Ministry of Health, Labour and Welfare


Contact:
Office of Import Food Safety,
Inspection and Safety Division,
Department of Environmental Health and Food Safety,
Pharmaceutical Safety and Environmental Health Bureau,
Ministry of Health, Labour and Welfare

Inspection Results of Imported Foods Monitoring
and Guidance Plan for FY 2016

Interim Report

December 2016
Department of Environmental Health and Food Safety
Pharmaceutical Safety and Environmental Health Bureau
Ministry of Health, Labour and Welfare


Inspection Results of Imported Foods Monitoring and Guidance Plan for FY 2016 (Interim Report)

1. Introduction

In order to ensure the safety of foods, etc., imported into Japan (hereinafter, “imported foods”), the government established the Imported Foods Monitoring and Guidance Plan for 2016 (hereinafter, “the Plan”) as per the regulations of Article 23, paragraph 1 of the Food Sanitation Act (Act No. 233, 1947; hereinafter, “the Act”), and monitoring and guidance for imported foods is being conducted based upon the Plan.
(The Plan is formulated based on the Guidelines for Monitoring and Guidance for Food Sanitation (Ministry of Health, Labour and Welfare Notification No. 301 of 2003) after conducting collection of public comments and risk communication. The plan is published in the Official Gazette as an official report according to the regulations of Article 23, paragraph 3 of the Act.)
This document publishes an outline of the implementation status of the monitoring and guidance for imported foods, conducted in accordance with the plan, for the period from April to September 2016.

Reference: Website on “For the Safety of Imported Food”

Safety of Imported Food

2. Overview of the Imported Foods Monitoring and Guidance Plan for FY 2016

(1) What is the Imported Foods Monitoring and Guidance Plan?

It is the plan for the implementation of monitoring and guidance for the import of foods by the Japanese government as stipulated by Article 23, paragraph 1 of the Act.

[Purpose] To further ensure the safety of imported foods by the national government promoting intensive, effective and efficient monitoring and guidance for imported foods and importers.

(2) Principles for Monitoring and Guidance on Imported Foods

Under the Article 4 of the Food Safety Basic Act (Act No.48 of 2003) (that is, Food safety shall be ensured by taking the necessary measures appropriately at each stage of the domestic and overseas Food Supply Processes.), the Plan is prepared in order that three stages of food safety measures are taken, namely, in the exporting country, at the time of importation, and at the time of domestic distribution.

(3) Priority Items for Monitoring and Guidance

*1: Systematic inspections based on statistical approach considering that take into account the volume of imports, violation rates and other factors, for each food type, in order to broadly monitor a wide variety of imported foods.

*2: Inspection for products with a high probability of violation where an inspection is ordered for the importer, and import and distribution is not permitted without the results being in compliance with the Act (Article 26 of the Act).

*3: Regulations by which the Minister of Health, Labour and Welfare may prohibit the sale or import of specified foods, without inspections, in cases where it is deemed specifically necessary from the perspective of preventing harm to public health (Articles 8 and 17 of the Act).

(4) Promotion of Foods Safety Measures in Exporting Countries
(5) Guidance for Importers on Voluntary Safety Control

3. Results of Imported Foods Monitoring and Guidance Plan for FY 2016 (Interim Report: Tentative)

The number of import notifications made from April through September of 2016 was 1,161,978 [1,134,155], and the weight of notified items was 11,874,000 tons [11,416,000 tons] (Table 1).

 Inspections were carried out on 98,172 items (monitoring inspections on 29,387 items, ordered inspection on 27,641, and independence inspection on 45,285 items, deducting duplicates) [101,922 items (monitoring inspections on 28,539 items, ordered inspection on 31,764 items, and independence inspections on 47,067 items, deducting duplicates)]. Of these, 358 cases [431 cases] were found to be in violation of the Act, and steps were taken for their reshipment, disposal, etc.

 Regarding violations categorized by provision, violations of Article 11 of the Act (compositional standards for food (microbial, agricultural chemical residues and veterinary drug residues) and standards for the use of additives in food, etc.) were the most common in 224 cases, followed by 89 cases in violation of Article 6 (adhesion of hazardous or toxic substances such as aflatoxin), 38 cases in violation of Article 18 (standards for apparatus or containers and packaging), 12 cases in violation of Article 10 (use of undesignated additives), 3 cases in violation of Article 9 (absence of health certificates of meat), and 2 cases in violation of Article 62 (standards for toys) (Table 2).

