FDA Five-Year Food Information Sharing Agreement Copyrighted
December 17, 2018
City of Dubuque Consent Items # 18.
ITEM TITLE: FDA Five-Year Food Information Sharing Agreement
SUMMARY: City Manager recommending approval to execute the FDA
Five-Year, Single-Signature, Long-Term Food Information
Sharing Agreement for sharing non-public food information.
SUGGESTED DISPOSITION: Suggested Disposition: Receive and File; Approve
ATTACHMENTS:
Description Type
FDA Food Information Sharing Agreement-NNM Memo City Manager Memo
Staff Memo Staff Memo
Agreement Supporting Documentation
THE CITY OF Dubuque
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TO: The Honorable Mayor and City Council Members
FROM: Michael C. Van Milligen, City Manager
SUBJECT: FDA Five-Year Single Signature Long-Term Food Information Sharing
Agreement
DATE: December 11 , 2018
Public Health Specialist Mary Rose Corrigan recommends City Council approval for the
City Manager to execute the FDA Five-Year Single Signature Long-Term Food
Information Sharing Agreement for sharing non-public food information.
I concur with the recommendation and respectfully request Mayor and City Council
approval.
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Mic ael C. Van Milligen �� �
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Attachment
cc: Crenna Brumwell, City Attorney
Teri Goodmann, Assistant City Manager
Cori Burbach, Assistant City Manager
Mary Rose Corrigan, RN, Public Health Specialist
Dubuque
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TO: Michael C. Van Milligen, City Manager
FROM: Mary Rose Corrigan, RN, Public Health Specialist
SUBJECT: FDA Five-Year Single Signature Long-Term Food Information Sharing
Agreement
DATE: December 10, 2018
INTRODUCTION
This memorandum provides information and a recommendation regarding the FDA
Five-Year Single Signature Long-Term Food Information Sharing Agreement with the
City of Dubuque for sharing non-public food information.
BACKGROUND
In July, the City approved an agreement with the lowa Department of Inspections and
Appeals (IDIA) to allowthe City to license, inspect and enforce the lowa Food Service
Sanitation Code, lowa Hotel Sanitation Code, the lowa Food and Home Food
Establishment Codes, and the lowa Food & Beverage Vending Machine laws. One of
the requirements of this agreement is to execute a 20.88 agreement with the FDA to
enhance the ability to share information during outbreaks and recalls by December 31,
2018. We have recently received guidance from the IDIA to execute this agreement.
The City fulfills the terms of the IDIA agreement through the two Environmental
Sanitarians in the Health Services Department. Regular inspections are made of
restaurants, schools, grocery and convenience stores, mobile food units, hotels,
taverns, temporary food stands, and food and beverage machines throughout the city.
DISCUSSION
This FDA 20.88 confidentiality agreement provides for the exchange of non-public food
information that will facilitate the investigation of adverse events such as food-borne
disease outbreaks, food source trace-back efforts, etc. All IDIA contracting agencies are
required to have this agreement in place, which specifies key individuals in the Health
Services Department who will have access to the shared "non-public" information. If a
citizen requests information under the Freedom of Information Act (FOIA), FDA will
provide guidance. The attached document and agreement provide additional, detailed
information.
RECOMMENDATION
It is recommended that the City Council approve the five-year 20.88 agreement with the
FDA.
ACTION STEP
The action step is for the City Council to authorize the City Manager to sign the
agreement on behalf of the City.
2
U.S. FOOD & DRUG
ADMINISTRATION
12420 Parklawn Drive
Element Building Room 4029
Rockville, MD 20852-1740
Memorandum
To: State and Local Officials Involved in the Protection of Public Health
From: Director, Office of Enforcement and Import Operations
Date: 12/17/2oi8
Subject: Five Year, Single-Signature"Long-Term Food Information Sharing Agreement"
or"Long-Term FoodISA"
i. The Food and Drug Administration (FDA) would like to offer your agency the opportunity to enter
into a confidentiality agreement to facilitate the exchange of non-public food (human food, pet food,
and animal feed) and cosmetic regulatory, public health, and safety information (referred to as non-
public food information) for a five-year period that will begin on July i, zoi4. This new Long-Term
Food Information Sharing Agreement (ISA) allows for the (division) head of the State or local
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 new agreement does not require that each individual in
the agency who has a need to know or official interest in the non-public information to sign the
confidentiality agreement. These streamlined procedures are in contrast to past 20.88
confidentiality food agreements that required each individual in the agency sign the agreement
prior to viewing non-public information.
z. Although FDA only requires one signature from the (division) head of your agency to permit the
legal exchange of non-public food 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. To facilitate this, we ask that
you provide us with the names and contact information for key individuals in your agency for food
along 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.
