Original: Japanese
Provisional Translation

Guidelines for Submission of Residue Data of Pesticides Registered Outsideof Japan for the Estimation of Maximum Residue Limits in Feeds(Director-General, Food safety and Consumers Affairs, MAFF, Japan, Notification No. 21Syouan-11433, 2 February, 2010, Revision Date : 13 March, 2018.)
I.

ObjectiveArticle 3.1 of the Law Concerning Safety Assurance and Quality Improvement ofFeeds (Act No. 35 of 1953; hereinafter referred to as the “Law”) stipulates that theMinister of Agriculture, Forestry and Fisheries establishes the Ministerial OrdinanceConcerning the Ingredient Standards for Feeds and Feed Additives (Ordinance ofMAFF No. 35 of 1971) in order to ensure steady supply and the safety of foods
derived from livestock through providing safe feeds. The Ordinance includes
maximum residue limits (MRLs) for pesticides in cereal grains and forage/hay(hereinafter referred to as “feed”) fed to livestock.
In order to ensure steady supply and the safety of foods derived from livestock, it isnecessary to ensure steady supply of safe feeds, not only domestically produced but
also imported. To meet this goal, the Ministry of Agriculture, Forestry and Fisheries
recently formalized a system for establishing/revising import tolerances in feeding
stuffs for pesticides not yet registered in Japan but only registered overseas for use on
feed crops to be exported to Japan on a basis of scientific data including thosespecified under the requirements in the Guidelines.
These Guidelines outline the procedures and requirements for applying for theestablishment and/or revision of MRLs in feeds for pesticides. As the requirements
for scientific data on each pesticide should be science- and risk-based, and any futurescientific developments should be taken into account, these Guidelines show the list ofstudies commonly required for the establishment of MRLs in feeds. They may besubstituted by other study(ies) or assessment(s) that can be regarded as sufficient for
estimation of MRLs.

II.

Procedures for Establishment and Revision of MRLs in Feeds for Pesticides

1.

Application
The Guidelines deal with those active ingredients that are newly registered or in aprocess of registration for use on feed crops in the United States of America,
Canada, Australia, Brazil, Argentine and/or People's Republic of China *1

(hereinafter referred to as "Countries").
* Countries considered may be reviewed as necessary.
Any person or company wishing to apply for the establishment/revision of MRLs for
active ingredients mentioned above in feeds expected to be exported to Japan, can doso by sending a duly filled Request Form to the Animal Products Safety Division,
Food Safety and Consumer Affairs Bureau, MAFF. The Request Form should beaddressed to the Director-General of Food Safety and Consumers Affairs. TheRequest Form should accompany study reports and any other information as requiredin Section III-1 of the Guidelines.
If the applicant lives abroad, an appropriate contact person in Japan should be
identified to deal with the application and any other process afterwards.
2.

Estimation of MRLs
The submitted study reports and any other information will be reviewed by responsible
officers in the Division for the estimation of an MRL in feed from the following pointsof view:(1) Exportation of the feed grown with the application of the active ingredientin question;(2) Residue concentrations in the feed; and(3) Residue transfer from the feed to edible tissues of livestock, milk and/oreggs.
If review of the data from points (1)-(3) indicates that no risk management option isnecessary, no MRL will be established for the active ingredient in the feed concerned.
If some or significant residues are expected to be found in edible tissues of livestock,
milk and or eggs, draft MRLs in these foods derived from livestock will be estimatedfrom the maximum animal burden calculated using the highest residue concentrations
in feed and the maximum proportion of agricultural commodities in animal feed;
animal metabolism studies; and animal feeding studies. These draft MRLs will befurther considered by the Ministry of Health, Labour and Welfare for their inclusion in
the so-called “Positive List”.
The Food Safety Commission will conduct risk assessment of the active ingredient inaccordance with Article 24.1.5 of the Food Safety Basic Law (Act No. 48 of 2003).
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MRLs for feed will be considered by the Agricultural Materials Council in accordancewith Article 3.2 of the Law, taking into account the risk assessments.
In response to the Council's report, the Division will take necessary procedures for theestablishment of MRLs in feeds, based on Article 3.1 of the Law.
The Food safety Commission and Council may ask for additional studies/informationfrom the applicant if necessary.
III.

Required Data

1.

