Implementation of "Imported Foods Monitoring Plan for FY 2019"

Notice No. 0330 Article2 of the Office of Import Food Safety
March 30, 2020

To: Head of each quarantine station

From: Head of the Office of Import Food Safety,
Food Inspection and Safety Division,

Pharmaceutical Safety and Environmental Health Bureau
(Seal Omitted)

Implementation of "Imported Foods Monitoring Plan for FY 2020"

We appreciate your efforts to realize and smoothly implement the monitoring inspections on imported foods based on the annexed Imported Foods Monitoring and Guidance Plan for FY 2020.

Separate instructions shall be given on the inspection reinforcement during the current interim FY, which will be conducted when the Food Sanitation Act concerning residual agricultural chemicals has been violated.

Annex

Imported Foods Monitoring Plan for FY 2020

I. Implementation Guidelines for Monitoring Inspections Concerning Imported Foods (common items)

1. Implementation period
From April 1, 2020, to March 31, 2021
2. Targets
- (1) Targeted foods
  - A. Foods listed in Schedule 1, excluding the foods indicated below.
    - (a) Defective items
    - (b) Returned shipments
    - (c) Foods reported by customs officers as having a food sanitation problem
    - (d) Food that are being imported into Japan for the first time
  - B. Also targeted are: i) foods with an inspection report issued by an inspection organization registered with the Minister of Health, Labour and Welfare, or by an official inspection organization in other country; ii) the same foods that are continuously imported, with previous inspection reports; and iii) foods registered on a pre-certification system for imported foods.
- (2) Items to be inspected and number of inspection spsecimens
  Follow the guidelines in Schedule 1, and develop an annual plan for systematic implementation of the inspections, based on the items and numbers to be inspected for each food type, assigned separately, to each quarantine station by the Office of Quarantine Stations Administration, Policy Planning Division for Environmental Health and Food Safety (hereinafter referred to as the "Administration Office").
  If an inspection is deemed necessary in consideration of the situation with regard to importation or violation of the Food Sanitation Act (hereinafter referred to as "the Act"), and/or information on raw materials, the processing method, etc. contained in the import declarations for items whose import volume has surged or items whose import has been done from new country and region, an inspection should be implemented at any time, regardless of Schedule 1.
3. Inspection methods
- (1) Collection of specimens
  Specimens shall be collected according to Schedule 4 to 6. The specimens shall be collected from randomly selected inspection targets, under instructions from the food sanitation inspectors, so that the specimens will be appropriately representative of the entire lot.
  In the case of indicated other than Schedule 4 to 6, specimens shall be collected with coordinating to the Inspection Division of Quarantine Station, the Imported Food Inspection Center and the Registered Conformity Assessment Bodies (hereinafter referred to as "Inspection division"),.
  Specimens shall be collected according to the standard operating procedures for specimen handling, and the collection methods, the cargo types of collected products, and indications on them shall be recorded in detail.
- (2) Methods of testing
  Select an appropriate method from the methods listed below, in consideration of the properties of each food, and perform the inspection accurately and promptly according to the standard operating procedures.
  - A. Testing methods defined by the Specification and Standards for Foods and Food Additives (Notification No. 370 of the Ministry of Health and Welfare, 1959) (hereinafter referred to as the "notified method")
  - B. Testing methods defined by the Ministerial Ordinance Concerning the Standards for Constituents of Milk and Milk Products (Ministerial Ordinance No. 52 of the Ministry of Health and Welfare, 1951)
  - C. Testing methods defined by the Notices from Directors of Food Safety Departments in the Ministry of Health, Labour and Welfare
  - D. Testing methods described in "Inspection Guidelines for Food Sanitation", supervised by the Ministry of Health, Labour and Welfare
  - E. Testing methods described in "Standard Methods of Analysis for Hygienic Chemists, Annotation", edited by the Pharmaceutical Society of Japan
  - F. Other reliable testing methods such as the AOAC methods
    In addition to the testing methods listed above, testing may be conducted using a method possessing specificity, and also a performance equivalent or superior in terms of accuracy, precision and quantitation limit compared to testing methods indicated in notices, etc.
4. Delivery of specimens to testing institutions
Specimens collected by quarantine stations shall be delivered, in storage conditions appropriate for testing, to the inspection division, as separately specified by the Administration Office and the trustee agreement signed at the quarantine stations.
Sufficient prior coordination with the representative of the receiving organization shall be carried out, so that the specimens are sent and received appropriately and that the testing of them can be carried out smoothly.
5. Issuance of certificates indicating that the food import declaration has been submitted
The certificates indicating that the food import declaration has been submitted may be issued for all food products that have completed the inspection, before the results of the inspection are obtained. However, instructions shall be provided to importers in advance that they obtain information on strage and distribution ofo products concerned and submit the Sales Plan to the quarantine station.The purpose of this measure is to make possible an immediate backward traceablity investigation and recall of the relevant products, if it is verified that the products are in violation of the Act.
6. Reporting results
In the case that the violation is suspected, quarantine station should report to Administration Office. If a violation is found in the monitoring inspection, importers should be provided with instructions to confirm the cargo status, and quarantine station should report promptly to Administration Office. with the form for reporting violations of the Act.
7. Other precautions
- (1) Enhancing of monitoring inspections
  The enhanced monitoring inspections upon the discovery of a violation of the Act concerning residual agricultural chemicals of which the frequency is increased by 30% shall follow Schedule 2, whereas instructions given to manufacturers, processing plants, exporters, and packagers to conduct voluntary inspections whenever they import the relevant items after violating relevant Acts shall follow Schedule 3.
  Enhancing of monitoring inspection will be cancelled in the case that the effectiveness of measurement against the cause of violation by exporting country can be confirmed or one year has passed from the day enhanced monitoring was enforced and/or after 60 or more enhanced inspections have found that the same violation has not been committed again.
- (2) Sampling of inspection targets
  It should be noted that: import declarations should be randomly selected to perform the relevant monitoring inspections; inspections should not be biased towards certain importers or otherwise, nor may inspections be canceled at the request of the importer.
- (3) Collection of specimens from bulk cargo
  For grains, beans and other products in bulk, it is necessary to take measures including instructing the importers to make declarations prior to the arrival of cargo so that the importation status can be identified in sufficient time.
  Based on the time and place available for the collection of inspection specimens, and the destination(s) of cargo in the same hold, to develop collection plans promptly, and notify the relevant importers of them.
- (4) Inspection on residual agricultural chemicals in processed foods (excluding simple processing)
  - A. Half of collected specimens shall be evenly homogenized for inspections as product, and the rest shall be stored without homogenization.
  - B. If residual agricultural chemicals are detected as a result of an inspection, the cause of detection shall be confirmed, and the conformity to the Specification and Standards shall be determined upon consideration of the standard value for residuals in raw materials, composition of ingredients, and production and processing method, etc.
  - C. In the cases where a cause of detection from the product is unknown or where inspection at product level is difficult, inspection shall be individually carried out on physically separable ingredients.

