Manufactures of chemical products wanting to protect their formulation intellectual property are required to submit a claim for exemption with Health Canada. This presentation describes how to navigate this complicated process.

1. YOUR NEW SDS AND YOUR
CBI ON THE SDS
Joe McCarthy
Senior Regulatory Affairs Specialist
Dell Tech Laboratories
September 28, 2016

2. Overview
 What is a Claim For Exemption?
 What can be claimed as Confidential Business Information
(CBI)?
 What is the Hazardous Materials Information Review
Act/Regulations?
 Who can make a Claim for Exemption and who manages the
program?
 How much? How long? How to apply? How to complete the
form? How to create a Generic Chemical Identity (CGI)? How is
the application reviewed?
 Where to apply? Where on the SDS to put the HMIRA
registration information? Where can it be used and not used
 When to apply, update the SDS, renew the registration.

3. What is a Claim for Exemption?
 It is an exemption for a supplier or employer from having to
disclose Confidential Business Information (CBI) on a Safety
Data Sheet and/or label that is otherwise required by the
Hazardous Products Act (HPA) and Hazardous Products
Regulations (HPR).

4. What can be claimed as Confidential
Business Information (CBI)?
 chemical identity of a hazardous ingredient
 concentration of a hazardous ingredient
 name of a toxicological study that identifies a trade-secret
hazardous ingredient
 name of a controlled product
 information that could be used to identify the supplier of a
controlled product

5. What is the Hazardous Materials
Information Review Act & Regulations?
 The Hazardous Materials Information Review Act &
Regulations (HMIRA/HMIRR) provides a mechanism to
protect the confidential business information (CBI) of chemical
suppliers and employers while ensuring ensure accurate and
complete health and safety information is available to workers.
 It defines the duties of the government and the applicant, fees,
application scope and review process, appeal process,
expiration and renewals.

6. WHO can file a Claim for Exemption?

7. Who manages the program?
 Health Canada, Healthy Environments and Consumer Safety
Branch, Workplace Hazardous Materials Directorate
http://www.hc-sc.gc.ca/ewh-semt/occup-travail/whmis-
simdut/hmira-lcrmd/index-eng.php

8. How much does it cost ?
 Fee is charged per product, not per number of elements claimed.
One product with 3 trade secret claims is still only 1800 $
 * Small business 50% fee reduction if both annual revenue < 3M$
and < 100 employees.

9. How long?

10. How long?

11. How to apply
 *Substantiating Information is not required at time of
submission but may be asked for during review.

12. How to apply – Application Form
 *Parts I to VI of the form are mostly administrative and do not
form part of the actual CBI claim. Though financial data in Part
IV is treated as CBI.

13. How to apply – Application Form
 The application form is a Adobe smart form. Selecting
Supplier vs. Employer will change fields in the subsequent
pages.

14. How to apply – Application Form
 New requirement, detail if based on similar products, supplier
SDS, Tox Databases, actual studies etc.

15. How to apply – Application Form
 Only need to attest to this on form but Health Canada may
request substantiating information that systems and practices
are in place to protect confidential information.

16. How to apply – Application Form
 If substantiating information is requested you will need the
following to complete the Substantiating Information Form.
- # of employees, officers or directors of the claimant having knowledge of or access to the CBI
- # of the other persons inside or outside Canada having knowledge of or access to the CBI.
- Do you have confidentiality agreements for all individuals with access to CBI?
- Other security measures, including those pertaining to site security, document security and
computer security, are employed? Provide detail on
a) Physical Security: Access to facilities and area (i.e. fences, locks, keycards, access
codes, authourized personnel or visitors), security measures (i.e. cameras, guards, visitors’
policy)
b) Document Security: How are confidential paper documents protected? Are they locked?
Are there any special measures to keep the documents confidential? Who has access and
when.
c) Computer Security: How are the electronic documents protected from access and
protected from changes? Are the electronic documents password protected?

17. How to apply – Application Form
Complete only 3A or 3B, not both
Economic Value means Revenue (or sales)
Financial loss or Financial gain means profit

18. How to apply – Application Form
 The fee calculation on the form will automatically update based on
how many “product identifiers” were entered in Part III and whether
you have claimed the small business fee.

19. How to apply – Application Form
 Part VII for suppliers -This is where you list the complete
formula. This gets put in a sealed envelope labelled
“Confidential business Information”

20. HOW do I create a Generic Chemical
Identity (CGI)?
Acceptable Examples
Unacceptable Examples
 You can mask specific functional groups, location and/or
number of substitutions. But cannot use broad or vague terms
such as “Trade Secret”

21. How to apply – Application Form
Part VII for suppliers – Used if Claim for Exemption is the name of product or supplier of the
product.
BOX G – Is the actual name of the Product. The masked name was the identifier used Part III.
BOX H – is the name of the actual manufacturer or supplier. The Employer is now on the SDS
as the Supplier.
This gets put in a sealed envelope labelled “Confidential business Information”

22. How is application reviewed
Two elements
1) Reviews validity of the claim to meet Sec. 3(1) of the HMIRR
 whether the information is confidential to the claimant;
 whether the claimant has taken measures that are reasonable in the circumstances to
maintain the confidentiality of the information; and
 whether the information has actual or potential economic value to the claimant or to the
claimant’s competitors because it is confidential and the disclosure of the information
would result in a material financial loss to the claimant or a material financial gain to the
claimant’s competitors.
2) Reviews the formula and Safety Data Sheet in its entirety
 Ingredients are researched in the literature, and a toxicologist constructs a hazard profile.
 Screening Officer reviews the SDS in context of that research to confirm its compliance.
 Issues a Statement of Decision (SOD) whether it is a valid claim as per HMIRR 3(1) and
whether SDS is compliant.
 If SDS is not compliant, SOD details required edits.

23. How is application reviewed
3 Choices for a Non-Compliant SDS
#1: Make edits, and resubmit SDS with “compliance undertaking” within
30 days
#2: Do not make the edits. Health Canada will publish a notice in the
Canada Gazette Part 1 an order that the changes be made. You still
get to use the HMIRA #.
#3: Appeal the decision. 2000$ application fee.

24. Where do I find forms & guidance?
 Must be requested from WHMIS-SIMDUT.conf@hc-sc.gc.ca
- Claim for Exemption under the HMIRA Application Form
- Claim for Exemption under the HMIRA Payment Authorization Form
- Substantiating Information Form in support of a Claim for Exemption
- Guidance Developing a Generic Chemical Name (December 1, 2015)
- Secure Document Exchange (SDX) Claimant User Manual
 Available online: Appendix A of Technical Guidance on the
Requirements of the Hazardous Products Act and the Hazardous
Products Regulations Phase 1
http://publications.gc.ca/collections/collection_2016/sc-hc/H129-64-2016-
eng.pdf
-

25. Where do I send the application?
 In person, by registered mail or courier to
Claims Registration
Health Canada, Healthy Environments and Consumer Safety Branch
Workplace Hazardous Materials Bureau
269 Laurier Avenue West, 8th Floor (4908B)
Ottawa, Ontario, K1A 0K9
 Electronically
Secure Document Exchange (SDX) system
Requires registration at https://sdx-edp.hc-sc.gc.ca/
Submitted as a zipped folder
14 page Instruction manual to use system.

26. Where do I put the HMIRA Registry
number and dated filed/granted?
 On the SDS. Location is not specified by the regulations.

27. When?

28. Questions?
Joe McCarthy
Lab Services Manager/Senior Regulatory Affairs Specialist
Dell Tech Laboratories
jmccarthy@delltech.com
519-858-5024