MEMORANDUM OF UNDERSTANDING
ON COOPERATION AND COMMUNICATION IN THE DEVELOPMENT OF HUMAN HEALTH TOXICOLOGICAL ASSESSMENTS AND OTHER RELATED SCIENTIFIC PROJECTS
BETWEEN
THE U.S. ENVIRONMENTAL PROTECTION AGENCY CENTER FOR PUBLIC HEALTH AND ENVIRONMENTAL ASSESSMENT
AND
THE U.S. FOOD AND DRUG ADMINISTRATION CENTER FOR FOOD SAFETY AND APPLIED NUTRITION

I. PURPOSE

This Memorandum of Understanding (MOU) serves as a mechanism for cooperation in the development of toxicological assessments. This MOU describes procedures and responsibilities of the Center for Food Safety and Applied Nutrition (CFSAN) of the U.S. Food and Drug Administration (FDA) and the Center for Public Health and Environmental Assessment (CPHEA) of the U.S. Environmental Protection Agency (EPA).

The purpose of this MOU is to facilitate communication and coordination of efforts to foster common practices in human health assessments and to harmonize hazard assessment methodologies.

II. BACKGROUND

Although EPA and FDA’s public health protection mandates are somewhat different, both agencies conduct chemical assessments using similar methods, and confront similar scientific challenges when interpreting the evidence presented in assessments. Through a commitment to share data and evaluations of scientific information and to collaborate via the exchange of scientific expertise and peer review of work products, the agencies will increase the quality and integrity of the toxicological assessments, ensure efficient use of federal resources, and avoid duplication of effort.

III. AUTHORITIES
 
EPA enters into this MOU pursuant to section 103 of the Clean Air Act [42 U.S.C. § 7403] and section 104 of the Clean Water Act [33 U.S.C. § 1254], both of which encourage cooperative research investigation, training, and information sharing.
FDA enters into this MOU pursuant to sections 301, 401, and 463 of the Public Health Service Act [42 U.S.C. § 241] and section 1003 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. § 393].
Both EPA and FDA understand that this agreement is not a funding instrument and is not intended to provide justification for sole source funding authorizations. All actions undertaken pursuant to this MOU shall be consistent with EPA and FDA applicable laws, policies, and management directives.

IV. ROLES AND RESPONSIBILITIES

EPA CPHEA and FDA CFSAN intend to share work plans and project schedules, and to involve the other office in discussions and evaluations of ongoing projects and draft documents, as much as is feasible. This coordination may involve:
1. Sharing reference lists and results of literature searches that have been conducted for the development of CPHEA Toxicological Reviews or CFSAN assessment products;
2. Exchanging reports of progress on risk assessment reviews or methods development;
3. Exchanging information on emerging problems and chemicals of concern;
4. Inviting chemical managers/study scientists (or their designated representatives) to attend relevant inter-agency meetings to discuss the toxicological assessments;
5. Joint evaluation of data and sharing of statistical, toxicological, and epidemiological expertise;
6. Providing the opportunity to review and comment on systematic review draft assessment plans/protocols and early draft toxicological assessments. Formal reviews will continue to follow the Integrated Risk Information System (IRIS) interagency review process for FDA review of IRIS documents and formal request via MOU coordinators for EPA review of FDA products;
7. Providing proposed new methods to each agency’s scientific staff for technical discussion of work in progress;
8. Maintaining confidentiality of information being shared as requested or in accordance with the standard procedures of both offices;
9. Promotion of regular discussions at the staff level, both formal and informal, aimed towards coordination of methods and results; and
10. Support for attendance of scientific staff, when possible, at both agencies’ symposia and conferences.

A. RESOLUTION OF DIFFERENCES

Insofar as EPA and FDA are subject to different statutes, mandates, and directives, some methodological differences are inherent, and must be accepted as beyond the scope of this MOU. Other differences should be discussed in a mutually supportive, scientific, objective, and transparent manner. Satisfactory resolution of such differences will improve efficiency and consistency between the two agencies. Therefore, be it resolved that EPA and FDA intend to:

1. Acknowledge the requirements of all applicable statutes, mandates, and
executive directives, and the extent to which these may result in different approaches;
2. Objectively consider scientific evaluations by all staff from both organizations, despite any major differences of interpretation;
3. When there are differences in risk assessment methods or data interpretations, work to clarify or explain these differences and respond to any questions about assumptions, transparency, and conclusions;
4. Work toward resolution of differences in methods and conclusions by all available consensus- building techniques, including personal telephone calls, teleconferences, videoconferences, development of position papers, or joint discussions in person, with written follow-up on the discussion results, communicated to both organizations; and
5. Agree that some differences can best be settled by a joint management decision, participated in by both organizations.

B. OUTCOMES

1. Through better coordination, achieve increased consistency between human health assessments conducted by these federal health agencies.
2. Combining the scientific expertise within EPA and FDA to improve the toxicological assessments.
3. Cost reduction for both agencies may be realized through increased communication, sharing of scientific information and work products, and avoiding duplication of effort.

V. LIMITATIONS

A. All commitments in this MOU are subject to the availability of appropriated funds and each agency’s budget priorities. Nothing in this MOU obligates FDA or EPA to expend appropriations or to enter into any contract, assistance agreement, interagency agreement, or other financial obligation. Both agencies agree not to submit a claim for compensation for services rendered to the other or any other federal agency for activities it undertakes in carrying out this MOU.

B. This MOU is neither a fiscal nor a fund obligation document. Any endeavor involving reimbursement or contribution of funds between the parties to this MOU will be handled in accordance with applicable laws, regulations, and procedures, and will be subject to separate subsidiary agreements that will be executed in writing by a representative of both agencies.