II. Implementation Guidelines for Monitoring Inspection of Livestock and Aquatic Foods

1. Targeted foods Livestock and aquatic foods, and their processed products
- (1) Meat (including internal organs) and Processed meat products
- (2) Cheeses and other milk/dairy products
- (3) Processed egg products
- (4) Honey-related products (honey, royal jelly, pollen, etc.)
- (5) Aquatic foods (fish (such as eel, salmon/trout and flounder), aquatic animals (such as prawns, squid and octopus), and shellfish, etc.)
2. Items to be inspected and the number of specimens
- (1) Livestock and aquatic foods(general)
  - A. Antibiotics, etc.
    Items subject to inspections are as listed in Schedule 7 and the number of inspections is as listed in Schedule 1.
  - B. Residual agricultural chemicals
    Items subject to inspections are as listed in Schedule 8 and the number of inspections is as listed in Schedule 1.
    Number of inspections: Whale meat－59 inspections
  - C. Foods that specification and standard is defined Specification and Standards for Foods and Food Additives (Notification No. 370 of the Ministry of Health and Welfare, 1959) and foods defined by the Ministerial Ordinance Concerning the Standards for Constituents of Milk and Milk Products ((Excludes pathogenic organism) .The number of inspections shall be as listed in Schedule 1.
  - D. Irradiated Foods
    Food indicated through "Detection Methods for Irradiated Foods" (Notice No. 0706002 from the Department of Food Safety, dated July 6, 2007, The last revision : Notice No.1128, Article 4 of the Environmental Health and Food Safety Department, dated on November 28, 2018). The number of inspections shall be as specified in Schedule 1.
- (2) Meat (including internal organs)
  - A. Pathogenic Microorganisms
    - (a) Enterohemorrhagic E. coli：Beef – 598 inspections; Horse meat – 59 inspections; Unheated meat products – 59 inspections
    - (b) Listeria monocytogenes：Unheated meat products to be consumed without further cooking – 299 inspections
    - (c) Salmonella：Unheated meat products to be consumed without further cooking – 119 inspections; Heated meat products – 598inspections
    - (d) Staphylococcus aureus：Unheated meat products – 119inspections; Heated meat products– 598 inspections
  - B. Specification and Standard.
    - (a) PCB：Beef – 59 inspections; Pork – 59 inspections
    - (b) Radioactive materials：Beef, pork, chicken, duck meat, other fresh livestock foods, milk products, gelatin, beef extracts, poultry and meat extracts imported from Europe (areas where are west of Turkey and the Ural Mountains of the former Soviet Union), etc. The number of inspections shall be as specified in the scope of Standards for constituents in Schedule 1.
- (3) Cheeses and other milk/dairy products
  - A. Pathogenic Microorganisms
    - (a) Enterohemorrhagic E. coli：Natural cheese – 598 inspections
    - (b) Listeria monocytogenes：Natural cheese (exclude products to be heated after packaging or products to be heated before eat) – 598 inspections; Other milk/dairy products – 299 inspections
    - (c) Salmonella：Natural cheese – 299 inspections; Ice cream – 59 inspections
  - B. Specification and Standard.
    Radioactive materials：mushrooms and their dried products, spices, herb and its processed products, milk products imported from Europe, etc.
    The number of inspections shall be as specified in the scope of Standards for constituents in Schedule 1.
- (4) Processed egg products
  - Pathogenic Microorganisms
    - Salmonella：Products of chicken/other egg – 59 inspections
- (5) Honey-related products (honey, royal jelly, pollen, etc.)
  - Specification and Standard.
    - Radioactive materials：honey imported from Europe, etc. The number of inspections shall be as specified in the scope of Standards for constituents in Schedule 1.
- (6) Aquatic foods (fish, aquatic animals, and shellfish, etc.)
  - A. Pathogenic Microorganisms
    - (a) Vibrio Parahaemolyticus：Targets and Number of Inspections are as shown in Ⅳ－ⅲ
    - (b) Norovirus：Bivalves to be eaten raw – 299 inspections; Shellfish other than bivalves to be eaten raw – 119 inspections
    - (c) Hepatitis A Virus：Bivalves to be eaten raw – 299 inspections; Shellfish other than bivalves to be eaten raw – 119inspections; Frozen short-neck clam (including shelled and peeled, excluding those enough heated during manufacturing process) – 119 inspections;
    - (d) Salmonella：Fish and Shellfish to be eaten raw – 598 inspections; Frozen food served without heating(aquatic products) – 299 inspections;
    - (e) Shigella：Fish and Shellfish to be eaten raw – 299 inspections; Frozen food served without heating(aquatic products) – 119 inspections
    - (f) Kudoa septempunctata：Flounder to be eaten raw other than frozen products – 598 inspections
  - B. Specification and Standard.
    - (a) Paralytic Shellfish Poison, Diarrheic Shellfish Poison：Bivalves (excluding scallops consisting of adductor muscle only) – 178 inspections; Shellfish other than bivalves – 29inspections
    - (b) Mercury：Fish and shellfish – 299 inspections
    - (c) PCB：Fish and shellfish – 147 inspections
  - C. Recombinant DNA Techniques
    - AquAdvantage：Salmon to be imported from Canada, Panama and the United States.– 59 inspections

