ME MORANDUM 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 ofUnderstanding (MOU) establishes a formal mechanism for sharing information between the Environmental Protection Agency's (EPA's) Office ofChemical Safety and Pollution Prevention (OCSPP), and the Food and Drug Administration's (FDA's) Foods and Veterinary Medicine (FVM) Program (including the Office ofFoods 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 ofmutual 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 inf ormation 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 ofFederal 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 ofa type customarily held in strict confidence or regarded as privileged and rrot disclosed to any member ofthe 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 offood, 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 ofan 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 ofthe same substance (labeled as a pesticide) will not cause unreasonable adverse effects on the environment. Having an MOU regarding the sharing ofinformation and opening channels of communication between the agencies will serve to facilitate the Participants' accomplishment of their respective missions. IV. Substance ofAgreement 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 ofthe non-public information that they receive from each other pursuant to this MOU. To ensure appropriate protection ofnonpublic information, each agency agrees to identify non-public information shared under this MOU. Disclosure ofnon-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 ofthe agency from which the non-public information originated. A. Information Sharing The Participants mutually agree that each agency will: 1. Designate liaison officers/points ofcontacts through whom inquiries may be exchanged. The liaison officers will make determinations ofthe 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 ofrecords, data, reports, and other information, which are ot herwi se 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 ofthis MOU
. 24. Develop intemal procedures, including for the receipt, review, and response to requests for information that each Participant agency will use to facil itate the exchange ofnon-public information, pursuant to this MOU, and to protect against unauthorized use or disclosure ofany 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 ofthe non-public information shared or exchanged pursuant to this MOU are necessary for effective implementation of thisMOU. 2. Proper safeguards shall include the adoption ofpolicies 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 confidentialityprovisions ofthe Food Security Act of 1985; Section 1619 ofthe 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) ofthe 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 ofinformation in response to a particular request. See Process for Information Sharing under Appendix 

### A. 4. Liaisons and Points ofContacts 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. Ifa 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 ofthe 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 ofa judicial or legislative mandate ordering disclosure ofnon-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. Ifthe 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 ofthe 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 ofChemical Safety and Pollution Prevention and Department ofHealth and Human Services, Food and Drug Administration, Office ofFoods and Veterinary Medicine, For

3 A trade secret may consist ofany commercially valuable plan, formula, process, or device that is used for the making, preparing, compounding, or processing oftrade commodities and that can be said to be the end product ofeither innovation or substanti al effort. There must be a direct relationship between the trade secret and the productive process. 21 CFR 20.6J(a). 

### 3Connection between Data Sharing from EPA and Data Sharing with FDA," dated November 19,20 14. 

### 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 ofinformation 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 staffnon-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 ofthe 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 ifso will ascertain whether a masked or aggregated form ofthe information may be provided whose disclosure is not prohibited by§ 

### 33l(j) or whether the company will provide written consent to the sharing ofthe specific trade secret infonnation with EPA. 2. EPA staffdesignated for access to non-public information provided by FDA must first be authorized access to non-public information relevant to the requirements oftheir 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 ofbusiness 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 staffwill 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 cont ractor 

### 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, ifmaterials**ar~** no longer needed by FDA and no longer need to be retained by FDA, FDA will return the documents to EPA or submit proofofappropriate destruction. Ifsuch materials are needed or otherwise must be retained, FDA, in consultation with EPA, will establish appropriate arrangements for the safeguarding ofthe materials.

4V. 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 peerreviewed. 

### VI. Other Understandings and Agreements A. This 

### MOU is intended to serve as an overarching statement ofthe 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 ofthis 

### 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 obligat ion or commitment offunds, nor a basis for the transf er 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 offunds, property, or services between the Participants. Each Participant to this 

### MOU recognizes the other's responsibility to fund and carry out its own activities sub j ect 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 offunds shall be the subject of a separate agreement. Any endeavor involving reimbursement or contribution offunds 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 byrepresentatives ofboth 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 ofthis 

### MOU is inconsistent with such authority, then that term shall be invalid, but the remaining terms and condit ions ofthis 

### 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 ofChemical Safety and Pollution Prevention Individual's name: Felecia Fort (primary contact) Organization: EPA/Office ofChemical Safety and Pollution Prevention/OPP T Title: Division Director (acting) Telephone Number: 202-564-6239 Email : For t.Fel ecia(@.epa.srov Office ofPollution Prevention and Toxics Individual's name: Scott M. Sher lock Organization: EPA/Office ofChemical Safety and Pollution Prevention/OPPT Title: Attorney Advisor Telephone Number: 202

-564-8257 Email: Sherlock.Scott@epa.!.!.OV Of fice ofPesticides Program Individual's name: Mark Hartman Organization: EPA/Office ofChemical Safety and Pollution Prevention/OPP Title: Division Director (acting) Telephone Nu mber: 703-308-0734 Email: Hartman.Mark@epa.gov
B. For FDA: Office ofFoods and Veterinary Medicine Individual's name: Susan Berndt Organization: FDNOfficc ofFoods and Veterinary Medicine Title: D irector, Executive Secretariat Staff Telephone )lumber: 240-402-2143

6Center for Food Safety and Applied Nutrition Individual's name: Thomas Zebovitz, Ph.D. Organization: CFSAN /Office ofFood Additive Safety Title: Consumer Safety Officer Telephone Number: 240

-402-1244 Center for Veterinary Medicine Individual 's name: Gorka Garcia-Malene Organization : CVM/Office ofthe Center Director Title : FOIA Officer Telephone Number: 240-276-9120 Each Participant may designate new liaisons/points ofcontact 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 ofthe 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 ofChemical Safety and Pollution



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

Oscar Morales Senior Information Officer Office ofChemical Safety and Pollution Prevention

Date 

# · --2.--1-/

- ?- -1- /_1



# -~- Tl 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**  si gned

### by Wal ter 5. Harris -5 

# w a 

# te r 

# 5• DN : c=U5, o=U .5
. Governm e nt, ou=HH5, ou=FDA, ou = People, 

# Harri s-5 0.9.2342
. 19200300
. 1 00. 1. 1= 1000468093, cn =Wa lter 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. ofthis Memorandum ofUnderstanding (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 ofinformation in response to a particular request." Nothing in this process described below changes Section IV .B. Requesting Information 

### When, under the MOU, staffat 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 ofthe request may not be appropriate due to concerns ofconfidentiality, 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 ofUnderstanding [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 ofthis 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 ofinformation in response to the request. Although identifying each piece ofinformation or document provided may be helpful, it would not be required for purposes of responding to a request. Note that the identification ofthe 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 ofUnderstanding 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 ofthis statement, responders would not have to use a particular format or include other pre-specified text. I A-1Processing 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 canbe 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 ofwhich may be prohibited by law
. Check all appropriate items: 0 

### Confidential commercial or financial information 0 

### Information the disclosure ofwhich would constitute a clearly unwarranted invasion of personal privacy 0 

### Information subject to the Privacy Act 0 

### Intra-agency records 0 

### Records or inform ation 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 ofthe information-sharing agency if there are any attempts to obtain shared information by compulsory process, including but not limited to, Freedom ofInformation 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 ofsuch 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