Guidelines for Preventing the Contamination ofFeed Products with Toxic Substances
I. Purpose
From the standpoint of the fundamental principle of prevention of adverse effects on thehealth of citizens as established by Article 5 of the Food Safety Basic Law (Law No. 48,
2003), the Ministry of Agriculture, Forestry and Fisheries institutes measures, forexample by determining specifications and standards concerning feed and related
products (“feed products”) pursuant to Article 3 of the Law Concerning Safety
Assurance and Quality Improvement of Feed (Law No. 35, 1953; “Feed Safety Law”).
For their part, importers and manufacturers of feed products ensure safety by fulfilling
their responsibilities of food-related businesses operators under Article 8 of the Food
Safety Basic Law. In view of the fact that Japan depends on imports for mostingredients used to manufacture feed products, it is difficult for individual feed productmanufacturers to prevent contamination of feed products with toxic substances on theirown, necessitating an broad-based effort on the part of importers and other companies
as well as concerned parties and institutions, including the Ministry of Agriculture,
Forestry and Fisheries. These Guidelines are provided from the perspective of making
all possible efforts to ensure the safety of feed products in order to both prevent
contamination with toxic substances from the ingredient stage and deal with thecircumstances of contamination and the scenarios in which it may occur by making
reasonable assumptions about their nature.
II. Definition
In addition to terms defined by the Feed Safety Law, these Guidelines make use of thefollowing terms:
1. Toxic substances
Chemical substances including residual pesticides, mold, and heavy metals that
may have an adverse impact on the health of humans or animals.
2. Ingredients
Ingredients and materials used to manufacture feed and feed additives.
3. Feed products
Feed, feed additives, and their respective ingredients.
4. Products
Manufactured feed and feed additives, including intermediate products.
5. SurveillanceInvestigations carried out to assess the extent or circumstances of feed productissues.
6. Monitoring
Investigations carried out to assess trends characterizing feed product issues
from the standpoint of determining whether corrective measures are necessary.
III. Action by the Ministry of Agriculture, Forestry and Fisheries
The Ministry of Agriculture, Forestry and Fisheries has established Basic Guidelines for
Dealing with Food Safety Emergencies (“Basic Guidelines”) as a blueprint for
responding to situations requiring emergency action related to food safety (“food safety
emergencies”). These Basic Guidelines describe the Ministry’s basic approach todealing with food safety emergencies. In the event of a food safety emergency triggeredby a feed product-related cause, the Ministry shall take action as necessary inaccordance with the Action Guidelines for Dealing with Food Safety Emergencies
Caused by Products Manufactured or Produced by the Agriculture, Forestry, andFisheries Industry (“Action Guidelines”). These Guidelines generally follow the Action
Guidelines in describing actions taken by the Ministry of Agriculture, Forestry and
Fisheries.
1. Action during ordinary times(1) The Ministry shall gather and analyze information concerning feed
products and enact the following regulations pursuant to the Feed Safety
Law:i. Establishment of specifications and standards relating to feed
product safety (Article 3)ii. Testing and labeling of feed products (Article 5)iii. Prevention of the distribution of feed products containing toxic
substances (injunctions prohibiting the manufacture, import, andsale of toxic feed products or requiring their destruction, etc.)(Articles 23 and 24)
iv. Establishment of the manufacture, distribution, etc., ofappropriate feed products at manufacturing, sales, and otherfacilities (notification of manufacturers and sellers, obtaining
reports, spot inspection, sampling of feed products, etc.) (Articles
50, 55, 56, and 57)(2) The Ministry shall provide for the use of industry companies templates
and/or examples of specifications, procedures and other documents
adopted on a voluntary basis by importers, manufacturers, and otherindustry companies in accordance with these Guidelines.
