MEMORANDUM OF UNDERSTANDING 

Between 

THE U.S. ENVIRONMENTAL PROTECTION AGENCY 

And 

THE U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES 

FOOD AND DRUG ADMINISTRATION 

CONCERNING INFORMATION SHARING RELATED TO THE EXCHANGE OF PESTICIDE ACTIVE 

INGREDIENT, LABEL and MAXIMUM RESIDUE LEVEL DATA 

I. Purpose 

This Memorandum of Understanding {MOU) establishes policies and procedures to enhance the 

exchange of information between participating agencies (each individually a "Participant" and 

collectively the "Participants") of the U.S. Environmental Protection Agency (EPA) and the Food and 

Drug Administration (FDA) of the U.S. Department of Health and Human Services {HHS) related to food 

safety pesticide data in an electronic format including pesticide labeling, Maximum Residue Levels 

(MRLs) and research activities substantiality affecting the public health. EPA is responsible for 

establishing health protective MRLs on food that may occur following the use of pesticide products in 

accordance with the pesticide label. FDA in turn is responsible for ensuring food safety, in part, by 

inspecting food to ensure compliance with MRLs. As such both agencies share the desire to readily 

access the same pesticide active ingredient, labeling and MRL information to support respective 

programs. 

II. Background 

A. The Environmental Protection Agency {EPA)'s mission is to protect human health and the 

environment in the United States. EPA's Office of Pesticide Programs (OPP) serves an important role in 

helping the Agency meet this mission by regulating the sale and distribution of pesticides in the United 

States. Under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended by the Food 

Quality Protection Act {FQPA) of 1996, all pesticides distributed or sold in the United States generally 

must be registered by EPA, based on scientific data showing that they will not cause unreasonable risks 

to human health or the environment when used as directed on product labeling. Section 22(b) of FIFRA 

mandates that EPA cooperate with other Federal agencies in carrying out the provisions of FIFRA. 

B. FDA is responsible for protecting and promoting the public health by ensuring, among other 

things, the safety of human food and animal feed by administering and enforcing the Federal Food, 
Drug, and Cosmetic Act (hereinafter the FD&C Act) and several related public health laws. In fulfilling its 

responsibilities under the FD&C Act, FDAs activities are directed toward protecting the public health by 

ensuring that foods are safe and wholesome and truthfully and informatively labeled. This is 

accomplished, in part, by inspecting the production, processing, a·nd distribution of foods and examining 

samples thereofto ensure compliance with applicable requirements. 

C. The USEPA and the FDA, have certain related objectives in carrying out their respective food 

safety, public health, and associated regulatory, marketing, trade, and research activities. The 

Participants believe it is desirable, from the standpoint of public health protection, to enhance the 

exchange of information between the USEPA and FDA related to pesticide data, and associated 

activities, that will assist in public health protection and in the effective and efficient execution of the 

responsibilities of the Participants. 

For EPA, science evaluations of data submitted to support a pesticide registration are translated into a 

set of conditions, directions, and precautions that define who may use a pesticide, as well as where, 

how, how much, and how often it may be used which is placed on the product label. The label is used 

by EPA to manage the potential risks pesticides may pose. 

EPA is responsible for establishing health protective MRLs on food that may occur following the use of 

pesticide products in accordance with the pesticide label. FDA in turn is responsible for ensuring food 

safety, in part, by inspecting food to ensure compliance with MRLs. As such the Participants share the 

desire to readily access the same pesticide active ingredient, labeling and MRL information to support 

respective programs. 

Ill. Substance of the Understanding 

A. Goals and Contributions 

1. Through this collaboration, the data standards developed for FDA's pharmaceutical labels will be 

adjusted to accommodate EPA's pesticide active ingredients, labels and MRLs. The information will be · 

exchanged between FDA and EPA, which both have the responsibility for regulation related to 

pesticides. To achieve this, the US EPA and FDA will collaborate in the development of label data 

elements, terminology, and validation rules. 

2. USEPA intends to be responsible for: 

a. The creation of pesticide label examples for testing during the development of the data 

standards and during a pilot program; 

b. Implementing processes to maintain up-to-date structured product label (SPL) files of 

pesticide active ingredient, label and MRL data; 

c. Implement processes to maintain up-to-date MRLs; 
d. Provide data in the SPL format for use by FDA. 

3. FDA intends to be responsible for: 

a. Updating the existing data standards for drug information to include pesticide 

information; 

b. Creation of an implementation guide with a validation procedure document, style sheet, 

and x-forms to accommodate pesticide data in the SPL format maintained by EPA; 

c. Processing files for testing and early piloting. 

B. Information Sharing 

The Participants mutually agree that each agency intends to: 

1. Coordinate, collaborate, and cooperate with each other in the exchange of records, data, 

reports, and other information on issues related to pesticide active ingredients, labels and MRLs for the 

purpose of achieving the goals explained above. 

2. Receive, review, and respond, in a timely manner, to requests for records, data, reports, and 

other public or non-public information made pursuant to this MOU. 

