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  6. MOU 225-22-027
  1. Domestic MOUs

MOU 225-22-027

MEMORANDUM OF UNDERSTANDING
BETWEEN THE
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR DISEASE CONTROL AND PREVENTION’s
NATIONAL CENTER FOR ENVIRONMENTAL HEALTH
AND
THE FOOD AND DRUG ADMINISTRATION

I. PURPOSE

This Memorandum of Understanding (MOU) constitutes an agreement between two Agencies within the U.S. Department of Health and Human Services (DHHS), specifically the Centers for Disease Control and Prevention’s (CDC) National Center for Environmental Health (NCEH) and the Food and Drug Administration (FDA) – hereinafter referred to individually as "Partner" and collectively as the "Partners."

The purpose of this MOU is to outline an agreement through which both Partners intend to advance collaborative efforts to reduce the occurrence of foodborne illness risk factors in retail and foodservice establishments. Both Partners intend to promote the joint efforts established under this MOU, subject to the availability of funding and other necessary resources, which will be based on communication as the foundation of the two Partners working together to advance safe food practices in the United States.

II. BACKGROUND

Under the FD&C Act, the FDA, is directed to promote and protect the public health by assuring the safety, efficacy, and security of drugs, veterinary products, medical devices and radiological products as well as the safety and security of foods, dietary supplements, and cosmetics. The FDA also has responsibility for regulating the manufacturing, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors. The mission of FDA is to enforce laws enacted by the U.S. Congress and regulations established by the Agency to protect the consumer's health and safety1. To accomplish its mission, the FDA must stay abreast of the latest developments in research and communicate with stakeholders about complex scientific and public health issues. Increased development of research, education, and outreach partnerships within the CDC NCEH will greatly contribute to FDA’s mission.

The FDA serves as a lead federal agency for retail food protection. Ensuring the safety of food at the retail level requires the collaboration of the FDA, other federal Agencies including, but not limited to, CDC and the U.S. Department of Agriculture, as well as state, tribal, local, and territorial (STLT) regulatory agencies, industry, academia, and consumers.

STLT governments exercise primary regulatory control over the retail segment of the food industry and provide the largest portion of the program’s resources. The FDA's ability to leverage the resources of STLTs, while providing expertise, guidance, and technical assistance, represents an effective public health partnership and a model for a national integrated food safety system (IFSS).

Within the FDA, the National Retail Food Team (NRFT) is responsible for formulating, coordinating, and implementing the Agency’s strategic plan and policy on retail food safety. The NRFT is comprised of representatives from the Office of Regulatory Affairs [including the Office of State Cooperative Programs (OSCP) with responsibility for field operations, the Office of Partnerships (OP) with responsibility for grants management, and the Office of Training, Education and Development (OTED) with responsibility for training] and the Center for Food Safety and Applied Nutrition’s (CFSAN’s) Office of Food Safety, Retail Food Protection Staff with responsibility over retail food protection policy. The NRFT’s overall goal is to reduce the occurrence of foodborne illness risk factors in retail and foodservice establishments. Its mission is to provide innovative strategies for advancing retail food safety regulatory programs that can be applied by STLT governments and within the retail food industry to reduce the occurrence of foodborne illness risk factors. All cooperative efforts between the NRFT and its stakeholders are designed to assist Federal and STLT entities and their regulated industries with preventing foodborne illness by reducing the occurrence of risk factors in the retail sector. To further this goal, the NRFT implements strategies designed to increase uniformity, consistency, and capacity of STLT retail food protection programs; promote industry’s active managerial control (AMC) of foodborne illness risk factors and a culture of food safety; and maintain a strong NRFT workforce to support STLT programs.

CDC's mission as the nation’s leading Public Health Agency is to save lives and protect the health of Americans. CDC seeks to accomplish its mission by working with partners throughout the nation and the world to monitor health, detect and investigate health problems, including illnesses and outbreaks, conduct research to enhance prevention, develop, and advocate sound public health policies, implement prevention strategies, promote healthy behaviors, foster safe and healthful environments, and provide leadership and training. CDC conducts its activities under the authority of the Public Health Service Act and other Federal statutes.

CDC NCEH’s goal is to support STLT environmental health programs in their efforts to respond to adverse environmental exposures and their health consequences. A key NCEH initiative is the Environmental Health Specialists Network (EHS-NET), a CDC cooperative agreement that funds environmental health programs to collaborate with epidemiology and laboratory programs to understand and prevent environmental causes of foodborne illness outbreaks at the retail level. EHS-NET collects data on food safety practices and foodborne illness risk factors in restaurants; these data have influenced national food safety policies and guidelines. Another key initiative of NCEH is the National Environmental Assessment Reporting System (NEARS), which collects, analyzes, and disseminates data from the environmental health component of foodborne outbreak investigations; these data on the root causes of outbreaks are key to prevention efforts.

