Umbrella Memorandum of Understanding between the Canada Border Services Agency and Health Canada

To outline our understanding of cooperation with respect to the administration and enforcement of Health Canada’s acts and regulations relating to travelers, conveyances, cargo and certain controlled, prohibited or regulated goods.

Between

The Canada Border Services Agency represented by the Vice-President, Canada Border Services Agency and hereinafter referred to as “CBSA”

and

Health Canada represented by the Assistant Deputy Minister of Health and hereinafter referred to as “Health Canada”

Effective Date: 14 November 2011

Table of Contents

Purpose

  1. The purpose of this Umbrella Memorandum of Understanding (UMOU) is to define, in general terms, the basis for ongoing cooperation and coordination between the Canada Border Services Agency (CBSA) and Health Canada (hereinafter referred to as the “Participants”) in the administration and enforcement of acts and regulations associated with Health Canada that relate to travelers, conveyances, cargo and certain controlled, prohibited or regulated goods under the program legislation listed in Appendix 1.
  2. The CBSA is responsible for providing integrated border services that support national security and public safety priorities and facilitate the free flow of persons and goods, including animals and plants, that meet all requirements under the program legislation.
  3. This includes supporting Health Canada’s mandate to enhance and protect the health of Canadians through monitoring health and safety risks as it relates to import, export and trans-border movement of regulated products, including drugs, chemicals, pesticides, medical devices, radiation emitting devices and certain consumer products.
  4. The Participants intend to cooperate on activities of a regulatory nature not limited to shipment inspections, investigations, collection and exchange of Information, training, targeting, monitoring, compliance verification and emergency planning.
  5. This UMOU serves as the foundation for individual program-specific annexes, which are intended to be developed and agreed to separately and subsequently attached as annexes to this UMOU. The Participants intend the annexes to clarify roles and responsibilities and to enhance communication and coordination relating to particular programs.
  6. This UMOU is not intended to preclude cooperation in other areas. The Participants may mutually agree on additional areas of cooperation and may identify the subject matter in an annex to this UMOU.

Definitions

  1. For the purpose of the UMOU, the following terms will have meanings as described below:

    “Annex” (Annexe) means any one of the attachments to this UMOU that is an arrangement between the Participants clarifying the roles, responsibilities, policies and procedures of each Participant in relation to the execution, administration or enforcement of a specific program, initiative, issue, or regulatory activity. The Annexes form an integral part of this UMOU;

    “Appendix” (Appendice) means any one of the attachments to this UMOU and/or to its annexes which provides further information or detail as it relates to a specific reference in the UMOU and/or Annex to which it is attached. The Appendices form an integral part of the UMOU and/or related Annex and shall be considered as if they were set out in full in the body of the UMOU and/or Annex;

    “Information” (Renseignements) means information or data in any form, whether oral or written, whether readable by person or machine, and whether capable of being transmitted by mail, telephone, fax, computer or any other physical or electronic means; for greater certainty, “Information” includes “Protected Client Information”;

    “Participants” (Participants) means the CBSA and Health Canada;

    “Program” (Programme) means an activity undertaken by Health Canada in relation to its respective legislative and regulatory responsibilities and for which it may coordinate activities and co-operate with the CBSA, but excludes the administrative or enforcement activities performed by the Canadian Food Inspection Agency (CFIA);

    “Protected Client Information” (Renseignements protégés sur les clients) means Information governed by the following legislation and regulations made pursuant to that legislation:

    • section 107 of the Customs Act;
    • the Privacy Act;
    • the Canada Charter of Rights and Freedoms;
    • the Access to Information Act; and
    • Confidential business Information that is protected under the common law.

Designated Officials

  1. The following designated officials, for the CBSA and Health Canada should have overall administrative responsibility for this UMOU, its Appendices and its Annexes.

    For Health Canada:

    Assistant Deputy Minister
    Health Products and Food Branch
    Health Canada
    Graham Spry Building
    250 Lanark Avenue
    Ottawa, Ontario K1A 0K9
    Telephone: 613-957-1804
    Fax: 613-954-3954

    For the CBSA:

    Vice-President
    Programs Branch
    Canada Border Services Agency
    191 Laurier Avenue West, 19th Floor
    Ottawa, Ontario K1A 0L8
    Telephone: 613-954-7220
    Fax: 613-941-6577

  2. Appendix 2 identifies those Health Canada and CBSA designated officials who should have specific responsibility for carrying out the terms and conditions of the UMOU, its Appendices, and for approving and coordinating amendments to these Appendices and the UMOU itself.
  3. CBSA and Health Canada designated officials who will have specific responsibility for approving and coordinating amendments, and carrying out the terms and conditions of program-specific Annexes will be identified in the related Annex and/or Appendices to the related Annex.