III. Implementation Guidelines for Monitoring Inspection of Agricultural Foods

1. Targeted foods
- Agricultural foods and their processed products
  - （1） Vegetables
  - （2） Fruits
  - （3） Grains (Including Minimum Access imported rice and tariffed rice), beans and nuts
  - （4） Tea
2. Items to be inspected and the number of specimens
- （1） Agricultural Foods(general)
  - A. Residual agricultural chemicals
    Items subject to inspections are as listed in Schedule 8 and the number of inspections is as listed in Schedule 1.
  - B. Pathogenic Microorganisms
    - (a) Salmonella：Frozen food served without heating(agricultural products) – 598 inspections
    - (b) Shigella：Frozen food served without heating(agricultural products) – 299 inspections
  - C. Mycotoxin
    Aflatoxin：The number of inspections shall be as listed in Schedule 1.
  - D. Irradiated Foods
    Food indicated through "Detection Methods for Irradiated Foods" (Notice No. 0706002 from the Department of Food Safety, dated July 6, 2007, The last revision : Notice No.1128, Article 4 of the Environmental Health and Food Safety Department, dated on November 28, 2018). The number of inspections shall be as specified in Schedule 1.
- (2) Vegetables
  - A. Residual agricultural chemicals
    Lead and arsenic：Vegetables (limited to potato, tomato, cucumber and spinach) – 119 inspections
  - B. Pathogenic Microorganisms
    - (a)Enterohemorrhagic E. coli：Vegetables to be eaten unheated and without peeling skin – 598 inspections; Fruits to be eaten unheated and without peeling skin – 299 inspections; Pickles–299 inspections
    - (b)Listeria monocytogenes：Frozen vegetables to be eaten unheated– 119 inspections;Frozen food served without heating(vegetable products) – 119 inspections
    - (c)Salmonella：Spices to be eaten unheated– 59 inspections; Dried wood ears– 29 inspections
  - C. Specification and Standard
    Radioactive materials：mushrooms and their dried products, spices, herb and its processed products imported from Europe, etc. The number of inspections shall be as specified in the scope of Standards for constituents in Schedule 1.
  - D. Recombinant DNA Techniques
    F10 and J3：Potatos and its products (made maily of potato, such as fried potato and potato chips) – 59 inspections
- (3) Fruits
  - A. Residual agricultural chemicals
    Lead and arsenic：Fruits (limited to Citrus natsudaidai, skin of Citrus natsudaidai, apple, Asian pear, peach, strawberry and grapes) – 119 inspections
  - B. Pathogenic Microorganisms
    - (a)Listeria monocytogenes：Frozen Fruites to be eaten unheated– 119 inspections; Frozen food served without heating(fruits products) – 119 inspections
    - (b)Hepatitis A Virus：Fruits to be eaten unheated and without peeling skin – 299 inspections; Frozen food served without heating (fruits products) (excluding those heated during manufacturing process) – 119inspections
  - C. Specification and Standard
    Radioactive materials：berries and its processed products(processed concentrated berries, puree, paste, preservation in syrup, juice, etc.), imported from Europe, etc. The number of inspections shall be as specified in the scope of Standards for constituents in Schedule 1.
  - D. Mycotoxin
    Patulin：Apple juice (juice produced only from apples) –59 inspections; Apple juice as raw material –59inspections
  - E. Recombinant DNA Techniques
    PRSV-YK, PRSV-SC and PRSV-HN：Papaya and its products (Limited to products that can be separated from the others) – 299 inspections
- (4) Grains, beans and nuts
  - A. Residual agricultural chemicals
    Lead in Rice –119 inspections
  - B. Pathogenic Microorganisms
    Salmonella：Peanuts and nuts (limited to those to be eaten unheated) – 299 inspections
  - C. Specification and Standard
    Cadmium and its compounds：Rice –119 inspections
  - D. Mycotoxin
    Deoxynivalenol (DON)：Targeting wheat, inspections shall be performed on ships to be separately instructed by the Administration Office.
  - E. Recombinant DNA Techniques
    - (a)63Bt, NNBt and CpTI rice：Rice and its products (made mainly of rice and unheated or heated lightly products, such as rice flour and rice vermicelli) – 299 inspections
    - (b)RT73 B.rapa：Rapeseed and its products – 29 inspections
    - (c)MON71100/71300, MON71700 and MON71800：Targeting Wheat produced in U.S.A. –59 inspections shall be performed on ships to be separately instructed by the Administration Office.
    - (d)MON71200：Targeting Wheat produced in Canada–59 inspections shall be performed on ships to be separately instructed by the Administration Office.
- (5) Tea
  Radioactive materials：tea (non-, semi-, and full-fermented) imported from Europe,etc. The number of inspections shall be as specified in the scope of Standards for constituents in Schedule 1.

