Ministry of Health, Labour and Welfare


Notice No. 0330 Article 2 of the Office of Imported Food Safety

March 30, 2010

To: Head of each quarantine station

From: Head of the Office of Import Food Safety,

Inspection and Safety Division,

Department Food Safety,

Pharmaceutical and Food Safety Bureau

(Seal Omitted)

Implementation of " Imported Foods Monitoring Plan for FY 2010"

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 2010.

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, etc. has been violated.


Annex

Imported Foods Monitoring Plan for FY 2010
I. Implementation Guidelines for Monitoring Inspections Concerning Imported Foods (common items)

1. Implementation period

From April 1, 2010, to March 31, 2011

2. Targets

(1) Targeted foods
A. Foods listed in Schedule 1-1, 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 the exporting country; ii) foods registered on a pre-checking system for imported foods; and iii) the same foods that are continuously imported, with previous inspection reports.
(2) Items to be inspected

Regarding the food groups specified in Schedule 1-1, inspection must be conducted on items specified in ordinances or notifications of the Ministry of Health, Labour and Welfare, i.e. additives, toxic and hazardous substances, and pathogenic microorganisms, etc.

(3) Number of specimens

Follow the guidelines in Schedule 1-1, 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 and Communication Division (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 compared to an average year or items whose import has been newly approved, an inspection should be implemented at any time, regardless of Schedule 1-1.

Further, the enhancement of monitoring inspections to be implemented upon the discovery of a violation of the Act concerning residual agricultural chemicals shall follow Schedule 1-2, whereas instructions given to manufacturers, exporters, or packagers to conduct voluntary inspections after violating relevant Acts shall follow Schedule 1-3. In principle, inspections will be carried out in line with the usual monitoring system after 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. Schedule 1-2 and/or Schedule 1-3 will be revised when usual monitoring resumes.

In order to carry out monitoring efficiently and effectively, more than one inspection should be implemented for one specimen.

3. Inspection methods

(1) Collection of specimens

Specimens shall be collected according to Schedule 2, in line with Article 28 of the Act. The specimens shall be collected from randomly selected inspection targets, under instructions from the food sanitation monitors, so that the specimens will be appropriately representative of the entire lot.

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, December 28, 1959) (hereinafter referred to as the "notified method")

B. Testing methods defined by the Ministerial Ordinance Concerning the Standards for Constituents of Milk and Dairy Products (Ministerial Ordinance No. 52 of the Ministry of Health and Welfare, December 27, 1951)

C. Testing methods defined by the Notices from Directors of 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 individual divisions in charge of inspection, as separately specified by the Administration Office or the trustee agreement signed at the quarantine stations.

Sufficient prior coordination is required with the representative of the receiving organization, so that the specimens are sent and received appropriately, and that the testing of them can be carried out smoothly.

5. Reporting results

If a violation is found in the monitoring inspection, importers should be provided with instructions to confirm the cargo status, and reports on the violation should be promptly submitted to the Office of Import Food Safety using the form for reporting violations of the Act.

6. Other precautions
(1) 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.

(2) Collection of specimens from bulk cargo

For grains, beans and other products in bulk, take necessary 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.

Also obtain information as to 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.

(3) 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

(1) Livestock and aquatic foods, and their processed products

A. Meat (including internal organs)

B. Processed meat products

C. Cheeses and other milk/dairy products

D. Honey-related products (honey, royal jelly, pollen, etc.)

E. Aquatic foods (fish (such as eel, salmon/trout and flounder), aquatic animals (such as prawns, squid and octopus), and shellfish (excluding scallops consisting of adductor muscle only), etc.)

(2) Items to be inspected and the number of specimens
A. Antibiotics, etc.

Items subject to inspections are as listed in Schedule 4 and inspections are performed on the items subject to analysis as described in each test method. The number of inspections is as listed in Schedule 1-1.

B. Residual agricultural chemicals

Items subject to inspections are as listed in Schedule 5 and inspections are performed on the items subject to analysis as described in each test method. The number of inspections is as listed in Schedule 1-1.

