Inspection and confirmation of compliance with the standard
provided for in Articles 5 to 19 of the Ministerial Ordinanceon Good Laboratory Practice for Agricultural Chemicals(Notification: 30 Shouan No.4215, issued on November 30, 2018 by Director-General, Food Safety andConsumer Affairs Bureau, the Ministry of Agriculture, Forestry and Fisheries)

DISCLAIMER:
The translations of notification on this page are not official. Only the original
Japanese texts of notification have legal effect, and the translations are to be
used solely as reference materials to aid in the understanding of the original
texts. Neither FAMIC nor the government of Japan shall be held responsible forthe accuracy, reliability or currency of the translations provided on this website,or for any consequences resulting from the use of information on this website.
For all purposes of interpreting and applying notices to any legal issue or dispute,users should consult the original Japanese texts. The translations may be revisedin the future. The data contained on this page may be reprinted or reproduced,
provided that the disclaimer is accompanied and the source is shown.

Revision: 1 Shouan No.914, issued on June 28, 2019
Revision: 2 Shouan No.4310, issued on Jan 5, 2021

Confirmation and Inspection on compliance with the standard provided for in
Articles 5 to 19 of the Ministerial Ordinance on Good Laboratory Practice for
Agricultural Chemicals
1 Purpose
Pursuant to Article 3, paragraph (2) of the Agricultural Chemicals Regulation Act (Act No. 82 of 1948), thetest results specified in Article 2 (hereinafter referred to as “Specified Test Results”) of the “Ministerial
Ordinance of the Good Laboratory Practice for Agricultural Chemicals” (hereinafter referred to as“Ministerial Ordinance”) must be derived from tests conducted in accordance with the standard provided forin Articles 5 to 19 of the Ministerial Ordinance as necessary to ensure the reliability of the results (hereinafterreferred to as “Agricultural Chemicals GLP Standards”).
This notification is to provide for the procedures of inspection and confirmation of compliance with theAgricultural Chemicals GLP Standards.
2 Confirmation of GLP Compliance by the Director-General, Food Safety and Consumer Affairs
Bureau(1) Confirmation of compliance with the Agricultural Chemicals GLP Standards must be made inaccordance with either (i) or (ii) below:(i) The Director-General, Food Safety and Consumer Affairs Bureau, Ministry of Agriculture,
Forestry and Fisheries (hereinafter referred to as the “Director-General, Food Safety andConsumer Affairs Bureau”) confirms that the test facility conducting studies is in compliancewith the Agricultural Chemicals GLP Standards (hereinafter referred to as a “Confirmation of
GLP Compliance”) at least once in every three years; or(ii) A government agency or an organization representing it confirms that the test facility conducting
studies is in compliance with standards of GLP (limited to the programs that have been confirmed
to be in compliance with GLP principles of the Organization for Economic Co-operation andDevelopment (OECD) or the programs of the countries which have concluded bilateralarrangements with Japan), on the basis of which the Director-General, Food Safety and Consumer
Affairs Bureau decides that the test facility conducting studies is in compliance with theAgricultural Chemicals GLP Standards.
(2) Regardless of (1), (i), if any doubt arises, as the result of the examination in Article 3, paragraph (4),Article 7, paragraph (2) or Article 8, paragraph (4) of the Act or on the basis of other information, as
to the reliability of the specified test results provided in Article 3, paragraph (2), Article 7, paragraph(1) or Article 8, paragraph (3) of the Act, and when the notice thereof is issued by the DirectorGeneral, Food Safety and Consumer Affairs Bureau, the test facility must undergo a confirmation of
GLP compliance by the Director-General, Food Safety and Consumer Affairs Bureau in order toeliminate the doubts regarding the reliability of the Specified Test Results.
3 Application for Confirmation of GLP Compliance(1) When conducting studies subject to a Confirmation of GLP Compliance in Article 2, (1), (i), a person
or, in case of a corporation, its representative (hereinafter referred to as “GLP Confirmation
Applicant.”) must submit the application for Confirmation of GLP Compliance of test facility(Appended Form 1), and the applicants for the registration of agricultural chemicals under 2, (2)must submit the application for Confirmation of GLP Compliance (Appended Form 2) to the
Director-General Food Safety and Consumer Affairs Bureau along with the following documentsfrom (i) to (iv):(i) Overview of the test facility (name, location, date of establishment, organizational and personnel
composition (describe both the organizational affiliations in the facility and the organizational1