C. Except as provided in Section V paragraphs (A) and (B) and Section VII INTELLECTUAL PROPERTY, this MOU is not legally binding and does not create any right or benefit, substantive or procedural, enforceable by law or equity against FDA or EPA, their officers, employees, or any other person. This MOU does not pertain or apply to any persons outside FDA or EPA.

VI. PROPRIETARY INFORMATION

To carry out the joint work resulting from this MOU, EPA and FDA may need to disclose proprietary or other non-public information to each other. For the purpose of this MOU, “proprietary information” is defined as commercial or financial information that an affected business or entity claims to be confidential.

To the extent any confidential or non-public information, including proprietary information, will be shared pursuant to this MOU, then any such written request submitted to FDA for this information must contain all substantive requirements of 21 C.F.R. § 20.85. Additionally, any written request submitted to EPA for proprietary information must contain all substantive requirements of 40 C.F.R. § 2.209(c). Access to the non-public information, including all proprietary information, shared under this MOU shall be restricted to authorized FDA and EPA employees, officers, or representatives 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. Except as otherwise authorized by 40 C.F.R. § 2.301(h), 40 C.F.R. § 2.302(h), and 40 C.F.R. § 2.308(i), proprietary information shared pursuant to this agreement shall not be further disclosed to EPA or FDA contractors.

EPA and FDA each agree to clearly identify any such confidential information disclosed in writing; and to clearly memorialize in writing, within a reasonable time, any confidential information initially disclosed orally. EPA and FDA agree not to disclose, copy, reproduce or otherwise make available in any form whatsoever to any other person, firm, corporation, partnership, association or other entity information designated as proprietary or confidential information without consent of the other party except as such information is subject to disclosure under the Freedom of Information Act (5 U.S.C. § 552) and EPA’s regulations at 40
C.F.R. part 2 and FDA’s regulations at 21 C.F.R. part 20, or as otherwise authorized or required by law.

If an agency that has received information under this MOU receives a Freedom of Information Act 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.
 
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. Pursuant to FDCA section 301(j) [21 U.S.C. 331(j)], FDA will not reveal to EPA any method or process which is entitled to protection as a trade secret.

VII. INTELLECTUAL PROPERTY

Neither EPA nor FDA federal personnel may assert a copyright in the subject matter produced as a result of the parties’ collaboration. However, to the extent either party utilizes any non- federal entities or non-federal personnel to effectuate their collaboration under this MOU, the parties agree that any copyrightable subject matter, including, but not limited to, journal articles, training, educational, or informational materials or software, created from those activities may be copyrighted. Copyrights by non-federal entities or non-federal personnel will be in accordance with the terms and conditions of the instrument under which they were utilized. To the extent any copyrights result from the parties’ collaboration under this MOU, any non-federal entities or non-federal personnel obtaining those copyrights will grant to the United States Government (Government) a royalty free, nonexclusive, irrevocable license to reproduce, distribute, make derivative works, and publish or perform the work(s) publicly, or to authorize other to do the same on their behalf.

Furthermore, the activities contemplated by this MOU may result in products or processes that are patentable or otherwise proprietary. The party whose work results in any invention shall disclose the invention to the other party and then prepare, file, and prosecute the appropriate patent applications. If protection is granted, the inventing party will manage the invention in accordance with its rules and regulations. Inventions resulting from the joint activities of both the EPA and FDA will be owned by the Government, regardless of inventorship, unless an alternative agreement indicates otherwise. Inventions created by contractors to either EPA or FDA performing under this MOU on behalf of the Government will grant the Government a non-exclusive, paid-up license to practice or have practiced for or on behalf of the Government worldwide, in accordance with 35 U.S.C. § 202(c)(4).

VIII. QUALITY ASSURANCE

Under this MOU, if participants plan to collaborate on research that is beneficial to furthering EPA’s knowledge and understanding in the identified key area, then EPA intends to implement Agency quality program protocols as outlined in the Agency's Environmental Information Quality Policy (CIO 2105.1). If this MOU involves scientific collaboration, participants intend to collaboratively develop quality planning documentation (e.g., a Quality Assurance Project Plan
 
[QAPP], or equivalent) that satisfactorily meet quality program standards such that the research produces environmental information of known and documented quality.

IX. POINTS OF CONTACT

U.S. Environmental Protection Agency:

Kristina Thayer, Ph.D.
Director, Chemical and Pollutant Assessment Division (CPAD) Center for Public Health and Environmental Assessment (CPHEA) ORD, USEPA
Mail Code: B243-01
Building: Bldg B (Room B211I)
Research Triangle Park, NC 27711
[email protected]

U.S. Food and Drug Administration:

Suzanne Fitzpatrick, PhD, DABT, ERT
Senior Advisor for Toxicology
Office of the Center Director
Center for Food Safety and Applied Nutrition
College Park, MD 20740
[email protected]

X. MODIFICATION, DURATION, TERMINATION

This MOU will be effective when signed by all parties. This MOU may be amended at any time by the mutual written consent of the parties. The parties will review this MOU every 5 years to determine whether it should be revised, renewed, or cancelled. This MOU may be terminated by either party at any time. A request to terminate this MOU by one party shall be sent to the other party in writing at least 90 days in advance of the termination date.

XI. APPROVAL

Accepted and approved for
U.S. Food and Drug Administration

/s/
Steven M. Musser, Ph.D.
Deputy Center Director for Scientific Operations Center for Food Safety and Applied Nutrition
Date: 12/22/2022

Accepted and approved for
U.S. Environmental Protection Agency

/s/
Wayne E. Cascio, MD, FACC
Center Director
Center for Public Health and Environmental Assessment
Date: 01/09/2023