MEMORANDUM OF UNDERSTANDING 

ON 

INFORMATION SHARING 

BETWEEN 

U.S. ENVIRONMENTAL PROTECTION AGENCY 

OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVE:t\TION 

I. Purpose 

AND 

DEPARTMENT OF HEALTH AND HlJMAN SERVICES 

FOOD AND DRUG ADMINISTRATION 

FOODS AND VETERINARY MEDICINE PROGRAM 

This Memorandum of Understanding (MOU) establishes a formal mechanism for sharing 

information between the Environmental Protection Agency's (EPA's) Office of Chemical Safety 

and Pollution Prevention (OCSPP), and the Food and Drug Administration's (FDA's) Foods and 

Veterinary Medicine (FVM) Program (including the Office of Foods and Veterinary Medicine 

(OFVM), the Center for Food Safety and Applied Nutrition (CFSAN), the Center for Vete1inary 

Medicine (CVM)]. The MOU represents the intent to share information in areas of mutual interest, 

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

effective and efficient execution offederal responsibilities. Under this MOU, FDA and EPA 

(collectively "Participants") may share with each other non-public information that may be exempt 

from public disclosure as confidential business information (CBI) 1 and/or confidential commercial 

information (CCI), 2 subject to applicable limitations below. Information intended to be shared 

includes memoranda, data from petitions and notifications, communications, and other documents. 

H. Authorities 

EPA has authority to enter into this agreement pursuant to the Toxic Substances Control Act 

(TSCA); the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA); and the Federal Food, 

DlUg, and Cosmetic Act (FD&C Act). 

FDA has authority to enter into this agreement pursuant to the, the Federal Food, Drug, and 

Cosmetic Act (FD&C Act) and the Public Health Service Act. 

1 Confidential Business Information (CBI): Any business information in any form received by EPA from any source that 

has been claimed as confidential in accordance with 40 CFR 2.203 or other provision in Title 40, Code of Federal 

Regulations, or which might be claimed as confidential as described by 40 CFR 2.204(c) (2), and which has not been 

disclosed to the public under the procedures in 40 CFR part 2, subpart B. 2 Confidential commercial information is commercial or financial information that is privileged or confidential means 

valuable data or information which is used in one's business and is of a type customarily held in strict confidence or 

regarded as privileged and rrot disclosed to any member of the public by the person to whom it belongs. 21 CFR 20.6 i(b). 
III. Background 

The FDA and the EPA have complementary roles in their regulatory authority for some substances 

incorporated in food (including animal food and feed), animal drugs, and cosmetics. 

FVM is responsible for protecting and promoting the public health by ensuring, among other 

things, the safety of food, including animal food and feed, animal drugs, and cosmetics by 

enforcing the FD&C Act, and several related public health laws. 

OCSPP is responsible for managing the EPA's pesticides and toxic substances programs under 

FTFRA, FD&C Act, TSCA, and for promoting coordination of all Agency programs engaged in 

toxic substances activities. 

Situations arise in which a given substance may be regulated by both agencies. For example, a 

manufacturer of an antimicrobial food wash is required to demonstrate to FDA that its use is safe 

and does not adulterate food. The manufacturer may also be required to demonstrate to EPA that 

use of the same substance (labeled as a pesticide) will not cause unreasonable adverse effects on 

the environment. Having an MOU regarding the sharing of information and opening channels of 

communication between the agencies will serve to facilitate the Participants' accomplishment of 

their respective missions. 

IV. Substance of Agreement 

The Participants enter into this MOU to share, on a reciprocal and as-needed basis, information, 

including non-public information, related to the agencies' respective programs regulating 

substances that may be present in human food, animal food and feed, animal drugs, and 

cosmetics. The Participants agree to protect the confidentiality of the non-public information that 

they receive from each other pursuant to this MOU. To ensure appropriate protection of nonpublic information, each agency agrees to identify non-public information shared under this MOU. 

