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  1. Domestic MOUs

MOU 225-19-015

MOU 225-19-015 has been amended, effective May 7, 2025.

MEMORANDUM OF UNDERSTANDING BETWEEN THE U.S. DEPARTMENT OF COMMERCE
NATIONAL INSTITUTE OF STANDARDS AND TECHNOLOGY: HOLLINGS MANUFACTURING EXTENSION PARTERSHIP PROGRAM,
THE U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION
AND
THE INSTITUTE FOR FOOD SAFETY AND HEALTH OF ILLINOIS INSTITUTE OF TECHNOLOGY

I. PURPOSE

This Memorandum of Understanding (MOU) constitutes an agreement between the U.S. Department of Commerce (DOC) National Institute of Standards and Technology (NIST) Hollings Manufacturing Extension Partnership Program (MEP), the U.S. Food and Drug Administration (FDA) and the Institute for Food Safety and Health (IFSH) of Illinois Institute of Technology (Illinois Tech) - hereinafter referred to individually as "Party" and collectively as "Parties."

The purpose of this MOU is to define an agreement through which all Parties intend to establish collaborative efforts to support the United States (U.S.) food manufacturing sector and advance and improve safe food manufacturing practices in the U.S. All Parties 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 three Parties working together to advance safe food manufacturing practices in the U.S.

II. AUTHORITIES

The authorities to enter this framework MOU are: NIST MEP: 15 U.S.C. §§272 (b)(I), and 278k FDA: 21 U.S.C. § 393(b) [Section 1003(b) of the Federal Food, Drug, and Cosmetic Act].

Ill. BACKGROUND

All Parties recognize that the dissemination of information on required and recognized food safety manufacturing practices and food safety culture is critical to the success of the Food Safety Modernization Act (FSMA), as well as other regulatory and industry standards. To help facilitate the dissemination of such information and associated training, the FDA, together with U.S. Department of Agriculture (USDA), has funded a network of public and private partners in the state, federal, tribal and international governments, industry, and academia for the development and delivery of training.

Likewise, the DOC NIST MEP funds and operates a nationwide network of locally operated and staffed non-profit, university-based, and state-based organizations that are focused on providing hands-on technical and business assistance to U.S. food industry manufacturers. The MEP National Network, with presence in every U.S. state and the Commonwealth of Puerto Rico, leverages federal, state, local, and private resources to accelerate the transfer of technology, best practices, expertise, and other key approaches to U.S. food industry manufacturers. This support boosts technological productivity, enhances global market competitiveness, and promotes profitable growth for these manufacturers.

The MEP National Network has a special focus on serving the needs of small-and- medium-sized food industry manufacturers (SMMs) in the U.S., including SMMs operating in the food sector. Both the FDA training network and the MEP National Network serve as spaces for dialogue, information-sharing, alignment and collaboration for all those providing training and assistance to food industry manufacturers in the food sector. All Parties recognize that food safety training is the responsibility of, among others, the food industry, FDA, and its partners. FDA is committed to helping the food industry improve food safety culture and to comply with requirements such as FSMA rules by making food safety and FSMA training resources accessible and comprehensive.

The Institute for Food Safety and Health (IFSH) is a one-of-a-kind applied food science research consortium comprised of Illinois Tech, the FDA, and the food industry. In collaboration with the FDA, IFSH provides stakeholders with the opportunity to develop and exchange knowledge, experience, and expertise in the areas of food safety, food defense, and nutrition. IFSH/FDA collaborative research programs cover the following five research platforms: Food Processing, Food Microbiology, Food Chemistry and Packaging, Proficiency Testing and Method Validation, and Nutrition. In addition, IFSH is the home institute for the Food Safety Preventive Controls Alliance (FSPCA), an internationally recognized trusted source for training programs and outreach for the prevention-oriented standards of FSMA and food safety culture. FSPCA ‘s mission is to assist the human and animal food industry and related entities in building food safety capacity through education, training and outreach with an emphasis on small-and- medium-sized manufacturers.

