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  1. Domestic MOUs

MOU 225-14-022

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 

  1. 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. 
  2. 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, and distribution of foods and examining samples thereof to ensure compliance with applicable requirements. 
  3. 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.

III.  Substance of the Understanding 

  1. 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 USEPA and FDA will collaborate in the development of label data elements, terminology, and validation rules. 
    2. USEPA intends to be responsible for: 
      1. The creation of pesticide label examples for testing during the development of the data standards and during a pilot program;
      2. Implementing processes to maintain up-to-date structured product label (SPL) files of pesticide active ingredient, label and MRL data; 
      3. Implement processes to maintain up-to-date MRLs; 
      4. Provide data in the SPL format for use by FDA. 
    3. FDA intends to be responsible for:
      1. Updating the existing data standards for drug information to include pesticide information; 
      2. 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; 
      3. Processing files for testing and early piloting. 
  2. 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. 
  3. 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 

  1. 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. 
  2. 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. 
  3. This MOU and all associated understandings or agreements will be subject to the applicable policies, rules, regulations, and statutes under which the Participants operate. 
  4. 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. 
  5. 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. 
  6. 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 

  1. 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. 
  2. This MOU does not nullify or negate any existing understandings or agreements among or between the Participants. 
  3. 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 

Randy Levin
Food and Drug Administration
11601 Landsdown Street, Room 10A13
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 

  1. This MOU will become effective when signed by all the Participants. 
  2. 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. 
  3. 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 

APPROVED AND ACCEPTED FOR THE FOOD AND DRUG ADMINISTRATION

Michael M. Landa, Director
Center for Food Safety and Applied Nutrition
DHHS Food and Drug Administration
September 10, 2014 

APPROVED AND ACCEPTED FOR THE ENVIRONMENTAL PROTECTION AGENCY 

Jack Housenger, Director
Office of Pesticide Programs
Environmental Protection Agency
September 9, 2014