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JICOSH Home > Guidelines > On enforcement of Ministerial Ordinance for amending a part of the Ordinance on Industrial Safety and Health, Ministerial Ordinance for amending a part of Ordinance on Safety of Boilers and Pressure Vessels and Ministerial Ordinance for amending a part of Ordinance on the Prevention of Organic Solvents Poisoning (abstract)ation Test using Cultured Mammalian Cells
Guideline

On enforcement of Ministerial Ordinance for amending a part of the Ordinance on Industrial Safety and Health, Ministerial Ordinance for amending a part of Ordinance on Safety of Boilers and Pressure Vessels and Ministerial Ordinance for amending a part of Ordinance on the Prevention of Organic Solvents Poisoning (abstract)

In Japanese(1988)
I.  2 Details  7 Related to Article 34-4  (3), (4)···2001 amended partially (In Japanese)


I. Ordinance on Industrial Safety and Health
1 Points of revision
(Item 1 through 8 omitted)
9   The toxicity investigation on new chemical substances shall be conducted at test facilities, etc. which have technical base necessary to carry out the toxicity investigation in appropriate manner with respect to the organization, facilities, etc. (related to Article 34-3).
10   As a document to be attached to the notification by those who are required to submit the notification related to Paragraph 9, a document which certifies that the relevant investigation was carried out at a proper test facilities, etc. shall be additionally included. (related to Article 34-4).
(Item 11 through 15 omitted.)
2 Details
(Item 1 through 5 omitted.)
6 Related to Article 34-3
(1)   The clause "that is recognized to be provided with the organization and basic technical potentiality" of Item 2 of Paragraph 1 means that the test facilities, etc. have the organization, facilities, equipment, apparatus, etc. necessary for conducting the toxicity investigation in a proper manner and are recognized to be properly administered and managed, and specifically, the organization, facilities, equipment, apparatus, etc. conform to the standard prescribed by Minister of Health, Labour, and Welfare pursuant to the provisions of Paragraph 2.
(2)   The "standard to be satisfied by the test facilities, etc. for conducting mutagenicity studies" so far in the notification of Director-General of Labour Standards Bureau of Ministry of Labour (LSB Notification No. 261 dated May 18, 1985) has been now prescribed by the ML Notification pursuant to the provision of Paragraph 2. The "Standard for Investigation by Mutagenicity Studies using Microorganisms" shown in the above notification has also been prescribed by the ML Notification pursuant to the provisions of Paragraph 1 of Article 57-2 of Industrial Safety and Health Law.
7 Related to Article 34-4
(1)   (Deleted)
(2)   The "document to certify that the said toxicity test has been conducted using the test facilities meeting the requirement of the Minister of Health, Labour and Welfare" shall be the following documents.
1)   The document that states the name of the test facilities, etc., location, date of establishment, main party of establishment, articles of association, organization, personnel composition, site area, stories and total floor area of the building in which the facilities, etc. are located, and outline of the location, kinds, contents, etc. of the equipment and apparatus. If any brochure concerning the appearance of the building, main facilities, etc. is available, this shall be attached.
2)   The document that states the name and responsibilities of the personnel (including study director) engaged in the study related to the notification in the test facilities, etc., their curriculum vitae, research career, names of academic societies or learned societies they belong to.
3)   Name and post of the person responsible for quality assurance of the study related to the notification.
4)   The statement of the management or the study director certifying that the relevant toxicity investigation has been carried out and compiled at the test facilities, etc. which satisfy the standard prescribed by Minister of Health, Labour, and Welfare (for the study carried out overseas, such a standard can be replaced with GLP of the relevant county recognized to conform to OECD-GLP).
(3)   Notwithstanding the provisions of Paragraph (2) above, the documents of Paragraph (2) may be replaced with any of the following documents.
1)   A copy (limited to that whose date of inspection recited on the relevant notification is within 3 years before the completion of the toxicity investigation related to the relevant notification) of judgment notification granted to the effect that the relevant test facilities, etc. have satisfied the standards prescribed by Minister of Health, Labour, and Welfare based on the results, etc. evaluated in conformity to Annex "Guidelines for certification of compliance with Industrial Safety and Health Law GLP concerning test facilities, etc." (partly amended by LSB No. 146 dated March 11, 1997 "Amendment for Guidelines for certification of compliance with the Industrial Safety and Health Law GLP concerning test facilities, etc.") to LSB No. 123 dated March 17, 1989 "Establishment of Guidelines for certification of compliance with Industrial Safety and Health Law GLP concerning test facilities, etc."
