Memorandum of Understanding
U.S. Department of Homeland Security, U.S. Customs and Border Protection
U.S. Immigration and Customs Enforcement, Homeland Security Investigations
U.S. Department of Health and Human Services, U.S. Food and Drug Administration
The Substance Use-Disorder Prevention That Promotes Opioid Recovery and Treatment for Patients and Communities Act (Support Act) for Enhanced U.S. Government Collaboration at International Mail Facilities
The Parties to this Memorandum of Understanding (MOU) are the U.S. Department of Homeland Security (DHS) through U.S. Customs and Border Protection (CBP) and U.S. Immigration and Customs Enforcement (ICE), Homeland Security Investigations (HSI), and the U.S. Department of Health and Human Services (HHS), U.S. Food and Drug Administration (FDA) (collectively referred to as “the Parties”).
The activities under this MOU are authorized pursuant to Section 3014 of the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities (SUPPORT) Act, Pub. L. No. 115-271, § 3014, 132 Stat. 3894, 3937-38 (2018) (codified at 21 U.S.C. § 384f); Section 405 of the Security and Accountability For Every Port Act of 2006 (SAFE Port Act), Pub. L. No. 109-347, § 405, 120 Stat. 1884, 1929; the Homeland Security Act of 2002 (Pub. L. No. 107-296, to include 6 U.S.C. § 112(b)(2); the Federal Food, Drug, and Cosmetic Act (FDCA), Pub. L. No. 75-715, 52 Stat. 1040 (1938) (codified as amended at 21 U.S.C. §§ 301-399g); section 6(c) of the Fair Packaging and Labeling Act (FPLA), Pub. L. No. 89-755, § 6(c), 80 Stat. 1296, 1300 (1966) (codified as amended at 15 U.S.C. §§1451-1461); Federal Caustic Poison Act, (Pub. L. 69-783), 44 Stat. 1406, as amended (1927); and the Public Health Service Act (PHSA), Part F, Subpart 1, Biological Products (58 Stat. 702, codified as 42 U.S.C. § 262).
FDA is responsible for ensuring that FDA-regulated drugs imported or offered for import into the United States meet the requirements of the FDCA as well as certain provisions of other statutes. To carry out this responsibility, section 801 of the FDCA authorizes examination of drugs which are being imported into the United States and, based on this examination and other circumstances, if a drug appears to be adulterated, misbranded, or in violation of section 505 of the FDCA, it is subject to refusal of admission into the United States. FDA may also administratively destroy, without the opportunity for export, any refused drug if such drug is valued at $2500 or less (or such higher amount as the Secretaries of the Treasury and Homeland Security may set by regulation) and was not brought into compliance under section 801(b) of the FDCA, after providing a notice and opportunity to introduce testimony. This MOU covers information obtained under section 801 authority.
The purpose of this MOU is to identify specific roles and responsibilities for DHS, CBP, ICE-HSI, and FDA to coordinate activities to respond to illegal controlled substances and drug imports, medical devices, and combination products at International Mail Facilities (IMF). Such activities will include facility improvements and increased technological and inspection capacity at the IMFs through collaborative information sharing, shared facilities, and coordinated operations at the IMFs.
Section 3014(a) of the SUPPORT Act calls for strengthening coordination and capacity between CBP and FDA on activities designed to improve detection and response to illegal controlled substance and drug imports in the IMFs throughout the country. Section 3014(a) also provides that collaborative activities may be set forth in an MOU between CBP and FDA and should include infrastructure and resource enhancements to increase inspection capacity at the IMF locations.
In accordance with section 3014(b)(1), this MOU also addresses facility improvements at IMFs to, among other things: enhance coordination among Federal agencies; improve ability to identify unlawful or dangerous products for destruction; increase laboratory capacity through the increased use of analytical screening tools at the IMFs, upgrade facility security; add innovative technology to collaborate with CBP, ICE-HSI, and FDA; and share near real-time information about test results, as appropriate.
5. Substance of the Agreement
5.1 Responsibilities of the Parties
- To include CBP and ICE-HSI in joint operations with FDA in the IMF environment specifically targeted at illicit opioids, including fentanyl and other unapproved or otherwise unlawful drugs and medical devices regulated under the FDCA.
- To provide monthly updates to CBP through the Commercial Targeting and Analysis Center (CTAC) for targeting and local referral of Active Pharmaceutical Ingredients (API) that meet both the “significant public health concern” and the approval/investigational use authorization conditions (section 801(u) of the FDCA).