3. Under this confidentiality agreement, you are committing on behalf of your agency to protect the
non-public information that FDA shares with individuals in your agency. This may include
information for which public disclosure is prohibited by law, and information
compiled for enforcement purposes. Any request to share this information outside of
your agency must be approved in advance by FDA. The reference to "non-public
information" covered by this agreement includes any information protected from public disclosure
under federal law and regulations, including the Freedom of Information Act and u CFR Part 20.
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.
www.fda.gov
Intero�ceMemorandum—FiveVear,Single-Signature"Long-TermFoodlnformation5haringAgreemenY'or Page2of9pages
"Long-Term Drug Residues in Animal Derived Food ISA"
4. Attachment A provides background information about the str�eamlined information sharing
procedures utilizing the Long-Term Food ISA. Attachment B describes the conditions for sharing of
non-public food information with State and local government officials. Attachment C is the
Certification or Confidentiality Commitment, which only needs to be signed by the head of the
agency (or division). Attachment D is used by the head of the agency to provide the contact
information for key individuals in the agency.
5. Attachment C must be completed and signed in order to establish the Long-Term Food ISA.
Attachment D is optional,but highly recommended. Please include a copy of your agency/division
organizational chart.
Please send a copy of Attachment C, Attachment D and an organizational chart to the following
email address with the subject line:Attention: Sara Ashton/2o.88 LT ISA
ORAOSPOPTestimonv-I nfoSharin�I'eam(a�fda.hhs.�ov.
6. If you have any questions about this program,please contact Sara Ashton at 202-308-4098 or
ORAOSPOPTestimonp-InfoSharingTeamCa�fda.hhs. o�v.
Director,Office of Enforcement
and Import Operations
ATTACHMENTS:
A. Background Information on FDA Sharing of Non-Public Information with State and Local
Government Officials using the Single-Signature Long-Term Food Information Sharing
Agreement;
B. Conditions for FDA Sharing of Non-Public Information with State and Local Government
Officials;
C. CERTIFICATION (CONFIDENTIALITY COMMITMENT) for State or Local Government
Agencies;
D. Designation of Key Points of Contact in State or Local Government Agencies;
www.fda.gov
Intero�ceMemorandum—FiveVear,Single-Signature"Long-TermFoodlnformation5haringAgreemenY'or Page3of9pages
"Long-Term Drug Residues in Animal Derived Food ISA"
ATTACHMENT A
Background Information on FDA Sharing of Non-Public Food and Cosmetic Information
with State and Local Government Officials Using the Single-Signature 20.88 Long-Term
Food Information Sharing Agreement
Under 21 CFR§ 20.88 FDA may share certain confidential Agency records on a discretionary basis with
State and local government officials who perform counterpart functions to FDA as part of cooperative
law enforcement or regulatory efforts provided that certain conditions are met. Such disclosures under
this provision are never mandatory and each State or local government request would 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, FDA can rapidly share non-public information, including confidential
commercial information and pre-decisional information, with State and local agencies and officials
responsible for food (food includes human food, animal feed, and dietary supplements) and cosmetic
inspection programs and laboratories that are associated with investigating adverse events. The
procedures also allow the sharing of food-related product information, inspection reports (omitting
trade secrets),enforcement actions,foodborne illness investigation data, and trace back information.
Under these agreements, State and local government agencies must provide a written statement that
they have the 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
information with your agency if it cannot certify that is has the ability to maintain the confidentiality of
all non-public information received from FDA. If State or local agency fails to maintain the
confidentiality of non-public information, FDA may refuse to share such information with the State or
local agency in the future. Moreover, unauthorized disclosure of confidential commercial information
could result in a civil or criminal violation. The conditions for confidential sharing of non-public
information are further described in Attachment B.
