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  1. Confidentiality Commitments

Export Inspection of India-FDA, Confidentiality Commitment

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STATEMENT OF AUTHORITY
AND
CONFIDENTIALITY COMMITMENT FROM
EXPORT INSPECTION COUNCIL OF INDIA
MINISTRY OF COMMERCE AND INDUSTRY
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 certain types of non-public information to the Export Inspection Council of India, Ministry of Commerce and Industry (EIC), regarding FDA regulatory activities in India pertaining to FDA-regulated foods for human and animal consumption that originate from facilities within India as part of cooperative law enforcement or cooperative regulatory activities.

EIC understands that some of the information it receives from FDA may include non-public information regarding foods for human and animal consumption that both organizations regulate and originate from India. This non-public information will relate exclusively to: reports and findings related to inspections conducted by FDA and information regarding the refusal of entry to the United States by FDA of foods that originate from facilities within India; foods for human and animal consumption originating in India that are implicated in outbreaks or similar incidents in the United States; and information submitted to FDA through the Reportable Food Registry regarding foods for human and animal consumption originating in India. Information shared by FDA may be exempt from public disclosure under the laws and regulations of the United States of America, and may include: confidential commercial information; personal privacy information; law enforcement information; or internal, pre-decisional information.

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

Therefore, EIC certifies that it:

  1. has the authority to protect from public disclosure such non-public information provided to EIC in confidence by FDA;
     
  2. 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;
     
  3. will inform FDA promptly of any effort made by judicial or legislative mandate to obtain FDA-provided non-public information from EIC. If such judicial or legislative mandate orders disclosure of FDA-provided non-public information, EIC 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 India’s laws, or to any relevant policies or procedures, that would affect EIC’s ability to honor the commitments in this document.

Signed in ____(Place)____ on ___(Date)____ in two original copies each in Hindi and English language. The two texts shall be equally authentic, in case of any divergence in the interpretation, the English text shall prevail.

Signature of EIC official

_________---/s/---____________         _____________________
Dr. S. K. Saxena                                      Date

Director, I&Q/C
Export Inspection Council of India
Ministry of Commerce & Industry 

3rd Floor NDYMCA
Cultural Centre Building
1, Jai Singh Road, New Delhi-110001

Phone: +91-11-23748025