Services and Information

  1. In order to promote better cooperation in administering this UMOU, or any Annex to it, all Participants should, in a timely manner:

(a) provide notice to the respective designated officials of any new activities or initiatives, or of change in legislation, regulations, operational policies and procedures, or practices relating to their Programs that may affect the administration of this UMOU, the Appendices or any Annex;

(b) provide technical advice, reports, statistics and other information to the respective designated officials which would be required by either Participant, subject to applicable regulatory requirements on the protection and disclosure of Information or intelligence;

(c) encourage mutual feedback at all administrative levels with respect to immediate or anticipated operational or enforcement problems or accomplishments, and facilitate the resolution of any such matters;

(d) maintain close and ongoing ties between the Participants with respect to activities identified in an Annex or an Appendix; and

(e) consult with respect to any existing matters outlined in this UMOU, its Appendices or Annexes, or new proposed measures, that may affect any activities or responsibilities of either Participant;

  1. The CBSA and Health Canada intend to consult and to work together to ensure service delivery and facilitate compliance while preserving Program integrity.

Compliance, Enforcement and Risk Management

  1. Health Canada intends to assume primary responsibility for the promotion of voluntary compliance with its legislation. Where agreed between Health Canada and the CBSA regarding the release of Health Canada general information and guidance, the CBSA intends to provide to the public, regulated parties and the manufacturing and importing community, and where applicable, to the exporting community, general information and guidance respecting Health Canada’s requirements applicable to, but not limited to, the import and export of goods. This general information and guidance should take the form of publications under the D Memoranda series of directives.
  2. The Participants intend to coordinate efforts to take advantage of complimentary roles and responsibilities, and to develop mutually acceptable strategies, plans and processes to enhance joint compliance and enforcement efforts. Specific activities will be provided in detail in Annexes to this UMOU, which will be separately developed and agreed to and will address, among other things, the policies and procedures applicable to, but not limited to, the seizure, detention and disposition of goods.
  3. CBSA and Health Canada are committed to incorporating risk management principles in their practices and priorities to better concentrate their efforts and decision-making activities with respect to the processing of people and goods, conveyances and cargo. With this in mind, Health Canada agrees to work with the CBSA to identify and provide Information regarding the risks arising from the importation of controlled, prohibited or regulated goods and the processing of people, conveyances and cargo entering Canada subject to Health Canada legislation and for which the CBSA provides assistance in the administration and enforcement of Health Canada’s legislative requirements.

Emergency Preparedness and Response (Contingency Planning)

  1. The CBSA and Health Canada intend to develop, through consultation, emergency plans and the capability to respond to and manage emergency situations on matters of mutual interest related to the Programs as set out in the Purpose section, and to ensure that preventative measures are in place to deter or minimize such situations.

Training

  1. The CBSA and Health Canada intend to consult on any training needs allowing a reasonable period of time to develop and arrange for the delivery of such training.
  2. For the purposes of occupational and public health risk management, Health Canada should provide the CBSA with Information related to health risks associated with its respective Programs as set out in the Purpose section of this UMOU.
  3. The details on training, including methods of training, means of delivery and monitoring of effectiveness will be addressed in the Annexes to this UMOU.

International Negotiations

  1. Health Canada and the CBSA intend to each lead negotiations with foreign governments with respect to the administration or enforcement of their respective legislation. Prior to the commencement of such negotiations, they intend to consult and work jointly to develop a position on issues which may have an impact on matters falling within the scope of this UMOU.

