15 Sho-An No. 1570
Dated September 16, 2003
From
Director-General, Food Safety and Consumer Affairs Bureau
Ministry of Agriculture, Forestry and Fisheries (MAFF)
To
Director, Japan Feed Trade Association

Subject: Establishment of New Guidelines for Prevention of Intermixing ofAnimal Origin Proteins in Ruminant Feeds
The “Guidelines for Prevention of Intermixing of Animal Origin Proteins in Ruminant
Feeds” (Notification No. 13 Sei-Chiku 1366 by Director-General, Agricultural Production
Bureau, MAFF, dated June 1, 2001; hereinafter referred to as “Old Guidelines”) were originallyestablished to strictly prevent the occurrence of bovine spongiform encephalopathy (BSE). The
Ministry's goal in issuing these guidelines was the total prevention of the intermixing of animal
proteins originating from ruminants and other animals in feed meant for ruminants (meaningcattle, sheep, goats and deer: and this meaning hereinafter) at formula feed manufacturing plants.
The Ministerial Ordinance Concerning Standards for the Components of Feeds and Feed
Additives (Ordinance No. 35, MAFF, 1976; hereinafter referred to as “the MinisterialOrdinance”) has been partly amended to separate the production process of ruminant feeds fromthe production process of feedstuffs containing protein of mammalian origin. In line with thisamendment, the New Guidelines on Prevention of Intermixing of Animal Origin Proteins inRuminant Feeds, given in the Annexure, have recently been established. The Ministry requests
the assistance of all concerned parties in ensuring that the New Guidelines become widelyknown.
Under the New Guidelines, feed manufacturers currently producing ruminant feeds using
production processes that are also used for production of feedstuffs containing animal origin
proteins are permitted to follow the old guidelines until March 31, 2005. However, to take all
possible measures for the prevention of BSE and related diseases, it is desirable to advise theconcerned parties to comply with the New Guidelines as soon as possible.

Annexure
Guidelines for Prevention of Intermixing of Animal Origin Proteins in Ruminant Feeds
I

Objective
These are basic guidelines on management measures to prevent intermixing of animal origin
proteins with ruminant feeds, at various stages of production, importation, distribution,storage, feeding, and handling of feeds and feed additives (hereinafter referred to as“feedstuffs”), so that everything possible is done to prevent the occurrence of transmissible
spongiform encephalopathies such as bovine spongiform encephalopathy (BSE) and relateddiseases.

IIDefinitions
Except for the terms defined below, the definitions of terms used in these guidelines are thesame as those in the Law Concerning Safety Assurance and Quality Improvement of Feed
(Law No. 35 of 1953, hereinafter referred to as “the Law”) and related laws and regulations.
1. Category A Feed
Feedstuffs and their raw materials that are intended to be fed, or that may possibly befed, to ruminants (meaning cattle, sheep, goat and deer; and this meaning hereinafter),
are to be handled in a manner to prevent intermixing of any animal origin protein orrelated material.
2. Category B Feed
Feedstuffs and their raw materials, other than those designated as Category A Feeds.
3. Animal Origin Protein
This category includes those listed below. However, the following are excluded: milkand milk products, eggs and egg products; gelatin and collagen approved by theMinister, MAFF; fats not originating from ruminants; and specific animal origin fatsspecified in attached table 1-4(1) of the Ministerial Ordinance.
(1)
Protein originating from mammals(2)
Protein originating from poultry(3)
Protein originating from fish and shellfish(4)
Animal fat(5)
Animal origin protein sourced from food residues(6)
Feed additives (limited to those containing substances listed under (1) to (5)above)
4. Containers
Holds of ships, barges, cargo containers, bulk carts, transport bags, shovels, buckets,
PP bags, paper bags, and other containers that come into direct contact with feedstuffs
and their raw materials, which are used for their transportation or storage.
5. Cleaning(1)
Cleaning by sweeping
The procedure of removing residues from a facility, installation, implement, or1(2)the like, cleaning it, and confirming, by visual inspection, swabbing, or othermethods, that no residues remain.
Cleaning by washing
The procedure of removing residues from a facility, installation, implement,or the like, cleaning and washing it (washing with a cleaning solution or
washing to achieve an equivalent effect), and confirming, by visual inspection,
swabbing, or other methods, that no residues remain.