- To continue to examine drugs, medical devices, combination products that contain a drug (such as pre-filled syringes, inhalers, and medical kits), APIs and drug excipients, dietary supplements, or dietary supplement ingredients to enhance future targeting of illegal controlled substances or drugs.
- To provide CBP with information on FDA’s facility and space requirements for IMFs to improve each agency’s applicable space design strategies and individual submissions to the U.S. General Services Administration (GSA) in order to achieve co-location at an IMF in which each agency has its own Occupancy Agreement for space that meets its own operational requirements.
- To assign sufficient FDA representatives to CTAC for support of activities outlined in this MOU.
- To provide parcel and product information regarding counterfeit FDA regulated products to CBP and ICE-HSI through FDA representatives assigned to CTAC.
- To have FDA representatives assigned to CTAC communicate and coordinate through CTAC with local CBP Office of Field Operations (OFO) personnel to hold international parcels for local FDA inspections.
- To expand the use of scientific screening tools and placement of laboratory personnel at IMF locations.
- To use CBP’s scientific reach-back capabilities for data interpretation.
- To accept responsibility for receipt and safeguarding of parcels that have been transferred to FDA from CBP via the appropriate DHS Forms 6051S or 6051D. FDA will monitor movement of the parcel for storage, laboratory testing, and final disposition. Once in FDA custody, allow movement of the FDA regulated product for inspection, testing, and final action. FDA Office of Criminal Investigations (OCI) will continue to coordinate with HSI on criminal cases as appropriate, including, but not limited to, counterfeit violations under 18 U.S.C. § 2320, once the product is referred to FDA.
CBP and ICE-HSI intend:
- To include FDA in joint operations with CBP and ICE-HSI in the IMF environment specifically targeted at illicit opioids, including fentanyl and other unapproved or otherwise unlawful drugs and medical devices regulated under the FDCA.
- To take appropriate review and referral actions on FDA-regulated products, provided adequate local CBP resources are available.
- To transfer to FDA, all unapproved, misbranded, and/or adulterated products, within the amount(s) established via the daily FDA referrals, for any action deemed appropriate by the FDA. The daily FDA referrals will consist of products which CBP has reason to believe may be regulated under the FDCA that are not independently subject to seizure under other provisions of U.S. law, including Titles 18 or 19 of the U.S. Code or which CBP and HSI determine, in accordance with existing procedures, will be referred to FDA despite other violations of law. Daily FDA referrals for which CBP and/or HSI, in accordance with existing procedures, have not resolved within 24 hours of the initial examination and notification to HSI, will be transferred to FDA.
- To notify FDA OCI and ICE-HSI of any potentially violative FDA-regulated products identified by CBP outside the daily FDA referrals.
- To continue the processing of parcels seized by CBP and transferred to FDA by CBP’s Fines, Penalties and Forfeitures Division. These parcels are packages relinquished to FDA via DHS Form 6051S, Custody Receipt for Seized Property and Evidence.
- To provide FDA information on CBP’s facility and space requirements for IMFs to improve each agency’s applicable space design strategies and individual submissions to GSA in order to achieve co-location at an IMF in which each agency has its own Occupancy Agreement for space that meets its own operational requirements.
- o incorporate counterfeit image library data received from FDA regarding identified counterfeits into inspection schema to improve identification efforts.
- To provide FDA scientific reach-back services for data interpretation.
- To share chain of custody information for FDA-regulated products.
- To support a formal entry of the FDA-regulated articles under the established entry process/regulatory framework.
6. Other Provisions
6.1 Information Sharing
The information sharing provisions apply to information exchanged under this MOU and not information collected under the Parties’ independent authorities.
The Parties recognize that information exchanged under this MOU that contains any of the following types of information must be protected from unauthorized use and disclosure: (1) confidential commercial information, such as the information that would be protected from public disclosure pursuant to Exemption 4 of the Freedom of Information Act (FOIA) (5 U.S.C. § 552(b)(4)); (2) personal privacy information, such as the information that would be protected from public disclosure pursuant to Exemption 6 or 7(C) of the FOIA (5 U.S.C. § 552(b)(6) and (7)(C)); or (3) information that is otherwise protected from public disclosure by Federal statutes and their implementing regulations (e.g., Trade Secrets Act (18 U.S.C. § 1905)), the Privacy Act (5 U.S.C. § 552a), other FOIA exemptions not mentioned above (5 U.S,C. § 552(b)), the FDCA (21 U.S.C. § 301 et seq.), and the Health Insurance Portability and Accountability Act (HIPAA), Pub. L. 104-191). Pursuant to the FDCA section 301(j) (21 U.S.C. § 331(j)), FDA will not reveal to DHS/CBP or DHS/ICE-HSI information concerning any method or process which is entitled to protection as a trade secret as covered by that section.
