As a private, non-governmental organization that sets public standards and that is not subject to the Freedom of Information Act, USP has implemented this document disclosure policy to promote transparency in its standard-setting process while, at the same time, protecting USP’s deliberative process and any confidential information in USP’s possession.
Consistent with this policy and the Rules & Procedures of the Council of Experts, certain general information pertaining to USP's standard-setting activities, including certain information regarding the work and deliberations of USP's Council of Experts and Expert Bodies, is posted and maintained on the USP website. This policy does not address the confidentiality of USP’s business related documents, which are generally not subject to disclosure to third parties.
In addition, under this policy, the public may request the disclosure of certain documents relating to USP’s standard-setting activities that are not already posted publicly. The following are categories of documents generally subject to disclosure under this policy:
- The final approved version of minutes of Expert Body meetings, excluding minutes from any closed portion(s) thereof
- Comments submitted to USP by third parties in response to:
- Proposals or Stimuli articles published in the Pharmacopeial Forum (PF)
- Proposals published in the Food Chemicals Codex Forum (FCC Forum)
- General Chapter Prospectuses
- Compendial Notices
- Communications about standard-setting activities between USP and third parties, such as copies of written correspondence to and from third parties and memoranda of in-person or telephone conversations and meetings between USP and third parties
- Copies of public speeches or presentations by USP
- Copies of USP Convention reports
With respect to comments submitted to USP by third parties, and communications about standard-setting activities between USP and third parties, documents (or portions thereof) will not be disclosed where information was clearly and specifically designated as confidential when submitted or communicated to USP. USP requests that confidentiality be indicated in an unambiguous manner in the document(s) or communication(s) and will not consider boilerplate headers/footers or watermarks describing a general presumption of confidentiality to represent the clear or specific designation of confidentiality.
The following are categories of documents that generally will not be disclosed under this policy:
- Documents relating to communications among USP staff
- Documents relating to communications among members of USP’s Board of Trustees, Council of Experts, and/or Expert Bodies
- Documents relating to communications between USP staff and members of USP’s Board of Trustees, Council of Experts, and/or Expert Bodies
All requests for documents must be made to the USP Executive Secretariat (execsec@usp.org), which is responsible for making decisions regarding the disclosure of information in accordance with this policy. Decisions to grant or deny document requests are made solely at USP’s discretion. For example, a request may be refused solely on the basis that it is unduly burdensome or if it is determined by USP that diversion of personnel from higher priority duties would be unreasonable.
USP reserves the right to charge reasonable fees for disclosure of any documents requested under this policy including: copying charges; charges for time spent by USP personnel to locate, review, and copy such documents; shipping or postage fees; and other expenses associated with responding to the request.
This policy does not cover situations in which USP is compelled to disclose documents by subpoena or court order. In such cases, USP will comply to the extent required by law.