2. Response to food safety emergencies(1) Food safety emergencies caused by feed products are assumed tocomprise cases such as the following where food safety may becompromised by the use of feed products, accidents, or otheroccurrences:i. Cases involving food contamination and harm to or adverse
effects on humans and animals on a large scale or throughout awidespread area
ii. Cases involving food contamination due to causes about which
there is insufficient scientific knowledge and harm to or adverse
effects on humans and animals, or where such is deemed possibleiii. Cases other than those described in III-2-(1)-(i) and III-2-(1)-(ii)above where the Ministry determines that emergency action isnecessary based on a consideration of social repercussions(2) Initial response to food safety emergencies
i. The Ministry’s initial response to an incident or accident shallconsist of communicating and coordinating action with the Food
Safety Commission and government ministries with food safety
responsibilities such as the Ministry of Health, Labour andWelfare based on an awareness of the fact that the most important
imperative is the protection of citizens’ health. At the same time,
the Ministry shall seek to gather information from the Food
Safety Commission; the Ministry of Health, Labour and Welfare;the Food and Agricultural Materials Inspection Center (FAMIC);
feed product companies; and food manufacturers and distributors.
It shall investigate whether the case comprises a food safety
emergency by analyzing this information.
ii. In the event that the Ministry determines that the case comprises
a food safety emergency, it shall set up a Ministry of Agriculture,
Forestry and Fisheries Food Safety Emergency Task Force(“Ministry Task Force”) in accordance with the Basic Guidelines.
iii. After setting up the Ministry Task Force, the Ministry shall set up
a communication system and immediately undertake thefollowing countermeasures:
1. It shall consider, execute, and issue instructions for any
countermeasures that need to be taken immediately.

2. It shall provide information to companies involved withthe feed products in question.
3. It shall gather, organize, and analyze information andother data concerning the region in which the food safety
emergency occurred.
4. It shall share information concerning the emergency, andcommunicate and coordinate with the Food Safety
Commission and government ministries with food safety
responsibilities such as the Ministry of Health, Labourand Welfare.
5. It shall establish a website and make information
available to the public through a media office.
iv. The Ministry shall dispatch FAMIC employees or employees
from the Ministry or Regional Agricultural Administration
Offices to the site of the emergency as necessary to conduct
on-site inspections and collect samples of feed products fortesting. At this time, the Ministry shall also request thecooperation of or advice from academic experts as necessary.
v. The Ministry shall release information to the news media in
accordance with the Action Guidelines.
vi. In addition to consulting with and working to accommodate theopinions of consumers and other stakeholders, the Ministry shallset up a consultation office in the Regional Agricultural
Administration Office. It shall also ask FAMIC to set up acoordinating office.
(3) Response when a feed product issue is discovered
Following the initial response to an incident or accident, the Ministry
shall take the following actions when they are judged to be necessary
from the standpoint of ensuring food safety in light of a comprehensive
determination based on gathered information:
i. The Ministry shall ask feed product importers, manufacturers,
and distributors to halt shipments and recall affected products.
Furthermore, the Ministry shall issue injunctions as necessary
requiring the recall of problematic feed products in accordancewith the Feed Safety Law.
The Ministry shall as necessary present methods for the analysisof toxic substances in order that importers of feed products andother companies be able to implement an appropriate level ofquality control.
ii. The Ministry shall issue written guidance via prefectural
governments; agriculture, forestry, and fisheries groups; and feed
product manufacturers’ groups so that livestock farmers andothers do not use affected feed products. The Ministry shall strive
through this guidance to provide information to a broad base via
the news media.
iii. Acting through Regional Agricultural Administration Offices andDistrict Agriculture Offices, the Ministry shall directly contact
livestock farmers and other potential users to provide guidance asnecessary so that they do not use affected feed products.
IV. Collection and Sharing of Information
1. Collection of information concerning country/region of production fromimporters
Importers shall gather and organize information that is likely to impact the safetyof feed products, for example unfavorable weather conditions such as droughts
in countries or regions that produce feed products, or pesticide application in
response to unusual contamination with mycotoxin or pest infestation duringstorage in warehouses or other facilities. Of this information, importers shallreport that which is judged important from a feed product safety standpoint via
FAMIC to the Animal Products Safety Division, Food Safety and Consumer
Affairs Bureau, the Ministry of Agriculture, Forestry and Fisheries (“Animal
Products Safety Division”).