affiliations under the Agricultural Chemicals GLP Standards), site area and building area, internaland external building layout, and the types and specifications of equipment);(ii) Summary of the competence to conduct Specified Tests and the numbers of the specified testcompleted over the past three years;(iii) List of Standard Operating Procedures and(iv) Documents concerning Test Facility Management (Test Site Management, if applicable), Study
Director, (Principal Investigator), study personnel, personnel of Quality Assurance Unit andArchivist, which list the names, career backgrounds, research histories and names of academic
societies and academic organizations to which they belong.
(2) Submission of the application for Confirmation of GLP Compliance of test facility and the relevant
documents in (1), can be made via Independent Administrative Agency, Food and Agricultural
Materials Inspection Center (hereinafter referred to as “FAMIC”). In this case, FAMIC may append
comments, etc. to the application.
(3) The Director-General, Food Safety and Consumer Affairs Bureau may request a GLP Confirmation
Applicant to submit further documents and other materials necessary for assessing GLP Compliance.
In this case, the GLP Confirmation Applicant may submit them to the Director-General, Food Safety
and Consumer Affairs Bureau via FAMIC.
4 Examination with document and Inspection
The Director-General Food Safety and Consumer Affairs Bureau examamines the documents submitted in
3 above, and then, if it is found to be necessary to conduct an inspection, the Director-General may have
either of the followings inspect the test facility:(i) FAMIC;(ii) Those appointed by the Director-General among those who have sufficient knowledge orexperience on the inspection related to test results or specimens, etc.
5 Inspection Procedure(1) Prior to the inspection, the Director-General, Food Safety Consumer Affairs Bureau notifies the GLP
Confirmation Applicant of the date of the inspection and other necessary matters.
(2) Inspection is conducted in accordance with the following steps.
(i) Inspection of the overall management of the test facility;(ii) Inspection of the facility and the maintenance of apparatus;(iii) Inspection of operations;(iv) Inspection of the documentation of study plan, Standard Operating Procedures, final report, etc.;(v) Inspection of the activity of the Quality Assurance Unit;(vi) Inspection of the management of retained raw data, specimen, etc.; and(vii) Inspection and verification of raw data, specimens, final reports, etc. related to the studies for
audit(3) If it is deemed necessary as a result of the inspection, a request may be made to submit samples oftest item, etc., specimens, raw data, and other necessary materials.
(4) After the inspection is completed, the personnel who conducted the inspection (hereinafter referred toas the “Inspector”) is to give advice or guidance on-site as necessary. The advice or guidance must
be recorded.
6 Reporting the results of inspections(1) The Inspector must prepare an inspection report including the following items, and submit it to the
Director-General, Food Safety and Consumer Affairs Bureau after conducting the inspection:2(i) Name(s) and affiliation(s) of the Inspector(s);(ii) Name and Address of the test facility inspected;(iii) Date(s) of inspection;(iv) Purpose of the inspection;(v) Overview of the test facility;(vi) Type(s) of study audited;(vii) Name(s) and affiliation(s) of personnel of the test facility who attended in the inspection;(viii) Compliance with the Agricultural Chemicals GLP Standards on the test facility and studies
inspected;(ix) Conclusion; and(x) Other items- Improvement(s) relating to deviation(s) found in the last inspection;- Implementable studies(2) Based on the inspection report, the Director-General, Food Safety and Consumer Affairs Bureauverifies whether the test facility complies with the Agricultural Chemicals GLP Standards, andnotifies the GLP Confirmation Applicant of the result.
7 Others(1) The representative of the test facility that has received the confirmation of the GLP compliance fromthe Director-General, Food Safety and Consumer Affairs Bureau under 2, (1), (i) or (2) must submit
a notification concerning the change of the application for Confirmation of GLP Compliance(Appended Form 3) to the Director-General, Food Safety and Consumer Affairs Bureau, in cases
where any changes to the following items occur in the contents of the application for Confirmation of
GLP Compliance of Test Facility (Appended Form 1):(i) Address or name of the GLP Confirmation Applicant; or(ii) Name or address of the test facility.
(2) The representative of the test facility that has received confirmation of GLP compliance from the
