可する。

6.4 USDA は当該違反施設の認定を取り消すことができるとともに、日本政府に施設名称、

住所及び施設番号を通知しなければならない。満足できる是正措置がとられたことが証明され

た後、米国農務省は指定が取り消された施設を再指定することができる。

7.(証明書)

7.1米国農務省は、日本向け輸出牛肉及び牛肉製品が家畜衛生条件を充足することを確認の

上、次の各事項を具体的に記載した英文による日本向け輸出健全証明書及び輸出牛肉及び牛

肉製品のための検査証明書を発行すること。

(a)各指定施設の名称、所在地及び施設番号 (b)と畜、及び加工期間(日/月/年~日/月/年) (c)検査証明書の発行年月日、発行機関名、発行場所並びに署名者の氏名及び肩書き (d)コンテナに取り付けられた封印の識別番号(前記 11 の規定に基づき、輸送コンテナが公

式封印により封印されている場合。)

(e)前述5.2から5.6までの各事項。

7.2 この米国から日本向けに輸出される牛肉及び牛肉製品の家畜衛生条件は、2019 年5月

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17 日から有効とする。

8.参考

http://www.fsis.usda.gov/wps/portal/fsis/topics/international-affairs/exporting-products/export-library-requirements-by-country/Japan

https://www.ams.usda.gov/services/imports-exports

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別添1 指定施設の条件

1.指定施設において取り扱うことができる偶蹄類の動物は、米国において出生し、飼養され

ていたもの(鹿については、慢性消耗性疾患と疫学的関連のある鹿を除く。豚については、ア

フリカ豚コレラ又は豚コレラと疫学的に関連のある豚を除く。)、又は、別添2に掲げる第3清

浄国若しくは特定国から直接米国に輸入される偶蹄類の動物であって、以下の1-(1)から

(6)の条件をすべて充足するものであること。

1-(1) 第3清浄国又は特定国において出生し、かつ、第3清浄国又は特定国においてのみ飼

養されていたものであること。

2-(2) BSE もしくはBSE の疑いのある牛若しくは BSE 牛のコホート(同居牛)が疑われる

牛は、米国において、ヒトや動物の消費用には用いられてはならない。

1-(3) 第3清浄国又は特定国の政府機関による輸出検査において、家畜の伝染性疾病のいか

なる徴候も認められなかったものであること。

1-(4) 第3清浄国又は特定国の政府機関発行の検査証明書が添付され、当該第3清浄国又は

特定国以外の国を経由することなく直接合法的に米国に輸入されたものであること。

1-(5) 米国当局による輸入検査において、家畜の伝染性疾病のいかなる徴候も認められなか

ったものであること。

2.日本へ輸出される食肉等は、米国において出生し、飼養されていた偶蹄類の動物に由来す

るものであって、米国の指定施設のみにおいて取り扱われたもの(鹿については、慢性消耗性

疾患と疫学的関連のある鹿肉等を除く。豚については、アフリカ豚コレラ又は豚コレラと疫学

的に関連のある豚肉等を除く。)、又は、別添2に掲げる第3清浄国等若しくは特定国から直接

米国に輸入される食肉等であって、以下の2-(1)から(4)の条件をすべて充足するもの

であること。

2-(1) 第3清浄国又は特定国において出生し、かつ、第3清浄国又は特定国においてのみ飼

養されていた偶蹄類の動物に由来するものであること。

2-(2) BSE もしくは BSE の疑いのある牛若しくは BSE 牛のコホート(同居牛)が疑われ

る牛は、米国において、ヒトや動物の消費用には用いられてはならない。

2-(3) 第3清浄国又は特定国における指定施設において取り扱われ、第3清浄国又は特定国

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の獣医官によると畜前及びと畜後の検査において、家畜の伝染性疾病のいかなる徴候も認めら

れなかった偶蹄類の動物に由来するものであること。

2-(4) 第3清浄国又は特定国の政府機関発行の検査証明書が添付され、当該第3清浄国又は

特定国以外の国を経由することなく直接合法的に米国に輸入されたものであること。

2-(5) 米国当局による輸入検査において、家畜の伝染性疾病のいかなる徴候も認められなか

ったものであり、かつ当該検査後、直接米国の指定施設に搬入されたものであること。

3.ただし、指定施設のうち保管施設にあっては、以下の条件を充足する場合、日本向け輸出

牛肉を取り扱う保管施設として指定することができる。なお、ここでいう保管施設とは、最終

製品となったものを出荷及び船積みまでの間、一時的に保管しておく施設をいう。

3-(1) 当該保管施設で取り扱われる日本向け輸出牛肉は、完全に包装及び箱詰めされ、上記

2の条件を充足する製品以外の肉等と効果的に隔離されること。

3-(2) その他、日本向け輸出牛肉が上記2の条件を充足する製品以外の肉等と交差汚染する

ことのないように取り扱うこと。

4.指定施設においては、取り扱われた偶蹄類の動物及び食肉等について、その種類、数量、

生産地域及び取扱い年月日(第3清浄国又は特定国から輸入されたものを取り扱う場合にあっ

ては、さらに輸入先国/地域名、輸入年月日を含む。)が記録原簿に記録され、当該記録原簿は、

少なくとも2年間保管されていること。

4-(1) 輸送途中の日本向け輸出牛肉については、当該疾病の発生との疫学的関係が明確に否

定されるもの以外は、日本への持込が禁止されることがある。

4-(2) 上記の日本向け輸出牛肉の輸出禁止の措置については、当該第3清浄国若しくは特定

国における当該疾病について日本国家畜衛生当局が清浄であると認めた場合又は米国当局が当

該第3清浄国若しくは特定国からの偶蹄類の動物及び食肉等を当該指定施設へ搬入することを

禁止し、その旨を日本国家畜衛生当局に通報した場合に解除することができる。(どのような場

合であっても、当該疾病の発生と疫学的に関連する牛肉の輸出は認められない。)

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別添2 第3清浄国及び特定国

1.偶蹄類の動物(鹿及び豚を除く)及びそれらの肉等(鹿肉等及び豚肉等を除く)に関する

第3清浄国

(日本国農林水産大臣又は家畜衛生当局が牛疫、口蹄疫及びBSEについて清浄であるとして、

食肉等の日本への輸出を認めている国あるいは地域)

最新のリストは農林水産省の以下のウェブサイトを参照のこと

http://www.maff.go.jp/aqs/english/news/third-free.html

2.鹿及び鹿肉等に関する第3清浄国

(日本国農林水産大臣又は家畜衛生当局が牛疫、口蹄疫及び慢性消耗性疾患について清浄であ

るとして、食肉等の日本への輸出を認めている国あるいは地域)

最新のリストは農林水産省の以下のウェブサイトを参照のこと

http://www.maff.go.jp/aqs/english/news/third-free.html

3.豚及び豚肉等に関する第3清浄国等

(日本国農林水産大臣又は家畜衛生当局が牛疫、口蹄疫、アフリカ豚コレラ及び豚コレラにつ

いて清浄であるとして、食肉等の日本への輸出を認めている国あるいは地域)

最新のリストは農林水産省の以下のウェブサイトを参照のこと

http://www.maff.go.jp/aqs/english/news/third-free.html

4.日本向け輸出牛肉、めん羊肉及び山羊肉に関する特定国

最新のリストは農林水産省の以下のウェブサイトを参照のこと

http://www.maff.go.jp/aqs/english/news/eligible-bse-country.html

(別添2)