2. Inspections and dissemination of information by FAMIC(1) Surveillance and monitoring of toxic substances contained in feed
products
FAMIC shall conduct systematic surveillance and monitoring inspections
for toxic substances in feed products, including actions undertaken inaccordance with the Annual Plan for the Surveillance and Monitoring of
Toxic Substances Related to Food Safety as established by the Ministryof Agriculture, Forestry and Fisheries.
(2) Dissemination of information
FAMIC shall regularly disseminate information provided in accordancewith IV-1 above, surveillance and monitoring inspection results provided
in accordance with IV-2-(1) above, and other information concerningtoxic substances in feed products to importers and manufacturers
registered in accordance with IV-3 below.
(3) Emergency response
During emergencies where a food safety issue caused by feed products
may occur, FAMIC shall move quickly to provide information toimporters and other involved companies by email, fax, or other means inaccordance with instructions from the Animal Products Safety Division.
3. Gathering of information concerning feed product safety by importers andmanufacturers
Importers and manufacturers shall register their email addresses with FAMIC sothat they can receive information from FAMIC.
Importers and manufacturers shall utilize information and other data obtained
from FAMIC in accordance with IV-2 above to access breaking information
deemed likely to have an impact on feed product safety.
V. Importation of Feed Products
Importers shall fulfill the following operational requirements:
1. Establishment of feed product specifications
Importers shall establish clear specifications for ensuring the safety of each
imported feed product they handle based on the information provided by FAMIC
in accordance with IV-2 above and in reference to the templates and examples
provided by the Ministry of Agriculture, Forestry and Fisheries in accordancewith III-1-(2) above.
2. Confirmation of compliance with feed product specifications
Importers shall take action to confirm safety of imported feed products, forexample by signing agreements with suppliers to satisfy the specifications
described in V-1 above, or take other action to have equivalent results. They
shall also confirm compliance with such as necessary, for example by visiting
overseas manufacturing plants and other facilities to assess the conditions underwhich feed products are manufactured, and record their findings.
3. Creation of procedures for quality control and other processes
Importers shall create procedures for quality control, complaint resolution, recall
processing, and education and training based on the templates and examples
described in III-1-(2) above in order to ensure that the operations stipulated in
V-4 through V-7 below are carried out in an appropriate manner. They shall havepreviously designated individuals or companies perform these operations inaccordance with the procedures.
4. Quality control

Importers shall perform the following operations related to quality control inaccordance with the procedures concerning quality control created in V-3 above:(1) Collect the necessary samples at a self-determined frequency and create
records of the same.
(2) Test the collected samples as necessary in order to confirm compliancewith the specifications described in V-1 above and create records of thesame.
(3) If any problems are discovered, for example analysis results that exceed
standard values, report this fact to FAMIC.
(4) In principle, records of the tests described in V-4-(2) above shall be
stored for a period of at least 2 years from the date of their creation.
5. Complaint resolution
When they receive a complaint concerning the presence of one or more toxic
substances in imported feed products from livestock farmers, manufacturers, orother companies, importers shall perform the following operations related tocompliant processing in accordance with the procedures concerning complaint
resolution created in V-3 above:(1) Investigate the cause of the circumstances surrounding the complaint andtake appropriate action.
(2) Create a complaint resolution record describing the nature of thecomplaint, the results of the investigation of its cause, any corrective
action taken, and any other relevant information. In principle, this record
shall be stored for a period of at least 2 years from the date of its
creation.
6. Recall processing
When recalling imported feed products, for example because they contain toxic
substances in excess of standard values, importers shall perform the following
operations related to recall processing in accordance with the procedures
concerning recall processing created in V-3 above:(1) Investigate the cause that led to the recall and take appropriate action.
(2) Process recalled feed products in an appropriate manner.
(3) Create a recall processing record describing the nature of the recall andassociated processing, the results of the investigation of its cause, any
corrective action taken, and any other relevant information. In principle,
this record shall be stored for a period of at least 2 years from the date ofits creation.
(4) In principle, whenever a recall is initiated, importers must report this fact

along with the underlying reason and circumstances of the recall to theAnimal Products Safety Division via FAMIC.