Monitoring inspection was conducted for 29,387 cases (58,416 cases compared to the planned cumulative total of 95,929 (implementation rate: approx. 61%)), and of which, 72 cases (running total of 76 cases) were confirmed to be in violation of the Act, and steps were taken for their recalls, etc. (Table 3). For imported foods that were found to be in violation of the Act by monitoring inspection, the inspection rate to 30% as necessary, to identify probable of violations (Table 4). Additionally, for imported foods that are considered to have a high probability of violating the Act, inspections were strengthened by making them subject of ordered inspections (Table 5).

 As of September 30, 2016, 17 items from all exporting countries and 72 items from 34 countries and 1 region were made subject to ordered inspection, and inspection was carried out for 27,641 cases (running total of 41,742 cases). Of these, violation of the Act was found in 111 cases (running total of 111 cases), and steps were taken for their reshipment or disposal, etc. (Table 6).

 As an emergency measures based on information from overseas, etc., reshipment, etc., was carried out for frozen vegetables and fruits potentially contaminated with Listeria monocytogenes from the USA. (Table 7).

Figures in brackets are for the same period in the previous year.

Table 1.Notification, Inspection and Violation (Apr­Sep 2016: Tentative)
Notifications
(cases)*1
Imported Weight
(thousand tons)*1
Inspections*2
(cases)
Proportion
*3
(%)
Violations
(cases)
Proportion
*3
(%)
1,161,978 11,874 98,172 (27,641) *4 8.4 358 0.03
(FY2015)
1,134,155
11,416 101,922 9.0 431 0.04

*1 Cargoes of planned Import System (excluding time of first importation.) are not included.

*2 Inspections by authorities, registered inspection organizations and foreign official laboratories, deducting duplicates.

*3 Proportion as compared to notifications.

*4 Number of ordered inspections.

Table 2. Violations by Legal Provision (Apr­Sep 2016: Tentative)
Provision violated Violations
(cases)
Proportion (%) Brief details of Violations
Article 6
(Foods and Additives prohibited to distribute)
89 24.2 Aflatoxin contamination in almonds, spices, corn, job’s tears, pistachio nuts, peanuts etc.; detection of cyanide; decay, deterioration and generation of mold due to accidents during the transport of barley, coffee beans, rice, wheat, soybeans; detection of Enterohemorrhagic Escherichia coli O103 from kimchi etc.,
Article 9
(Limitation on distribution, etc. of diseased meat)
3 0.8 No health certificate attached or incomplete
Article 10
(Limitation of distribution, etc. of additives)
12 3.3 Use of undesignated additives (TBHQ, azorubin, carbon monoxide, cyclamic acid, sodium ethoxide, potassium iodized, etc.)
Article 11
(Standards and criteria for foods and additives)
224 60.9 Violation of standards for constituents for vegetables or frozen vegetables (excess of standards on residual agricultural chemicals),  violation of standards for constituents for meat, aquatic foods and processed products (excess of standards on residual veterinary drugs, excess of standards on residual agricultural chemicals),  violation of standards for constituents for other processed products (coliform bacteria positive, etc.), violation of criteria on use of additives (sucralose, sorbic acid, sulfur dioxide, etc.), violation of standards for constituents for additives, excess of standards on radioactive substance, detection of  unauthorized genetically modified, etc.
Article 18
(Standards and criteria for apparatus, containers and packaging)
38 10.3 Violation of standards for apparatus, containers and packaging
Violation of materials standards for raw materials
Article 62
(Mutatis mutandis application for toys)
2 0.5 Violations of standards for toys
Total 368(Gross )*1
358(Actual )*2
 