The Parties will establish proper safeguards to ensure that information shared under this MOU shall be used and disclosed solely in accordance with applicable laws and regulations, including through use of appropriate markings. Access to the information shared under this MOU shall be restricted to authorized FDA and DHS employees, agents, and officials who require access to perform their official duties in accordance with the uses of information as authorized by this MOU. For purposes of this MOU, DHS and each of its components are considered one agency as a matter of law and DHS policy regarding the sharing of information, and the signing of this MOU is on behalf of DHS. Therefore, transfers of information to DHS and any of its components are not considered third party disclosures. Transfers within DHS will be made strictly on a “need to know” basis, subject to the terms of this MOU. Personnel who receive such information are obligated to abide by the requirements of this MOU and shall be advised of: (1) the confidential nature of the information; (2) safeguards required to protect the information, and (3) the administrative, civil, and criminal penalties for noncompliance contained in applicable Federal laws. Contractors, their subcontractors, and agents requiring access to the information shared under this agreement will be required to sign a non-disclosure agreement by which they will commit to keep the information confidential.
6.2 Provisions for sharing of non-public information
The requesting/receiving Party will comply with the following conditions:
- The requesting/receiving Party will limit the dissemination of shared non-public information it receives under this MOU to employees or officials of the requesting Party who require access to the information to perform their official duties in accordance with the uses of the information as authorized in this MOU, unless otherwise authorized in writing by the sharing Party. The unit official who signs the request letter will be responsible for ensuring that there are no inappropriate recipients of the information.
- The requesting Party will agree in writing, by using the model request letter (see Attachment A), or a mutually agreed upon variation, not to disclose any shared non-public information in any manner not authorized by law or regulation, including disclosure in publications and public meetings, and will not disclose any shared information without the written permission of the sharing Party. In the event disclosure is required by law, the disclosing party shall consult with the sharing party prior to such disclosure, to the extent practicable. If it is not practicable to get written permission in advance of the sharing, this MOU constitutes such written permission, with the understanding that the Requesting Party will promptly notify the Sharing Party to whom the information is being shared, for what purposes, and a description of the information being shared to the extent allowed by law.
- The requesting Party will promptly notify the contact person or designee of the sharing Party of any attempt by Congress, the Government Accountability Office or other third party to obtain shared non-public information so that the Parties may determine the appropriate response and measures to take to protect the information from disclosure.
- The requesting Party will promptly notify the sharing Party before complying with any judicial order that compels the release of shared non-public information, or any other attempt by a third party to obtain shared non-public information by compulsory process, including but not limited to a subpoena, discovery request, or litigation complaint or motion, so that the Parties may determine the appropriate measures to take, including, where appropriate, legal action.
- If the requesting Party receives a FOIA request for the shared information, the requesting Party will: (a) after consultation with the sharing Party to ensure no concerns with a referral, refer the FOIA request to the information-sharing contact person or designee for the sharing Party to respond directly to the FOIA requester regarding whether the information is releasable; and (b) notify the FOIA requester of the referral and that a response will issue directly from the sharing Party. The requesting Party will leave all final disclosure decisions up to the sharing Party, including decisions on whether the records are responsive and whether they must be disclosed. Accordingly, the requesting Party will not indicate to the FOIA requester whether the sharing Party has responsive records or releasable records.
- The sharing Party will include a transmittal letter, along with any agency information shared. The transmittal letter will indicate the type of information (e.g., confidential commercial information, personal privacy, pre-decisional, etc.). A model transmittal letter is attached (Attachment B). The shared documents containing non-public information should be stamped “Do not disclose without permission of [Insert Name of sharing Party]”.
- In the event that assistance in response to a request is postponed, or denied in whole or part, the sharing Party will promptly notify the requesting Party, and provide a statement of the reasons for postponement or denial of the request, unless otherwise prohibited by law, regulation, directive, policy, or procedure.
6.3 Treatment of Data
Each Party must ensure, in accordance with the Privacy Act of 1974 (Privacy Act), as amended (5 U.S.C. § 552a), that, if applicable, a System of Records Notice (SORN) will be published or amended on a timely basis for any systems that will maintain data received from another Party under this MOU. Furthermore, in accordance with the E-Government Act of 2002 (E-Government Act) (Pub L No. 107-347, 116 Stat. 2899), each Party is to ensure that a Privacy Impact Assessment (PIA) is published if appropriate.
