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Food and Drug Administration (FDA) Long-Term Limited Scope Food, Feed and Cosmetics Information Sharing Agreement (ISA)City of Dubuque City Council Meeting Consent Items # 025. Copyrighted June 17, 2024 ITEM TITLE: Food and Drug Administration (FDA) Long -Term Limited Scope Food, Feed and Cosmetics Information Sharing Agreement (I SA) SUMMARY: City Manager recommending City Council approve the five-year 20.88 agreement with the FDA and authorize the City Manager to sign the agreement. SUGGESTED Suggested Disposition: Receive and File; Approve DISPOSITION: ATTACHMENTS: Description Type MVM Memo City Manager Memo Staff Memo Staff Memo FDA FCC Five Year Agreement Supporting Documentation THE CITY OF Dubuque DUB TEE1. All -America City Masterpiece on the Mississippi � pp zoo�•*o 13 zoi720zoi9 TO: The Honorable Mayor and City Council Members FROM: Michael C. Van Milligen, City Manager SUBJECT: Food and Drug Administration (FDA) Long -Term Limited Scope Food, Feed and Cosmetics Information Sharing Agreement (ISA) DATE: June 12, 2024 Public Health Director Mary Rose Corrigan is recommending City Council approve the five-year 20.88 agreement with the FDA and authorize the City Manager to sign the agreement. The current FDA agreement expires June 30, 2024. The new agreement changes are minimal and include communication process requirements with Iowa Department of Inspections, Appeals, and Licensure and FOIA request notifications to the Food Drug Administration. I concur with the recommendation and respectfully request Mayor and City Council approval. Mic ael C. Van Milligen MCVM:sv Attachment cc: Crenna Brumwell, City Attorney Cori Burbach, Assistant City Manager Mary Rose Corrigan, Public Health Director THE CDubuque DUUB �t NI-NnericaCh 1 I Masterpiece on the Mississippi 2007 • 2012 • 2013 • 2017 TO: Michael C. Van Milligen, City Manager FROM: Mary Rose Corrigan, Public Health Director SUBJECT: Food and Drug Administration (FDA) Long -Term Limited Scope Food, Feed and Cosmetics Information Sharing Agreement (ISA) DATE: June 10, 2024 INTRODUCTION This memorandum provides information and a recommendation regarding the FDA Long -Term Limited Scope Food, Feed and Cosmetics Food Information Sharing Agreement with the City of Dubuque for sharing non-public food information. BACKGROUND The City maintains an agreement with the Iowa Department of Inspections, Appeals and Licensure (IDIAL) to allow the City to license, inspect and enforce the Iowa Food Service Sanitation Code, Iowa Hotel Sanitation Code, the Iowa Food and Home Food Establishment Codes, and the Iowa Food & Beverage Vending Machine laws. One of the requirements of this agreement is to maintain a 20.88 agreement with the FDA to enhance the ability to share information during outbreaks and recalls. The current FDA agreement expires June 30, 2024. The new agreement changes are minimal and include communication process requirements with IDIAL and FOIA request notifications to the FDA. DISCUSSION The ISA confidentiality agreement facilitates sharing of non-public food (human food, pet food, and animal feed) dietary supplements and cosmetic related information (referred to as non-public food information) that will begin upon execution of this agreement until June 30, 2029. This Long -Term Limited Scope Food, Feed and Cosmetics Information Sharing Agreement (ISA) allows for the (division) head of the Local Public Health agency to affirm that the non-public information provided by FDA will not be disclosed with anyone outside of their agency without written confirmation from FDA that such information can be released to the public. Furthermore, this agreement does not require that everyone in the agency who has a need to know or official interest in the non-public information sign the confidentiality agreement. BUDGET IMPACT No budget impacts. RECOMMENDATION It is recommended that the City Council approve the five-year 20.88 agreement with the FDA and authorize the City Manager to sign the agreement. FDA sigma OFFICE OF REGULATORY AFFAIRS 12420 Parklawn Drive Element Building Room 4029 Memorandum Rockville, MD 20852-1740 To: State Involved in the Protection of Public Health From: Steven Tave, Director, Office of Policy, Compliance and Enforcement Date: 6/17/24 Subject: Long -Term Limited Scope Food, Feed and Cosmetics Information Sharing Agreement (ISA) The Food and Drug Administration (FDA) would like to offer your agency the opportunity to enter into a confidentiality agreement to facilitate sharing of non-public food (human food, pet food, and animal feed) dietary supplements and cosmetic related information (referred to as non-public food information) that will begin on the date above until June 30, 2029. This Long -Term Limited Scope Food, Feed and Cosmetics Information Sharing Agreement (ISA) allows for the (division) head of the Local Public Health agency to affirm that the non-public information provided by FDA will not be disclosed with anyone