Statement of Authority and Confidentiality Commitment from the Healthy Environments and Consumer Safety Branch of Health Canada Not to Publicly Disclose Non-Public Information Shared by The United States Food and Drug Administration

With which third party is Health Canada sharing personal information

Under this agreement, Healthy Environments and Consumer Safety Branch (HECSB) within Health Canada (HC) may share personal information to the United States Food and Administration (U.S. FDA). This two-way, indeterminate agreement came into effect on August 8, 2023. The agreement has no end date or scheduled review because it was designed to be flexible and require fewer updates.

Why is Health Canada sharing personal information

HC and the U.S. FDA created this agreement to share information health and safety information about products and substances within their respective mandates, as part of cooperative law enforcement or cooperative regulatory activities, including regulatory compliance activities.

The Canada Consumer Product Safety Act allows this information sharing; however, HC and the U.S. FDA have not shared personal information under this agreement so far. If personal information is ever shared, HC and the U.S. FDA have agreed not to publicly share any non-public information received from each other without a written agreement or a judicial or legislative order. HC and the U.S. FDA will inform each other if there is a judicial or legislative order.

What personal information is Health Canada sharing

The personal information shared by HC may include:

• Name
• Address
• Telephone number of the contact person

Info Source describes how HC manages your personal information at infosource.gc.ca. Refer to the Personal Information Bank HC PPU 088 - Branch Incident Reporting.

Who can I contact for more information

Consumer and Hazardous Product Safety Directorate
cps-spc@hc-sc.gc.ca

Copies of the signed agreements are available for reference on the U.S. FDA website:

• HECSB signed agreement (EN): https://www.fda.gov/media/171457/download?attachment
• HECSB signed agreement (FR): https://www.fda.gov/media/171458/download?attachmentFDA
• FDA signed agreement: (EN): https://www.fda.gov/media/171455/download?attachment
• FDA signed agreement (FR): https://www.fda.gov/media/171456/download?attachment