Disclosure of non-public information to the Participants. Subject to Paragraphs B., C., and D. 

below, neither FDA nor EPA shall further disclose non-public information received under this 

MOU except with the written permission of the agency from which the non-public information 

originated. 

A. Information Sharing 

The Participants mutually agree that each agency will: 

1. Designate liaison officers/points of contacts through whom inquiries may be exchanged. The 

liaison officers will make determinations of the resources needed to address inquiries and 

utilize their respective agency processes to provide the requested information. 

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

and other information, which are otherwise not publicly available, on issues related to safety; 

efficacy (as applicable); public health; and associated regulatory, marketing, trade, and research 

activities. 

3. Request intonnation sharing and exchange and respond to such requests using the language in 

Appendix A and B of this MOU. 

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4. Develop intemal procedures, including for the receipt, review, and response to requests for 

information that each Participant agency will use to facilitate the exchange of non-public 

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. 

B. General Safeguards for Non-public Information 

The Participants mutually agree that: 

1. Proper safeguards against unauthorized use and disclosure of the non-public information 

shared or exchanged pursuant to this MOU are necessary for effective implementation of 

thisMOU. 

2. Proper safeguards shall include the adoption of policies and procedures to ensure that the 

information shared under this MOU shall be shared and used consistent with the Trade 

Secrets Act; the FD&C Act; FIFRA; TSCA; the Privacy Act of 1974, as amended; FOIA; 

the confidentiality provisions of the Food Security Act of 1985; Section 1619 of the Food, 

Conservation, and Energy Act of2008, to the extent applicable; other applicable Federal 

laws and implementing regulations; and other Participant policies, orders, and directives. 

Pursuant to Section 301(j) of the FD&C Act (21 U.S.C. 331(j)), FDA will not reveal to any 

Participant any method or process that is entitled to protection as a trade secret. 3 

3. Any Participant may decide not to share information in response to a particular request for 

information or to limit the scope of information in response to a particular request. See 

Process for Information Sharing under Appendix A. 

4. Liaisons and Points of Contacts identified in the related Interconnection Security 

Agreement, will immediately notify their designated counterpart(s) by telephone or e-mail 

when a security incident(s) has been detected, so the other party may take steps to 

determine whether its system has been compromised and to take appropriate security 

actions. 

5. If a Participant that has received information under this MOU receives a FOIA request 

where there are responsive records which originated with the other Participant, the agency 

will refer the pertinent portion of the FOIA request to the originating agency for it to 

respond directly to the FOIA requestor. In such cases, the agency that received the FOIA 

request will notify the FOIA requestor that it has refened the FOIA request to the other 

agency and that a response will issue directly from that agency. 

6. An agency in receipt of a judicial or legislative mandate ordering disclosure of non-public 

information provided by the other agency will promptly notify the agency that provided this 

information and consult with the originating agency regarding the appropriate legal 

response. If the agency provides the information to the requesting authority, the agency will 

in accordance with and to the extent consistent with its regulations advise the requesting 

authority of the need to protect the information from public disclosure. 

7. More detailed information on security, access, and protocols is provided in 

·'Interconnection Security Agreement Between U.S Environmental Protection Agency, 

Office of Chemical Safety and Pollution Prevention and Department of Health and Human 

Services, Food and Drug Administration, Office of Foods and Veterinary Medicine, For 

3 A trade secret may consist of any commercially valuable plan, formula, process, or device that is used for the making, 

preparing, compounding, or processing of trade commodities and that can be said to be the end product of either innovation 

or substantial effort. There must be a direct relationship between the trade secret and the productive process. 21 CFR 

20.6J(a). 

3 
Connection between Data Sharing from EPA and Data Sharing with FDA," dated 

November 19,2014. 