C. Others
(a) Enterohemorrhagic E. coli O157 and O26

Number of Inspections: Beef - 598 inspections; Horse meat - 59 inspections; Unheated meat products to be consumed without further cooking - 119 inspections; Natural cheese - 299 inspections

(b) Listeria

Number of Inspections: Unheated meat products to be consumed without further cooking - 119 inspections; Natural cheese - 299 inspections

(c) Norovirus

Number of Inspections: Bivalves to be eaten raw - 119 inspections; Shellfish other than bivalves to be eaten raw - 5 inspections

(d) Hepatitis A Virus

Number of Inspections: Bivalves to be eaten raw - 119 inspections; Shellfish other than bivalves to be eaten raw - 5 inspections

(e) Paralytic Shellfish Poison, Diarrheic Shellfish Poison

Number of Inspections: Bivalves - 299 inspections; Shellfish other than bivalves - 5 inspections

(f) Mercury

Number of Inspections: Fish and shellfish - 299 inspections

(g) PCB

Number of Inspections: Beef - 59 inspections; Pork - 59 inspections; Fish and shellfish - 119 inspections

(h) Pufferfish being mixed

Number of Inspections: Dried thread-sail filefish product - 5 inspections; Sliced anglerfish and/or its internal organs - 29 inspections;

2. Inspection methods

(1) Collection of specimens

A. Collect the specimens as specified in "Residual hazardous substances in livestock and aquatic foods" in Schedule 2 for residual agricultural chemicals, such as antibacterial substances (excluding high grade processed food), mercury and PCB. The quantity declared in each import declaration shall be handled as one lot.

B. The collected specimens other than those to be subject to microorganism testing 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 both methods, the positive substance must be identified and quantified.

B. Residual agricultural chemicals

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.

C. Streptomycin

Honey shall be examined according to Attachment 2 in Annex 2 of the Notice No. 0329005 from the Inspection and Safety Division dated March 29, 2002.

D. Nitrofurans

Testing shall be carried out on AOZ (3-amino-2-oxazolidinone), 1-aminohydantoin, 3-amino-5-morpholinomethyl-2-oxazolidinone and nitrofurazone, according to the Notification method.

E. Enterohaemorrhagic Escherichia coli O157 and O26

Testing shall be carried out according to the "Detection Method for Enterohemorrhagic E. coli O-157 and O-26 in Foods," which was annexed in the "Detection Methods for Enterohemorrhagic E. coli O-157 and O-26." (Notice No. 1102006 from the Inspection and Safety Division, dated November 2, 2006)

F. Listeria monocytogenes

Testing shall be carried out according to "Prevention of Contaminations of Milk and Dairy Products by Listeria" in Notice Einyu No. 169, dated August 2, 1993.

G. Norovirus

Testing shall be carried out according to "Detection Method for Norovirus" (Notice No. 1105001 from the Inspection and Safety Department, dated November 5, 2003).

H. Hepatitis A virus

Testing shall be carried out according to "Method of Inspection for Hepatitis A Virus in Food and Feces" (Notice No. 0816001 from the Inspection and Safety Division, dated August 16, 2002).

I. 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" in Notice Kannyu No. 37, dated May 19, 1981.

J. Mercury

Testing for mercury shall be carried out according to Attachments 1 and 2 of Notice Kannyu No. 99, dated July 23, 1973.

K. PCB

Testing for PCB shall be carried out according to the method of analysis described in Notice Kanshoku No. 442, dated August 24, 1972.

L. Pufferfish being mixed

Testing for pufferfish shall be carried out according to "Testing method for pufferfish in imported processed fish products," Notice No. 0330003 of the Office of Imported Food Safety, dated March 30, 2009.


III. Implementation Guidelines for the Monitoring Inspection of Vibrio Parahaemolyticus Related to Fresh Fish and Shellfish to be Eaten Raw

1. Implementation period, and targets of the inspection

(1) Food products subject to enhanced inspection
A. Implementation period

From June 1 to October 31, 2010

B. Targeted foods

(a) Foods in which violations concerning Vibrio parahaemolyticus were identified, in the monitoring inspection conducted at the quarantine stations in FY 2009.

a. Sea urchin from China to be eaten raw

b. Ark shells from South Korea to be eaten raw

c. Sea urchin from South Korea to be eaten raw

d. Boiled octopus from China

(b) Foods in which violations concerning Vibrio parahaemolyticus were not identified in the monitoring inspection of FY 2009, but in which violations were identified in the inspection of FY 2008.

Sea urchin from the Philippines to be eaten raw

(c) If a legal violation is identified in a food in 1.(2) below, the relevant food of the relevant country in legal violation shall be thereafter handled as "Food products subject to enhanced inspection" of 1.(1) above.

(2) Food products other than those subject to enhanced inspection
A. Implementation period

From April 1, 2010, to March 31, 2011

B. Targeted foods

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 December 1959).

(3) Items to be inspected

Vibrio parahaemolyticus

(4) Number of specimens

Inspections shall be carried out for every import declaration for the foods specified as targeted foods in (a) and (c) of 1.(1) B. above during the designated period, and for 30% of all import declarations for the foods specified in (b) of 1.(1) B. above. Outside the designated period, testing for both 1. (1) and (2) shall be carried out within the range of the numbers of specimens for each item, specified in the "Standards for constituents" for processed seafood in Schedule 1-1.