The collaboration of the Partners, as Federal retail food safety leaders, presents a unique opportunity for the two agencies to join forces to provide unified, national leadership and support to STLTs to reduce the occurrence of foodborne illness risk factors in retail and foodservice establishments (including facilities that serve highly susceptible populations (HSP) such as institutional foodservice, correctional facilities, schools, and healthcare facilities).

III. LEGAL AUTHORITY

The authorities to enter this framework MOU are:

  • FDA: 21 U.S.C. § 393(b) and (c) [Sections 1003(b) and (c) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)].
  • CDC: 42 U.S.C. § 243, as amended [Section 311 of the Public Health Service Act].

IV. OBJECTIVES AND RESPONSIBILITIES

The Partners have three primary goals related to reducing the occurrence of foodborne illness risk factors:

(1) Increase uniformity, consistency, and capacity of STLT retail food protection programs;
(2) promote industry’s AMC of foodborne illness risk factors and promote a culture of food safety; and
(3) maintain a strong FDA NRFT and CDC NCEH workforce to assist STLT partners.

To achieve the goals, the Partners have the following objectives:

  • Improve STLT’s effectiveness in conducting risk-based inspections and foodborne illness investigations.
  • Promote a culture of food safety and food safety management systems within retail and foodservice establishments (including facilities that serve highly susceptible populations (HSP) such as institutional foodservice, correctional facilities, schools, and healthcare facilities).
  • Improve research in support of foodborne illness risk factor reduction.
  • Improve the knowledge, skills, and abilities of FDA NRFT and CDC NCEH staff.

The responsibilities of the partners include:

  1. Develop and execute action plans to achieve the objectives of the MOU.
  2. Establish metrics to measure success of collaborations.
  3. Establish direct and consistent relationships at multiple organizational levels within Partners to document and share best practices.
  4. Identify opportunities for efficiencies in Partners’ respective studies designed to impact food worker behavior.
  5. Identify opportunities for leveraging the resources of the respective Partners to more efficiently and effectively support STLT retail regulatory programs.
  6. Identify opportunities for mutual support for both FDA and CDC retail food protection initiatives.
  7. Develop, promote, and co-sponsor joint complementary training events, presentations, and information sessions beneficial to STLT retail regulatory officials and/or industry.
  8. Share information related to the Partners' goals and work collaboratively to seek continuous improvement and enhanced performance over time.
  9. Serve as technical resources for each other.
  10. Notify the other Partner as soon as possible when issues of mutual concern become evident.
  11. Determine need for complementary interagency agreements and develop and execute, as necessary, to achieve the goals of this MOU.

V. FUNDING

This MOU represents the broad outline of the Partners’ present intent to enter specific agreements for collaborative efforts in areas of mutual interest to the FDA and CDC’s NCEH. All activities undertaken through the 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 Partners. This MOU does not create binding, enforceable obligations against any Partner. This MOU and all associated agreements will be subject to the applicable policies, rules, regulations, and statutes under which the FDA and the CDC’s NCEH operate.

VI. GENERAL PROVISIONS

  1. This is an internal government agreement between FDA and CDC’s NCEH and does not confer any rights or benefits to any person or Partners.
  2. The Partners agree that this MOU is non-exclusive and nothing contained herein prevents either Partner from entering into similar agreements with any third party. If any terms of this MOU are inconsistent with existing authorities or directives of either of the Partners entering this MOU, those portions of this MOU that are determined to be inconsistent shall be invalid; the remaining terms and conditions shall remain in full force and effect.
  3. Nothing herein shall be construed to create any joint venture or similar relationship or to subject the Partners to any implied duties or obligations respecting the conduct of their affairs that are not expressly stated herein. Neither Partner shall have any right or authority to assume or create any obligation or responsibility, either expressed or implied, on behalf of or in the name of the other Partner, or to bind the other Partner in any matter whatsoever. Neither Partner shall be deemed to be an agent or principal of the other.
  4. This MOU does not and is not intended to impose any legally binding requirements on the Partners. If necessary or desirable, the Partners may jointly agree upon and issue formal guidance interpreting this MOU and background materials upon which it is based.
  5. This MOU does not constitute final agency action on any issue. Any actions contemplated by this MOU are to be carried out in an appropriate administrative process by the acting Partner in accordance with all applicable laws and regulations.
  6. This MOU does not direct or apply to any person outside of the Partners.
  7. Each Partner will be responsible for its own acts and the results thereof and shall not be responsible for the acts of the other Partner and the results thereof.
  8. To the extent any confidential or other non-public information is requested pursuant to this MOU, then a written request for the information should be submitted to the FDA in writing. Agencies will follow proper safeguards against unauthorized use and disclosure of the information exchanged under this MOU. Proper safeguards shall include the adoption of policies and procedures to ensure that the information shared under this MOU shall be used consistent with the Trade Secrets Act [18 U.S.C. § 1905], the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.], the Privacy Act of 1974, as amended [5 U.S.C. § 552a], the Freedom of Information Act [5 U.S.C. § 552], any other applicable Federal law and their implementing regulations.
  9. Access to the non-public information shared under this MOU shall be restricted to authorized FDA and CDC employees, agents, and officials who require access to perform their official duties in accordance with the uses of the information as authorized in this MOU, unless authorized in writing by the agency that provided the information or otherwise required by law. Such personnel shall be advised of (1) the confidential nature of the information; (2) safeguards against unauthorized disclosure of confidential information, and (3) the administrative, civil, and criminal penalties contained in applicable Federal laws for the unauthorized disclosure of confidential information.
  10. If an agency that has received information under this MOU receives a Freedom of Information Act (FOIA) request for which there are responsive records that originated with the other agency, to the extent practicable, it will refer that request to the other agency for it to respond directly to the requestor regarding the releasability of the information. In such cases, the agency making the referral will notify the requestor that a referral has been made and that a response will issue directly from the other agency.