If a State and local agency does not sign the Certification in Attachment C and does not
have an official that holds a current FDA commission, it may be excluded from
conference calls and meetings with FDA and will be required to request all confidential
information according to the procedures set forth in 2i CFR§ 20.88.
The procedures for releasing non-public information to State and local governments are listed below.
i. Directors of State or local agencies sign the certification form.
2. To request non-public information pertaining to drug compounding, the State or local agency
sends a written request to the FDA District Director or State Liaison who has jurisdiction over
that State or to Sara Ashton (ORA/Office of Str�ategic Planning and Operational Policy
(OSPOP), Division of Information Disclosure Policy(DIDP)).
3. When necessary and without receiving a formal request, an FDA District Director has the
discretion to provide selected non-public information specific to food protection issues to the
signatories listed on the certification or to a State official commissioned by FDA. This should be
done onl,��pecial circumstances.
www.fda.gov
Intero�ceMemorandum—FiveVear,Single-Signature"Long-TermFoodlnformation5haringAgreemenY'or Page4of9pages
"Long-Term Drug Residues in Animal Derived Food ISA"
ATTACHMENT B
Conditions for FDA Sharing of Non-Public Information with State
and Local Government Officials
The United States Food and Drug Administr�ation (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.
In an effort to enhance regulatory and enforcement cooperation between FDA and State and local
government officials who perform counterpart functions to FDA, FDA promulgated a regulation under
2i CFR § 20.88 governing the communication of non-public information with State and local
government 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 State and local 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 State or local government 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 agency is FDA's property, 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. Na�er. The Citv of Atlanta, et al.. 887 F.2d 1528
1 8 .
Before FDA may share non-public pre-decisional, confidential commercial, and/or other non-public
information with non-commissioned State or local officials, FDA must receive a written certification
from the State or local agency that it understands the conditions under which FDA shares non-public
information,and certifies that it: (i) 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 sponsor of the information. FDA will rely on the State or
local government agency's certification about its authority to protect the non-public information from
disclosure. If changes occur in the State or local agency's statutes, laws, policies, or procedures that
may affect the agency's ability to protect the non-public information from disclosure, it (i) will notify
FDA immediately and (2) will not disclose the non-public information without the consent of the
sponsor,submitter,individual,or FDA as described above.
In the event an agency receives a subpoena, court order, or other compulsory process including a
request under the Freedom of Information Act to release non-public information received from FDA, it
will contact FDA within two business days of receipt of the notice and the agency will take appropriate
legal measures to resist the release of such information. The State or local 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
State or local agency of its determination—which shall be made in a timely manner. The certification or
confidentiality commitment is provided as Attachment C.
When FDA receives the written certification setting out the commitment on the part of the State or local
agency,it may share the information only when the following determinations are made.
www.fda.gov
Intero�ceMemorandum—FiveVear,Single-Signature"Long-TermFoodlnformation5haringAgreemenY'or Page5of9pages
"Long-Term Drug Residues in Animal Derived Food ISA"
Requests for non-public pre-decisional information:
The requested information must be reasonably necessary to improve Federal-State uniformity,
cooperative regulatory activities, or implementation of Federal-State agreements.
Requests for confidential commercial information:
FDA must determine if (i) 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 State or local governmenYs possessing information concerning the safety, effectiveness, or
quality of a product or information concerning an investigation, or by reason of the State or local
government ability to exercise its regulatory authority more expeditiously than FDA.
As a regulatory and law enforcement agency, it is important that FDA avoid providing any company
with a competitive advantage, placing a submitting company at a disadvantage relative to its
competitors, or committing an unwarranted invasion of personal privacy of an individual through
unauthorized disclosure of non-public information. It is essential that State and local officials engaged
in information exchanges with FDA understand and respect the obligations to protect non-public
information from unauthorized disclosure, and take adequate security measures to prevent the
unauthorized release of shared non-public information.
