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  1. Domestic MOUs

MOU 225-25-005

MEMORANDUM OF UNDERSTANDING
BETWEEN THE
WESTERN GROWERS ASSOCIATION
AND THE
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION

This Memorandum of Understanding (MOU) sets forth the terms and understanding between the Western Growers Association (WGA) and the United States Food and Drug Administration (FDA) (the parties) to encourage and foster the sharing of data in produce safety compliance, education, outreach, and research.

I. Purpose

Through data and information sharing, this MOU will (1) advance food safety knowledge for public health authorities and industry, (2) encourage preventive food safety behaviors, (3) facilitate public health agencies’ resource management through better priority setting and focus, and (4) minimize industry supply chain disruption. Information provided to FDA and collaboration between FDA and WGA may complement research, advance understanding of hazards and further inform preventive measures, and foster improved education and outreach to promote produce safety. 

The primary outcome will be opportunities for FDA and WGA to learn from each other and foster a better understanding of the safety of growing, harvesting, packing and holding of produce.

II. Background

FDA is authorized to enforce the Federal Food, Drug, and Cosmetic Act (the Act) as amended (21 U.S.C. 301, et seq.). In fulfilling its responsibilities under the Act, FDA, among other things, directs its activities toward promoting and protecting the public health by assuring the safety, efficacy, and security of drugs, veterinary products, medical devices and radiological products and the safety and security of foods, dietary, supplements and cosmetics.  FDA also has a responsibility for regulating the manufacturing, marketing and distribution of tobacco products to protect the public health and to reduce tobacco use by minors.  To accomplish its mission, FDA must stay abreast of the latest science and data and continually consider the science and data to address public health concerns.  Public-private collaborative activities, including data sharing with WGA, will greatly contribute to the FDA’s mission.

FDA's Human Foods Program surveillance strategy guides the collection and generation of data needed to understand the state of the food supply and the impact of risk management efforts on it. Emerging risks are prioritized according to their public health impacts and addressed through risk management strategies, which may include inspections and sample collections. The program's limited resources necessitate careful decision making to guide the most effective and efficient deployment of risk management actions across its portfolio (e.g., inspections and sample collections).

WGA represents operations growing produce in Arizona, California, Colorado and New Mexico.  WGA and its members strive to protect and enhance the economic outlook of the association’s growers, their farmworker partners, and the many others whose livelihoods are tied to growing produce.

III.  Substance of the Agreement

This MOU outlines areas of mutual interest and the general guidelines for interaction.  It is not intended to cover all areas of mutual interest.  The areas covered by this agreement include coordination of specific projects and programs focused on the sharing of data and information between the parties, while ensuring the exchange of such data and information complies with applicable law.  This MOU provides for food safety related data-sharing pilot projects, such as those that will focus on microbiological and chemical testing data from individual produce operations.
 
A standardized approach to conducting testing and submitting data will be jointly developed and outlined in addendums to this agreement, based on the following:

  • WGA will facilitate the collection of member-owned data from its pilot-participating member companies through GreenLink®.  FDA will have access to anonymized, aggregated data through reports accessible via GreenLink®.  FDA will not be provided with individual company raw data.
  • FDA and WGA will collaborate on the process and mechanism for data sharing, and on acceptable testing parameters to be used for pilot projects.
  • FDA and WGA will collaborate on the development of stakeholder communications, announcing any projects and providing status updates.
  • Records obtained by FDA under this MOU are subject to the Freedom of Information Act (FOIA) and data sharing guidelines below.  Among other purposes, FDA may use the information received to help:
    • Inform a sampling or inspection assignment based on data gaps or trends (for a hazard in a commodity)
    • Identify preventative measures
    • Develop action levels
    • Communicate risks to consumers

IV.  Data Sharing Guidelines: 

WGA considers information provided pursuant to this agreement to be valuable data that is commercial in nature because members who provide the data use it to make decisions regarding their business operations, including but not limited to the growing, harvesting, and sale of produce. WGA and its members customarily and actually hold the information in strict confidence. (See 21 CFR 20.61(b)).

WGA attests that neither it nor its members discloses such information to the public, that such information is shared among WGA and its participating members pursuant to a non-disclosure agreement (See 21 CFR 20.81), and that such participating WGA members have authorized WGA to share this data with FDA pursuant to this MOU.

In furnishing information to FDA, WGA will designate, in writing, any information in such records it considers to be exempt from disclosure under exemption 4 of the FOIA (e.g., confidential commercial information) (see 21 CFR 20.61 (d)). Consistent with 21 CFR 20.61(c), FDA will not further disclose such information unless FDA is legally required to do so, such as by the FOIA or a court order, or FDA is sharing the information with another federal, state, local, or foreign government agency (see, e.g., 21 CFR 20.85, 21 CFR 20.88, 21 CFR 20.89). In any such disclosure, FDA will follow applicable laws, including FDA’s general regulations concerning the public availability of FDA records in 21 CFR part 20. As part of this, FDA will follow the pre-disclosure notification requirements of 21 CFR 20.61(e) when they apply.

FDA will not provide to WGA, and WGA is not authorized to have access to, any information under this MOU that is not otherwise publicly releasable, including but not limited to (1) trade secrets and confidential commercial information (see Exemption 4 of the FOIA (5 U.S.C. 552(b)(4)); (2) personal privacy information (see Exemptions 6 and 7(c) of the FOIA (5 U.S.C. 552(b)(6) and (b)(7)(C)); and (3) deliberative or pre-decisional information exempted from public disclosure (see Exemption 5 of the FOIA (5 U.S.C. 552(b)(5)).

V.  Resource Obligations

This MOU represents the broad outline of FDA and WGA intent to enter into specific agreements for collaborative efforts and data sharing.  All activities undertaken pursuant to 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 FDA and WGA.  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 WGA operate.

VI.  Liaison Officers

For Western Growers Association:
Sonia Salas
Associate Vice President, Science
Western Growers Association
6501 Irvine Center Dr, Suite 100
Irvine CA 92618
(949) 863-1000

For the Food and Drug Administration:
Girvin Liggans, Ph.D.
FDA/ Human Foods Program, Office of Microbiological Food Safety, Office of Produce Safety
Acting Director
5001 Campus Drive
College Park, Maryland
(240) 402-1382

Samir Assar, Ph.D.
FDA/ Human Foods Program, Office of Microbiological Food Safety, Office of Produce Safety, Division of Fresh Produce Safety
5001 Campus Drive
College Park, Maryland
(240) 402-1636

VII.  Effective Date

This MOU will take effect immediately once signed by both parties and shall continue in force for five years, unless both parties agree in writing to extend the length of the MOU.  The MOU will be reviewed annually.  The MOU may be modified by mutual written consent the Parties.  Any modification or addendum will be made in writing and signed by authorized representatives of both parties. The MOU may be terminated by either party upon 90 days’ written notice to the other party.  Except as expressly provided in this agreement, this MOU and any written addendums or modifications constitute the entire agreement between WGA and FDA with respect to the matters set forth herein.

APPROVED AND ACCEPTED FOR

Western Growers Association

/s/
Dave Puglia
President & CEO
Date: 03/18/2025

APPROVED AND ACCEPTED FOR

U.S. Food and Drug Administration

/s/
Kyle Diamantas
Acting Deputy Commissioner for Human Foods
Date: 03/14/2025

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