2. Inspection methods

(1) Collection of the specimens

Specimens shall be collected according to "Microorganisms" in the inspection items of Schedule 2.

(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 with the provision of Notice No. 23 from the Standard and Evaluation Division, dated June 29, 2001.

3. Other

(1) Sampling of inspection targets

In the collection of specimens of foods specified in 1. (2), be very efficient, especially in summer, mainly for sea urchins to be eaten raw and shellfish with a high risk of contamination, in careful consideration of the food types, the exporting countries, the treating facilities, the importers, and past inspection records.

(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, attention should be paid to the following points in the issuance:

A. With regard to the food products specified in 1. (1), in order 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.
B. With regard to the food products specified in 1. (2) above, instructions shall be provided to importers in advance that they obtain information on the storage and distribution of the products concerned. The purpose of this measure is to make possible an immediate backward traceability investigation and recall of the relevant products, if it is verified that the products are in violation of the Act.
(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), if the results of the inspection indicate that the most probable number of Vibrio parahaemolyticus is less than 100/g but more than 3.0/g, instructions shall be provided to importers that they strictly observe the preservation standards in the storage and distribution of the products in Japan, in order to prevent Vibrio parahaemolyticus from propagating to cause food poisoning. 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 storage of food products, and submission of import declarations for each plant as a separate lot, if the food product is manufactured at different plants.


IV. Implementation Guidelines for Monitoring Inspection for Residual Agricultural Chemicals in Agricultural Foods

1. Targeted foods

(1) Agricultural foods, and their processed products

A. Vegetables

B. Fruits

C. Grains (Minimum Access imported rice and tariffed rice), beans and nuts

D. Tea

(2) Items to be inspected and the number of specimens
A. Residual agricultural chemicals

Items subject to inspections are as listed in Schedule 5 and inspections shall be performed on the items subject to analysis as described in each test method. The number of inspections is as listed in Schedule 1-1.

B. Aflatoxin

The number of inspections shall be as listed in Schedule 1-1.

C. Patulin

Number of Inspections: Apple juice (juice produced only from apples) - 59 inspections; Apple juice as raw material: 59 inspections

D. Deoxynivalenol (DON)

Targeting wheat, inspections shall be performed on ships to be separately instructed by the Administration Office.

E. Cadmium and its compounds

Number of Inspections: Rice 299 inspections

2. Inspection methods

(1) Collection of the specimens
A. Agricultural chemical residue (excluding rice)

In accordance with the methods detailed in the inspection item "Agricultural Chemicals" in Schedule 2 or in accordance with the bulk cargo method

B. Agricultural chemical residue, aflatoxin and cadmium and its compounds in rice

In accordance with Schedule 3

C. Aflatoxin (excluding rice)

In accordance with the methods detailed in the inspection item "Aflatoxin" in Schedule 2 or in accordance with the bulk cargo method

D. Patulin

In accordance with methods (2) or (3) detailed in the inspection item "Patulin" in Schedule 2

E. DON

In accordance with the methods detailed in the inspection item "Aflatoxin" in Schedule 2 or in accordance with the bulk cargo method

(2) Methods of testing
A. Residual agricultural chemicals

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.

B. Aflatoxin

Testing shall be carried out according to the methods described in the "Handling of Food Products Contaminated with Mycotoxin (Aflatoxin)" (Notice No. 0326001 from the Inspection and Safety Division, dated March 26, 2002) or other methods equivalent to it.

However, verification assays shall be carried out on the toxins detected by other methods in accordance with the methods specified in the said notice.

C. Patulin

Testing shall be carried out according to the Notification method.

D. DON

Testing shall be carried out according to Schedule 2 in the "Setting the Temporary Standard Value for Deoxynivalenol in Wheat" (Notice No. 521002 from the Food Safety Department, dated May 21, 2002).

E. Cadmium and its compounds

Testing shall be carried out according to the Notification method.

3. Other

(1) 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 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)

(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. 521002 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.


V. Implementation Guidelines for the Monitoring Inspection of Foods Produced Using Recombinant DNA Techniques

1. Targets

(1) Genetically modified foods whose safety has not been certified

A. Papaya and its processed products

B. Rice and its processed products

C. Rapeseed and its processed products

(2) Content rate of genetically modified foods whose safety has been certified

A. Corn and ground corn products (limited to corn grits, cornflour, cornmeal, other ground products and their preparations, in which proteins newly expressed as a result of genetic modification undergo no physiochemical change)

B. Soybeans and ground soybean products (limited to products in which proteins and DNA newly expressed as a result of genetic modification undergo no physiochemical change)

(3) Items to be inspected and the number of specimens

Items to be inspected and the number of specimens shall conform with Schedule 6.