6.

Conveyance
The moving of feedstuffs and their raw materials within the premises of a facility orbetween facilities, using different modes of conveyance.

7.

Sub-dividing
Sub-dividing feedstuffs and their raw materials, and changing the packaging to suit theneeds of consumers.

III

Basic Guidelines
In order to do everything possible to prevent BSE and related diseases, it is necessary totake measures to ensure that no feed containing animal origin protein is fed to ruminants. On
the other hand, it is very difficult to avoid giving feeds that contain animal origin protein toanimals other than ruminants. Therefore, it was decided to adopt suitable means, such asensuring the isolation of Category A and Category B feeds by appropriate methods, toeffectively and efficiently prevent intermixing of animal origin protein in Category A feed ateach stage of feed production and use, i.e., production, importation, distribution, storage andfeeding.
If a person/party who manufactures, imports, distributes, stores, or provides such feedstuffs
does not carry out the actions described in Guidelines 1 and 2 above, but instead commissions
some other party to do so, said person/party should enter into an agreement with the party
actually undertaking the work to ensure implementation of the necessary measures, andregularly check and verify that the agreement is adhered to.
1. General Rules(1)
Adopt suitable measures so that no Category B feed, or animal origin protein
is intermixed with feedstuffs to be used as Category A feed at any stage ofproduction, importation, distribution, storage, or feeding.
(2)
If Category B feed, or animal origin protein is intermixed with feedstuffs tobe used as Category A feed, or if there is a possibility that such intermixing
may have occurred, recall and appropriately repurpose or discard thefeedstuffs to ensure that they are not used as Category A feed.
(3)
Adopt suitable measures so that no meat-and-bone meal derived fromruminants or the like is contained or intermixed with feedstuffs to be used as
Category B feed at any stage of production, importation, distribution, storage,or feeding.
2(4)
(5)
(6)

(7)

(8)

(9)

2.

If Category B feed, or animal origin protein is packed in containers intended
for use with Category A feed, clean the containers by washing without delay.
If Category B feed, or animal origin protein is passed directly through a sitewhere Category A feed is handled, clean the site by washing without delay.
Regularly clean, inspect and test the facilities, installations, premises,machines, devices and environments where feedstuffs or their raw materials
are handled.
After workers have handled Category B feed, or animal origin protein,ensure that they change their clothes or use air blowers or other means toremove any residue adhering to their hands, feet, clothing, or footwear before
they handle Category A feed.
When facilities, equipment, or machinery that has previously been used forhandling Category B feed, or animal origin protein is to be converted for use
with Category A feed, implement the following procedures:• Clean by washing.
• After cleaning by washing, check that no animal origin protein is containedin the first lot of Category A feed handled by the facility, equipment, ormachinery
Always use a washing method whose cleansing efficacy has previously beenthoroughly verified.