Data Required When Applying for Establishment/Revision of MRLs in Feed
The study reports given below are required when applying for the establishment and/orrevision of MRLs. Feedingstuffs for which MRLs are to be estimated are listed in theAppendix**.
** The list includes feed crops and their portions that are fed to livestock at
significant amounts in Japan. The list may be reviewed as necessary.
<Studies related to feed crops>(1) Plant Metabolism Studies
Plant metabolism study(ies) on the feed crop(s) to be considered for MRLs should be
conducted in accordance with the "Data Requirements for Supporting Registration ofPesticides" (Director-General, Agricultural Production Bureau, MAFF, Japan,Notification No. 12-Nousan-8147, 24 November, 2000. hereinafter referred to as"Notification").
The Notice is available in English at the URL below:
http://www.mhlw.go.jp/english/topics/foodsafety/residue/dl/01.pdf
If there is no study on the concerned feed crop(s), study(ies) on the botanically related
crops may be submitted in lieu of the required data after consultation with the Division.
(2) Feed Crop Supervised Residue Trials
Feed crop supervised residue trials should be conducted in accordance with theNotification and in Countries. It is desirable that the supervised residue trials include
decline studies.
If a by-product of agricultural commodity is used as feed in Japan, a processing study
3should also be conducted.
<Studies on livestock>(3) Livestock Metabolism Studies
Livestock metabolism study(ies) should be conducted in accordance with OECD Test
Guideline 503 “Metabolism in Livestock”.
(4) Livestock Feeding Studies
Livestock Feeding Study(ies) should be conducted in accordance with OECD Test
Guideline 505 “Residues in Livestock”.
< Other necessary studies>(5) Storage Stability Studies
Storage stability study(ies) should be conducted in accordance with OECD Test
Guideline 506 “Stability of Pesticide Residues in Stored Commodities”.
(6) Information on Analytical Method(s) for (1)-(5)Detailed information on analytical method(s) for residues of the active ingredient in
the feed crops in question and, if necessary, in foods derived from farm animal
shall be submitted.
(7) Toxicity Studies
Toxicity studies (excluding those on toxic effects on aquatic animals and plants,effects on beneficial organisms other than aquatic animals and plants, and study onwater contamination) and studies indicating residue situations (excluding study on
fate in soil) should be conducted in accordance with the Notification.
(8) Label of the Pesticide Product
The officially approved label(s) or draft label(s) of a product(s) containing the active
ingredient that is to be used on a feed crop(s) expected to be exported to Japan shall besubmitted. The label or draft label should clearly indicate the approved or planned use
pattern of the product.
(9) Information on Registration in the Countries
Information on the registration of the active ingredient in the Countries, e.g., country4name, applicable MRLs in that country, shall be submitted.
2.

GLP Compliance
In principle, studies mentioned in Section 1 should be conducted in compliance with
the GLP requirements.
If submitted study was not conducted or commissioned by the applicant, priorpermission shall be obtained from the study authors unless they have been publicly
available in scientific literature.

3.

Submission of Study Reports
The monograph of the studies specified in Section 1, (1)-(7) shall be submitted bothelectronically, e.g., in CD-ROM, and in printed form. The monograph should be inJapanese. However, if it is not possible to submit it in Japanese, the English text may
be acceptable upon consultation with the Division.
Individual reports of the studies specified in Section1, (1)-(6) shall be submitted
electronically, e.g., in CD-ROM.
The monograph and study reports in languages other than Japanese or English are notacceptable.

IV.

Other Requirements

1.

Additional Requirements
If the Division determines additional study data are necessary for the establishment orrevision of MRLs, the applicant may be requested to submit them.

2.

Conditions of Registration in the Countries
If the registration of an active ingredient for which import tolerances have been
established in Japan is revoked or withdrawn in the Country(ies), the applicant shallimmediately inform the Division of this fact.
For an active ingredient in a process of registration, the applicant shall submit theapproved label to the Division immediately after it is approved.

3.

Revision or Correction of Data Set
If any of submitted study report or monograph is revised or corrected, the applicant
5shall submit the revised/corrected study report or monograph to the Division and anote indicating the revision/correction and the reason thereof.

6Request Form
Date

Director-General of Food Safety and Consumers Affairs
Address of applicant(For a corporation, principal place of business)
Name of applicant(For a corporation, its name and the representative’s name) Seal
We hereby apply for the establishment [revision] of MRLs in feeds for the pesticide
given below, in accordance with Article 3.1 of the Law Concerning Safety Assurance andQuality Improvement of Feeds (Act No. 35 of 1953).

Name of substance(Notes for applicants)
1. Use JIS A4-size paper.
2. Use black ink (or "SUMI"), and write in clear block letters in English or Japanese.
3. Identify and provide the contact information within Japan, if the applicant lives overseas.
The seal may be replaced by the applicant's signature.

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Appendix: List of feedstuffs
CROP

FEEDSTUFF

Barleygrain

Brewer's grain

dried

Wheat

grain

Wheat

milled byproducts

OatgrainOat

hay and straw

RyegrainRye

hay and straw

Ricebran/pollard

Ricestraw

Corn, (field and pop)

grain

Corn gluten

feedCorn gluten

meal

Corn, field

milled byproducts

Corn, fieldhominy meal

Distiller's grain

driedBeet, sugar

dried pulp

Sorghum, grain

grain

Sorghum, grainstoverSoybeanseed

Soybeanmeal

Soybeanokara

Soybean

hulls

Rape

meal

Palm

kernel meal

Sesame seed

meal

Alfalfa

hay and meal

Vetchhay

Grasshay8