*1 Gross number of inspection cases by inspected substances

*2 Number of notification cases for which inspections were carried out

Table 3. Implementation of Monitoring Inspections (Apr­Sep 2016: Tentative)
Food Groups Inspected Substances *1 Planned Number in FY*2 Actual Number Violations
Livestock Foods
Beef, pork, chicken, horse meat, other poultry meat, etc.
Antibacterial substances, etc. 1,879 1,054 1
Residual agricultural chemicals 1,191 974 0
Additives 118 65 0
Pathogenic microorganism 657 340 0
Standards for constituents 415 260 0
Radiation irradiation 29 18 0
Removal of SRM - 1,102 3
Processed Livestock Foods
Natural cheeses, processed meat products, ice cream, frozen (meat) products, etc.
Antibacterial substances, etc.  2,182 1,354 0
Residual agricultural chemicals 1,697 1,139 0
Additives 1,247 820 0
Pathogenic microorganism 3,584 2,231 0
Standards for constituents 1,937 1,224 2
Mycotoxins - 3 0
Genetically modified food - 2 2
Aquatic Foods
Bivalves, fish, crustacea(shrimps, crabs), etc.
Antibacterial substances, etc. 2,572 1,407 1
Residual agricultural chemicals 1,134 1,080 0
Additives 297 166 0
Pathogenic microorganism 1,074 792 0
Standards for constituents 354 265 0
Radiation irradiation 34 21 0
Processed Aquatic Foods Processed fish products (fillet, dried or minced fish, etc.), frozen food (aquatic animals, fish), processed marine product eggs, etc. Antibacterial substances, etc. 4,234 3,033 3
Residual agricultural chemicals 4,111 3,012 0
Additives 1,894 1,424 0
Pathogenic microorganism 4,661 3,176 1
Standards for constituents 4,930 2,734 20
Radiation irradiation - 3 0
Agricultural Foods
Vegetables, fruits, wheat, maize, pulses, peanuts, nuts, seeds, etc.
Antibacterial substances, etc. 2,559 1,975 0
Residual agricultural chemicals 9,190 5,507 15
Additives 474 384 0
Pathogenic microorganism 1,495 997 0
Standards for constituents 355 250 0
Mycotoxins 2,273 1,279 0
Genetically modified food 469 241 0
Radiation irradiation 119 111 0
Processed Agricultural Foods
Frozen food(vegetables), processed vegetable products, processed fruit products, spices, instant noodles, etc
Antibacterial substances, etc. 598 440 0
Residual agricultural chemicals 6,800 4,781 5
Additives 4,551 3,425 1
Pathogenic microorganism 956 914 1
Standards for constituents 2,648 1,844 4
Mycotoxins 2,774 1,759 0
Genetically modified food 252 185 0
Radiation irradiation 424 285 0
Other Foods
Health foods, soups, seasonings, confectionery, cooking oil and fat, frozen food, etc.
Antibacterial substances, etc. - 2 0
Residual agricultural chemicals 1,074 716 0
Additives 3,344 1,981 1
Pathogenic microorganism - 1 0
Standards for constituents 598 319 4
Mycotoxins 955 639 0
Genetically modified food - 2 0
Beverages
Mineral waters, soft drinks, alcoholic drinks, etc.
Residual agricultural chemicals 118 130 0
Additives 1,075 743 0
Standards for constituents 657 404 1
Mycotoxins 178 94 0
Additives / Apparatus, containers and packaging / Toys Standards for constituents 1,762 1,309 11

Total (gross)

95,929*3

58,416
Implementation
rate of 61%

76

*1: Examples of inspected substances

*2:The number of item-by-item programs planned of antibacterial substances, agricultural chemicals, etc.

*3:10,000 cases planned as enhanced monitoring were added to the number of items by item of each food groups

Table 4. Items Subject to Enhanced Monitoring Inspections*1(Apr-Sep 2016*2 )
Country/Region Subject Item Inspected Substances
India Cardamom immature fruit Triazophos
Cumin seeds Iprobenfos

Chickpea

Aflatoxin
Fennel seed Iprobenfos
Profenofos
China Taro Chlorpyrifos
Lotus seeds Aflatoxin
Cultured shrimp Malachite green
Lychees (Liche) 4-Chlorophenoxyacetic acid
Thailand Red hot pepper Propiconazole
Shrimp for raw consumption Vibrio parahaemolyticus (MPN) *3
Boiled crab for raw consumption Vibrio parahaemolyticus*3
Vietnam Shrimp Chloramphenicol
Cultured shrimp Sulfadiazine
Sulfamethoxazole
Philippines Sea urchin for raw consumption Vibrio parahaemolyticus (MPN) *3
Boiled octopus Vibrio parahaemolyticus *3
Ecuador Cacao beans Malathion
South Korea Ark shells for raw consumption Vibrio parahaemolyticus (MPN) *4
Spain Pistachio processed products Aflatoxin
France Pigeon meat Oxytetracycline
USA Corn (popcorn only) Pirimiphosmethyl

*1 Include the Items which were rescinded from inspection orders.If no similar violations were detected within 60 enhanced monitoring inspections or within 1 year, the items in question were subjected to the normal inspection state.