Management of Information, Information Exchange and Security of Information

  1. The CBSA and Health Canada intend to exchange such Information as may enable each Participant to meet its obligations under its respective mandate regarding matters related to their respective mandates and to the extent permitted by law. As Annexes to this UMOU are developed, specific parameters for the exchange of Information should be identified.
  2. Outside of a request for Information under the Privacy Act or the Access to Information Act, the CBSA and Health Canada intend not to disclose any Protected Client Information supplied by the other without prior consent, as indicated in the program-specific Annexes, except in response to a subpoena or court order requiring disclosure. Where CBSA and Health Canada are subject to a subpoena or court order with respect to Information supplied by the other, it should immediately notify the supplying Participant of the subpoena or court order and of the Information to which it refers. All disclosures under this paragraph are subject to paragraph 21.
  3. Should CBSA or Health Canada receive a request under the Privacy Act or the Access to Information Act for information supplied by, or relevant to the other Participant, the first Participant’s agrees to consult with the other Participant’s Access to Information and Privacy Division and to solicit its recommendations as to the disclosure of the requested Information. Recommendations for disclosure will be in accordance with the provisions of the Access to Information Act and Privacy Act.
  4. The CBSA and Health Canada intend to use their best efforts to verify the accuracy and completeness of any Information disclosed to the other. Each Participant intends to promptly notify the other if it learns that inaccurate information may have been disclosed and take all reasonable remedial steps to address the situation.
  5. The CBSA and Health Canada intend to promptly inform each other’s designated official for addressing privacy breaches of any unauthorized use or disclosure of information exchanged under this UMOU and intend to provide the designated official with details of such unauthorized use or disclosure. In the event of such an occurrence the Participant responsible for the safeguarding of the Information intends to:
    • (a) take the necessary steps to remedy the incident,

    • (b) notify the applicable party whose Information was compromised of the measures that were taken to correct the breach, and

    • (c) take all reasonable necessary steps to prevent a recurrence.

  6. The CBSA and Health Canada intend to return any Information that should not have been disclosed to it by a party to this UMOU.
  7. The CBSA and Health Canada intend to cooperate with and address any observations or recommendations designed to enhance the public’s right of access to information, the protection of personal information or the mitigation of privacy risks which may be made by the Information Commissioner or the Privacy Commissioner of Canada.

Periodic Internal Audits of Protected Client Information

  1. The CBSA and Health Canada intend to conduct their own internal audits on the use, communication to others, security, retention and disposition with respect to Protected Client Information, provided under the terms of the program-specific Annexes, and intend to report their findings to each other. This will ensure:
    • (a) that the Protected Client Information is being used and disclosed strictly in accordance with the federal legislation providing for its use and disclosure, and the terms and conditions set out in this UMOU and the Program-specific Annexes; and

    • (b) that all required security processes and procedures are observed.

  2. Either Participant may request that an audit be undertaken. Audits may be conducted by the internal audit organization of either Participant or by an independent auditor agreed to by the Participants.
  3. A report of the audit results and any action plans resulting from the audit should be sent to the designated officials listed in Appendix 2 of this UMOU.

Monitoring and Reporting

  1. CBSA and Health Canada intend to jointly develop and implement a monitoring and reporting plan.

Dispute Resolution

  1. Health Canada and the CBSA intend to make all reasonable efforts, in good faith, to promptly resolve any dispute arising between them in relation to this UMOU, the Appendices and its program-specific Annexes.
  2. Where a dispute cannot be resolved, the designated officials listed in Appendix 2 to this UMOU may be contacted, unless otherwise provided for in the Annex.

Financing

  1. This UMOU defines, in general terms, the basis on which the parties intend to cooperate, and does not create any financial obligation or serve as a basis for expenditure. Each Participant should be responsible for the administration and expenditure of its own resources relevant to its legislation and policy objectives in respect of this UMOU.
  2. When engaging in discussions on the development of Program-specific Annexes to this MOU, each Participant intends to ensure, as a matter of priority, that adequate resources and mechanisms are put in place to enable the Participants to effectively discharge their obligations and responsibilities in relation to the specific programs and the activities to be undertaken pursuant to those program-specific Annexes. Nothing in this section prevents the Participants from negotiating terms of agreements for cost recovery, cost-sharing and financial expenditures. Such arrangements should be attached to the MOU in a Program-specific Annex.
  3. Cost sharing and/or cost recovery may be applicable in areas where incremental costs may be incurred, such as detention, storage, disposition of goods, request for Information (i.e. reports), program-specific training or enhancements. In the event that a Participant is required to undertake new initiatives or functions falling within the scope of this UMOU, the Participant should endeavour to realize a cost-neutral implementation. In this respect, the Participant may discontinue one or more activities or modify the scope or schedule of activities in order to adopt a new activity without expending new resources. In the alternative, the Participants may adopt cost-sharing or cost-recovery measures. The Participants intend to consult and/or negotiate, where applicable, with each other should a need for substitution of activities and cost-sharing, financial expenditures or cost-recovery measures be identified.

