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MOU 225-18-010

MEMORANDUM OF UNDERSTANDING
BETWEEN THE STATE OF WISCONSIN
DEPARTMENT OF AGRICULTURE, TRADE AND CONSUMER PROTECTION – DIVISION OF FOOD AND RECREATIONAL SAFETY
AND THE
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
OFFICE OF HUMAN AND ANIMAL FOOD OPERATIONS – DIVISION 1 WEST

I. Purpose

The United States Food and Drug Administration, Office of Human and Animal Food Operations – Division 1 West (“HAF 1W” or “FDA”) and the State of Wisconsin Department of Agriculture, Trade and Consumer Protection (“WDATCP”) desire to enter into this MOU to set forth a framework for a formal working partnership. HAF 1W and WDATCP are each referred to individually as a “Party” and collectively as the “Parties.”  Both Parties understand the importance of partnerships that leverage resources and increase effectiveness. FDA and WDATCP share mutual interest in collaborating on compliance, enforcement, and information sharing activities that directly impact food safety and public health. 

In Federal fiscal year 2016, HAF 1W and WDATCP identified several initiatives as part of a pilot project to enhance integration and minimize duplication of inspection and sampling efforts. This MOU is intended to formalize initiatives that enhance communication, increase program familiarity, maximize efficiency, minimize duplication, and set a foundation for the ongoing development of an integrated food safety system in Wisconsin. These activities have been demonstrated to enhance integration between the Parties and decrease duplication of routine inspections.

WDATCP does not have regulatory oversight over dietary supplements and is not trained in the GMPs specific to infant formula. As such, regulatory matters for these products will be referred to HAF 1W by WDATCP as necessary. Matters related to produce inspections and information sharing will be handled pursuant to the State Produce Safety Program Implementation Cooperative Agreement Program.

II. Background

FDA is responsible for implementing and enforcing the Federal Food, Drug, and Cosmetic Act (the Act) as amended (21 U.S.C. § 301 et seq.). Included within the FDA’s responsibilities under the Act is the responsibility for regulation of human and animal food.  In carrying out its responsibilities, FDA conducts inspections of establishments that manufacture, process, pack, or hold food, with the exception of certain establishments that are regulated exclusively by the United States Department of Agriculture.  HAF 1W has regulatory oversight of approximately 3,800 manufactured food firms within the state of Wisconsin.

WDATCP has regulatory oversight of approximately 3,500 manufactured food firms. WDATCP is given regulatory oversight authority for all manufactured food firms in Wis. Statutes Chapter Ch. 97 and Ch. 93, as well as Wis. Administrative codes ATCP 65, 70, 71, 81, 83, 85, 87, and 88.  WDATCP is responsible for the licensing and inspection of all food and dairy processing, packaging and storage facilities within the state of Wisconsin, with the exclusion of certain facilities that manufacture infant formula or dietary supplements.

WDATCP has established a mechanism to count inspections conducted by HAF 1W as part of WDATCP’s mandated inspections upon receipt of an unredacted Establishment Inspection Report from HAF 1W. 

Section 201 of the FDA Food Safety Modernization Act (FSMA) requires that domestic high-risk facilities be inspected at least every three years and that domestic non-high-risk facilities be inspected at least every five years.  Section 201 of FSMA also provides that inspections conducted by state agencies under interagency agreements, contracts, memoranda of understanding, or other obligation may be counted in meeting those requirements.  If WDATCP conducts the first inspection (whether or not conducted under contract with FDA) of a firm in a FSMA inspection cycle, it will count as an inspection for purposes of section 201 of FSMA once FDA has received an inspection report from WDATCP and entered inspection data into FDA’s eSAF system (which transfers data to the FDA FACTS system upon endorsement).

FDA may commission certain WDATCP employees (referred to as “commissioned officials”) under section 702(a)(1)(A) of the Act.  FDA may share non-public information (including trade secrets) with these WDATCP employees in their capacity as commissioned officials.

Under FDA’s regulations, 21 CFR 20.88, FDA may share certain non-public information with state government officials as part of cooperative law enforcement or regulatory efforts if certain conditions are met, including a written commitment by the State government agency to protect non-public information from public disclosure.  An agreement between FDA and a State government agency under 21 CFR 20.88 is referred to as a 20.88 agreement.  FDA and WDATCP already have a 20.88 agreement.

III. General Provisions

A. Information Sharing

1. To identify and address areas of routine inspection overlap and to facilitate integration between the Parties:

a. HAF 1W will share the following non-public information with WDATCP commissioned officials:

i. Copies of unredacted establishment inspection reports (EIRs) for manufactured food firms in Wisconsin (excluding manufacturers of only infant formula or dietary supplements).
ii. Copies of unredacted warning letters and untitled letters issued to manufactured food firms in Wisconsin.
iii. Other information upon request, that may include trade secrets, as needed to facilitate surveillance or regulatory activities within Wisconsin.

b. HAF 1W will share the following non-public information with WDATCP employees who are covered by a 20.88 agreement:

i. Periodic summary reports identifying food samples collected from Wisconsin firms.
ii. A copy of the annual manufactured food work plan for Wisconsin.
iii. Other information upon request, that does not contain trade secrets, as needed to facilitate surveillance or regulatory activities within Wisconsin.

c. WDATCP will share the following non-public information with HAF 1W:

i. Copies of unredacted warning letters and untitled letters issued to manufactured food firms in Wisconsin.
ii. Copies of WDATCP’s licensed manufactured food firm inventory to facilitate comparison with HAF 1W’s inventory list.
iii. Copies of conditional licensing agreements and voluntary compliance agreements when established for violative manufactured food firms.
iv. Other information upon request, as needed to facilitate surveillance or regulatory activities.

