Health Sante 1+1 Canada Canada

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 
 

The Healthy Environments and Consumer Safety Branch of Health Canada (HECSB) 

understands that the United States Food and Drug Administration (FDA), is authorized 

under 21 C.F.R. § 20.89 to disclose non-public information to HECSB regarding FDAregulated products as part of cooperative law enforcement or cooperative regulatory 

activities, including regulatory compliance activities. 

HECSB understands that, unless otherwise specified by FDA, the information shared 

under this Statement ofAuthority and Confidentiality Commitment, ("Statement of 

Authority") is authorized for use only for cooperative law enforcement or cooperative 

regulatory activities, namely the regulation ofsubstances, pet foods, cosmetics and 

personal care products and radiation-emitting products under the mandate ofHECSB. 

HECSB understands that some ofthe shared information that it receives from FDA may 

include non-public information exempt from public disclosure under the laws and 

regulations ofthe United States ofAmerica, including but not limited to, confidential 

commercial information, trade secret information, personal privacy information, law 

enforcement information, or internal, pre-decisional information; FDA will advise 

HECSB ofthe non-public status ofthe information at the time that the information is 

shared. 

HECSB understands that the information is provided in confidence and understands that 

public disclosure ofthis information by it could seriously jeopardize any further scientific 

and regulatory interactions between FDA and HECSB. 

Therefore, HECSB certifies that it: 

1. has the authority to protect from public disclosure such non-public information 

provided to it in confidence by FDA; 

2. will protect such non-public information from public disclosure in accordance 

with its applicable laws and policies; 
2 

3. will not publicly disclose such FDA provided non-public information without: (a) 

the written authorization of FDA, or if FDA cannot provide that authorization, from the 

individual or entity that can provide such authorization, as determined by FDA and 

HECSB on a case-by-case basis; or (b) a written statement from FDA that the non-public 

information has become publicly available; 

4. will ensure the security and integrity ofthe non-public information entrusted to it 

and safeguard the information against accidental or unauthorized access, disclosure, or 

use; 

5. in the event ofaccidental or unauthorized access, disclosure, or use ofthe shared 

non-public information, will promptly take all reasonable steps to minimize the extent of 

the unauthorized access, disclosure, or use; will contact the recipients ofthe accidental or 

unauthorized disclosure ofinformation and request that the recipients destroy or return all 

aforesaid information in whatever form it exists, including copies and request written 

confirmation that the aforesaid information was not further distributed to other third 

parties; will promptly notify FDA of the occurrence, and will prevent a recurrence ofthe 

event; 

6. will notify FDA promptly of any effort made by judicial or legislative mandate to 

obtain from HECSB non-public information provided by FDA. Ifsuch judicial or 

legislative mandate orders disclosure of non-public information provided by FDA, 

HECSB will take all appropriate legal measures in an effort to ensure that the information 

will be disclosed in a manner that protects the information from public disclosure; and 

7. will promptly inform FDA ofany changes to Canada's laws, or to any relevant 

policies or procedures, that would affect HECSB's ability to protect the non-public 

information. 
3 

Notwithstanding any other provision or commitment~ this Statement ofAuthority does 

not compromise the regulatory authority ofHECSB to carry out its respective 

responsibilities, nor does it create legally binding obligations on HECSB to share 

information with FDA. 

Signed on behalfofHECSB: 

---/S/---

Hilary Gelle11 

Assistant D ty ·nister 

Healthy Environments and Consumer Safety Branch 

Health Canada 

269 Laurier Avenue West 

Ottawa, Ontario KIA OK9 

CANADA 

Telephone: 613-946-6701 

F acsirnile: 613-946-6666