- If any Party experiences an incident involving a loss or breach of Personally Identifiable Information (PII) provided by another Party under the terms of this MOU, that Party will follow the incident reporting guidelines issued by the Office of Management and Budget (OMB). In the event of a reportable incident under OMB guidance involving PII, the Party experiencing the incident is responsible for following its established procedures, including notification to the proper organizations (e.g., United States Computer Emergency Readiness Team, the Party’s privacy office, etc.). In addition, the Party experiencing the incident will notify the other Party’s Systems Security Contact.
- The Parties intend to make reasonable efforts to ensure that the information shared under this MOU is accurate, complete, timely, and relevant. If a Party identifies inaccuracies in shared information, it is incumbent on the Party who identified the inaccuracy to notify the other Party of those inaccuracies, and on the other Party to take the appropriate corrective action.
The terms of this MOU and its attachments may be modified upon the mutual written agreement of all Parties.
8. Resource Obligations
This MOU represents the broad outline of the Parties’ intent to enter into specific agreements for collaborative efforts in intellectual areas of mutual interest to CBP, ICE-HSI, and FDA. All activities undertaken pursuant to the MOU are subject to the availability of personnel, resources, and funds. No appropriated funds are obligated by this MOU, that is, this document is not a financial or fund obligating document. This MOU does not affect or supersede any existing or future agreements or arrangements among the Parties. This MOU does not create binding, enforceable obligations against any Party. This MOU and all associated agreements will be subject to the applicable policies, rules, regulations, and statutes under which CBP, ICE-HSI, and FDA operate.
9. Effective Date and Termination
This MOU shall become effective upon the date of signature of all the Parties and is to be evaluated biennially between Parties. The MOU will remain in effect until terminated by all Parties.
Any Party may end its participation in this MOU at any time by providing one hundred twenty (120) days’ written notice to the other Parties. In the event that all the Parties mutually agree to terminate this MOU, the Parties shall continue to apply the terms of this MOU regarding maintenance and protection of any data received pursuant to this MOU.
10. Severability Clause
Nothing in this MOU is intended to conflict with the current laws, regulations, or directives of DHS/CBP, DHS/ICE-HSI, or HHS/FDA. If a term of this MOU is inconsistent with such authority, then that term shall be invalid, but the remaining terms and conditions of the MOU shall remain in full force and effect.
11. Emergency Situations
11.1 If a national or regional disaster disrupts communications between DHS/CBP, DHS/ICE-HSI, and HHS/FDA, an emergency contingency plan shall become operational. The procedures of that plan are to be developed in consultation with all the Parties.
11.2 The Parties reserve the right to suspend, interrupt, or modify, as necessary, any information sharing operations that are implemented under this MOU, or are the result of the MOU during times of national emergency, including as indicated by changes in the National Terrorism Advisory System (NTAS), or any successor system. A Party will give the other Party notice as soon as practicable regarding the suspension, interruption, or modification of any information sharing operations pursuant to this paragraph.
12. No Private Right of Action Created
This MOU is an internal government agreement and does not explicitly or implicitly create, confer, grant, or authorize any rights, privileges, or obligations, substantive or procedural, enforceable at law or otherwise by any of the Parties against another Party, 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.
13. Contact Information for Liaison Offices
13.1 The following offices will act as liaisons among CBP, ICE-HSI, and FDA for the purpose of coordinating the implementation, or the modification, if any, of this MOU:
Contacts for CBP:
Director, Manifest Conveyance and Security, Office of Field Operations
Director, Interagency Collaboration, Trade Policy and Programs, Office of Trade
Contact for ICE-HSI:
Division Chief, Transnational Organized Crime Division II
Contacts for FDA:
Assistant Commissioner, Office of Enforcement and Import Operations
Associate Director, Office of Medical Products and Specialty Laboratory Operations
Assistant Commissioner for Criminal Investigations
Approved and accepted for U.S. Department of Health and Human Services, U.S. Food and Drug Administration by:
Stephen M. Hahn
Food and Drug Administration
Date: October 27, 2020
Approved and accepted for U.S. Department of Homeland Security, U.S. Customs and Border Protection by:
Mark A. Morgan
Chief Operating Officer and Senior Official Performing the Duties of the Commissioner
U.S. Customs and Border Protection
Date: October 28, 2020
Approved and accepted for United States Department of Homeland Security, U.S. Immigration and Customs Enforcement, Homeland Security Investigations by:
Tony H. Pham
Deputy Director and Senior Official Performing the Duties of the Director
U.S. Immigration and Customs Enforcement
Date: October 28, 2020
- Attachment A: Model Language - Information Sharing Request from Participating Parties
- Attachment B: Model Language for Response to Information Sharing Request/Transmittal Letter from Sharing Party