DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service 

Food and Drug Administration 

Silver Spring, MD 20993 

STATEMENT OF AUTHORITY 


AND 


CONFIDENTIALITY COMMITMENT FROM 


THE UNITED STATES FOOD AND DRUG ADMINISTRATION 


NOT TO PUBLICLY DISCLOSE NON-PUBLIC INFORMATION SHARED 


BY 


THE HEALTHY ENVIRONMENTS AND CONSUMER SAFETY BRANCH OF 


HEALTH CANADA 


The United States Food and Drug Administration (FDA) understands that the Healthy Environments 

and Consumer Safety Branch of Health Canada (HECSB), as part of its responsibilities for the 

regulation of substances, pet foods, cosmetics and personal care products and radiation-emitting 

products in Canada under the mandate of HECSB, may disclose non-public information to the FDA 

regarding the above-noted HECSB-regulated products as part of cooperative law enforcement or 

cooperative regulatory activities, including regulatory compliance activities. 

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

Statement of Authority and Confidentiality Commitment ("Statement of Authority") is authorized 

for use only for cooperative law enforcement or cooperative regulatory activities, namely, the 

regulation ofproducts under the mandate of FDA. 

FDA understands that some ofthe shared information that it receives from HECSB may include nonpublic information exempt from public disclosure under the laws and regulations of Canada, including, 

but not limited to, confidential commercial information, trade secret information, personal privacy 

information, law enforcement information, or internal, pre-decisional information; HECSB will advise 

FDA of the non-public status ofthe information at the time that the information is shared. 

FDA 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 HECSB and FDA. 

Therefore, FDA certifies that it: 

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

confidence by HECSB; 

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

applicable laws and policies; 

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

w.ritten authorization ofHECSB, or ifHECSB cannot provide that authorization, from the individual or 
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entity that can provide such authorization, as determined by HECSB and FDA on a case-by-case basis; 

or (b) a written statement from HECSB that the non-public information has become publicly available; 

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

the information against accidental or unauthorized access, disclosure, or use; 

5. in the event of accidental or unauthorized access, disclosure, or use ofthe shared non-public 

information, will promptly take all reasonable steps to minimize the extent ofthe unauthorized access, 

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

information 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 HECSB ofthe occurrence, and will 

prevent a recurrence ofthe event; 

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

from FDA non-public information provided by HECSB. Ifsuch judicial or legislative mandate orders 

disclosure of non-public information provided by HECSB, FDA 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 HECSB of any changes to the United States of America's laws, or to any 

relevant policies or procedures, that would affect FDA's ability to protect the non-public information. 
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Notwithstanding any other provision or commitment, this Statement ~of Authority does not compromise 

the regulatory authority of FDA to carry out its respective responsibilities, nor does it create legally 

binding obligations on FDA to share information with HECSB. 

Howard R. Sklamberg 

Deputy Commissioner 

---/S/---

Date 

Global Regulatory Operations and Policy 

U.S. Food and Drug Administration 

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

UNITED STATES OF AMERICA 

Tel.+1.301.796.4600 

Facsimile: + 1.301.595.7937