Date in Effect, Review, Amendment Termination and Withdrawal

  1. This UMOU will come into effect on the date of last signature and will remain in effect until terminated by either Participant.
  2. This UMOU may be amended by the Participants by an exchange of letters between the designated officials listed in paragraph 8 provided the amendment is mutually agreed upon and subject to any necessary approvals, authorizations or legislative requirements.
  3. Appendices to this UMOU may be amended at any time with the mutual consent of the CBSA and Health Canada, and such amendments should be carried out by an exchange of letters between the officials designated for that purpose in Appendix 2 of this UMOU.
  4. Annexes to this UMOU may be amended at any time with the mutual consent of the CBSA and Health Canada and such amendments should be effected by an exchange of letters between the officials designated for that purpose in the related Annex.
  5. Amending documentation will form a part of this UMOU and will be effective as of the date specified therein.
  6. Both Participants intend to review this UMOU every three years, in order to ascertain what, if any, amendments are necessary.
  7. Where there is a conflict between a program-specific Annex and the UMOU regarding an amendment or termination times, the Annex will apply.

Termination

  1. Either Participant may terminate the UMOU upon 30 days written notice to the other Participant. The UMOU may be terminated immediately upon consent of both Participants.
  2. Termination of this UMOU will also result in termination of the Annexes; however, termination of one or more Annexes will not result in the termination of the UMOU itself.
  3. Termination does not release a Participant from any responsibilities which accrued while the arrangement was in force and the responsibilities of confidentiality will survive the expiry or termination of this UMOU.

Legal Disclaimer

  1. This UMOU is not legally binding.

    Signed in two originals through an exchange of letters.

    For the Canada Border Services Agency
    Cathy Munroe
    Vice-President, Canada Border Services Agency

    For Health Canada
    Paul Glover
    Assistant Deputy Minister, Health Canada

Appendix 1 – List of Laws

List of laws for the CBSA

And regulations made pursuant to these Acts.

All as amended replaced or otherwise modernized from time to time.

List of laws for Health Canada

And regulations made pursuant to these Acts.

All as amended replaced or otherwise modernized from time to time.

Appendix 2 – List of Designated Officials

Designated Officials for the Canada Border Services Agency

For the purposes of the implementation and operation of this Umbrella Memorandum of Understanding

  • Vice-President
    Programs Branch
    Canada Border Services Agency
    191 Laurier Avenue West, 19th Floor
    Ottawa, Ontario K1A 0L8
    Telephone: 613-954-7220
    Facsimile: 613-941-6577

For the purposes of approving and coordinating additions and amendments to the Appendices of this Umbrella Memorandum of Understanding and for resolving disputes:

  • Director
    Partnerships Division
    Canada Border Services Agency
    191 Laurier Avenue West, 17th Floor
    Ottawa, Ontario K1A 0L8
    Telephone: 613-948-9740
    Facsimile: 613-954-2224

Appendix 2 – List of Designated Officials

Designated Officials for Health Canada

For the purposes of the implementation and operation of this Umbrella Memorandum of Understanding:

  • Assistant Deputy Minister
    Health Products and Food Branch
    Graham Spry Building
    250 Lanark Avenue
    Ottawa, Ontario K1A 0K9
    Telephone: 613-957-1804
    Facsimile: 613-957-3954

For the purposes of approving and coordinating additions and amendments to the Appendices of this Umbrella Memorandum of Understanding, except the protection of Information and security requirements for handling CBSA Information and for resolving disputes:

  • Assistant Deputy Minister
    Health Products and Food Branch
    Graham Spry Building
    250 Lanark Avenue
    Ottawa, Ontario K1A 0K9
    Telephone: 613-957-1804
    Facsimile: 613-957-3954

  • Assistant Deputy Minister
    Health Environments and Consumer Safety Branch
    269 Laurier Avenue West
    Ottawa, Ontario K1A 0K9
    Telephone: 613-946-6701
    Facsimile: 613-946-6666

  • Executive Director
    Pest Management Regulatory Agency
    Tupper Building
    2720 Riverside Drive
    Ottawa, Ontario K1A 0K9
    Telephone: 613-736-3701
    Facsimile: 613-736-3707

Appendix 2 – List of Designated Officials

For the purposes of the protection of Information and security requirements for handling CBSA Information:

  • Executive Director
    Safety, Emergency & Security Management Division
    Corporate Services Branch
    Jeanne Mance Building, 12th Floor
    Tunney’s Pasture
    Ottawa, Ontario K1A 0K9
    Telephone: 613-957-1556
    Facsimile: 613-941-2396

For the purposes of auditing and reporting audit results of the protection of Client Information:

  • Director
    Audit Operations Divisions
    Audit and Accountability Bureau
    Vanguard Building, 13th Floor
    171 Slater Street
    Ottawa, Ontario K1A 0K9
    Telephone: 613-957-3895
    Facsimile: 613-957-8910
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