Detailed Rules
1) Conveyance(1)
See that the conveyance route of Category A feed is not common with theconveyance route of Category B feed, or of animal origin protein.
(2)
Use exclusive containers for conveying Category A feed, and in principle
make the conveyance system an enclosed system, by providing, for example,
a suitable cover over the conveyance route. If the system needs to be left
open for any reason, take measures to prevent intermixing of Category B
feed, or animal origin protein.
(3)
Rules (1) and (2) above are not applicable to facilities from which Category
B feed alone is shipped, nor to farms where no ruminants are raised.
2) Production, Sub-dividing, etc.
a.
Facilities for production, etc.
In principle, make production and handling systems for Category A feed enclosed
systems, and when they need to be left open for any reason, take measures toprevent intermixing of Category B feed, or animal origin protein. When it isimpossible to make production and handling systems for Category A feed enclosed
systems, set them up at locations sufficiently removed, or separated by a wall orpartition, from facilities handling Category B feed, or animal origin protein toprevent intermixing.
b.
Packaging facilities, etc.
3(1)Make sure that packaging facilities for Category A feed are not common withthose of Category B feed, or animal origin protein.
(2)
Set up packaging facilities for Category A feed sufficiently away, orseparated by a wall or partition, from packaging facilities handling Category
B feed, or animal origin protein to prevent intermixing.
(3)
Use exclusive containers for packaging Category A feed products.
(4)
With all packaged feedstuffs, confirm that the containers used for packaging
have no tears or other damage.
3) Transportation(1)
For transporting Category A feed, use exclusive containers that bear displays
stating that they are exclusively meant for Category A feeds or ruminantfeeds. In the case of containers such as bulk-loading ships, marine containers,barges, and the like where exclusive use is not possible, clean by sweeping
before loading Category A feed. Moreover, if some residue of Category B
feed, or animal origin protein is noticed, take preventive measures againstintermixing, such as cleaning by washing, before use.
(2)
With regard to containers used for Category A feed, store transportation bags
and other containers that are reused separately from containers used fortransporting Category B feed, and clean by sweeping or washing regularly, as
well as before use.
4) Receiving(1)
When receiving Category A feed, confirm by checking the bill of lading orother documentation that the feed concerned has indeed been handled as
Category A feed.
(2)
Minimize the scattering of dust and particulate matter.
(3)
Do not receive Category A and Category B feed simultaneously or one
immediately after the other.
(4)
Keep the receiving point (meaning chute, unloading dock, or other offloading
point; and this meaning hereinafter) of Category A feed away from receiving
points for Category B feed, or animal origin protein. However, this rule neednot be applied if packaged feedstuffs are received without opening the seal
and the unloading site for Category A feed is clearly separated from that ofCategory B feed, or animal origin protein.
(5)
Make containers used for receiving the feed, as well as implements such as
brooms that come into direct contact with Category A feed, exclusive. Clean
by washing before using unloading devices and other equipment that cannot
be made exclusive.
(6)(1) to (5) above are not applicable to facilities from which only Category B
feed is shipped, nor to farms where no ruminants are raised.
5) Storage(1)
Use exclusive containers or exclusive storage locations for storing Category
A feed.
4(2)Adopt suitable measures such as color-coding or the use of signage
displaying target animals to eliminate human error during shipping andhandling operations at feed storage sites and other facilities.
(3)(1) and (2) above are not applicable to facilities from which only Category B
feed is shipped, nor to farms where no ruminants are raised.
6) Shippinga.
Shipping and handling of unpackaged products(1)
Use exclusive outlets for loading loose Category A feeds into containers
such as bulk carts used for transportation.
(2)
Keep outlets for Category A feed sufficiently away from outlets forCategory B feed, and animal origin protein, or separate them by a wall orpartition to prevent intermixing.
b.
Shipping and handling of packaged products
Ship packaged Category A products separately from Category B feed, andanimal origin protein.
7) Feeding(1)
Do not feed Category B feed to ruminants.
(2)
Use exclusive implements for feeding Category A feed to ruminants.
IV

Management system
1.
Management of Business Operations(1)
Formulate Feed Operation Management Rules and document them in order toeffectively and efficiently implement the basic guidelines stipulated in 1. and1) to 6) of 2.
(2)
Maintain detailed records of management operations relating to Feed
Operation Management Rules and their verification, and store the records for
8 years.
(3)
The Feed Production Controller stipulated in Article 25 of the Law should
manage practical implementation so that operations are managed according tothe Feed Operation Management Rules.
(4)
In plants where a Feed Production Controller is not required, designate aperson to be in charge of measures to prevent intermixing, and ensure that thedesignated person manages operations according to Feed Operation
Management Rules.
(5)(1) to (4) above are applicable to manufacturers and dealers.
2.
Quality control(1)
Regularly test whether there is any intermixing of animal origin protein orrelated materials with Category A feed to verify that the management ofoperations is effective, and to control the quality of the Category A feed.
(2)
Formulate Feed Quality Control Rules for (1) above and document them.
(3)
Maintain detailed records of management operations relating to Feed Quality
Control Rules and their verification, and store the records for 8 years.
5(4)

(5)
V

Designate a person to be in charge of quality control, and ensure that thedesignated person manages the quality control procedures according to theFeed Quality Control Rules.
(1) to (4) above are applicable to manufacturers of feed and related products.

Interim measures
Feed manufacturers who currently manufacture ruminant feeds using the same process used
to produce feeds containing protein originating from mammals, poultry, fish and shellfish arepermitted to continue to follow the Old Guidelines until March 31, 2005.

6