C. Non-public Information Provided by FDA 

1. FDA may share non-public information with EPA, upon written request, in a manner 

consistent with the requirements of21 CFR 20.85 regarding the disclosure of information 

by FDA to other Federal government departments and agencies. Specifically, FDA 

liaison(s) designated in this MOU are authorized to share with EPA and its staff non-public 

information in response to a written request and agreement not to disclose further the 

information without FDA's written permission. Consistent with the requirements of 21 CFR 

20.85, FDA may share with EPA confidential commercial information related to its 

program for food (including animal food and feed), animal drugs, and cosmetics, to the 

extent such sharing is not prohibited under 21 U.S.C. § 33l(j) or other applicable 

law. Under 21 U.S.C. § 331(j), FDA is prohibited from sharing certain trade secrets outside 

of the Department ofHealth and Human Services except in very limited 

circumstances. Nonetheless, upon request by EPA for specific information identified by a 

company as trade secret, FDA will assess whether the information is in fact trade secret 

under § 331 (j), and if so will ascertain whether a masked or aggregated form of the 

information may be provided whose disclosure is not prohibited by§ 33l(j) or whether the 

company will provide written consent to the sharing of the specific trade secret infonnation 

with EPA. 

2. EPA staff designated for access to non-public information provided by FDA must first be 

authorized access to non-public information relevant to the requirements of their respective 

statutes and regulations, as appropriate, within their respective organizations. EPA will 

share confidential information provided by FDA only with EPA personnel who EPA has 

authorized to have access to CBI. 

D. Non-public Information Provided by EPA 

l . EPA may share information subject to a claim of business confidentiality with FDA in 

accordance with 40 CFR 2.209(c). 

2. FDA will share non-public information subject to protection under FIFRA or TSCA 

provided by EPA only with those FDA personnel who FDA has authorized to have access 

to CBI. 

3. FDA staff will protect all non-public information provided by EPA in accordance with 40 

CFR 2.209(c)(5) and the applicable Information Security Manual. 

4. No state, county, or local official or FDA grantee or contractor will be permitted to have 

access to non-public information provided by EPA. 

5. For documents identified as TSCNFIFRA CBI, as permissible under the applicable 

National Archives and Records Administration (NARA) schedules, if materials ar~ no 

longer needed by FDA and no longer need to be retained by FDA, FDA will return the 

documents to EPA or submit proof of appropriate destruction. If such materials are needed 

or otherwise must be retained, FDA, in consultation with EPA, will establish appropriate 

arrangements for the safeguarding of the materials. 

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V. Limitations 

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

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

B. 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 infonnation is contrary to law or regulation. 

C. The MOU does not restrict any Participant from protecting infonnation in connection with 

research that has not been peer reviewed. 

VI. 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. The Participants mutually agree to promote and advance the purpose of this MOC to enhance 

information sharing, when necessary, beyond any existing understandings or agreements, 

including this one. 

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

understandings or agreements with another Participant. 

VII. Resource Obligations 

This MOU is not an obligation or commitment of funds, nor a basis for the transfer of funds. 

Unless otherwise agreed to in writing, each Party shall bear its own costs in relation to this MOU. 

Expenditures by each Party will be subject to its budgetary processes and to the availability of 

funds and resources pursuant to applicable laws, regulations, and policies. The Parties expressly 

acknowledge that this in no way implies that Congress will appropriate funds for such 

expenditures. 

None of the activities outlined in this MOU requires the exchange of funds, property, or services 

between the Participants. Each Participant to this MOU recognizes the other's responsibility to fund 

and carry out its own activities subject to, and to the extent made possible by, the availability of 

appropriated funds, and no funds will be transferred under this MOU. Any specific collaborative 

activities arising from this MOU that require transfer of funds shall be the subject of a separate 

agreement. Any endeavor involving reimbursement or contribution of funds between the 

Participants to the MOU will be handled in accordance with applicable laws, regulations, and 

procedures. Such endeavors will be outlined in separate interagency agreements that shall be made 

in writing by representatives of both Participants and shall be independently authorized by 

appropriate statutory authority. 

VIII. Severability Clause 

Nothing in this MOU is intended to conflict with the current laws, regulations, or policies 

applicable to each Party. If a term of this MOU is inconsistent with such authority, then that 

term shall be invalid, but the remaining terms and conditions of this MOU shall remain in full 

force and effect. 

