Australian Government Department of Agriculture, Water and the Environment – FDA Confidentiality Commitment
STATEMENT OF AUTHORITY AND CONFIDENTIALITY COMMITMENT FROM THE AUSTRALIAN GOVERNMENT DEPARTMENT OF AGRICULTURE, WATER AND THE ENVIRONMENT NOT TO PUBLICLY DISCLOSE NON-PUBLIC INFORMATION SHARED BY THE UNITED STATES FOOD AND DRUG ADMINISTRATION
The United States Food and Drug Administration (FDA) is authorized under 21 C.F.R. § 20.89 to disclose non-public information to the Australian Government Department of Agriculture, Water and the Environment (DAWE) regarding FDA-regulated products as part of cooperative law enforcement or cooperative regulatory activities.
DAWE acknowledges that:
- this Statement of Authority and Confidentiality Commitment replaces and continues the protections of information previously shared under the Confidentiality Commitment Statement of Legal Authority and Commitment From the Australian Quarantine and Inspection Service Not to Publicly Disclose Non public Information Shared by the US Food and Drug Administration, US Department of Health and Human Services, signed by the Australian Quarantine and Inspection Service (AQIS) on March 17, 2009 ("2009 Confidentiality Commitment Statement of Legal Authority and Commitment");
- as a result of machinery of government changes implemented under Australian Law, DAWE has assumed the responsibilities of the Department of State of which AQIS was a division. Further changes may occur in the future which may result in other Australian Government Departments or agencies becoming responsible for this Statement of Authority and Confidentiality Commitment; and
- DAWE will continue to provide the same protections for any non-public information provided by AQIS under the 2009 Confidentiality Commitment Statement of Legal Authority and Commitment.
DAWE understands that some of the information it receives from FDA may include non-public information exempt from public disclosure under the laws and regulations of the United States of America, which is confidential commercial information; trade secret information; personal privacy information; law enforcement information; designated national security information; or internal, pre-decisional information. DAWE understands that this non-public information is shared in confidence and that FDA considers it critical that DAWE maintain the confidentiality of the information. Public disclosure of this information by DAWE could seriously jeopardize any further scientific and regulatory interactions between FDA and DAWE. FDA will advise DAWE of the non-public status of the information at the time that the information is shared.
Therefore, DAWE certifies that it:
- has the authority to protect from public disclosure such non-public information provided to DAWE in confidence by FDA;
- will not publicly disclose such FDA-provided non-public information without the written authorization of the owner of the information, the written authorization from the individual who is the subject of the personal privacy information, or a written statement from FDA that the information no longer has non-public status;
- will inform FDA promptly of any effort made by judicial or legislative mandate to obtain FDA-provided non-public information from DAWE. If such judicial or legislative mandate orders disclosure of FDA-provided non-public information, DAWE will take all appropriate legal measures in an effort to ensure that the information will be disclosed in a manner that protects the information from public disclosure; and
- will promptly inform FDA of any changes to Australia's laws, or to any relevant policies or procedures, that would affect DAWE's ability to honor the commitments in this document.
Signed on behalf of DAWE:
Fran Freemari Date: 17/7/2020
First Assistant Secretary, Exports Division
Department of Agriculture, Water and the Environment
18 Marcus Clarke Street
Canberra ACT 2601