2)   A copy of the notification of evaluation results based on the GLP investigation to the effect that the facilities for conducting studies for application for approval of manufacture, etc. of pharmaceuticals pursuant to the provisions of the Pharmaceutical Affairs Law (Law No. 145, 1960) satisfy the relevant standards granted from PMSB Director-General of MHLW to the applicant based on the results of evaluations on the compliance of the test facilities with the "MHW Ordinance concerning Standards for Non-Clinical Safety Studies on Pharmaceuticals" (1997 Ordinance No. 21 of Ministry of Health and Welfare), or a copy of notification on evaluation results based on the GLP investigation to the effect that the test facilities, etc. satisfy the relevant standards granted by Director of the Organization for Drug ADR Relief R&D Promotion and Product Review to the applicant or a copy of the certificate of GLP compliance (including a copy of the judgment notification of the compliance with the relevant standards granted by PMSB Director-General of MHW issued on and before June 30, 1997 to the applicant and a copy of the judgment notification of the compliance with the relevant standards granted by PMSB Director-General of MHW issued from July 1, 1997 to January 5, 2001, to the applicant, and limited to a copy whose date of the execution of investigation recited in the relevant notification is within 3 years before the completion of the toxicity investigation related to the relevant notification and whose study subject to the investigation recited in the relevant notification contains items of toxicity investigation attached to the notification.)
3)   For the test facilities, etc. confirmed to the effect that the test facilities, etc. are "the test facilities, etc. which possess facilities, equipment, personnel, etc. necessary for securing the quality of test results and which is properly administered and managed" as provided in Article 4 of the Order (1974 Ordinance No. 1 of Prime Minister's Office, Ministry of Health and Welfare, and Ministry of International Trade and Industry) for prescribing the items, etc. of the studies related to the new chemical substances and the toxicity investigation related to the designated chemical substances pursuant to the provisions of Article 4 and Article 24 of the Law concerning Examination and Regulation of Manufacture, etc. of Chemical Substances (Law No. 117, 1973), a copy of judgment notification granted by PMSB Director-General of MHLW to the applicant for confirmation (including a copy of the judgment notification granted by EHB Director-General of MHW to the applicant for confirmation issued on and before January 5, 2001, and limited to the copy whose date of the execution of inspection recited in the relevant notification shall be within 3 years before the completion of the toxicity investigation and whose study subject to investigation recited in the relevant notification contain the items of the toxicity investigation attached to the notification).
4)   The document or a copy thereof that certifies the governmental agency of the relevant country or the organization that corresponds to this has confirmed that the relevant test facilities, etc. conform to GLP of the relevant country, whose GLP has been recognized to conform to OECD-GLP, when the toxicity investigation has been conducted at the test facilities, etc. in a foreign country (if the employer cannot obtain the above-mentioned document because GLP does not exist in the relevant country or due to other good reasons, the employer shall be instructed to consult with Chemical Substances Investigation Division, Safety and Health Department, Labour Standards Bureau, Ministry of Health, Labour, and Welfare).
(4)   I n order to confirm the matters recited in the document of Paragraph (2) or (3) notified, the test facilities, etc. shall be inspected, and the management of the test facilities, etc. shall be asked to report, etc. as required.
  With respect to the inspection and other results evaluation, etc., Appendix "Guidelines for inspection on Industrial Safety and Health Law GLP" of Annex "Guidelines for certification of Compliance with Industrial Safety and Health Law GLP concerning test facilities, etc." (partly amended by LSB Notification No. 146 dated March 11, 1997 "Amendment to Guidelines for Certification of compliance with Industrial Safety and Health Law GLP concerning test facilities, etc.") of LSB Notification No. 123 dated March 17 1989 "Establishment of Guidelines for Certification of Compliance with Industrial Safety and Health Law GLP concerning test facilities, etc." shall be applied mutatis mutandis.

(The rest is omitted.)
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