FSANZ Australia - FDA, Confidentiality Commitment
CONFIDENTIALITY COMMITMENT STATEMENT OF LEGAL AUTHORITY AND COMMITMENT FROM THE FOOD STANDARDS AUSTRALIA NEW ZEALAND NOT TO PUBLICLY DISCLOSE NON-PUBLIC INFORMATION SHARED BY THE U.S. FOOD AND DRUG ADMINISTRATION, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
The United States Food and Drug Administration (USFDA), a part of the United States Department of Health and Human Services, is authorized under 21 C.F.R. § 20.89 (“Communications with Foreign Government Officials”) to disclose non-public information to Food Standards Australia New Zealand (FSANZ) regarding USFDA-regulated products as part of cooperative law enforcement or cooperative regulatory activities.
FSANZ acknowledges that some of the information it receives from USFDA may include non-public information exempt from public disclosure under the laws and regulations of the United States of America, such as confidential commercial information; trade secret information; personal privacy information; law enforcement information; or internal, pre-decisional information.
FSANZ acknowledges that this non-public information is shared in confidence, and that USFDA considers it critical that FSANZ maintain the confidentiality of the information. Public disclosure of this information by FSANZ could seriously jeopardize any further scientific and regulatory interactions between USFDA and FSANZ.
USFDA will advise FSANZ of the status of the non-public information at the time that the information is shared.
Subject to judicial and legislative mandate, FSANZ has the authority to protect such non-public information provided to it in confidence by USFDA from public disclosure.
FSANZ will not publicly disclose such non-public information provided by USFDA in confidence without:
(a) the written authorization of the owner of the information;
(b) the written authorization from the individual who is the subject of the personal privacy information; or
(c) a written statement from USFDA that the information no longer has non-public status.
FSANZ will only communicate confidential commercial information for enforcement or recall purposes with “prescribed authorities or person[s]” under paragraph 114 (4)(b) of the Food Standards Australia New Zealand Act 1991 (FSANZ Act) and the Food Standards Australia New Zealand Regulations 1994. All such “prescribed authorities or person[s]” are subject to a duty under section 114 of the FSANZ Act not to disclose confidential commercial information. The FSANZ Act defines confidential commercial information as:
(a) a trade secret relating to food; or
(b) any other information relating to food that has a commercial value that would be, or could reasonably be expected to be, destroyed or diminished if the information were disclosed.
FSANZ will inform USFDA promptly of any effort made to obtain USFDA-provided non-public information from FSANZ by judicial or legislative mandate. If such judicial or legislative mandate orders disclosure of USFDA-provided non-public information, FSANZ will take all measures in an effort to ensure that the information will be disclosed in a manner that protects the information from public disclosure.
FSANZ will promptly inform USFDA of any changes to its legislation, regulations, policies or procedures that would affect FSANZ’s ability to honor the commitments in this document.
The officer responsible for day-to-day operations under this confidentiality commitment is the person holding the position of Manager, Food Safety, FSANZ.
Date: April 15, 2008
Stephen D. McCutcheon
Chief Executive Officer
Food Standards Australia New Zealand
55 Blackall Street
Barton ACT 2600
Tel. 02-6271 2222
Fax. 02-6271 2278