3. Develop internal procedures, including for the receipt, review, and response to requests for 

information, that each Participant agency will use to facilitate the exchange of information, pursuant to 

this MOU, and to protect against unauthorized use or disclosure of any non-public information shared or 

exchanged pursuant to this MOU. 

C. Information Safeguards 

The Participants mutually agree that: 

1. This MOU is not intended to cover the exchange of confidential commercial information or trade 

secrets though it is expected to entail the exchange of other non-public information. Proper safeguards 

against unauthorized use and disclosure of the non-public information shared or exchanged pursuant to 

this MOU are important for effective implementation of this MOU. Non-public information may include 

any information that is otherwise protected by public disclosure by Federal statutes and their 

implementing regulations (e.g., the Privacy Act (5 USC 552a), Freedom of Information Act exemptions (5 

USC 552(b)), the Federal Food, Drug, and Cosmetic Act (21 USC 301 et seq.), and the Health Insurance 

Portability and Accountability Act (HIPAA), Pub. L. 104-191). 
2. Access to Non-public information shared under this MOU will be restricted to the employees, 

agents, and officials of the Participants, to perform official duties in accordance with the uses of the 

information in this MOU. Sharing of information beyond those employees will be limited to situations 

that are authorized in writing by the Participant agency that provided the information or as required by 

law. Disclosure of non-public information to EPA and FDA employees pursuant to the MOU is provided 

with the understanding that those employees are not considered members of the public for purposes of 

disclosure of such designated information and thus such disclosure does not constitute a waiver of any 

FOIA exemption protection. 

3. The Participants agree to notify promptly each other of any actual or suspected inappropriate 

disclosure to the public of any information shared pursuant to this MOU. 

4. If a Participant agency that has received information under this MOU receives a Freedom of 

information Act (FOIA) request where there are responsive records, which originated with another 

Participant agency, the agency will refer the FOIA request to the other agency for it to respond directly 

to the FOIA requestor. In such cases, the Participant agency, which received the FOIA request, will notify 

the FOIA requestor that it has referred the FOIA request to another agency and that a response will 

issue directly from that agency. 

IV. Limitations 

A. This MOU represents the broad outline of the Participants' present intent to share public and 

non-public information in areas of mutual interest of pesticide active ingredient, label and MRls 

consistent with programmatic goals and resources that will assist in public health protection and the 

effective and efficient execution of the responsibilities of the Participants. 

B. This MOU does not create binding, enforceable obligations against any Participant, and all 

activities undertaken pursuant to this MOU are subject to the availability of personnel, resources, and 

funds. 

C. This MOU and all associated understandings or agreements will be subject to the applicable 

policies, rules, regulations, and statutes under which the Participants operate. 

D. This MOU does not restrict any Participant from protecting any records, data, reports, or other 

information, which is otherwise not publicly available, when the Participant determines that sharing the 

information is contrary to law or regulation. 

E. All commitments made by EPA and FDA in this MOU are subject to the availability of 

appropriated funds and budget priorities. Nothing in this MOU, in and of itself, obligates any Participant 

to expend appropriations or to enter into any contract, assistance agreement, interagency agreement, 

or incur other financial obligations. Any transaction involving transfers of funds between the parties to 
this MOU will be handled in accordance with applicable laws, regulations, and procedures under 

separate written agreements: 

F. This MOU does not create any right or benefit, substantive or procedural, enforceable by law or 

equity, by persons who are not party to this agreement, against EPA or FDA, their officers or employees, 

or any other person. This MOU does not apply to any person outside of EPA and FDA. 

V. Other Understandings and Agreements 

A. This MOU is intended to serve as an overarching statement of the intention of the Participants 

to enhance information sharing among and between the Participants. 

B. This MOU does not nullify or negate any existing understandings or agreements among or 

between the Participants. 

C. This MOU does not preclude any Participant from entering into additional separate 

understandings or agreements with another Participant. 

VI. LIAISON OFFICES AND CONTACTS FOR PARTIES 

Ra.ndy Levin 

Food and Drug Administration 

11601 Landsdown Street, Room 10Al3 

North Bethesda, MD 20852 

Philip Villanueva 

Senior IT Advisor 

The Environmental Protection Agency (EPA) 

Office of Pesticide Programs, U.S. EPA 

1200 Pennsylvania Avenue, NW (7507P) 

Washington, DC 20460 

VII. Effective Date, Terms, Termination, and Modification 

A. This MOU will become effective when signed by all the Participants. 

B. This MOU will continue in effect unless modified by mutual and unanimous written consent or 

terminated by any of the Participants upon a 60-day advance written notice to the other Participants. 

C. The Participants agree that they will review this MOU every three years to determine whether it 

should be modified or terminated. 
VIII. SIGNATURES OF RESPONSIBLE PARTIES 

A;cz;;t;r;~;:_:;:UG ADMINISTRATION 

Michael Landa, Director 

Center for Food Safety and Applied Nutrition 

DHHS Food and Drug Administration 

Date: r (to j fL/ 

APPROVED AND ACCEPTED FOR THE ENVIRONMENTAL PROTECTION AGENCY 

Environmental Protection Agency 

Date rtf j/'f