Director-General, Food Safety and Consumer Affairs Bureau under 2, (1), (i) or (2) is promptly tosubmit the notification of business abolition (Appended Form 4) to the Director-General, Food
Safety and Consumer Affairs Bureau, in cases where the GLP operation of a test facility is to beclosed.
Supplementary provisions (December 1, 2018)
1 This notification applies on December 1, 2018. However, it does not apply to the test results listed below.
(1) Following test results initiated before September 30, 1984: Acute oral toxicity, acute dermal toxicity,
acute inhalation toxicity, skin irritation, eye irritation, skin sensitization, acute delayed neurotoxicity,
90-day repeated dose oral toxicity, 21-day repeated dose dermal toxicity, 90-day repeated inhalation
toxicity, 28-day repeated dose delayed neurotoxicity, 1-year repeated dose oral toxicity,
carcinogenicity, reproductive toxicity, teratogenicity and mutagenicity;(2) Following test results initiated before August 28, 1997: Human safety of microbial pesticides;(3) Following test results initiated before September 30, 1999: Properties, stability, degradability, etc. of
active ingredient (excluding test results regarding color, shape and odor, and bioconcentration);(4) Following test results initiated before January 31, 2001: Acute neurotoxicity, repeated dose oral
neurotoxicity, detoxification methods or emergency medical treatment, metabolism in animals,
metabolism in plants, behavior in soil, behavior in water, fish acute toxicity, Acute immobilization
on daphnids, Reproduction on daphnids, and growth inhibition on algae;3(5) Following test results initiated before January 9, 2003: Analysis of composition of an agriculturalchemical's TGAI, and analysis of dioxins in an agricultural chemical TGAI;(6) Following test results initiated before March 31, 2005: Fish (incubated larvae) acute toxicity, Acuteimmobilization on daphnids (adults), effects of coexisting organic substances on fish acute toxicity /acute swimming inhibition of the genus Daphnia, Acute toxicity on freshwater shrimps (Paratya
compressa compressa and Paratya compressa improvisa) and amphipoda, and Acute immobilization
on chironomid larvae;(7) Following test results initiated before October 1, 2007: Bioconcentration;(8) Following test results initiated before March 31, 2011: Residues in crops;(9) Following test results initiated before November 13, 2014: Residues in livestock; and(10) Following test results initiated before March 31, 2017: Analysis of composition of an agriculturalchemical TGAI used in toxicity tests, toxicity for additives and impurities, and Analysis methods onan agricultural chemical TGAI
2 “The Good Laboratory Practice for Agricultural Chemicals” (The notification: 11 Nousan No.6283,
issued on October 1, 1999 by Director-General of Agricultural Production Bureau, the Ministry ofAgriculture, Forestry and Fisheries; hereinafter referred to as the “former notification”) is hereby
abolished.
3 With regard to an application for the confirmation of the GLP compliance based on 4 of the former
notification filed prior to the enforcement of this notification, and for which no notification has been madefor the results of the confirmation of the GLP compliance on 7, (2), of the former notification, theprocedure for the confirmation of the GLP compliance then in force must remain applicable.
4 With regard to test results that may not be in compliance with the standards set out in Articles 5 to 19 of
the Ministerial Ordinance on GLP for Agricultural Chemicals under the provision of paragraph (2) of the
supplementary provisions of the Ministerial Ordinance on GLP for Agricultural Chemicals, and that are
subject to the Agricultural Chemicals GLP Standards in the former notification (other than those listed in
1, (1) to (10)), the provisions of the former Notification (including the attached standards) is to remain inforce.
Supplementary provisions (June 28, 2019)
1 This notification applies on July 1, 2019.
2 Notwithstanding the provisions of the preceding paragraph, the provisions for revising relating to thefollowing studies applies on April 1, 2020: Physical and chemical properties of formulation products inthe physical and chemical properties area; dermal absorption and Exposure of operator to agriculturalchemicals applying them in the field in the toxicity area; growth inhibition on algae and cyanobacteria,
growth inhibition on Lemna sp., acute oral toxicity on avian, acute dermal toxicity on honeybees (adults),
acute oral toxicity on honeybees (adults), chronic oral toxicity on honeybees (adults), oral toxicity on
honeybees (larvae) and residues in pollen and nectar in the adverse effects on aquatic and terrestrialorganisms area; provided however, that it does not preclude the application of the provisions of therevised notification on the Confirmation of GLP Compliance, etc. to these studies on or before March 31,
2020.