outside of their agency without written confirmation from FDA that such information can be released to the public. Furthermore, this agreement does not require that everyone in the agency who has a need to know or official interest in the non-public information sign the confidentiality agreement. Although FDA only requires one signature from the (division) head of your agency to permit the sharing of non- public information under this confidentiality agreement, we recognize that other individuals in your agency may need to know about and disseminate the non-public information quickly in an emergency such as a foodborne outbreak, recall, or a report of a suspect or illegitimate product in the supply chain. To facilitate this, we ask that you provide us with the names and contact information for key individuals in your agency with their title, specialty, or subject matter expertise. For example, the Commissioner of a State Department of Agriculture may want to provide contact information for division directors or managers in charge of laboratories or inspections. Underthis confidentiality agreement, you are certifying, on behalf ofyouragency, thatthe agency hasthe legal authority to protect all non-public food information that FDA shares with individuals in your agency and committing not to disclose such information. The reference to "non-public information" covered by this agreement includes information subjectto limitations on public disclosure underfederal law and regulations. For FDA documents shared under this agreement, this may include confidential commercial information, personal privacy information, pre -decisional information, deliberative information, and law enforcement records. Trade secrets may not be shared under this agreement. Any request to share non-public information outside of your agency must be approved in advance by FDA. www.fda.gov Long -Terra Limited Scope FFC ISA VA (1/24) Page 2 of 10 pages Attachment A -provides background Informationaboutthe information sharing procedures-utilizingtheLong= Term Limited Scope Food, Feed and Cosmetics ISA. Attachment B describes the conditions for sharing of non- public food information with State government officials. Attachment C must be completed and signed to establish the Long -Term Limited Scope Food, Feed and Cosmetics ISA. Attachment D is optional, but highly recommended. Please send a copy of entire agreement (pages 1-10) and an organizational chart to the email address 012AInfoShare fda.hhs gov. Mara Digitallyslgned by Marla Hendrlksson-S Hendriksson-S Date, 2024.06.2709:09:11 -04'00 for Steven Tave Director, Office of Policy, Compliance and Enforcement ATTACHMENTS: A. Background Information on FDA Sharing of Non -Public Information with Local Public Health Agency Officials using the Single -Signature Long -Term Limited Scope Food, Feed and Cosmetics Information Sharing Agreement. B. Conditions for FDA Sharing of Non -Public Information with Local Public Health Officials. C. CONFIDENTIALITY COMMITMENT for Local Public Health Agencies. D. Designation of Key Points of Contact in Local Public Health Agencies. E. Limited Scope Food, Feed and Cosmetics Sharing Agreement Language. www.fda.gov Long -Term Limited Scope FFC ISA v.4 (1/24) Page 3 of 10 pages ATTACHMENT A Background Information on FDA Sharing of Non -Public Food, Dietary Supplement and Cosmetic Information with Local Public Health Agency Officials Using the Single -Signature 20.88 Long -Term Limited Scope Food, Feed and Cosmetics Information Sharing Agreement Under 21 CFR § 20.88 FDA may share certain non-public Agency records on a discretionary basis with Local Public agency officials who perform counterpart functions to FDA as part of cooperative law enforcement or regulatory efforts provided that certain conditions are met. Information sharing under this provision is never mandatory and each Local Public Health agency request will be processed only after duly considering FDA's concerns for confidentiality, the requester's need for the information, and the benefit to the public health that may result from such sharing. Under this agreement, the authorized primary State agency and FDA can rapidly share non-public information with local public health agencies that have entered into the Limited Scope Food, Feed and Cosmetics 20.88, including confidential commercial and pre -decisional information. This includes but not limited to food -related product information, inspection reports (omitting trade secrets), enforcement actions, foodborne illness investigation data, trace back information and warning letters. Under this agreement, Local Public Health agencies must provide a written statement that they have the legal authority to protect any shared information from any public disclosure and a commitment not to disclose such information without the written confirmation from FDA that such information can be released to the public. FDA will be unable to share non-public food protection related information with your agency if it