2. Each Party will promptly provide the other with information on official actions taken against jointly regulated firms.

B. Commissions/20.88 Information Sharing Agreements – To facilitate the sharing of the information identified above, FDA commissions (certificates only) will be offered to all applicable WDATCP field sanitarians and all necessary management, administrative, and compliance staff following application and approval by HAF 1W management. HAF 1W and WDATCP will also continue to maintain a 20.88 agreement to provide broad coverage of state personnel for information sharing purposes.

IV. Inspection Sharing and Prevention of Duplication:

A. The following activities will be conducted to facilitate inspection sharing and minimize the duplication of routine inspections:

1. HAF 1W and WDATCP will meet no less than two times a year for work planning and inspectional coordination.

2. WDATCP will compare the high risk (HR) and non-high risk (non-HR) firms provided by HAF 1W against its inspection mandates for the same fiscal year and notify HAF 1W of firms that WDATCP is scheduled to inspect.

3. For firms on the HAF 1W work plan that WDATCP is not required to inspect during the Federal fiscal year, WDATCP will enter an “inspection placeholder” in its electronic system indicating that an FDA inspection will take place at the firm during the federal fiscal year to prevent routine inspection duplication.

4. For firms that both parties are required to inspect during the Federal fiscal year, the parties will jointly determine which firms WDATCP will inspect in addition to those included within WDATCP’s manufactured food contract with FDA.

5. For the HR and non-HR firms described in paragraph 4 that are inspected by WDATCP outside of the manufactured food contract, WDATCP will email a copy of the completed inspection report to HAF 1W as well as enter inspection information into eSAF or any subsequent, replacement database established by FDA to capture this information.

6. HAF 1W will create an electronic inspection assignment for each non-contract state inspection done at a firm described in paragraph 4 using PAC 03S800 (non-contract state work) in eSAF or any subsequent replacement system established by FDA for this purpose.  This electronic assignment allows for inspection data entered by WDATCP to be transferred to and accounted for by FDA data systems.

7. Independent inspections by both Parties may occur at a particular firm in the same year. If each Party is to independently inspect the same firm within the same year, the Parties will seek to maximize the length of time between the inspections, with a goal of at least five months between inspections.

B. Joint Contributions /Joint Planning –WDATCP will advise FDA if they desire to accompany FDA on any planned FDA inspections and FDA will do the same for planned WDATCP inspections. 

1. Joint Inspections – Joint inspections may be requested by either Party. Implementation of joint inspections will depend upon the availability of personnel and agency priorities.

2. Compliance Activities – Unless otherwise mutually agreed upon, the Party that discovers a violation associated with an inspection will have primary responsibility to pursue its correction. Parties will consider the most effective and/or efficient compliance outcome and may propose to refer a compliance matter to the other Party when it appears resolution can best be achieved under the authority of the other Party.

3. Emergency Response – HAF 1W and WDATCP will continue to develop and participate in a Rapid Response Team and will coordinate on outbreak response and sharing of recall notifications and violative sample results through their recall & emergency response personnel. 

4. Training – Training may be requested by either Party with the understanding that the ability to respond to such a request will depend on the availability of personnel and resources, as well as priorities of the responding Party.

5. Complaints – Significant consumer or industry complaints (including reports of real and/or potential tampering) regarding regulated products will be shared by the Party receiving the initial complaint or referred to the Party with jurisdiction. Each complaint will be transmitted along with a statement indicating whether follow-up is needed by either Party or that the purpose of sharing the complaint is for information exchange only.

V. Resource Obligations

All activities that may be undertaken pursuant to this MOU are subject to the availability of personnel, resources, and funds. This MOU does not affect or supersede any existing or future agreements or arrangements among the Parties and does not affect the ability of the Parties to enter other agreements or arrangements related to this MOU. This MOU does not create binding, enforceable obligations against any Party. This MOU and all associated agreements will be subject to the applicable policies, rules, regulations, and statutes under which FDA and the State of Wisconsin operate.

VI. Liaison Officers

A. Wisconsin Department of Agriculture, Trade and Consumer Protection
Steve Ingham, Administrator of Division of Food and Recreational Safety
2811 Agriculture Drive
Madison, WI 53708

B. U.S. Food and Drug Administration
Michael Dutcher, District Director
Office of Human and Animal Food Operations – Division 1 West
250 Marquette Ave, Suite 600
Minneapolis, MN 55401

VII. PERIOD OF AGREEMENT

This MOU, when accepted by both Parties, will be effective from the date of the last signature and will continue in effect for three years. It may be modified by mutual written consent at any time or terminated in writing by either Party.

Notice of termination must be sent to the address listed in Section VII. In the event of termination, any collaboration that commenced before the date of termination may be completed upon the written agreement of both Parties.

VIII. APPROVALS

APPROVED AND ACCEPTED FOR THE FOOD AND DRUG ADMINISTRATION OFFICE OF REGULATORY AFFAIRS 

By: Melinda K. Plaisier
Title: Associate Commissioner for Regulatory Affairs 
Date: May 9, 2018 

APPROVED AND ACCEPTED FOR THE WISCONSIN DEPARTMENT OF AGRICULTURE, TRADE AND CONSUMER PROTECTION – DIVISION OF FOOD AND RECREATIONAL SAFETY

By: Keely Moll
Title: Deputy Secretary
Date: May 10, 2018