4

Appended Form 1

Date:
To the Director-General, Food Safety andConsumer Affairs Bureau, the Ministry ofAgriculture, Forestry and Fisheries,
Address: (For corporate body, the address of the main office)Name: (For corporate body, its name and the name of its representative)
Contact point: (phone / fax number, e-mail address, department / name of
person in charge)

I hereby apply for the confirmation (on-site inspection) of the below-mentioned test facility inaccordance with the provisions of Article 3 of “Inspection and Confirmation of compliance withthe standard provided for in Articles 5 to 19 of the Ministerial Ordinance on Good Laboratory
Practice for Agricultural Chemicals” (Notification: 30 Shouan No.4215, issued on November 30,
2018 by the Director-General, Food Safety and Consumer Affairs Bureau, Ministry ofAgriculture, Forestry and Fisheries). Attached are documents required in the Article.

1 Name of test facility:
2 Address of test facility:
3 Area(s) of the studies:
4 If there has been confirmation of GLP compliance in the past, the date of confirmation and
the Area(s) of the studies:（Japanese Industrial Standard A4）
Remarks(Note 1) The documents, etc. provided in “3: Application for Confirmation of GLP Compliance” areto be attached as related documents.
(Note 2) For Notes 1 and 2 above, write them in English alongside.
(Note 3) Refer to appendix for the area in 3 and 4 above.

5Appended Form 2

Date:
To the Director-General, Food Safety andConsumer Affairs Bureau, the Ministry ofAgriculture, Forestry and Fisheries,
Address:
Name: (For corporate body, its name and the name of its representative)

I have been notified on [yymmdd] that there are doubts regarding the reliability of the test result
indicated below. In order to have the doubts eliminated, I hereby apply for inspection with
relevant documents attached.

1 Title of the test result(s) concerning the doubts:
2 Name of test facility:
3 Address of test facility:（Japanese Industrial Standard A4）
Remarks(Note 1) The documents, etc. provided in “3: Application for Confirmation of GLP Compliance” areto be attached as related documents.
(Note 2) For 2 and 3 above, write them in English alongside.

6

Appended Form 3

Date:
To the Director-General, Food Safety andConsumer Affairs Bureau, the Ministry ofAgriculture, Forestry and Fisheries,
Address:
Name: (For corporate body, its name and the name of its representative)

I hereby notify change(s) in the information stated in the Application for Confirmation of GLP
Compliance of test facility as shown below, in accordance with the provisions in 7 (1) of“Inspection and confirmation of compliance with the standard provided for in Articles 5 to 19 of
the Ministerial Ordinance on Good Laboratory Practice for Agricultural Chemicals.”

