Public Document Request Submitted to Osaka City Mayor Over Unclear Statements on P. adametzioides and Kobayashi Pharmaceutical

Public Document Request Issued to Osaka City Mayor

On September 1, 2023, a formal public document request (including a clarification request) was submitted to the Mayor of Osaka, initiated by the company, Kunsai Club, located in Hayashima Town, Okayama Prefecture. This inquiry specifically concerns a statement from Document 3 titled "Progress on Cause Investigation" presented at the third meeting of the Osaka City Food Poisoning Control Headquarters, held on May 29, 2024. The contentious statement details the confirmation of a strain of mold, P. adametzioides, isolated from Kobayashi Pharmaceutical's Wakayama factory, which was said to produce puberulic acid.

The request is seeking to clarify contradictions in responses from both Osaka City and the Osaka Health Safety Foundation (referred to as "Daiken") regarding the source and reliability of this information.

Responses from Osaka City and Daiken

Osaka City's Explanation

On August 17, 2023, Osaka City provided an explanation (Notice No. DDA 8290) regarding the absence of specific documents supporting the claims made in the statement. They stated:

"This documentation was reflected in the materials based on findings from Kobayashi Pharmaceutical. However, there are no existing records pertaining to this confirmation, nor has Osaka City independently verified the information from Kobayashi Pharmaceutical, nor is there a record of a judgment not to conduct such verification."

Daiken's Decision

In response to queries submitted by Kunsai Club on August 3 and 4, 2023, Daiken issued notices on September 1, 2023. They confirmed that:

- Documents related to the above statement do not exist as they were not created or retained as legal documents.
- Any advice provided to Osaka City was given verbally, thus also not documented.
- There are no documents indicating independent verification by Daiken regarding the production assertion of puberulic acid.

They concluded:

"Daiken has not published any conclusions regarding the production of puberulic acid. Making definitive statements based solely on species estimation is not an acceptable method. Thus, we have never stated definitively that the substance is produced based just on species estimation."

The Current Document Request

In their latest request, Kunsai Club seeks to obtain:

- The primary source document that details where the information from Kobayashi Pharmaceutical originated.
- Documents that clarify how this information was communicated to Osaka City, specifically whether it was received directly from Kobayashi or through other agencies like the Ministry of Health, Labour and Welfare.

Moreover, Kunsai Club has posed three specific inquiries:
1. Where is the primary source of the information noted above?
2. Was this information directly communicated to Osaka City, or was it channeled through other agencies?
3. Clarification on the discrepancy between Osaka City's statement about incorporating Kobayashi's confirmation and Daiken's assertion of lacking documentation and providing only verbal advice.

For Clarification

Osaka City states that their explanation reflects Kobayashi Pharmaceutical's confirmation details, yet no record of such confirmation exists. Daiken maintains they lack the supporting documents and only provided verbal assistance to Osaka City. Kunsai Club aims to ascertain how the source of the published statement and the communication route is validated in the documents of both institutions.

Recent Correspondences and Deadlines

- Final demands sent to Osaka City's health department on August 22, 2023, with a response deadline of September 4, 2023.
- A scientific inquiry petition directed to the head of Daiken on August 23, 2023, due by September 11, 2023.
- Request for investigation sent to the Ministry of Education, Culture, Sports, Science and Technology on August 25, 2023, also due by September 11, 2023.
- Inquiry to the Osaka Governor sent on August 24, 2023, with a deadline of September 30, 2023.
- Public document request sent to the Mayor of Osaka on September 1, 2023 (subject of this release).

Note on This Release

This release clarifies that the term "nonexistent" refers specifically to the institutions' responses regarding the availability of documents related to this request, not the broader scientific veracity of the statements involved.

Furthermore, interpretations such as "There are differing explanations" are based on Kunsai Club's understanding and do not reflect definitive conclusions regarding the accuracy of the institutions' explanations. The possibility of both explanations being valid will be explored during this clarification request.

This statement does not express any judgments regarding the causal relationship with health hazards or legality.

Additional Information

Kunsai Club has also launched an official LINE account to promote the recovery of the reputation of red yeast culture. The account will provide updates on the status of information disclosure requests and the contents of released administrative documents.