cannot certify that it can and will maintain the confidentiality of all non-public information received from FDA. If the Local Public Health agency fails to maintain the confidentiality of non-public information, FDA may refuse to share such information with the Local Public Health agency in the future. The conditions for confidential sharing of non-public information are further described in Attachment B. If the Local Public Health agency does not sign the Confidentiality Commitment in Attachment C, it will not receive non-public information and may be excluded from conference calls and meetings with FDA where non- public information is discussed, including, and not limited to outbreak and recalls. The procedures for releasing non-public information to Local Public Health agencies are listed below. 1. Directors of Local Public Health agencies sign the certification form. 2. To request non-public information pertaining to food protection, the Local Public Health agency sends a written request to the primary State agency. If the primary State agency is not already in possession of the requested FDA non- public information, then the primary State agency sends a written request to the FDA District Director or State Liaison who has jurisdiction over that p r i m a r y State agency or to Division of Information Disclosure Programs (DIDP)) at ORAInfoShare@fda.hhs.gov. 3. When necessary and without receiving a formal request, a primary State agency has the discretion to provide selected non-public information specific to food protection issues to the signatories listed on the certification. This should be done only for special circumstances. www.fda.gov Long -Term Limited Scope FFC ISA v.4 (1/24) Page 4 of 10 pages ATTACHMENT B Conditions for FDA Sharing of Non -Public Information with Local Public Health Agency Officials The United States Food and Drug Administration (FDA), an Agency within the United States Department of Health and Human Services, is charged with protecting and promoting the health of the American people. It is responsible for assuring that foods are safe, wholesome, and sanitary; human and veterinary drugs, biological products, and medical devices are safe and effective; cosmetics are safe; and products that emit radiation are safe. To enhance regulatory and enforcement cooperation between FDA and Local Public Health agency officials who perform counterpart functions to FDA, FDA promulgated a regulation under 21 CFR § 20.88 governing the communication of non-public information with Local Public Health officials. 21 CFR § 20.88 permits FDA, on a discretionary basis, to release non-public pre -decisional, confidential commercial, and/or other non-public information regarding FDA -regulated products to Local Public Health officials. As long as the requirements in 21 CFR § 20.88 have been met at the time of the release, FDA's release of non-public information to a Local Public Health agency is not a public disclosure and does not compel FDA, if requested, to release such information to the public. Non-public information that FDA shares with the Local Public Health agency belongs exclusively to FDA loaned for the purpose for which it was requested or for other cooperative law enforcement efforts. FDA may take steps to retrieve the information shared with an agency at any time and it may initiate judicial proceedings if necessary [see United States v. Napper, The City of Atlanta, et al., 887 F.2d 1528 (1989)]. • Before FDA may share non-public pre -decisional, confidential commercial, and/or other non-public information with Local Public Health officials, FDA must receive a written Confidentiality Commitment (Attachment C) from the Local Public Health agency that it understands the conditions under which FDA shares non-public information, and certifies that it: (1) has the authority to protect the information from public disclosure and (2) will not disclose such information without written confirmation from FDA that the information no longer has non-public status, or in cases involving confidential commercial information concerning a regulated product -without the consent of the owner of the information (e.g., drug sponsor). FDA will rely on the Local Public Health agency's Confidentiality Commitment regarding its authority to protect FDA non-public information from disclosure. If changes occur in the Local Public Health agency's statutes, laws, policies, or procedures that may affect the agency's ability to protect FDA non-public information from disclosure, it: (1) will notify FDA immediately and (2) will not disclose the non-public information without the consent of the owner, submitter, individual, or FDA as described above. In the event the agency receives a subpoena, court order, or other compulsory process including a request under a state public records act or Freedom of Information act to release non-public information received from FDA, it will contact FDA within five business days of receipt of the notice and the agency will take