1 Name of test facility:
2 Content(s) of change(s):3 Reason for change(s):4 Date that change was made:（Japanese Industrial Standard A4）

7

Appended Form 4

Date:
To the Director-General, Food Safety andConsumer Affairs Bureau, the Ministry ofAgriculture, Forestry and Fisheries,
Address:
Name: (For corporate body, its name and the name of its representative)

I hereby notify the discontinuation of the business of GLP test facility as follows, in accordancewith the provisions in 7 (2) of “Inspection and Confirmation of compliance with the standard
provided for in Articles 5 to 19 of the Ministerial Ordinance on Good Laboratory Practice for
Agricultural Chemicals”.

1 Name of test facility:
2 Contents of abolishment:(1) Reason for abolishment:(2) List of place of transfers of final reports, specimens, raw data, etc. after abolishment:(3) (Scheduled) date of abolishment:（Japanese Industrial Standard A4）
Remarks(Note) About 2 (2), the list may be submitted as an attached document of the application.

8

Appendix
Area

Analysis of thetechnical grade
active ingredient(TGAI)
Physical andchemicalproperties
Toxicity

Name of study

Analysis of composition of an agricultural chemical TGAI
Analysis methods on an agricultural chemical TGAI
Physical and chemical properties of an active ingredient
Physical and chemical properties of formulation products
Acute oral toxicity
Acute dermal toxicity
Acute inhalation toxicity
Skin irritation
Eye irritation
Skin sensitization
Acute neurotoxicity
Acute delayed neurotoxicity
90-day repeated dose oral toxicity
21-day repeated dose dermal toxicity
90-day repeated inhalation toxicity
Repeated dose oral neurotoxicity
28-day repeated dose delayed neurotoxicity
Chronic toxicity
Carcinogenicity
Combined of Carcinogenicity and Carcinogenicity
Reproductive toxicity
Developmental toxicity
Developmental neurotoxicity
Detoxification methods or emergency medical treatment
Dermal absorption
Exposure of operator to agricultural chemicals applying them in the field
metabolism in animals
Acute oral toxicity / infectivity
Acute dermal toxicity / infectivity
Acute pulmonary toxicity / infectivity
Acute intravenous toxicity / infectivity
Cell culture
Repeated dose toxicity / infectivity
Reproductive toxicity / infectivity
Viral carcinogenicity
Immunodeficiency inducing
1

Area

Item

Effect on primates
Histopathological specimen preparation
Mutagenicity

Reverse mutation
Chromosomal aberration
Micronucleus
Gene mutation or DNA damage

Residues

Metabolism in plants
Residues in crops
Analysis methods on residues in crops
Residues in processed commodities
Metabolism in livestock
Residues in livestock
Analysis methods on residues in livestock
Stability in stored commodities

Environmental
behavior

Aerobic flooding soil
Aerobic soil
Anaerobic soil
Hydrolysis
Photolysis in water
Soil adsorption
Bioconcentration

Ecotoxicity

Fish acute toxicity
Acute immobilization on daphnids
Acute immobilization on daphnids (adults)
Reproduction on daphnids
Adverse effects of coexistent organic substances on fish acute toxicity and daphnids acuteimmobilization
Acute toxicity on freshwater shrimps (Paratya compressa compressa and Paratya
compressa improvisa) and amphipoda
Acute immobilization on chironomid larvae
Growth inhibition on algae and cyanobacteria
Growth inhibition on Lemna sp.
Acute oral toxicity on avian
Acute dermal toxicity on honeybees (adults)
Acute oral toxicity on honeybees (adults)
Chronic oral toxicity on honeybees (adults)
Oral toxicity on honeybees (larvae)
Residues in pollen and nectar2