7. Education and training
Importers shall perform the following operations related to education andtraining in accordance with the procedures concerning education and training
created in V-3 above:(1) Systematically implement necessary education and training programs
related to feed product safety for employees involved in import
operations, for example by making use of training and other services
provided by FAMIC.
(2) Create records of implemented education and training programs. In
principle, these records shall be stored for a period of at least 2 years
from the date of their creation.
8. Cooperation with surveillance and monitoring
Importers shall cooperate with the collection of samples targeted for toxic
substance surveillance and monitoring by FAMIC as described in IV-2 above.
VI. Acceptance of Ingredients at Manufacturing Plants
Manufacturers shall perform the following operations when accepting ingredients, or
have them performed by previously designated individuals or companies as appropriate
given the nature of the operations:
1. Establishment of ingredient specifications
Manufacturers shall establish clear specifications for ensuring safety for each
ingredient they handle based on the information provided by FAMIC inaccordance with IV-2 above and in reference to the templates and examples
provided by the Ministry of Agriculture, Forestry and Fisheries in accordancewith III-1-(2) above.
2. Confirmation of compliance with ingredient specifications
Manufacturers shall sign agreements with suppliers of ingredients requiringthem to satisfy the specifications described in VI-1 above. They shall also
confirm compliance with such as necessary, for example by visiting
manufacturing plants and other facilities to assess the conditions under which
ingredients are manufactured, and create records of their findings. Regarding
imported ingredients, they shall confirm conditions at manufacturing plants
through importers and other involved companies, and create records of theirfindings. In contract manufacturing arrangements where the contractor is tosupply ingredients, the contractor shall be responsible for confirming thecompliance of ingredients with feed product specifications.
3. Cooperation with surveillance and monitoring
Manufacturers shall cooperate with the collection of samples targeted for toxic
substance surveillance and monitoring by FAMIC as described in IV-2 above.
VII. Guidelines Concerning the Manufacture of Feed Products
Manufacturers shall perform the following operations when manufacturing feed
products. Some of the following may be omitted when it is judged that the likelihood ofcontamination by a toxic substance during the manufacturing process is low.
1. Process control standards and quality control standards(1) Manufacturers shall create process control standards for each plant they
operate describing manufacturing process control and other necessary
information.
(2) Manufacturers shall create quality control standards for each plant they
operate describing sample collection methods, testing methods, test
result judgment methods, and other necessary information.
2. Appointment of manufacturing control officers and quality control officers(1) Manufacturers shall appoint a manufacturing control officer and quality
control officer for each plant they operate.
(2) Manufacturing control officers shall possess knowledge related to
manufacturing control.
(3) In principle, quality control officers shall possess knowledge related toquality control.
(4) In principle, the same person may not serve as a plant’s manufacturingcontrol officer and quality control officer at the same time. In the eventthat a given plant has a feed manufacturing manager as stipulated by
Article 25 of the Feed Safety Law, the feed manufacturing manager may
also serve as the manufacturing control officer.
3. Responsibilities of manufacturing control officers
Manufacturers shall have the manufacturing control officer of each plant
perform the following operations related to product manufacturing control inaccordance with process control standards and in an appropriate manner:(1) Officers shall create procedures related to manufacturing describing
manufacturing process instructions, precautions, and other necessary
information in order to prevent contamination with toxic substances.
(2) Officers shall perform the following operations themselves, or have them

performed by previously designated individuals as appropriate given thenature of the operations:i. Manufacture products in accordance with manufacturing-related
procedures.
ii. Create product manufacturing records for each lot.
iii. Inspect and maintain manufacturing equipment on a regular basis
and create records of the same.
iv. Perform other operations related to manufacturing control asnecessary.
(3) Officers shall confirm that manufacturing control is being carried out inan appropriate manner and in accordance with process control standards.
(4) Officer shall store manufacturing-related records for a period of 8 years
from the date of their creation in accordance with Article 52 of the Feed
Safety Law. Additionally, they shall in principle store records related to
manufacturing control for a period of at least 2 years from the date of
their creation.