appropriate legal measures to resist the release of such information. The Local Public Health agency will not release the information until FDA has had the opportunity to take appropriate legal measures to resist the disclosure of such information, has determined whether it will take such measures, and has notified the Local Public Health agency of its determination— which shall be made in a timely manner. The Confidentiality Commitment is provided as Attachment C. When FDA receives the Confidentiality Commitment from the Local Public Health agency, it may share the information only when the following determinations are made. www.fda.gov Long -Term Limited Scope FFC ISA v.4 (1/24) Page 5 of 10 pages Requests for non-public pre -decisional information: The requested information must be reasonably necessary to improve Federal -Local Public Health uniformity, cooperative regulatory activities, or implementation of Federal -Local Public Health agreements. sts for confidential commercial information: FDA must determine if (1) the sponsor for the product application has provided written authorization for the exchange or (2) the disclosure of the information would be in the interest of public health by reason of the Local Public Health agency possessing information concerning the safety, effectiveness, or quality of a product or information concerning an investigation, or by reason of the Local Public Health agency's ability to exercise its regulatory authority more expeditiously than FDA. As a regulatory and law enforcement agency, it is important that FDA avoid unauthorized disclosure of non-public information, particularly disclosures that might provide any company with a competitive advantage, place a submitting company at a disadvantage relative to its competitors, or result in an unwarranted invasion of personal privacy of an individual It is essential that Local Public Health agency officials engaged in information exchanges with FDA understand and respect the obligations to protect FDA non-public information from unauthorized disclosure and take adequate security measures to prevent the unauthorized release of shared FDA non-public information. Once the agreement has been signed, send the signed copy to ORAInfoShare@fda.hhs.gov. www.fda.gov Long -Term Limited Scope FFC ISA v.4 (1/24) Page 6 of 10 pages ATTACHMENT C CONFIDENTIALITY COMMITMENT for Local Public Health Agencies Statement of legal authority and commitment not to disclose non-public information including, but not limited to, confidential commercial or non-public pre -decisional information shared by the FDA. Reference: Information regarding the investigations of food establishments and/or the facilitation of food (human food, animal feed, and dietary supplements) and cosmetic safety. FDA may share non-public information concerning the safety, effectiveness, or quality of a product with City of Dubuque Health Services (Local Public Health Agency) in accordance with 21 CFR 20.88. This sharing is in the interest of public health and is for the limited purpose of conducting cooperative law enforcement or regulatory efforts as they relate to human food, animal feed, dietary supplements, or cosmetics. My agency understands that: 1. Some or all of the non-public information it receives from FDA is confidential commercial, personal privacy information, or non-public pre -decisional information exempt from disclosure under the laws and regulations of the United States and that FDA considers it extremely important that my agency maintain the confidentiality of the information. 2. The non-public information received from FDA belongs exclusively to FDA and does not belong to my state agency. FDA may take steps at any time and may initiate judicial proceedings to retrieve non-public information shared with my agency. 3. Disclosure of non-public information shared by FDA could seriously jeopardize any further cooperative information sharing between FDA and my agency. 4. FDA will not reveal to a non-commissioned official any method or process that is entitled to protection as a trade secret under section 301 (j) of the FD&C Act [21U.S.C. 331(j)]. Therefore, City of Dubuque Health Services certifies that it: (Local Public Health Agency) 1. Has the legal authority to protect FDA non-public information from disclosure, including but not limited to confidential commercial information, personal privacy information, and pre -decisional information. 