IV. Implementation Guidelines for the Monitoring Inspection of Each Inspection Item

IV-i Antibiotics, etc.

1. Targeted foods
- (1) Livestock and aquatic foods, and their processed products
  - A. Meat (including internal organs)
  - B. Processed livestock foods (Processed meat products, milk/diary products, egg products, etc)
  - C. Honey-related products (honey, royal jelly, pollen, etc.)
  - D. Aquatic foods (fish, aquatic animals, and shellfish, etc.)
- (2) Items to be inspected and the number of specimens
  Items subject to inspections are as listed in Schedule 7 and inspections targeting milk/dairy products are performed on the items separately instructed by Administration Office in addition to 2 (2) A. The number of inspections is as listed in Schedule 1.
2. Inspection methods
- (1) Collection of specimens
  Collect the specimens as specified in "Residual hazardous substances in livestock and aquatic foods" in Schedule 4. In principle, the collected specimens shall be delivered to the testing institution in a frozen state and handled accordingly.
- (2) Methods of testing
  Regarding any items to be inspected which are not indicated below, testing shall be carried out according to the notified method or "Testing Methods for Constituent Substances of Residual Agricultural Chemicals, Feedstuff Additives and Veterinary Drugs in Food" in Notice No. 0124001 from the Department of Food Safety, dated January 24, 2005 (hereinafter referred to as "Notice on Testing Methods for Residual Agricultural Chemicals").
  - A. Antibiotics
    Testing shall be carried out according to "Simple Inspection Methods for Residual Antibiotics in Livestock and Aquatic Foods (Revision)" in Notice Einyu No. 113, dated July 13, 1994. If a specimen tests positive, it must be further examined according to "Fractional Estimation Methods for Residual Antibiotics in Livestock and Aquatic Foods (Revision)" described in the same Notice.
    If the specimen tests positive for above methods, the positive substance must be identified and quantified.
  - B. Streptomycin
    Honey shall be examined according to Attachment 2 of the Notice No. 0329005 from the Inspection and Safety Division dated March 29, 2002.

IV-ii Residual agricultural chemicals, etc

1. Targeted foods
- (1) Livestock, Aquatic and Agricultural foods and their processed products
  - A. Vegetables
  - B. Fruits
  - C. Grains (Including Minimum Access imported rice and tariffed rice), beans and nuts
  - D. Tea
  - E. Livestock foods
  - F. Aquatic foods
- (2) Items to be inspected and the number of specimens
  - A. Residual agricultural chemicals
    Items subject to inspections are as listed in Schedule 8 and the number of inspections is as listed in Schedule 1.
    Number of inspections :Whale meat –59 inspections.
  - B. Lead and arsenic
    Number of inspections: Vegetables (limited to potato, tomato, cucumber and spinach) – 119 inspections; Fruits (limited to Citrus natsudaidai, skin of Citrus natsudaidai, apple, Asian pear, peach, strawberry and grapes) – 119 inspections；Lead in Rice –119 inspections
2. Inspection methods
- (1) Collection of the specimens
  - A. Residual agricultural chemicals (excluding rice)
    In accordance with the methods detailed in the inspection item "Agricultural Chemicals" in Schedule 4 or the bulk cargo method
  - B. Residual agricultural chemicals and lead in rice
    In accordance with Schedule 6
  - C. Residual agricultural chemicals on livestock and aquatic foods
    Collect the specimens as specified in "Residual hazardous substances in livestock and aquatic foods" in Schedule 4. In principle, the collected specimens shall be delivered to the testing institution in a frozen state and handled accordingly.
- (2) Methods of testing
  Testing shall be carried out in the solid-phase extraction for the simultaneous analysis method for residual agricultural chemicals, the Notice on Testing Methods for Residual Agricultural Chemicals, or the notified method.
  If, upon conducting testing by solid-phase extraction for the simultaneous analysis method for residual agricultural chemicals, the tested value is suspected to exceed the designated residue level, further examine the specimen according to the Notice on Testing Methods for Residual Agricultural Chemicals or to the notified method.
  However, the testing of processed foods (excluding simple processing) shall be carried out according to "Testing Methods for Residual Organophosphorus Agricultural Chemicals in Food" in the notice dated March 7, 2008.
3. Other
Notes on the inspection of rice
- A.　In 1.(1) C. above, Minimum Access imported rice refers to that specified in Articles 30 and 31 of the Act on Stabilization of Supply-Demand and Price of Staple Food; tariffed rice refers to that specified in Article 34 of the Act on Stabilization of Supply-Demand and Price of Staple Food which is imported with tax.
- B.　Within the same lot (the same variety of rice (such as brown rice, milled rice, crushed rice, non glutinous rice or glutinous rice), the same origin, the same importer and the same ship), inspections shall be conducted at the first port where the cargo is discharged (hereinafter referred to as "the primary port"). To do this, the inspection results of the same lot cargo at the primary port shall be appropriately reported by the quarantine station with jurisdiction over the primary port to the quarantine stations with jurisdiction over the secondary and following ports.
- C.　When fumigation is carried out according to the Plant Protection Act, instructions shall be given to implement voluntary inspections on the used fumigation agents.
- D.　Inspections of contamination of foreign matters in food at the time of sampling shall be carried out with consideration to the "Outline of Handling of the Seeds of Convolvuloceous Plants Mixed in with Imported Rice" (Notice No. 81 from Eishoku, dated April 26, 1957)
- E.　Result of the inspection, if the lead is detected over 0.2ppm, which is the maximum reference value in the Codex standard, should be instructed to return shipments to the importer.