Via this MOU, the MEP National Network and IFSH are additional, value-adding resources to extend assistance to SMMs relating to food safety best practices, understanding what needs to occur to operate in compliance with food safety regulations, FSMA training, and food safety culture. NIST MEP and IFSH seek to leverage the FDA network of public and private partners in state and federal governments, industry, and academia for access to training needed by SMMs, including the delivery of existing and established training, as well as the development and delivery of new training as needed. In doing so, NIST MEP intends to document and share complementary assistance best practices across the MEP National Network, including sharing facilities for group events, employing webinars for virtual events, establishing joint newsletters, and sharing websites to facilitate dissemination of new manufacturing funding initiatives and implementation services available to food industry manufacturers.

The MEP National Network works with over 35,000 manufacturers across the U.S. each year, serving as trusted advisors, focused on solving manufacturers' process and product challenges and identifying opportunities for growth. Food industry manufacturing is present throughout the U.S, with food industry a majority of MEP Centers work with food. This focus offers the FDA a chance to collaborate with the MEP, enabling them to promote and offer food safety training opportunities to these clients.

In this regard, areas of collaboration between the Parties established via this MOU may include, but are not limited to, the following efforts:

  • Provide training and technical support to U.S. food industry manufacturers to plan for and adopt safe food manufacturing practices.
  • Acquire, preserve and share knowledge regarding food safety culture and practices consistent with FDA policies, including policy based on FSMA, with NIST MEP.
  • Promote and co-sponsor joint training events that assist U.S. food industry manufacturers in complying with applicable federal laws (including FSMA).
  • Establish direct and consistent relationships at multiple organizational levels within all Parties to document and share complementary assistance best practices.
  • Develop clear objectives, benchmarks and goals to measure success, added value, and synergy of collaborations among NIST MEP, IFSH, and FDA.

IV. OBJECTIVES AND RESPONSIBILITIES

A. The Parties have two primary goals:

  1. To assist U.S. based small-and-medium-sized food industry manufacturers (SMMs) with providing safe food.
  2. Increase food safety culture.

B. To achieve these goals, the Parties have the following objectives:

  1. Increase understanding, appreciation and benefits of the MOU and the roles/responsibilities of MOU participants within our respective organizations and to stakeholders such as state/local regulatory and industry.
  2. Increase MEP Centers’ awareness of FSMA requirements.
  3. Increase MEP Centers’ awareness of food safety culture.
  4. Increase industry awareness of FSMA requirements.
  5. Increase industry awareness of food safety culture.
  6. Increase collaborative applied food science research across FDA, NIST and MEP Centers.

C. The intended responsibilities of the parties include:

  1. FDA and IFSH intend to serve as collaborative resources to NIST MEP to assist with providing food safety training and awareness to SMMs across the Nation that otherwise are challenged to receive information on food safety requirements and FDA guidance via existing FDA networks and alliances.
  2. The Parties intend to jointly promote and co-sponsor training events regarding food safety for U.S. food industry manufacturers.
  3. The Parties intend to leverage their respective communications and outreach capabilities to share information regarding food safety for U.S. food manufacturers.
  4. FDA intends to participate in dialogue with NIST MEP and IFSH, training and educational events that are intended to help the NIST MEP National Network and IFSH to accurately and effectively create and support awareness and understanding of laws enforced by FDA and FDA guidance.
  5. The Parties intend to jointly develop a plan that outlines goals, objectives, and current gaps in training, technical support, and information/data dissemination to various sized U.S. food industry manufacturing, to ensure added value by all Parties.
  6. NIST MEP intends to establish direct and ongoing relationships with FDA at the program Office level and Division levels and IFSH to maintain active and timely communications for the bidirectional dissemination of current information about food safety requirements and food industry manufacturing needs.
  7. NIST MEP intends to conduct regular FDA and MEP informational sessions to extend the reach of the Parties' collaboration to other relevant stakeholders and partners to and determine how best to leverage resources, such as other government agencies, trade associations, food science-oriented institutions, and training institutions.
  8. The Parties intend to jointly develop clear objectives, benchmarks and goals to measure success of the collaboration outlined in this MOU.

