STATEMENT OF AUTHORITY AND CONFIDENTIALITY COMMITMENT FROM THE NATIONAL FISHERIES AND AQUACULTURE SERVICE OF CHILE 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 National Fisheries and Aquaculture Service of Chile (SERNAPESCA) regarding FDA-regulated products as part of cooperative law enforcement or cooperative regulatory activities.

SERNAPESCA 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.

SERNAPESCA understands that this non-public information is shared in confidence and that FDA considers it critical that SERNAPESCA maintain the confidentiality of the information. Public disclosure of this information by SERNAPESCA could seriously jeopardize any further scientific and regulatory interactions between FDA and SERNAPESCA. FDA will advise SERNAPESCA of the non-public status of the information at the time that the information is shared.

In Chile, the access to Government Administration information is a right that it is authorized by Law 20,285 of 2008, which established that the public function is exercised with transparency, so that it permits and promotes the knowledge of procedures, contents and decisions taken in the exercise of it. Consequently, under the principle of transparency of the public function, acts and resolutions of the organs of state administration, its foundations, the documents that directly and essentially support and supplement them, and the procedures used for their issuance are public. Similarly, the information developed with public funds and all other information held by the organs of government is public, regardless of format, medium, creation date, source, categorization or processing.

Law 20,285 established exceptions to disclosure of information held by the State Administration, so that all or part of accurate and specific information can be declared secret or confidential in exceptional cases indicated in the same Law. Pursuant to these exceptions SERNAPESCA has the right to deny access to non-public information provided to SERNAPESCA in confidence by FDA.

Therefore, SERNAPESCA certifies that it:

1. has the authority to protect from public disclosure such non-public information provided to SERNAPESCA in confidence by FDA, in accordance with the provisions of Article 21, Law 20,285, which established that access to all or part of information may be denied when public access thereto or communication, or knowledge thereof affects the national interest, especially if it relates to public health;
    
2. will not publicly disclose such FDA-provided non-public information without the prior 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;
    
3. will inform FDA promptly of any effort made by judicial or legislative mandate to obtain FDA-provided non-public information from SERNAPESCA. If such judicial or legislative mandate orders disclosure of FDA-provided non-public information, SERNAPESCA 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
    
4. will promptly inform FDA of any changes to the laws of the Republic of Chile, or to any relevant policies or procedures, that would affect SERNAPESCA's ability to honor the commitments in this document.

 

Signature of foreign agency official