4. Responsibilities of quality control officers
Manufacturers shall have the quality control officer of each plant perform thefollowing operations related to ingredient and product quality control inaccordance with quality control standards and in an appropriate and systematicmanner:(1) Officers shall perform the following operations themselves, or have them
performed by previously designated individuals as appropriate given thenature of the operations:i. Collect samples from ingredient and product lots at a frequency
determined to be appropriate, and create records of the same.
ii. Test collected samples as necessary in order to confirm
compliance with the specifications established by VI-1 above andcreate records of the same. Timing of tests shall reflect aconsideration of the chemical stability of the target toxic
substances.
iii. Store collected samples under appropriate storage conditions for aperiod of time that determined to be sufficient, even after testing.
iv. Inspect and maintain testing equipment and instruments used totest samples on a regular basis and create records of the same.
v. Perform other necessary operations related to quality control.

(2) Officers shall judge test results and report them in writing to the
manufacturing control officer. If any problems are discovered, forexample analysis results that exceed standard values, they shall report
this fact to FAMIC.
(3) In principle, records of the tests described in VII-4-(1)-ii above shall be
stored for a period of at least 2 years from the date of their creation.
5. Incident response and other procedures
Manufacturers shall create procedures for each plant they operate related toincident response, complaint resolution, recall processing, self-inspections, andeducation and training in reference to the templates and examples described in
III-1-(2) above in order to ensure that the operations described in VII-6 to VII-10
below are performed in an appropriate manner.
6. Incident response
In the event of an incident involving product contamination with a toxic
substance or the possibility of contamination as a result of an equipment
accident or other event during a manufacturing process, manufacturers shallhave the plant’s manufacturing control officer perform the following operations
related to incident response in accordance with the procedures concerning
incident response created by VII-5 above:(1) Investigate the cause of the incident and, if improvements to
manufacturing control or quality control are necessary, take appropriate
action.
(2) Process products for which an abnormality was detected in an
appropriate manner.
(3) Create an incident response record as necessary describing the nature of
the incident, the results of the investigation of its cause, and any
corrective action taken. In principle, this record shall be stored for aperiod of at least 2 years from the date of its creation.
7. Complaint resolution
When they receive a complaint concerning the presence of one or more toxic
substances in a manufactured product from livestock farmers or other companies,
manufacturers shall have the manufacturing control officer or quality control
officer at the plant in question perform the following operations related tocomplaint resolution in accordance with the procedures concerning complaint
resolution created by VII-5 above:(1) Investigate the cause of the circumstances surrounding the complaint and,if improvements to manufacturing control or quality control arenecessary, take appropriate action.
(2) Create a complaint resolution record describing the nature of thecomplaint, the results of the investigation of its cause, any corrective
action taken, and any other relevant information. In principle, this record
shall be stored for a period of at least 2 years from the date of its
creation.
8. Recall processing
When recalling manufactured products, for example because they contain toxic
substances in excess of standard values, manufacturers shall have the
manufacturing control officer at the plant in question perform the following
operations related to recall processing in accordance with the procedures
concerning recall processing created by VII-5 above:(1) Investigate the cause that led to the recall and, if improvements to
manufacturing control or quality control are necessary, take appropriate
action.
(2) Process recalled products in an appropriate manner.
(3) Create a recall processing record describing the nature of the recall andassociated processing, the results of the investigation of its cause, any
corrective action taken, and any other relevant information. In principle,
this record shall be stored for a period of at least 2 years from the date ofits creation.
(4) In principle, whenever a recall is initiated, manufacturers must report thisfact along with the underlying reason to the Animal Products Safety
Division via FAMIC.
9. Self-inspections(1) In principle, manufacturers shall have the manufacturing control officer
and quality control officer at each plant they operate perform thefollowing operations related to self-inspections in accordance with theprocedures concerning self-inspections created by VII-5 above:
i. Perform regular self-inspections to assess the state of
manufacturing control and quality control for products at theplant in question in accordance with procedures related toself-inspections.
ii. Create records of self-inspection results. In principle, suchrecords shall be stored for a period of at least 2 years from thedate of their creation.
(2) In the event that improvements to manufacturing control or quality

control are necessary, manufacturers shall take appropriate action basedon the self-inspection results described in VII-9-(1)-i above and create
records of the same. In principle, such records shall be stored for a periodof at least 2 years from the date of their creation.