V. FUNDING

This MOU represents the broad outline of the Parties’ present intent to enter specific agreements for collaborative efforts in areas of mutual interest to the FDA, NIST-MEP and IFSH. No funding is obligated by this MOU. 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 Parties. 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 the FDA, NIST-MEP and IFSH operate.

VII. GENERAL PROVISIONS

A. This is an agreement between FDA, NIST-MEP and IFSH and does not confer any rights or benefits to any person or Parties.

B. The Parties agree that this MOU is non-exclusive and nothing contained herein prevents any Party from entering into similar agreements with any fourth party. If any terms of this MOU are inconsistent with existing authorities or directives of the Parties 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.

C. Nothing herein shall be construed to create any joint venture or similar relationship or to subject the Parties to any implied duties or obligations respecting the conduct of their affairs that are not expressly stated herein. No Party 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 another Party, or to bind a Party in any matter whatsoever. No Party shall be deemed to be an agent or principal of the other.

D. This MOU does not and is not intended to impose any legally binding requirements on the Parties. If necessary or desirable, the Parties may jointly agree upon and issue formal guidance interpreting this MOU and background materials upon which it is based. Any such guidance will apply with all applicable laws.

E. 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 Party in accordance with all applicable laws and regulations.

F. This MOU does not direct or apply to any person outside of the Parties.

G. Each Party will be responsible for its own acts and the results thereof and shall not be responsible for the acts of the other Parties and the results thereof.

H. If differences in understanding arise regarding this MOU, the Parties intend to resolve such differences by mutual consultation.

I. The FDA will not, as a part of the activities covered by this MOU, share any non-public information, including “confidential commercial or financial information” (21 CFR 20.61) or trade secret information (21 U.S.C. 360j(c)) obtained by or provided directly to FDA from a third party.

VI. PROGRAM/LIAISON OFFICERS

A. Liaison Officer FDA:

Michelle Motsinger
Acting Deputy Director, Office of Domestic Partnerships Human Foods Program
U.S. Food and Drug Administration
One Denver Federal Center
Lakewood, CO 80225
Tel: 303-349-9972
michelle.motsinger@fda.hhs.gov

B. Liaison Officer NIST MEP:

Jyoti Malhotra
Division Chief, National Programs, NIST MEP 100 Bureau Drive Stop 4800
Gaithersburg, MD 20899
Tel: 202-240-0949
jyoti.malhotra@nist.gov

C. Liaison Officer IFSH:

Jason Wan, Ph.D.
Associate Director, Institute for Food Safety and Health Illinois Institute of Technology
6502 South Archer Road, Bedford Park, IL 60501 Tel: 708-563-8287
jwan1@iit.edu

IX.  Commencement/Duration/Modification/Termination

This MOU will be effective on the date of the last signatory to the agreement for a period of five years. This agreement may be modified or terminated by mutual written consent by the parties or may be terminated by any Party upon a 30 day advance written notice to other parties. The Parties will review this agreement and goals annually. The Parties 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 Parties 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 Party may submit a proposed amendment or modification on its initiative, in writing for review. Modifications and amendments will be tracked and documented throughout the duration of the MOU.

--

/s/
G. Nagesh Rao
Acting Director
NIST Manufacturing Extension Partnership
100 Bureau Drive, Stop 4800
Gaithersburg, MD 20899
202-913-1484
g.rao@nist.gov
Date: 05/07/2025

/s/
Kyle Diamantas, J.D. 
Acting Deputy Commissioner for Human Foods
Human Foods Program
U.S. Food and Drug Administration
Date: 05/05/2025

/s/
Erik Mettler
Assistant Commissioner for Integrated Food Safety Systems
Office of Integrated Food Safety System
Human Foods Program
U.S. Food and Drug Administration
Date: 05/02/2025

/s/
Brian Schaneberg, Ph.D.
Executive Director, IFSH
Illinois Institute of Technology
Date: 05/05/2025

/s/
Authorized Organizational Representative:
Domenica G. Pappas
Associate Vice Provost for Research
Illinois Institute of Technology
Date: 05/06/2025

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