2. Inspection methods

(1) Collection of the specimens
A. Corn, papaya, soybean, rapeseed and their products, and rice products

Specimens shall be collected according to the methods specified in the "Inspection Methods for Foods Produced Using Recombinant DNA Techniques" in Notice No. 110 from the Food Safety Department, dated March 27, 2001.

As to the testing specified in 1.(2), check whether the confirmation of separate production and distribution management has been properly performed, according to the relevant certificates and shipment documents.

B. Rice (excluding rice products)

Specimens shall be collected according to Schedule 3. 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
A. Corn, papaya, soybean and their products

Testing shall be carried out according to the "Inspection Methods for Foods Produced Using Recombinant DNA Techniques" in Notice No. 110 from the Food Safety Department, dated March 27, 2001, and "Inspection Methods for Foods Produced Using Recombinant DNA Techniques (Supplemental) " in Notice No. 0803, Article 8, from the Department of Food Safety, dated August 3, 2009.

B. Rice and its products
(a) CrylAc, CrylAb, CrylF, Cry9c, and Cry3Bb (Cry3Bb1) among the new Bt proteins that are made by genetic modification

Testing shall be carried out according to the methods of commercially available lateral flow strip type test kits (Seed Bulk Test Bt1Ac (for Cry1Ac), Trait Corn Bulk Test Bt1 (for Cry1Ab), Trait Corn Bulk Test Bt1F (for Cry1F), Trait Corn Bulk Test CryBt9 (for Cry9c), and Trait Corn Bulk Test Cry3Bb (for Cry3Bb (Cry3Bb1), of Strategic Diagnostics, Inc. (SDI)). Testing procedures shall basically follow the test kit instructions. Samples used shall be collected randomly in the required volume for each test kit (9 g for Cry1Ac test kit, 25 g for Cry1F test kit, and 200 g to be used commonly for the other test kits), from 1 kg of rice collected as specimen and ground. In the test kit for Cry1Ac, the time for setting the Bt1Ac test strip up in the supernatant shall be 20 minutes.

(b) Modified DNA that produces Bt Protein (CrylAc protein)

Testing shall be carried out according to the "Detection of Rice Products from China Whose Safety Has Yet to Be Examined." (Notice No. 0126006 from the Inspection and Safety Division, dated January 26, 2007)

(c) LLRICE601

Testing shall be carried out according to the "Handling of Rice (Long-grain) from the United States and Its Products." (Notice No. 0915002 from the Office of Import Food Safety, dated September 15, 2006)

C. Rapeseed and its processed products

Testing shall be carried out according to the "Temporary Testing Methods for Genetically Modified Brassica rapa (RT73 B. rapa) whose Safety Has Yet to Be Examined (Revised)" (Notice No. 0914, Article 5, from the Inspection and Safety Division, dated September 14, 2009).

3. Reporting results, and responding actions

(1) Handling of corn or soybeans containing genetically modified ingredients at a level of over 5%

If the content ratio of genetically modified foods is found to be over 5% in corn or soybeans, despite the fact that its import declaration states that it is not genetically modified, or that the declaration does not contain statements concerning genetic modification, the relevant importers shall be provided instructions to investigate whether separate production and distribution management has been properly performed. If it is ascertained in the investigation that separate production and distribution management, based on the relevant certificates and other documents, has not been properly performed, the importers shall be provided instructions to revise the relevant information in the import declarations according to Article 27 of the Act and investigate the status of the cargo. Contact must be made promptly with the Office of Import Food Safety, by way of the Administration Office.

(2) Notes on the inspection of rice

Take heed of the items in 3. of IV of this Notice when inspecting rice.


VI. Implementation Guidelines for Monitoring Inspection of Irradiated Foods

1. Targets

(1) Livestock products, agricultural products and seafood

Food indicated through "Detection Methods for Irradiated Foods" (Notice No. 0330 Article 3 from the Department of Food Safety, dated March 30, 2010)

(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 1-1.

2. Inspection methods

(1) Collection of specimens

Specimens shall be collected according to the methods listed in the inspection item "Irradiation" of Schedule 2.

(2) Methods of testing

Testing shall be carried out according to the methods specified in the "Detection Methods for Irradiated Foods" (Notice No. 0330 Article 3 from the Department of Food Safety, dated on March 30, 2010).

3. Other

(1) Standard dose of Irradiation

Standard irradiation for specimens shall be entrusted to the following organization:

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

(2) Dealing with inspection results

Detection of radiation, if any, shall be treated as a violation of 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.


VII. 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 disposal schedule, the name of the customs 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 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 belonging to the same lot is dealt with at more than one port and if that cargo is identified as violating the Act. Therefore, it shall be ensures that the inspection will be implemented at the first port.


Return To Top