VII. PROGRAM/LIAISON OFFICERS

A Liaison Officer for each Partner (see the designations below) will be responsible for facilitating exchanges of information and expeditiously informing other interested parties within each respective organization on matters requiring prompt attention. Contact Information for both Partners is provided below:

Program/Liaison Officer for the FDA Center for Food Safety and Applied Nutrition (CFSAN):
Individual's name: Glenda Lewis, M.S.P.H.
Organization: FDA Center for Food Safety and Applied Nutrition, Office of Food Safety, Retail Food Protection Staff
Title: Director, Retail Food Protection Staff
Email Address: Glenda.Lewis@fda.hhs.gov

Program/Liaison Officer for the FDA Office of Regulatory Affairs (ORA):
Individual's name: Andre Pierce, MPA, REHS
Organization: FDA Office of Regulatory Affairs, Office of Human and Animal Foods, Office of State
Cooperative Programs
Title: Director, Retail Food Protection Division
Email Address: Andre.Pierce@fda.hhs.gov

Program/Liaison Officer for CDC/NCEH:
Individual's name: Laura Brown, Ph.D.
Organization: CDC National Center for Environmental Health; Division of Environmental Health
Science and Practice
Title: Lead, Safe Food Section
Email Address: lrg0@cdc.gov

Program/Liaison Officer for CDC/NCEH:
Individual's name: Sherri McGarry
Organization: CDC Food Safety Office
Title: CDC Liaison to FDA
Email Address: nmc6@cdc.gov

Each Partner may designate new liaisons at any time by notifying the other Partner's administrative liaison in writing. If, at any time, an individual designated as a liaison under this agreement becomes unavailable to fulfill those functions, the Partners will name a new liaison within two (2) weeks and notify the other Partner through the designated administrative liaison.

VIII. EFFECTIVE DATE, TERMINATION, AND MODIFICATION

This MOU will be effective on the date of the last signatory to the agreement. This agreement may be modified or terminated by mutual written consent by the partners or may be terminated by either Partner upon a 60 day advance written notice to the other. The Partners will review this agreement and goals annually. The Partners will make all reasonable attempts to meet, at a minimum annually, to discuss the current agreement, evaluate its usefulness, and make modifications, as needed. During the annual review and evaluation meeting, the Partners will jointly prepare options for follow-up. If new areas for developing agreement activities are identified and agreed upon, this agreement may be revised to reflect them. Revisions to the agreement may be submitted for consideration and approval by the appropriate agency signatories.

Any Partner on its initiative may submit a proposed amendment or modification in writing for review. Modifications and amendments will be tracked and documented throughout the duration of the agreement and will be reviewed at least annually during the annual review and maintained for historical purposes.

 

Signed,

 

/s/
Patrick Breysse, Ph.D., CIH
Director
National Center for Environmental Health/Agency for Toxic Substances
and Disease Registry Centers for Disease Control and Prevention
U.S. Department of Health and Human Services
Date: 9/21/2022

 

/s/
Susan T. Mayne, Ph.D.
Director
Center for Food Safety and Applied
Nutrition Food and Drug Administration
U.S. Department of Health and Human Services
Date: 9/21/2022

 

/s/
Judy McMeekin, Pharm.D.
Associate Commissioner for Regulatory
Affairs Office of Regulatory Affairs
Food and Drug Administration
U.S. Department of Health and Human Services
Date: 9/21/2022

1FDA Related Laws, Regulations, and Guidances, FDA.COM, https://www.fda.gov/drugs/cder-small- business-industry-assistance-sbia/fda-related-laws-regulations-and-guidances (last updated Feb. 18, 2022).

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