*2 Excludes items included in Table 5.

*3 Item which all (100%) import declarations were inspected as a measure to enhance inspections during the summer period, (Jun-Oct 2016).

*4 Item which 30% of import declarations were inspected as a measure to enhance inspections during the summer period, (Jun-Oct 2016)

Table 5. Items transferred to Inspection Order (Apr-Sep 2016)
Country/Region Subject Item Inspected Substances
South Korea Kimchi (manufacturers limited) Enterohemorrhagic E. coli O103
Oriental melon Chlorfenapyr
Egypt Calendula (Calendula officinalis) Chlorpyrifos
Spain Non glutinous rice Tebuconazole
Thailand Boiled crab (manufacturers limited) Vibrio parahaemolyticus
China Cumin seeds Profenofos
Chile Kiwi fruit Fenhexamid
France Natural cheese (manufacturers limited) Listeria monocytogenes
USA Celery Bifenthrin
Peru Cacao beans 2, 4-D
Table 6. Major Items subject to Ordered Inspections and Inspection Outcomes (Apr-Sep 2016: Tentative)
Country/Region Major subject item Major Inspected Substances Inspections violations

All exporting countries
(17 items)

Almond, Chili pepper, Peanut, etc. Aflatoxin 5,588 53
Cassava, Beans containing cyanide Cyanide 277 2
Salted salmon roe Nitrite 225 0

China
(16 items)

Vegetables (Green soybean, Onion, Spinach, etc.), Lychees, short-neck clam, Clam Endrin, Chlorpyrifos, Difenoconazole, Diflubenzuron Thiamethoxam, Dieldrin (including aldrin), Prometryn, etc. 10,628 9
Bivalves Paralytic shellfish poison, Diarrhetic shellfish poison 4,024 0
Processed products Cyclamic acid 333 0
Eel, Soft-shelled turtle Enrofloxacin, Oxolinic acid, Sulfadimidine 138 0
Lotus seed Aflatoxin 2 0

South Korea
(13 items)

Tomato, Paprika, Cherry tomato Chlorpyrifos , Fluquinconazole 62 0
Bivalves Paralytic shellfish poison, Diarrhetic shellfish poison 60 0
Cultured olive flounder Enrofloxacin, Oxytetracycline 4 0

Thailand
(10 items)

Okra, Green asparagus, Durian, Banana, Mango, Mangosteen EPN, Imazalil, Chlorpyrifos, Cypermethrin, Propiconazole, Metalaxyl, mefenoxam 1,351 0
Boiled crab Vibrio parahaemolyticus 10 0

Italy
(7 items)

Almond, Pistachio Aflatoxin 150 0
Rice Pirimiphos-methyl 18 0
Natural cheese Listeria monocytogenes 16 1

India
(7 items)

Cultured shrimp Furazolidone 898 1
Cumin seed, Black tea, Chili pepper, Chickpea Glyphosate, Triazophos, Profenofos, Hexaconazole 96 3
Cassia torea, Fenugreek seed Aflatoxin 92 3

USA
(7 items)

Corn, Pistachio Aflatoxin 1,594 3
Celery Bifenthrin 90 1
Natural cheese Listeria monocytogenes 5 0

Other (28 countries and 1 region, total 36 items)

16,081 35

Total (Gross)

41,742 111
Table 7. Major Enhanced Monitoring based on Overseas Information (Apr-Sep 2016)
Month of
enhancement
Subject
country
Subject food and details Background and status
May USA

Frozen vegetables and fruits
(Possible contamination with Listeria monocytogenes)

Information was received stating that in the USA. a manufacturer was conducting voluntary recall of frozen vegetables and fruits for potential contamination with Listeria monocytogenes. When an import notification was made for such recall products, steps were taken for reshipment, etc.