5 
IX. l\o Private Right of Action Created 

This MOU is an internal government agreement and does not explicitly or impliedly create, confer, 

grant, or authorize any rights, privileges, benefits, or obligations, substantive or procedural, 

enforceable at law or otherwise, by either Party against the other or by any third party against the 

Parties; their parent agencies; the United States; or the officers, employees, agents, or other 

associated personnel thereof and is not intended, nor should be construed, as creating any such 

right, privilege, benefit, or obligation. 

X. Relationship to Other Authorities 

Nothing in this MOU is intended to restrict the Participants from taking any action that the 

agencies would otherwise be authorized to take under law. 

XI. Administrative Liaison Officers 

A. ForEPA: 

Office of Chemical Safety and Pollution Prevention 

Individual's name: Felecia Fort (primary contact) 

Organization: EPA/Office of Chemical Safety and Pollution Prevention/OPPT 

Title: Division Director (acting) 

Telephone Number: 202-564-6239 

Email: Fort.Felecia(@.epa.srov 

Office of Pollution Prevention and Toxics 

Individual's name: Scott M. Sherlock 

Organization: EPA/Office of Chemical Safety and Pollution Prevention/OPPT 

Title: Attorney Advisor 

Telephone Number: 202-564-8257 

Email: Sherlock.Scott@epa.!.!.OV 

Office of Pesticides Program 

Individual's name: Mark Hartman 

Organization: EPA/Office of Chemical Safety and Pollution Prevention/OPP 

Title: Division Director (acting) 

Telephone Number: 703-308-0734 

Email: Hartman.Mark@epa.gov 

B. For FDA: 

Office of Foods and Veterinary Medicine 

Individual's name: Susan Berndt 

Organization: FDNOfficc of Foods and Veterinary Medicine 

Title: Director, Executive Secretariat Staff 

Telephone )lumber: 240-402-2143 

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Center for Food Safety and Applied Nutrition 

Individual's name: Thomas Zebovitz, Ph.D. 

Organization: CFSAN/Office of Food Additive Safety 

Title: Consumer Safety Officer 

Telephone Number: 240-402-1244 

Center for Veterinary Medicine 

Individual's name: Gorka Garcia-Malene 

Organization: CVM/Office of the Center Director 

Title: FOIA Officer 

Telephone Number: 240-276-9120 

Each Participant may designate new liaisons/points of contact 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, tbe Participant will name a 

new liaison within 30 days and notify the other Participant through the designated administrative 

liaison. 

XII. Term, Termination, and Modification 

This agreement will be effective when accepted by all Particip&"lts. At any time, this MOU may be 

modified by mutual written consent of the Participants or may be terminated by either Participant 

upon a 60-day advance written notice to the other. 

APPROVED AND ACCEPTED FOR EPA 

James J. Jones 

Assistant Administrator 

Office of Chemical Safety and Pollution 

Pre~'t....-.t.-----":::::=:-

Oscar Morales 

Senior Information Officer 

Office of Chemical Safety and Pollution 

Prevention 

Date ·--2.--1-/ Tl 

-?- -1- /_1 -~-

APPROVED AND ACCEPTED FOR FDA 

Michael R. Taylor 

Deputy Commissioner for Foods 

and Veterinary Medicine 

Date tJ (>I/!'-{ 

Walter Harris 

Chief, Information Officer (A~B7gffJuy signed by Walter 5. Harris -5 w a t e r 5 • DN: c=U5, o=U.5. Government, ou=HH5, 

ou=FDA, ou=People, 

Harris -5 0.9.2342.19200300.1 00.1.1= 1000468093, 

cn=Walter 5. Harris -5 

Date: 201 5.o1.09 15:29:22 -05'00' 

Date - - - ----- ---

7 
Appendix A- Information Sharing Request 

MOU Control No. 225-15-004 

PROCESS FOR INFORMATION SHARING 

Pursuant to Section IV.B. of this Memorandum of Understanding (MOU) entered by the Food and 

Drug Administration (FDA) and the Environmental Protection Agency (EPA), any Federal partner 

"may decide not to share information in response to a particular request for information or to limit the 

scope of information in response to a particular request." Nothing in this process described below 

changes Section IV .B. 