IV-iii Pathogenic Microorganisms.

IV-iii-i Inspection of Vibrio Parahaemolyticus Related to Fresh Fish and Shellfish to be Eaten Raw

1. Targets
- (1) Food products definied in below.
  - Boiled octopus and crabs (limited to the ones to be eaten without heating); fresh fish and shellfish to be eaten raw; oysters to be eaten raw (limited to shelled ones); and frozen food products (limited to frozen fish and shellfish to be eaten raw); in relation to which the constituent standards for Vibrio parahaemolyticus are established in "Specifications and Standards for Foods and Food Additives" (Notification No. 370, issued by the Ministry of Health and Welfare in 1959).
- (2) Number of specimens
  - A. Foods indicated in (1) .
    Inspection shall be carried out within the range of the number of specimens specified in the "Pathogenic Microorganism" for processed seafood in Schedule 1.
  - B. Foods indicated in (1)
    Inspections shall be carried out for 30% of all import declarations from June 1 to October 31, 2020.
2. Inspection methods
- (1) Collection of the specimens
  Specimens shall be collected according to "Microorganisms" in the inspection items of Schedule 4.
- (2) Methods of testing
  Testing shall be carried out according to the notified method. Among the testing methods concerning Vibrio parahaemolyticus, the "identification method" and the "inspection method that is recognized to have equivalent or better performance" shall conform to the provision of Notice No. 23 from the Standard and Evaluation Division, dated June 29, 2001.
3. Other
- (1) Sampling of inspection targets
  With careful consideration of the food types, the exporting countries, the food-processing facilities, the importers and past inspection records, the collection of specimens of foods specified 1. (1)A, which are mainly sea urchins to be eaten raw and shellfish with a high risk of contamination, shall be carried out efficiently, especially in summer.
- (2) Issuance of certificates indicating that the food import declaration has been submitted
  The certificates indicating that the food import declaration has been submitted may be issued for all food products that have completed the inspection, before the results of the inspection are obtained. However, to prevent food poisoning from occurring, importers shall be instructed to suspend the sale of those food products to be eaten raw, to retailers and consumers until the inspection results are obtained.
- (3) Handling of food detected to contain Vibrio parahaemolyticus not exceeding the threshold value.
  With regard to fresh fish and shellfish to be eaten raw, oysters to be eaten raw (limited to shelled ones), and frozen food products (limited to frozen fish and shellfish to be eaten raw), instructions shall be provided to importers that they strictly observe the preservation standards during the storage and the distribution of the products in domestic, in order to prevent Vibrio parahaemolyticus from propagating to cause food poisoning, if the results of the inspection indicate that the most probable number of Vibrio parahaemolyticus is equal to or less than 100/g but equal to or more than 3.0/g, Importers shall also be instructed that they obtain information with sufficient care, on the distribution and other matters related to the products concerned, in order to make possible an immediate backward traceability investigation of the products if those products cause food poisoning.
- (4) Guidance on sanitation control
  With reference to "Ensuring the Safety of Imported Shelled Sea Urchins and Ark Shells to be Eaten Raw" in Notice No. 0919007 from the Inspection and Safety Division, dated September 19, 2003, guidance shall be provided to importers to ensure that they strictly oversee the sanitation control, including the observance of the processing standards at processing plants in the exporting countries, the observance of the preservation standards in the transportation and the storage of food products, and the submission of import declarations for each plant as a separate lot, if the food product is processed at different plants.

IV-iii-ii Inspection of Pathogenic Microorganisms other than Vibrio Parahaemolyticus

