Memorandum of Understanding between
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Veterinary Medicine
and Texas A&M AgriLife Research
The United States Food and Drug Administration (FDA) and Texas A&M AgriLife Research (AgriLife) (collectively, the Participants) share interests in promoting scientific progress through collaborating in areas of common interest and developing a common approach to analytical methods in support of food safety in relation to the protection of public health and international trade.
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 directs its activities toward, among other things, 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 and cosmetics. 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. To accomplish its mission, FDA must stay abreast of the latest developments in research and communication with stakeholders about complex scientific public health issues. Increased development of research, education, and outreach partnerships with Texas A&M AgriLife Research will greatly contribute to FDA’s mission.
Texas A&M AgriLife Research is the leading research and technology development agency in Texas for agriculture, natural resources, and the life sciences. Its mission is scientific discovery that benefits consumers and expands agricultural sustainability, profitability, and environmental stewardship. AgriLife supports and collaborates with the Texas A&M University College of Veterinary Medicine & Biomedical Sciences Clinical Microbiology Laboratory which is a member of the Veterinary Laboratory Investigational and Response Network (“Vet-LIRN”), which is supported by the FDA. Vet-LIRN is a network of veterinary diagnostic laboratories that supports the documentation, investigation, and diagnosis of animal feed or drug related illnesses. These efforts also contribute to overall food safety as animal feed events could signal potential issues in the human food system.
III. Substance of Understanding
FDA’s Center for Veterinary Medicine (CVM) coordinates facilities, equipment, and professional expertise of government and veterinary diagnostic laboratories to respond to high priority chemical and microbial feed/drug contamination events. CVM manages Vet-LIRN, a network to provide the means for rapid response to reports of animal injury and establishes protocols to facilitate veterinary diagnostic testing at network laboratories to help FDA investigate potential adverse events affecting the United States’ animal feed and drug supply by conducting testing of veterinary products, animal feeds, or diagnostic samples. As a Vet-LIRN laboratory Network member, laboratories will maintain preparedness by optimizing and harmonizing testing methods, as well as conducting limited surveillance exercises and participating in network proficiency tests.
FDA and AgriLife intend to seek opportunities to participate together to:
- Investigate potential problems with FDA regulated products, e.g., animal feed and animal drugs;
- Promote human and animal health by, among other things, collaborating with veterinary diagnostic laboratories to provide scientific information; build laboratory capacity for routine and emergency response, and train scientists; and
- further and support their respective missions as mutually agreed and appropriate.
Vet-LIRN conducts case investigations including: reviewing medical histories, completing necropsies with complete histopathology work up, toxicology testing, microbiology testing, and whole genome sequencing.
The Participants have the option of entering into future contracts, grants, or cooperative research agreements to the extent authorized by the law or policies of each Participant’s institutions and available appropriations. The Participants intend that the terms and conditions of any such arrangements, if any, will be in accordance with applicable law, policies, and regulations and will be negotiated and executed by appropriate representatives of institutions within AgriLife and FDA. The Participants intend that, when applicable, these arrangements incorporate by reference this MOU.
IV. General Provisions
The Participants intend that:
- Rights to any inventions resulting from collaborative research will be negotiated and documented in separate written research arrangements governing the effort, based on current U.S. patent regulations and any other applicable statutes and regulations.
- AgriLife and FDA may decide to enter into Cooperative Research and Development Agreements (CRADA) specific to collaborative projects. The terms of such CRADAs will address Intellectual Property rights.
- Where applicable, each Participant will comply with the other Participant’s security procedures and policies, as well as statutes and regulations, regarding access to and use of facilities. A Participant can either restrict or limit access to its property and facilities at any time and for any reason.
- It is recognized that from time to time, as part of future collaborative projects resulting from this MOU, the FDA and AgriLife may agree to share expenses and/or may agree to monetary compensation of one Participant by the other. It is agreed that as projects are developed, details of how expenses are to be shared or handled will be mutually agreed to in advance and documented in a written agreement signed by an authorized representative of each Participant, as appropriate and in compliance with all applicable institutional requirements.
Proprietary and/or nonpublic information will not be disclosed under this MOU, unless such disclosure is permitted by law and is governed by an appropriate confidentiality and non-disclosure agreement, to be separately negotiated and executed by the Participants. FDA will not disclose any personally identifiable information to AgriLife.
V. Resource Obligations
This MOU represents the broad outline of the FDA and AgriLife’s intent to collaborate in areas of mutual interest. It is not intended to create obligations under international or other law. All activities that may be undertaken under this MOU are subject to the availability of personnel, resources, and funds and shall be documented in a separate written agreement signed by an authorized representative of each Participant. This MOU does not affect or supersede any existing or future arrangements between the Participants and does not affect the ability of the Participants to enter other arrangements related to this MOU.
VI. Liaison Officers
The following are designated as MOU liaisons for the Participant to seek out and discuss opportunities contemplated by this MOU:
A. For Texas A&M AgriLife Research:
Dr. Sara Lawhon Associate Professor, Veterinary Pathobiology, College of Veterinary Medicine and Biomedical Sciences
HWY 60 BLDG 1085 Room 2015, College Station, TX 77843
B. For the Food and Drug Administration:
Dr. Regina Tan, Director, Office of Research
FDA/Center for Veterinary Medicine
8401 Muirkirk Road, Laurel, MD 20708
Each Participant can designate a new liaison at any time by notifying the other Participant’s administrative liaison in writing. If, at any time, an individual designated as a liaison under this agreement becomes unavailable to fulfill those functions, that Participant will name a new liaison within 2 weeks and notify the other Participant through its designated administrative liaison.
VII. Term, Termination, and Modification
The Participants intend that this MOU become effective when accepted by both Participants and will have an effective term of 5 years from such date. It can be modified by mutual written consent by the Participants or can be terminated, without cause, by either Participant(s) upon a 60-day advance written notice to the other.
APPROVED AND ACCEPTED FOR
TEXAS A&M AGRILIFE RESEARCH
Stephen A. Schulze
Asst. Vice Chancellor for Administration
Texas A&M AgriLife
APPROVED AND ACCEPTED FOR THE
FOOD AND DRUG ADMINISTRATION
Dr. Steven Solomon
Director, Center for Veterinary Medicine