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  1. Confidentiality Commitments

SAGARPA Mexico - FDA, Confidentiality Commitment

CONFIDENTIALITY COMMITMENT STATEMENT OF LEGAL AUTHORITY AND COMMITMENT FROM MEXICO’S SECRETARIA DE AGRICULTURA, GANADERIA, DESARROLLO RURAL, PESCA Y ALIMENTACION (SAGARPA) NOT TO PUBLICLY DISCLOSE NON-PUBLIC INFORMATION SHARED BY THE U. S. FOOD AND DRUG ADMINISTRATION (USFDA), 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 Mexico's Secretaria de Agricultura, Ganaderia, Desarrollo Rural, Pesca y Alimentacion (SAGARPA) regarding US FDA regulated products as part of cooperative law enforcement or cooperative regulatory activities.

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

Therefore, SAGARPA certifies that it:

  1. has the authority to protect the non-public information provided to SAGARPA in confidence by the USFDA from public disclosure; 
     
  2. will not publicly disclose the US 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 USFDA that the information no longer has non-public status; 
     
  3. will inform USFDA within two working days of any effort made to obtain USFDA- provided non-public information from SAGARPA by judicial or legislative mandate. If such judicial or legislative mandate orders disclosure of USFDA-provided non-public information, SAGARPA 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; and 
     
  4. will promptly inform USFDA of any changes to SAGARPA laws, SAGARPA policies or procedures that would affect SAGARPA ability to honor the agreements in this document.

___________/s/_____________
Signature of foreign government official

Mr. Javier Bernado Usabiaga Arroyo
_______________________________
Print or Type Foreign Government official

Secretario de Agricultura. Ganaderia. Desarrollo RuraL Pesca y Alimentacion
____________________________________
Title of foreign government agency official

Secretaria de Agricultura. Ganaderia, Desarrollo RuraL Pesca y Alimentacion
_________________________________
Name of foreign government agency

Address:
Municipio Libre 377
Col. Santa Cruz Atoyac
Del. Benito Juuarez
03310 Mexico. D.F.

Telephone and facsimile: 52 (55) 91 83 10 00

Date: May 7, 2004

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