1. Targets
- (1) Livestock, Aquatic and Agricultural foods, and their processed products
  - A. Meat (including internal organs)
  - B. Processed meat products
  - C. Cheeses and other milk/dairy products
  - D. Processed egg products
  - E. Aquatic foods, aquatic animals and their processed products
  - F. Vegetables
  - G. Fruits
  - H. nuts
- (2) Items to be inspected and the number of specimens
  - A. Enterohemorrhagic E. coli
    Number of Inspections: Beef – 598 inspections; Horse meat – 59 inspections; Unheated meat products – 59 inspections; Natural cheese– 598 inspections; Vegetables to be eaten unheated and without peeling skin – 598 inspections; Fruits to be eaten unheated and without peeling skin – 299 inspections; Pickles–299 inspections
  - B. Listeria monocytogenes
    Number of Inspections: Unheated meat products to be consumed without further cooking – 299 inspections; Natural cheese (exclude products to be heated after packaging or products to be heated before eat) – 598 inspections; Other milk/dairy products – 299 inspections; Frozen vegetables to be eaten unheated– 119 inspections; Frozen Fruites to be eaten unheated– 119 inspections; Frozen food served without heating(vegetable products) – 119 inspections; Frozen food served without heating(fruits products) – 119 inspections
  - C. Norovirus
    Number of Inspections: Bivalves to be eaten raw – 299 inspections; Shellfish other than bivalves to be eaten raw – 119 inspections
  - D. Hepatitis A Virus
    Number of Inspections: Bivalves to be eaten raw – 299 inspections; Shellfish other than bivalves to be eaten raw – 119inspections; Frozen short-neck clam (including shelled and peeled, excluding those enough heated during manufacturing process) – 119 inspections; Fruits to be eaten unheated and without peeling skin – 299 inspections; Frozen food served without heating (fruits products) (excluding those heated during manufacturing process) – 119inspections
  - E. Salmonella
    Number of Inspections: Unheated meat products to be consumed without further cooking – 119 inspections; Heated meat products – 598inspections; Natural cheese – 299 inspections; Ice cream – 59 inspections; Products of chicken/other egg – 59 inspections; Fish and Shellfish to be eaten raw – 598 inspections; Frozen food served without heating(aquatic products) – 299 inspections; Peanuts and nuts (limited to those to be eaten unheated) – 299 inspections; Frozen food served without heating(agricultural products) – 598 inspections; Spices to be eaten unheated– 59 inspections; Dried wood ears – 29 inspections
  - F. Shigella
    Number of Inspections: Fish and Shellfish to be eaten raw – 299 inspections; Frozen food served without heating(aquatic products) – 119 inspections; Frozen food served without heating(agricultural products) – 229 inspections
  - G. Kudoa septempunctata
    Number of Inspections: Flounder to be eaten raw other than frozen products – 598 inspections
  - H. Staphylococcus aureus
    Number of Inspections: Unheated meat products – 119inspections; Heated meat products– 598 inspections
2. Inspection methods
- (1) Collection of specimens
  - A. Collect the specimens as specified in "Microorganisms" in Schedule 4.
  - B. When collecting specimens for norovirus or hepatitis A virus、pay attention to the amount of midgut gland collected based on the Notice No.1105001 Article 1 of the Food Inspection and Safety Division November 5, 2003; " norovirus test method" and the Notice No.1201 Article 1 of the Food Inspection and Safety Division December 1, 2009; " hepatitis A virus test method "
  - C. The collected specimens to be subject to Kudoa septempunctata testing shall be delivered in a chilled or a frozen state and handled accordingly.
- (2) Methods of testing
  - A. Enterohaemorrhagic Escherichia coli O26, O103, O104, O111, O121, O145 and O157
    Testing shall be carried out according to the "Detection Method for Enterohemorrhagic E. coli O26, O103, O111, O121, O145 and O157" (Notice No. 1120 Article 3, from the Inspection and Safety Division, dated November 20, 2014) and the "Detection Method for Enterohemorrhagic E. coli O104" (Notice No. 1120, Article 1, from the Office of Imported Food Safety, dated November 20, 2014). In the case thatVTgene is positive, confirmation test for serotype shall be followed.
  - B. Listeria monocytogenes
    Testing shall be carried out according to Test method with simple measuring device certidied by AOAC (hereinafter reffered to as the "Simple Method of Listeria monocytogenes") or the "Detection Method for Listeria monocytogenes" (Notice No. 1128 Article 3, from the Food Safety Department, dated November 28, 2014; hereinafter reffered to as the "Method of Listeria monocytogenes").
    In the case of detection by the Simple Method of Listeria monocytogenes, "the Quantitative Test Method of Listeria monocytogenes" in Attachement 1 of Method of Listeria monocytogenes".
  - C. Norovirus
    Testing shall be carried out according to "Detection Method for Norovirus" (Notice No. 1105001 from the Inspection and Safety Division, dated November 5, 2003).
  - D. Hepatitis A virus
    Testing shall be carried out according to "Detection Method for Hepatitis A Virus" (Notice No. 1201, Article 1, from the Inspection and Safety Division, dated December 1, 2009).
  - E. Salmonella
    Testing shall be carried out according to Test method with simple measuring device certidied by AOAC (hereinafter reffered to as the "Simple Method of Salmonella") or the methods described in "Testing Methods for Salmonella" (Article 3-1-(3) of Annex 1 of Notice Einyu No. 54, dated March 17, 1993) for fish to be eaten raw and "Standard Methods of Analysis in Food Safety Regulation, Microbiological Section II. Section 2-4 Salmonella 1 (1)" for other foods. In the case that it cannot be deterimined as negative by the Simple Method of Salmonella, the above test method shall be carried out.
  - F. Shigella
    Testing shall be carried out according to "Testing Methods for Shigella" in the notice dated January 9, 2002.
  - G. Kudoa septempunctata
    Testing shall be carried out according to "Testing Methods for Kudoa septempunctata" Notice No. 0427 Article 3, from the Inspection and Safety Division, dated April 27, 2016.
  - H. Staphylococcus aureus
    Testing shall be carried out according to "Testing Methods for Staphylococcus aureus" , of Notice Einyu No. 54, dated March 17, 1993.

IV-iv Specification and Standard.

