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U.S. Department of Health and Human Services

International Programs

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FDA - FSA

October 2,2008

Dear Mr. Smith:

The United States Food and Drug Administration, an agency within the Department of Health and Human Services (HHSIFDA), is pleased to propose cooperation with the Food Standards Agency of the United Kingdom of Great Britain and Northern Ireland (the FSA) in sharing non-public information.

FDA is authorized under 21 C.F.R. $20.89 to disclose non-public information to the FSA relating to FDA-regulated products as part of cooperative law enforcement or regulatory activities.

The FSA is a Government Department created by the Food Standards Act 1999, which, together with other legislation, defines its powers and duties in UK law.

Therefore, HHSIFDA and the FSA wish to facilitate the sharing of information, including otherwise non-public documents and information, for cooperative law enforcement and other regulatory activities. Each authority will treat such non-public information as confidential within the meaning of its national law and will deal with it according to the procedures outlined below.

HHSIFDA understands and respects the duties and powers of the FSA under UK law, in particular its power contained in s. 19 of the Food Standards Act 1999, to publish any information in its possession, whatever its source.

HHSIFDA understands that some of the information it receives from the FSA may include non-public information which would be exempt from disclosure under the laws of the United Kingdom, such as confidential commercial information; trade secret information; personal information; law enforcement information; or information relating to the formulation of Government policy.

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

FDA affirms that it has the authority to protect such non-public information provided to it (including its officials and representatives) by the FSA, and will protect such information as information not to be disclosed under the US Freedom of Information Act. The FDA understands that the FSA considers it crucial that such non-public information should not be disclosed without the consent of the FSA and that disclosure made without such consent could endanger the international relations between the parties.

If a request is made to HHSIFDA for disclosure of non-public information received fiom the FSA according to this understanding and identified as such, HHS/FDA will:

  1. Consult the FSA before responding to the request for information. 
  2. Allow 5 working days for the FSA to respond with its view on whether the information in question should be disclosed. 
  3. Take account of the FSA's view before making a decision on disclosure. 
  4. In any case have in mind the understanding outlined above as to the confidentiality of information identified as non-public. 
  5. If the FSA objects to disclosure, and within the framework of applicable laws and regulations, take whatever steps it considers appropriate within the laws and regulations of the United States of America to protect the information from disclosure. HHS/FDA will keep the FSA informed of any material changes to relevant access to information legislation or regulations in the United States of America that would affect HHSIFDA's ability to act in accordance with the understanding outlined in this document.

If HHS/FDA is ordered or directed by a competent judicial, legislative, or regulatory authority to disclose or publish non-public information provided by the FSA, HHSIFDA will notify the FSA as soon as possible. In this event, HHSIFDA will endeavour, so far as may be possible within the terms of the order or direction, to disclose information in such a way as to limit its circulation or use so as to minimize any harm which may be occasioned by disclosure.

FSA

The FSA understands that some of the information it receives from HHSIFDA 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.

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

The FSA affirms that it has the authority to protect such non-public information provided to it (including its officials and representatives) by HHS/FDA and will protect such information as information not to be disclosed under the UK Data Protection Act 1998, UK Freedom of Information Act 2000 or the Environmental Information Regulations 2004. The FSA understands that the HHS/FDA considers it crucial that such non-public information should not be disclosed without the consent of the HHS/FDA and that disclosure made without such consent could endanger the international relations between the parties.

If a request is made to FSA for disclosure of non-public information received from HHSIFDA according to this understanding and identified as such, FSA will:

  1. Consult HHSIFDA before responding to the request for information. 
  2. Allow 5 working days for HHS/FDA to respond with its view on whether the information in question should be disclosed. 
  3. Take account of HHS/FDA's view before making a decision on disclosure. 
  4. In any case have in mind the understanding outlined above as to the confidentiality of the information, where it is identified as confidential. 
  5. If the HHS/FDA objects to disclosure, and within the framework of applicable information law, take whatever steps it considers appropriate in the circumstances to protect the information from disclosure. This may include, but is not limited to, applying the following exemptions from disclosure contained in relevant law where they appear appropriate and it is in the public interest to do so:

Freedom of Information Act 2000: s. 27 (prejudice to international relations/confidential information obtained from another state; 35 (information relating to formulation or development of government policy; 36(2) (c) (disclosure would be likely to prejudice the effective conduct of public affairs); 41 (information provided in confidence); 43 (trade secret/prejudice to commercial interests).

Environmental Information Regulations 2004 (4) (d) (incomplete material, unfinished documents/data); 12(5) (a) (adverse effect on international relations); 12(5) (c) (adverse effect on intellectual property rights); 12(5) (e) (adverse effect on confidentiality of commercial or industrial information as provided by law to protect a legitimate economic interest); 12(5) (f) (adverse effect on the interests of a person who voluntarily supplied the information and has not consented to its disclosure).

In a case where the FSA is considering the exercise of its power to publish information in its possession under s. 19 of the Food Standards Act 1999, and the information was provided by HHSIFDA under this understanding, FSA will:

  1. Consult HHSIFDA before publication, allowing as much time as is reasonably practicable in the circumstances for FDA to reply, except in the case of a public health emergency where the urgency of the situation means that consultation is impracticable. 
  2. Take account of any view put forward by HHS/FDA when consulted, prior to deciding whether to exercise its power to publish the information. 
  3. In all cases, for the purposes of s. 19(4) of the Food Standards Act 1999, the FSA will regard the understanding in this document as a "consideration of confidentiality" relating to non-public information received under it.

The FSA will keep HHSIFDA informed of any material changes to relevant United Kingdom or European Union access to information legislation or regulations that would affect the FSA's ability to act in accordance with the understanding outlined in this document.

If the FSA is ordered or directed by a competent judicial, legislative, or regulatory authority to disclose or publish non-public information provided by HHSIFDA, the FSA will notify HHSIFDA as soon as possible. In this event, the FSA will endeavour, so far as may be possible within the terms of the order or direction, to disclose information in such a way as to limit its circulation or use so as to minimize any harm which may be occasioned by disclosure.

Final Matters

Each Participant may choose to limit the amount of information shared with the other in any particular case, and will inform the other when incomplete information is shared.

If information shared by either HHSIFDA or FSA is not identified as non-public or confidential at the time it is communicated, the receiving Participant will assume that there is no impediment to its wider disclosure or publication at the discretion of that Participant.

Any dispute about the interpretation or application of this arrangement will be resolved by consultations between HHS/FDA and the FSA, and will not be referred to any national or international tribunal or third party for settlement. This arrangement will commence on the day on which the affirmative reply is signed by the FSA. It creates no legal obligation on the part of HHS/FDA or the FSA.

If this arrangement is acceptable to you, please provide us with your affirmative reply at your earliest convenience.

Sincerely,

---/s/---

Murray M. Lumpkin, M.D., M.Sc.
Deputy Commissioner
International and Special Programs
Food and Drug Administration
Department of Health and Human Services
United States of America

Address:
5600 Fishers Lane
Rockville, MD 20857
(301) 827-5709 (ph)
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