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 ofinformation between participating agencies (each individually a "Participant" and collectively the "Participants") ofthe U
.S. Environmental Protection Agency (EPA) and the Food and Drug Administration (FDA) ofthe 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 ofpesticide 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 orsold 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 environmentwhen 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 enforcingthe 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 ofthe responsibilities ofthe Participants. For EPA, science evaluations ofdata submitted to support a pesticide registration are translated into a set ofconditions, 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 informationto support respective programs. Ill. Substance ofthe 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 USEPA 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 ofpesticide label examples fortesting during the development ofthe 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 processesto 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 fordrug information to include pesticide information; b. Creation ofan implementation guide with avalidation procedure document, style sheet, and x-forms to accommodate pesticide data in the SPL format maintained by EPA;
c. Processing files fortesting 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 forthe 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 pursuantto 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 ordisclosure ofany 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 ofconfidential commercial information ortrade secrets though it is expected to entail the exchange ofother non-public information
. Proper safeguards against unauthorized use and disclosure ofthe non-public information shared orexchanged pursuantto this MOU are importantfor effective implementation ofthis 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 underthis MOU will be restricted to the employees, agents, and officials ofthe Participants, to perform official duties in accordance with the uses ofthe information in this MOU. Sharing of information beyond those employees will be limited to situations that are authorized in writing bythe Participant agency that provided the information or as required by law
. Disclosure ofnon-public information to EPA and FDA employees pursuant to the MOU is provided with the understanding that those employees are not considered members ofthe public for purposes of disclosure ofsuch designated information and thus such disclosure does not constitute awaiver ofany FOIA exemption protection
. 3. The Participants agree to notify promptly each other ofany actual orsuspected inappropriate disclosure to the public ofany information shared pursuant to this MOU. 4. Ifa 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 referthe FOIA request to the otheragency 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 anotheragency and that a response will issue directly from that agency. IV. Limitations A. This MOU represents the broad outline ofthe Participants' present intentto share public and non-public information in areas ofmutual interest ofpesticide active ingredient, label and MRls consistent with programmatic goals and resources that will assist in public health protection and the effective and efficient execution ofthe responsibilities ofthe 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 oragreements 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 orto enter into any contract, assistance agreement, interagency agreement, or incur otherfinancial obligations. Any transaction involving transfers offunds between the parties tothis 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 ofthe intention ofthe Participants to enhance information sharing among and between the Participants
. B
. This MOU does not nullifyor negate any existing understandings or agreementsamong 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 ofthe Participants upon a 60-day advance written notice to the other Participants
. C
. The Participants agree that they will review this MOU everythree years to determine whether it should be modified orterminated.VIII. SIGNATURES OF RESPONSIBLE PARTIES

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Michael Landa, Director Centerfor Food Safety and Applied Nutrition DHHS Food and DrugAdministration Date: 

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APPROVED AND ACCEPTED FOR THE ENVIRONMENTAL PROTECTION AGENCY

Environmental Protection Agency Date 

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