1. Targeted foods
- (1) Foods
  - A. Foods defined by the Specification and Standards for Foods and Food Additives (Notification No. 370 of the Ministry of Health and Welfare, 1959) (Excludes items separately specified in this procedure)
  - B. Foods defined by the Ministerial Ordinance Concerning the Standards for Constituents of Milk and Milk Products ((Excludes pathogenic organism)
  - C. Food indicated in 1(2)
- (2) Items to be inspected and the number of specimens
  - A. Foods that specification and standard is defined
    The number of inspections shall be as listed in Schedule 1.
  - B. Paralytic Shellfish Poison, Diarrheic Shellfish Poison
    Number of Inspections: Bivalves (excluding scallops consisting of adductor muscle only) – 178 inspections; Shellfish other than bivalves – 29inspections
  - C. Mercury
    Number of Inspections: Fish and shellfish – 299 inspections
  - D. PCB
    Number of Inspections: Beef – 59 inspections; Pork – 59 inspections; Fish and shellfish – 147 inspections
  - E. Cadmium and its compounds
    Number of Inspections: Rice –119 inspections
  - F. Radioactive materials
    Beef, pork, chicken, duck meat, other fresh livestock foods, milk products, honey, gelatin, beef extracts, poultry and meat extracts, mushrooms and their dried products, berries and its processed products(processed concentrated berries, puree, paste, preservation in syrup, juice, etc.), spices, herb and its processed products, tea (non-, semi-, and full-fermented) imported from Europe, etc. The number of inspections shall be as specified in the scope of Standards for constituents in Schedule 1.
2. Inspection methods
- (1) Collection of specimens
  - A. Paralytic Shellfish Poison, Diarrheic Shellfish Poison, Mercury and PCB
    Collect the specimens as specified in "Residual hazardous substances in livestock and aquatic foods" in Schedule 4.
  - B. Cadmium and its compounds for rice
    In accordance with Schedule 6.
  - C. Radioactive materials
    Specimens shall be collected according to the methods listed in the inspection item "Radioactive Materials" of Schedule 4.
  - D.In principle, the collected specimens for livestock and aquaculture products shall be delivered to the testing institution in a frozen state and handled accordingly, except for the inspection of bacteria.
- (2) Methods of testing
  - A.Foods that specification nd standard is defined
    Testing shall be carried out according to Ⅰ3 (2).
  - B. Paralytic shellfish poison and diarrhetic shellfish poison
    Testing for paralytic shellfish poisons shall be carried out according to "Method of Inspecting for Shellfish Poison" in Notice Kannyu No. 30, dated July 1, 1980, while diarrhetic shellfish poisons shall be tested according to "Method of Inspecting for Diarretic Shellfish Poison (OAs)" in Notice No. 0306, Article 4 of the Standars and Evaluation Division, Notice No. 0306, Article 2 of the Inspection and Safety Division, dated March 6, 2015.
  - C. Mercury
    Testing for mercury shall be carried out according to Attachments 2 of Notice Kannyu No. 99, dated July 23, 1973.
  - D. PCB
    Testing for PCB shall be carried out according to the method of analysis described in Notice Kanshoku No. 442, dated August 24, 1972.
  - E. Radioactive materials
    Testing shall be carried out according to the methods specified in the "Testing Methods for Radioactive Cesium in Foods" (Notice No. 0315, Article 5 from the Department of Food Safety, dated on March 15, 2012), or "Partial Revision of the Screening Methods for Radioactive Cesium in foods" in the notice dated March 1, 2012.
3. Other
Notes on the inspection of rice take heed of the items in 3. of IV-ⅱ of this Notice when inspecting rice.

IV-v Mycotoxin.

1. Targeted foods
- (1) Agricultural foods and their processed products
  - A.Vegetables
  - B.Fruits
  - C.Grains (Including Minimum Access imported rice and tariffed rice), beans and nuts
  - D.Tea
- (2) Items to be inspected and the number of specimens
  - A. Aflatoxin
    The number of inspections shall be as listed in Schedule 1.
  - B. Patulin
    Number of Inspections: Apple juice (juice produced only from apples) –59 inspections; Apple juice as raw material –59inspections
  - C. Deoxynivalenol (DON)
    Targeting wheat, inspections shall be performed on ships to be separately instructed by the Administration Office.
2. Inspection methods
- (1) Collection of the specimens
  - A. Aflatoxin (rice)
    In accordance with Schedule 6
  - B. Aflatoxin(excluding rice)
    In accordance with the methods detailed in Schedule 5 or the bulk cargo method, and "Sampling in Aflatoxin Inspection" (Notice No. 0922, Article 1 of the Office of Imported Food Safety, dated September 22, 2011).
  - C. Patulin
    In accordance with methods (2) or (3) detailed in the inspection item "Patulin and DON" in Schedule 4
  - D. DON
    In accordance with the methods detailed in the inspection item "Patulin and DON" in Schedule 4 or the bulk cargo method
- (2) Methods of testing
  - A. Aflatoxin
    Testing shall be carried out according to the methods described in the "Testing Methods for Total Aflatoxin" (Notice No. 0816, Article 2 of the Food Safety Department, dated August 16, 2011) or other methods equivalent to it.
  - B. Patulin
    Testing shall be carried out according to the Notification method. (Notice No. 1222, Article 5 of the Food Safety Department, dated December 22, 2014).
  - C. DON
    Testing shall be carried out according to the Notification method. (Notice No. 0717002 of the Food Safety Department, dated July 17, 2003).
3. Other
- (1) Notes on the inspection of rice take heed of the items in 3. of IV-ii of this Notice when inspecting rice.
- (2) Dealing with the results of DON inspections
  When the result of a DON inspection exceeds the temporarily set standard value for DON listed in the "Setting the Temporary Standard Value for Deoxynivalenol in Wheat" (Notice No. 0521002 from the Food Safety Department, dated May 21, 2002), instructions shall be given to the importer to take voluntary restriction measures of import, sales, etc., in accordance with item 3 of the said notice.