Requesting Information 

When, under the MOU, staff at FDA or EPA request from the other agency information that may 

contain confidential material, the request must be in writing (and may be an informal email) and need 

only identify the subject for which information is requested. Although a more specific description of 

the information asked for may be helpful, it is not required. Note that electronic transmittal of the 

request may not be appropriate due to concerns of confidentiality, for example, company-identified 

studies in which the identity is confidential or a reference to a chemical on the CBI portion ofTSCA 

inventory. 

The following language must be included in the request: 

"Information that is shared under this process will be under Memorandum of Understanding 

[MOU Number]. We agree not to disclose any shared information in any manner without your 

written permission or as required by law, with advance notice to the originating agency." 

With the inclusion of this statement, the requestor does not have to use a particular format or include 

other pre-specified text. 

Responding to the Request 

A response to an information request must also be in writing and can be an informal email that 

acknowledges transmission of information in response to the request. Although identifying each piece 

of information or document provided may be helpful, it would not be required for purposes of 

responding to a request. Note that the identification of the information or document(s) to be provided 

should not disclose non-public information. 

The following language must be included in the response: 

"Pursuant to the FDA-EPA Memorandum of Understanding to Share Information (MOU #225-

15-004 ), this communication may contain privileged and/or confidential information exempt 

from public disclosure. It may not be disclosed or shared in any manner without our express 

written consent or as required by law with advance notice to the originating agency." 

With the inclusion of this statement, responders would not have to use a particular format or include 

other pre-specified text. 

I 

A-1 
Processing the Request 

The requested information will be copied onto an electronic disk or other appropriate electronic media, 

encrypted or other means as agreed, or shall be in hard copy and sent to the requesting agency via 

secure transport (certified mail, messenger, Fed Ex), along with Appendix B, Information Sharing 

Response. Public documents can be directed to the requesting agency electronically. 

The receiving agency secures the material, consistent with agreed upon security protocols and utilizes 

a stand-alone computer for viewing the infonnation. 

Name Date 

- ---- -------- Telephone number 

Email Address 

A-2 
Appendix B-Information Sharing Response 

MOU Control No. 225-15-004 

These agency records contain one or more ofthe following categories ofnonpublic information, 

including information the public disclosure of which may be prohibited by law. 

Check all appropriate items: 

0 Confidential commercial or financial information 

0 Information the disclosure of which would constitute a clearly unwarranted invasion of 

personal privacy 

0 Information subject to the Privacy Act 

0 Intra-agency records 

0 Records or information compiled for law enforcement purposes 

0 Information protected for national security reasons; or 

0 Other (explain), _ ___ _ _ _ ____ _ 

You, as the requesting agency, must notify the appropriate office of the information-sharing agency if 

there are any attempts to obtain shared information by compulsory process, including but not limited 

to, Freedom of Information Act requests, subpoenas, discovery requests, and litigation complaints or 

motions. 

You, as the requesting agency, must notify the information-sharing agency before complying with any 

judicial order that compels the release of such information that the Participants may take appropriate 

measures, including filing a motion \Vith the court or an appeal. 

The requesting agency has agreed, by this letter or e-mail and by a signed request letter dated 

---------~ not to disclose the above-described information without the informationsharing agency's prior written permission. The requesting agency acknowledges that applicable laws 

and regulations may prohibit the disclosure of such information. See, e.g., 21 U.S.C. section 331 U); 18 

U.S.C. section 1095,21 C.F.R. Parts 20 and 21,45 CF.R. Parts 5 and 5b and 42 U.S.C. Section 24l(d). 

Name Date 

Telephone number 

Email Address 

B-1