(Reference) Description of Key Terms
Term Description
Nitrite Additive (color fixative agent)
Aflatoxin Mycotoxin (produced by the fungus Aspergillus, etc.)
Genetic modification Technology such as fragmentation of bacterial genes, followed by arrangement of the gene sequences or introducing the arranged genes into other organism’s genes.
Iprobenfos Agricultural chemical (organophosphorus fungicide)
Imazalil Agricultural chemical (imidazole fungicide)
Endrin Agricultural chemical (organochlorine insecticide)
Enrofloxacin Veterinary drug (new quinolone synthetic antibacterial agent)
Oxytetracycline Veterinary drug (tetracycline antibiotical agent)
Oxolinic acid Veterinary drug (quinolone synthetic antibacterial agent)
Glyphosate Agricultural chemical (organophosphorus herbicide)
Chloramphenicol Veterinary drug
Chlorpyrifos Agricultural chemical (organophosphorus insecticide)
Chlorfenapyr Agricultural chemical (Insecticide with pyrrole ring)
Diarrhetic shellfish toxin Shellfish poison (mainly refers to toxins produced by a harmful plankton accumulated in bivalves)
Cyanide Harmful or poisonous compound (cyanide-related compounds (e.g., cyanogenic glycoside) ) found in vegetables such as some varieties of beans.
Difenoconazole Agricultural chemical (triazole fungicide)
Diflubenzuron Agricultural chemical (urea insecticide)
Cypermethrin Agricultural chemical (pyrethroid insecticide)
Sucralose Additive (sweetener)
Sulfadiazine Veterinary drug (synthetic antibacterial agent)
Sulfadimidine Veterinary drug (synthetic antibacterial agent)
Sulfamethoxazole Veterinary drug (synthetic antibacterial agent)
Sorbic acid Additive (preservative)
Thiamethoxam Agricultural chemical (neonicotinoid insecticide)
Vibrio parahaemolyticus Pathogenic microorganism (A bacterium living in seawater (estuaries, coastal areas, etc.) that commonly contaminates fish and shellfish, and causes abdominal pain, watery diarrhea, fever and vomiting.)
Enterohemorrhagic E. coli Pathogenic microorganism (A bacterium that normally lives in the intestines of animals. It contaminates foods and drinking water by way of feces and urine, and causes acute abdominal pain and bloody diarrhea together with large amounts of blood after early cold-like symptoms.)
Dieldrin (including aldrin) Agricultural chemical (organochlorine insecticide)
Deoxynivalenol Mycotoxin (produced by the fungus Fusarium)
Tebuconazole Agricultural chemical (triazole fungicide)
Triazophos Agricultural chemical (organophosphorus insecticide)
Sulfur dioxide Additive (antioxidant agents)
Patulin Mycotoxin (produced by fungi such as Penicillium and Aspergillus, etc.)
Bifenthrin Agricultural chemical (pyrethroid insecticide)
Pirimiphos-methyl Agricultural chemical (organophosphorus insecticide)
Fenhexamid Agricultural chemical (hydroxyanilide fungicide)
Furazolidone Veterinary drug (nitrofuran synthetic antibacterial agent), generates AOZ when metabolized
Fluquinconazole Agricultural chemical (triazole fungicide)
Propiconazole Agricultural chemical (triazole fungicide )
Profenofos Agricultural chemical (organophosphorus insecticide)
Prometryn Agricultural chemical (triazine herbicide)
Hexaconazole Agricultural chemical (triazole fungicide)
Paralytic shellfish poison Shellfish poison (mainly refers to toxins produced by a harmful plankton accumulated in clams)
Malachite green Veterinary drug (triphenylmethane synthetic antibacterial agent)
Malathion Agricultural chemical (organophosphorus insecticide)
Metalaxyl Agricultural chemical (anilide fungicide)
Mefenoxam Agricultural chemical (anilide fungicide)
Listeria monocytogenes Pathogenic microorganism (A normal flora in the natural environment that contaminates daily products and processed meat products, and causes influenza-like symptoms including tiredness and fever)
2,4-D Agricultural chemical (phenoxy acid herbicide)
4-Chlorophenoxyacetic acid Agricultural chemical (plant growth regulator)
EPN Agricultural chemical (organophosphorus insecticide)

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