IV-vi Recombinant DNA Techniques

1. Targets
- (1) Genetically modified foods whose safety inspection procedures has not been undergone
  - A. Rice and its products
  - B. Rapeseed and its products
  - C. Papaya and its products
  - D. Wheat
  - E. Potatos and its products
  - F. Salmon and its products
- (2) Items to be inspected and the number of specimens
  - A. 63Bt, NNBt and CpTI rice
    Number of inspections: Rice and its products (made mainly of rice and unheated or heated lightly products, such as rice flour and rice vermicelli) – 299 inspections
  - B. RT73 B.rapa
    Number of inspections: Rapeseed and its products – 29 inspections
  - C. PRSV-YK, PRSV-SC and PRSV-HN
    Number of inspections: Papaya and its products (Limited to products that can be separated from the others) – 299 inspections
  - D. MON71100/71300, MON71200, MON71700 and MON71800
    MON71200：Targeting Wheat produced in Canada –59 inspections, MON71100/71300, MON71700 and MON71800：Targeting Wheat produced in U.S.A. –59 inspections shall be performed on ships to be separately instructed by the Administration Office.
  - E. F10 and J3
    Number of inspections: Potatos and its products (made maily of potato, such as fried potato and potato chips) – 59 inspectionsInspection methods
  - F. AquAdvantage
    Number of inspections: Salmon to be imported from Canada, Panama and the United States.– 59 inspections
2. Inspection methods
- (1) Collection of the specimens
  Speciments shall be collected according to the "Inspection Methods for Foods Produced Using Unreviewed Recombinant DNA Techniques" (Notice No.1116, Article 4 of the Food Safety Department, dated November 16, 2012; Final revision-Notice No.0813, Article 2 of the Environmental Health and Food Safety Department, dated August 13, 2019) However, if testing is to be conducted with other tests such as residual agricultural chemicals, a total of 2kg of specimen shall be collected.
- (2) Methods of testing
  Testing shall be carried out according to the " Inspection Methods for Foods Produced Using Unreviewed Recombinant DNA Techniques" (Notice No.1116, Article 4 of the Food Safety Department, dated November 16, 2012; Final revision-Notice No.0709, Article 6 of the Environmental Health and Food Safety Department, dated July 9, 2018)
3. Other
Notes on the inspection of rice take heed of the items in 3. of IV-ii of this Notice when inspecting rice.

IV-vii Irradiated Foods

1. Targets
- (1) Livestock foods, aquatic foods and agricultural foods
  Food indicated through "Detection Methods for Irradiated Foods" (Notice No. 0706002 from the Department of Food Safety, dated July 6, 2007, The last revision : Notice No.1128, Article 4 of the Environmental Health and Food Safety Department, dated on November 28, 2018)
- (2) Items to be inspected and number of inspections
  Inspection shall be carried out to find evidence of irradiation. The number of inspections shall be as specified in Schedule 1.
2. Inspection methods
- (1) Collection of specimens
  Specimens shall be collected according to the methods listed in the inspection item "Irradiation" of Schedule 4.
- (2) Methods of testing
  Testing shall be carried out according to the methods specified in the "Detection Methods for Irradiated Foods" (Notice No. 0706002 from the Department of Food Safety, dated July 6, 2007, The last revision : Notice No.1128, Article 4 of the Environmental Health and Food Safety Department, dated on November 28, 2018).
3. Other
- (1) Standard dose of Irradiation
  Standard irradiation for specimens shall be entrusted to the following organization:
  A.Nuclear Fuel Industries, Ltd. Kumatori Works
  1-950 Asashiro-Nishi, Kumatori-cho, Sennan-gun, Osaka, 590-0481
  TEL: 072-452-3901 FAX: 072-453-3559
  B.Kansai Electron Beam Co.,Ltd.
  1-3-3 Matsubara,Mihama,Mikata District,Fukui, 919-1122
  TEL: 0770-32-3371 FAX: 0770-32-3374
- (2) Dealing with inspection results
  Detection of radiation, if any, shall be treated as a violation of Section 2, Article 11 of the Act, and it shall be confirmed from the importer whether there is presence of irradiation in the producing countries of the products as well as of raw materials.

V. Implementation Guidelines for Monitoring Inspections Concerning Planned Imported Foods

1. Implementation of the inspection
- (1) Inspection at the time of initial declaration
  For agricultural products under the importation procedures stipulated in Section 4, Article 32 of the Ordinance for Enforcement of the Act, on-site inspection and inspection for residual agricultural chemicals must be conducted upon their initial declaration. For cases where reports of voluntary inspection are attached and the monitoring inspection for residual agricultural chemicals seems unnecessary, confirm with the Office of Import Food Safety, by way of the Administration Office.
- (2) Confirmation of cargo information
  Contact the relevant importer in the previous month of the planned arrival date, and confirm the date of importation, the freight handling schedule, the name of the custom broker, and other information required for inspection. If the cargo will clear the customs aboard ship, sufficiently coordinate with the importer to realize smooth collection of specimens, and ensure that the quarantine station that has jurisdiction over the arrival port will collect the specimens appropriately.
2. Collection of the specimens
The quarantine station that has accepted the initial declaration shall implement the monitoring inspection according to the importation plan submitted by the importer, in consideration of the time of importation, the area of production, etc., approximately at the frequencies indicated below.
In the case where the number of inspections instructed in this Implementation Guidelines can not be implemented with the following frequency, increase the frequency of monitoring inspection.
In cases where the targeted cargo arrives at a port under the jurisdiction of another quarantine station, consult with the relevant station to develop an appropriate inspection plan.

Annual number of imports under the importation plan (from the second time on) Times of monitoring (from the second time on)

11－40 1

41 ≦ 2
3. Other
In the inspection specified in 2., a huge amount of cargo needs to be promptly dealt with if the cargo is identified as violating the Act and its same lot unloaded at more than one ports. Therefore, it shall be ensures that the inspection will be implemented at the first port.

Annual number of imports under the importation plan (from the second time on)	Times of monitoring (from the second time on)
11－40	1
41 ≦	2