MEMORANUM OF UNDERSTANDING ON INFORMATION SHARING
BETWEEN U.S. ENVIRONMENTAL PROTECTION AGENCY OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION
AND DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION FOODS AND VETERINARY MEDICINE PROGRAM
This Memorandum of Understanding 9MOU) 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 (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 Veterinary 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 of federal 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)* and/or confidential commercial information (CCI), ** subject to applicable limitations below. Information intended to be shared includes memoranda, data from petitions and notifications, communications, and other documents.
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, Drug, and Cosmetic Act (FD&C Act).
FDA has the authority to enter into this agreement pursuant to the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Public Health Service Act.
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 FIFRA, FD&C Act, TSCS, 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 a MOU, regarding sharing of information and opening channels of communication between the agencies will service 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 non-public 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:
- 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.
- 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.
- Request information sharing and exchange and respond to such requests using the language in Appendix A and B of this MOU.
- 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 non-public information, pursuant to this MOU, and to protect against unauthorized use or disclosure of any non-public information share or exchanged pursuant to this MOU.
B. General Safeguards or Non-public Information
The Participants mutually agree that:
- 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 this MOU.
- 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 of 2008, to the extent applicable; other applicable Federal laws and implementing regulations; 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 methods or process that is entitled to protection as a trade secret. ***
- 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.
- Liaison 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 take appropriate security actions.
- 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 referred the FOIA request to the other agency ad that a response will issue directly from that agency.
- 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 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.
- 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 Connection between Data Sharing from EPA and Data Sharing with FDA,” dated November 19, 2014.
C. Non-public Information Provided by FDA
- FDA may share non-public information with EPA, upon written request, in a manner consistent with the requirements of 21 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. section 331(j) or other applicable law. Under 21 U.S.C. section 331(j), FDA is prohibited from sharing certain trade secrets outside of the Department of Health and Human Services except in very limited circumstances. Nonetheless, upon request by EPA for specific information identified by a company as a trade secret, FDA will assess whether the information is in fact trade secret under section 331(j), and if so will ascertain whether a masked or aggregated form of the information may be provided whose disclose is not prohibited by section 331(J) or whether the company will provide written consent to the sharing of the specific trade secret information with EPA.
- 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
- EPA may share information subject to a claim of business confidentiality with FDA in accordance with 40 CFR 2.209(c).
- 2FDA will share non-pubic information subject to protection under FIFRA or TSCA provide by EPA only with those FDA personnel who FDA has authorized to have access to CBI.
- 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.
- No state, county, or local official or FDA grantee or contractor will be permitted to have access to non-public information provided by EPA.
- For documents identified as TSCA/FIRFA CBI, as permissible under the applicable National Archives and Records Administration (NARA) schedules, if materials are no longer need by FDA and no longer need to be retained by FDA, FDA will return the documents to FPA 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.
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 information is contrary to law or regulation.
C. The MOU does not restrict any Participant from protecting information 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 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 MOU 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 is 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 funs between the Participants to this 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 terms shall be invalid, but the remaining terms and conditions of this MOU shall remain in full force and effect.
IX. No 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 the law.
XI. Administrative Liaison Officers
A. For EPA:
Office of Chemical Safety and Pollution Prevention
Individual’s name: Tala Henry
Organization: EPA/Office of Chemical Safety and Pollution Prevention
Title: Deputy Director for Programs
Office of Pollution Prevention and Toxics
Individual’s name: Mark Hartman
Organization: EPA/Office of Pollution Prevention and Toxics
Title: Deputy Director for Management
Telephone Number: 703-308-0734
Office of Chemical Safety and Pollution Prevention
Individual’s name: Dana Vogel
Organization: EPA/ Office of Chemical Safety and Pollution Prevention, Health Effects Division
Title: Division Director
B. For FDA:
Office of Food Additive Safety
Individual’s name: Sharon Koh-Fallet
Organization: FDA/CFSAN/Office of Food Additive Safety
Title: Lead Regulatory Review Scientist
Telephone Number: 301-796-7732
Office of Cosmetics and Colors
Individual’s name: Deborah Smegal
Organization: FDA/CFSAN/ Office of Cosmetics and Colors
Title: Associate Director
Telephone Number: 240-402-1818
Freedom of Information Act Staff
Individual’s name: Sandra Cepeda
Organization: FDA/CVM/Freedom of Information Act Staff
Telephone Number: 240-402-6812
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, the 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 Participants. At any time, this MOU may be modified by mutual written in writing. If, at any time, an individual designated as a liaison under this agreement become unavailable to fulfill those functions, the Participant will name a new liaison within 30 days and notify the other Participant through the designated administrative liaison.
*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 any 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.
**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 not disclosed to any member of the public by the person to whom it belongs. 21CFR 2051(b).
***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 20.61(a).
APPROVED AND ACCEPTED FOR EPA
James J. Jones
Office of Chemical Safety and Pollution Prevention
January 30, 2015
Senior Information Officer
Office of Chemical Safety and Pollution Prevention
February 2, 2015
APPROVED AND ACCEPTED FOR FDA
Michael R. Taylor
Deputy Commissioner for Foods and Veterinary Medicine
December 23, 2014
Chief Information Officer (Acting)
January 9, 2015
APPENDIX A – INFORMATION SHARING REQUEST
MOU Control No.
PROCESS FOR INFORMATION SHARING
Pursuant to Section IV.B. of this Memorandum of Understanding (MOU) entered by the Food and Drug Administration (FDA) and 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.
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 of TSCA 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, responders would not have to use a particular format or include other pre-specified text.
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 information.
APPENDIX B – INFORMATION SHARING RESPONSE
MOU Control No.
These agency records contain one or more of the following categories of nonpublic information, including information the public disclosure of which may be prohibited by law.
Check all appropriate items:
___Confidential commercial or financial information
___Information the disclosure of which would constitute a clearly unwarranted invasion of personal privacy
___Information subject to the Privacy Act
___Records of information compiled for law enforcement purposes
___Information protected for national security reasons; or
___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 with 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 information-sharing 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(j); 18 U.SC. section 1095, 21 C.F.R. Parts 20 and 21, 45 C.F.R. Parts 5 and 5b and 42 U.S.C. Section 241(d).