AOAC Conformity Assessment

AOAC Research Institute Policies and Procedures

Reviewing package inserts and user manuals to confirm that the

analytical performance claims in these documents are supported by

the Method Developer and independent site data and

Determining modification levels and data required, if any, to validate

modifications.

11.3 Confidentiality:

All documents generated by AOAC-RI or received by the AOAC-RI from applicant

Method Developer and/or Licensee containing proprietary or confidential information

shall be clearly marked as "CONFIDENTIAL".

The AOAC-RI considers the following items to be confidential information and

therefore subject to this policy:

The names of test methods and their manufacturers: with test methods under

review; who are discussing the possibility of submitting a test methods for review; or

who have submitted test kits that the AOAC-RI have declined to certify.

The contents of data submissions; the results of independent testing; the comments

of Expert Reviewers and/or independent testing laboratories; and the progress or

status of test kits under evaluation.

The progress of negotiations on license, indemnification, or other agreements with

specific test kit manufacturers; including the fact of, and progress of an appeal by a

test kit manufacturer.

If there is any doubt as to whether information in any form is confidential, it should

be handled as confidential information until the AOAC-RI Managing Director

determines otherwise.

11.3.1 Access to Confidential Information:

AOAC-RI employees, volunteers, and contractors are expressly forbidden to

discuss any confidential or proprietary information with: AOAC International

staff employees; Directors or Board members; AOAC-RI Board members or

officers; or with any other persons who are not directly involved in the

evaluation of the program who have not executed an AOAC-RI

Nondisclosure Agreement. Employees of AOAC-RI contractors and

consultants are contractually obligated by the nondisclosure clause of the

contract between their employer and the AOAC-RI.

11.3.2 Sanctions to Release Information:

AOAC-RI employees, volunteers, and contractors may release confidential

or proprietary information only if: 1) the release is specifically sanctioned by

a majority vote of the AOAC Research Institute Board of Directors, who may