10. Education and Training
Manufacturers shall have a previously designated individual perform thefollowing operations related to education and training in accordance with theprocedures concerning education and training created in VII-5 above:(1) Systematically implement necessary education and training programs
related to manufacturing control and quality control for employees
involved in manufacturing and quality control operations, for example bymaking use of training and other services provided by FAMIC.
(2) Report on the status of education and training programs in writing to the
manufacturer.
(3) Create records of implemented education and training programs. In
principle, these records shall be stored for a period of at least 2 years
from the date of their creation.
VIII. Guidelines Concerning the Transport and Storage of Feed Products
1. Creation of procedures concerning transport and storage
Importers, manufacturers, and distributors shall create procedures concerning thetransport and storage of feed products in order to prevent contamination with
toxic substances or increases in such.
2. Conduct of operations in accordance with procedures
Importers, manufacturers, and distributors shall transport and store feed products
in accordance with predetermined procedures.
3. Management of operations by importers and warehouse providers
In the event that importers, manufacturers, and distributors opt to outsource
transport and storage operations instead of performing them themselves, theyshall confirm in writing as necessary that transport and warehouse providers
manage operations in accordance with relevant procedures in order to prevent
contamination with toxic substances or increases in the same.
IX. Response to the Possibility of Production of Toxic Animal Products
In the event that the Ministry of Agriculture, Forestry and Fisheries determines that
there is a possibility that a toxic farm product has been produced or that livestock orother animals have been harmed, importers, manufacturers, and distributors shall takethe following actions:
1. When the manufacturing lot of feed products containing the toxic substances has
been identified
Importers, manufacturers, and distributors shall investigate whether they have
handled feed products belonging to the manufacturing lot in question. If so, theyshall report this fact immediately to any companies or individuals to whom theproduct was shipped, request that the sale and use of the product be halted, andinitiate a recall. They shall also report the situation to the Animal Products
Safety Division and feed product supplier as quickly as possible and provide asummary of how the recalled feed product was processed to the Animal Products
Safety Division via FAMIC.
Suppliers receiving this information shall immediately notify all buyers of thefeed product in question, request that the sale and use of the product be halted,
and initiate a recall. They shall also provide a summary of how the recalled feed
product was processed to the Animal Products Safety Division via FAMIC.
Furthermore, in the event that the feed product in question has been shipped tolivestock farmers or other users, importers, manufacturers, and distributors shallimmediately set up consultation offices and work to ensure the safety of animal
products.
2. When there is information indicating the country of manufacturer and feed
product type for the contaminated feed productIn this case, importers, manufacturers, and distributors shall investigate whether
they have handled the feed product in question. If so, they shall report this fact
immediately to any companies or individuals to whom the product was shipped,
request that the sale and use of the product be halted, and analyze the feed
product in question for toxic substances. They shall also report the situation to
the Animal Products Safety Division and feed product supplier as quickly as
possible.
Suppliers receiving this information shall immediately notify all buyers of thefeed product in question and request that the sale and use of the product behalted.
If a toxic substance is detected by the analysis, importers, manufacturers, anddistributors shall immediately notify the Animal Products Safety Division andthe supplier and initiate a recall of feed products from the same manufacturing
lot as the feed product in question from companies or individuals to whom theproduct was shipped. They shall also provide an overview of how the recalled
feed product was processed to the Animal Products Safety Division via FAMIC.

Furthermore, in the event that the feed product in question has been shipped tolivestock farmers or other users, importers, manufacturers, and distributors shallimmediately set up consultation offices and work to ensure the safety of animal
products.
X. Reporting of Import and Manufacturing Volume
By July 31 each year, importers and manufacturers of feed products shall report thevolume of feed products they imported or manufactured during the previous fiscal year
to the Animal Products Safety Division using a separately documented form, to be sentby email, fax, or other means.
This report need not be filed if the importer or manufacturer already submits a similarreport to the Ministry of Agriculture, Forestry and Fisheries.
*These Guidelines do not include the separately documented form.