FSA UK - FDA, Affirmative Response to Confidentiality Proposal
Dr Murray M Lumpkin M.D.
International and Special Programmes
US Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857
United States of America
2 October 2008
The Food Standards Agency of the United Kingdom of Great Britain and Northern Ireland (the FSA) is pleased to cooperate with the United States Food and Drug Administration, an agency within the Department of Health and Human Services (HHS/FDA), in sharing non-public information. This letter constitutes an affirmative reply to your letter proposing such cooperation of 2 October.
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.
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 and HHS/FDA 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.
The FSA understands that some of the information it receives from HHS/FDA 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 information relating to the formulation of Government policy.
The FSA understands that this non-public information is shared in confidence and that HHS/FDA 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 HHS/FDA and the FSA. HHS/FDA 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, the 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 the FSA for disclosure of non-public information received from HHS/FDA according to this understanding and identified as such, FSA will:
- Consult HHS/FDA before responding to the request for information.
- Allow 5 working days for HHS/FDA to respond with its view on whether the information in question should be disclosed.
- Take account of HHS/FDA's view before making a decision on disclosure.
- In any case have in mind the understanding outlined above as to the confidentiality of the information, where it is identified as confidential.
- 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: r.12 (4) (d) (incomplete material, unfinished documents/data); 12(5) (a) (adv.erse 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 HHS/FDA under this understanding, FSA will:
- Consult HHS/FDA 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.
- Take account of any view put forward by HHS/FDA when consulted, prior to deciding whether to exercise its power to publish the information.
- 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.
If the FSA is ordered or directed by a competent judicial, legislative, or regulatory authority to disclose or publish non-public information provided by HHS/FDA, the FSA will notify HHS/FDA 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.
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 the FSA or HHS/FDA 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 the FSA and HHS/FDA, 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 this affirmative reply is signed. It creates no legal obligation on the part of HHS/FDA or the FSA.
TIM J SMITH
On behalf of the Food Standards Agency