2. If requested, has attached copies of the relevant statutes, regulations, court decisions, or other documents that establish this authority or has provided a summary of its legal authority. Subject to the notice provisions of this paragraph, will not disclose FDA non-public information without the written statement from FDA that the information no longer has non-public status or, in cases involving confidential commercial information concerning a regulated product, without the consent of the owner of the information. My agency will inform FDA within five business days of any effort made to obtain the information from it by subpoena, court order, or other compulsory process, including a request under any state public records act or Freedom of Information Act and will refrain from disclosing such information. www.fda.gov Long -Term Limited Scope FFC ISA v.4 (1/24) Page 7 of 10 pages Under such circumstances, my agency will refrain from disclosing the information until FDA has had the opportunity to take appropriate legal measures to resist the disclosure of such information, has determined whether it will take such measures, and has notified my agency of its determination. FDA will make this determination in a timely fashion. The agency may disclose the information to a court of competent jurisdiction if 1) the court orders such disclosure, 2) the agency has taken legal measures to ensure that the information will be disclosed in a manner that protects the information from public disclosure and, 3) the agency has notified FDA but failed to receive a timely determination of FDA actions. 4. Will promptly inform FDA of any changes to its laws, policies, or procedures that would affect its ability to maintain the confidentiality of the information FDA shares. 5. Has safeguards, including the adoption of policies and procedures to ensure that the information shared under this agreement will not be further disclosed consistent with the rest of this agreement. 6. Access to the non-public information shared under this agreement shall be restricted to the employees, and officials of the Participants, who require access to such information to perform their official duties in accordance with the uses of the information as authorized in this agreement, unless otherwise authorized in writing by FDA. All such personnel shall be advised of (1) the confidential nature of the information; and the obligation to keep such information confidential; and (2) safeguards against unauthorized disclosure of confidential information. 7. Will notify FDA of any actual or suspected unauthorized disclosure of any information shared pursuant to this agreement. Michael C Van Milligen Name of certifying official City Manager Title of certifying official Signature of certifying official 563-589-4110 Phone Number of certifying official ctymgr@cityofdubuque.org E-mail Address of certifying official Date www.fda.gov Long -Term Limited Scope FFC ISA v.4 (1/24) Page 8 of 10 pages ATTACHMENT D Designation of Key Points of Contact in Local Public Health Agencies This Attachment is used by the Local Public Health agency to provide FDA with key points of contact. FDA may wish to contact these individuals as primary respondents in emergencies, recipients of certain regulatory action notices, or recipients of pre -decisional information. If more space is needed, please attach a separate page with the name, position (for example, Director of Manufactured Foods), program area (food, feed, dietary supplements or cosmetics), a telephone number, and an e-mail address for the individual(s). Please include an agency/division organizational chart. * In the first section, please enter the name of at least one person from your agency who's responsible for release of information to the public (e.g. FOIA/Public Records/Open Records Officer). *This person is a. FOIA Officer Adrienne Breitfelder Mary Rose Corrigan Name Name City Clerk Public Health Director Position Position City of Dubuque City of Dubuque Program Area Program Area 563-589-4100 563-589-4181 Phone Number Phone Number abreitfe@cityofdubuque.org mcorriga@cityofdubuque.org E-mail Address E-mail Address Tim Link Sydney Althoff Name Name Environmental Sanitarian Environmental Sanitarian Position Position City of Dubuque City of Dubuque Program Area Program Area 563-589-4102 563-589-4183 Phone Number Phone Number tlink@cityofdubuque.org salthoff@cityofdubuque.org E-mail Address E-mail Address www.fda.gov Long -Term Limited Scope FFC ISA v.4 (1/24) Page 9 of 10 pages Mark Murphy Name Name Enivronmental Sanitarian Position Position City of Dubuque Program Area Program Area 563-589-4124 Phone Number Phone Number mmurphy@cityofdubuque.org E-mail Address E-mail Address Name Name Position Position Program Area Program Area Phone Number Phone Number E-mail Address E-mail Address Name Name Position Position Program Area Program Area Phone Number Phone Number E-mail Address www.fda.gov E-mail Address Long -Term Limited Scope FFC ISA v.4 (1/24) Page 10 of 10 pages Attachment E Limited Scope 20.88 for [Local Public Health Agency Insert Name] The scope of this long-term 20.88 ISA is limited to the sharing of FDA non-public information that has been transmitted to [primary State Agency Insert Name] under a valid 20.88 agreement with an addendum that authorizes that primary State Agency to further share and transmit the information to local public health officials at [Local Public Health Agency Insert Name]. It also authorizes the local public health government officials to receive FDA non-public information orally.