Once the agreement has been signed, send the signed copy to ORAOSPOPT'estimonv-
InfoSharingTeamCa�fda.hhs. o�v with the subject line:Attention: Sara Ashton/2o.88 LT ISA
www.fda.gov
Intero�ceMemorandum—FiveVear,Single-Signature"Long-TermFoodlnformation5haringAgreemenY'or Page6of9pages
"Long-Term Drug Residues in Animal Derived Food ISA"
ATTACHMENT C
CERTIFICATION(CONFIDENTIALITY COMNIITMENT)for State or Local Government
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 U.S. FOOD AND DRUG ADMINISTRATON (FDA)
Reference: Informaiion regarding the inaesiigaiions offood establishments and/or the
facilitaiion of food (human food, animal feed, and dietary supplements) and cosmeiic
safety.
FDA may share non-public information concerning its law enforcement or regulatory investigation of
the safety,effectiveness, or quality of a product with
City of Dubuque
State or local gouernment agency
in accordance with 2i 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 investigations of food establishments and/or the facilitation of food and
cosmetic safety and protection.
My agency understands that:
i. Some or all of the non-public information it receives from FDA is considered to be 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 remains FDA's property. FDA may take steps at
any time and may initiate judicial proceedings to retrieve non-public information shared with
my agency.
3. Disclosure of information shared by FDA could seriously jeopardize any further cooperative
information sharing between FDA and my agency. Moreover, unauthorized disclosure of
confidential commercial information could be a civil or criminal violation and carry
consequences for the disclosing official.
Therefore, City of Dubuque certifiesthatit:
State or local gouernment agency
i. Has the authority to protect the confidential commercial, personal privacy information, and
non-public pre-decisional information from disclosure.
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.
3. Subject to the notice provisions of this paragraph, will not disclose the 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 sponsor of the information. My agency will inform FDA within two
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 Freedom of Information type of law,
and will refrain from disclosing such information. Under such circumstances, my agency will
refrain from disclosing the information until FDA has had the opportunity to take appropriate
www.fda.gov
·interoffice Memorandum -Five Year, Single-Signature "Long-Term Food Information Sharing Agreement" or
"Long-Term Drug Residues in Animal Derived Food ISA"
Page 7 of 9 pages
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 in an effort 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 shall be shared and used consistent with the Food,
Drug, and Cosmetic Act (FD&C Act) as amended [21 U.S.C. 301 et seq.], the Privacy Act of 1974,
as amended [5 U.S.C. 552a], and the Freedom of Information Act [5 U.S.C. 552]. Pursuant to
section 301(j) of the FD&C Act [21 U.S.C. 331(j)], FDA will not reveal to non-commissioned
officials any method or process that is entitled to protection as a trade secret.
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 Van Milligen 12/17/2018
Name of certifying official Date
City Manager
Title of certifyin~----...
Signature
563-589-4110
Phone Number
ctymgr@cityofdubuque.org
E-mail Address
www.fda.gov
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"Long-Term Drug Residues in Animal Derived Food ISA"
Attachment D
Designation of Key Points of Contact in State or Local Government Agencies
This Attachment is used by the State or local government 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, 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 Offlcel'
Kevin Firnstahl Mary Rose Corrigan
*Name Name
City Clerk Public Health Specialist
*Position Position
City of Dubuque City of Dubuque
*Program Area Program Area
563-589-4100 563-589-4181
*Phone Number Phone Number
kfirnsta@cityofdubuque.org mcorriga@cityofdubuque.org
*E-mail Address E-mail Address
Tim Link Katie Baker
Name Name
Environmental Sanitarian Environmental Sanitarian
Position Position
City of Dubuque City of Dubuque
Program Area Program Area
563-589-4181 563-589-4181
Phone Number Phone Number
tlink@cityofdubuque.org kkieffer@cityofdubuque.org
E-mail Address E-mail Address
www.fda.gov
Intero�ceMemorandum—FiveVear,Single-Signature"Long-TermFoodlnformation5haringAgreemenY'or Page9of9pages
"Long-Term Drug Residues in Animal Derived Food ISA"
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 E-mail Address
Name Name
Position Position
Program Area Program Area
Phone Number Phone Number
E-mail Address E-mail Address
www.fda.gov