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HMIRA Trade Secret Registrations in Canada

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HMIRA Trade Secret Registrations in Canada

  1. 1. dell tech laboratories ltd. 1 Hazardous Materials Information Review Act (HMIRA) Claim for Exemption On Safety Data Sheets (Trade Secret Registrations) Dell Tech Laboratories - www.delltech.com - 519-858-5021 Dell Tech Laboratories Joe McCarthy Senior Regulatory Affairs Specialist 519-858-5024 jmccarthy@delltech.com http://delltech.com/product-safety-group/
  2. 2. dell tech laboratories ltd. 2 WHAT is a HMIRA Claim for Exemption? It is is an exemption from having to disclose confidential business information otherwise required by the Hazard Products Act/Regulations on a Safety Data Sheet (SDS) or Label WHAT can be exempted from disclosure? •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 Hazardous product •information that could be used to identify the supplier of a hazardous product
  3. 3. dell tech laboratories ltd. 3 WHAT can a HMIRA Registration be used for? Safety Data Sheets & Labels WHAT can it not be used for? Anything else. (i.e. Consumer Labels, pesticides, fertilizer, cosmetics)
  4. 4. dell tech laboratories ltd. 4 WHY do we have HMIRA Claim for Exemptions? 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.
  5. 5. dell tech laboratories ltd. 5 SUPPLIER EMPLOYER Chemical identity X X Concentration X X Name of a toxicological study X X Name of a hazardous product X Information to identify the supplier X WHO can file a HMIRA Claim for Exemptions?
  6. 6. dell tech laboratories ltd. 6 WHO MANAGES THE PROGRAM ? Health Canada, Healthy Environments and Consumer Safety Branch Workplace Hazardous Materials Bureau
  7. 7. dell tech laboratories ltd. 7 HOW much? Original Claims* Renewed claims* • Fee is charged per product, not per number of elements claimed. One product with 3 trade secret claims is not 3x the cost • Fees increase annual on April 1st each year based on Stats Canada CPI * Small business 50% reduction in annual revenue < 3M$ and < 100 employees 2018 fee 2019 fee Claims 1 -15 1800$ each 1840$ each Claims 16- 25 400$ each 409$ each Claims 26 + 200$ each 204$ each 2018 fee 2019 fee Claims 1 -15 1440$ each 1472$ each Claims 16- 25 320$ each 327$ each Claims 26 + 160$ each 164$ each
  8. 8. dell tech laboratories ltd. 8 HOW Long To get a HMIRA # ? For WHMD to review and make a decision? 7 days* 150 days* *Target under current pilot project, actual experience is 2 weeks **Target under current pilot project, actual experience is 1-2 years HOW long does a registration last? 3 years, or until the formula changes or new information changes the SDS HOW is that calculated From date of end of appeal period. (Not date granted)
  9. 9. dell tech laboratories ltd. 9 HOW to apply Submit Claim for Exemption Application Form HPR compliant SDS Fee Form (with Credit Card info) Any toxicological studies used to classify the product
  10. 10. dell tech laboratories ltd. 10 How to complete Form Not protected information Part I Company & Contact Parts II & III List products names Part IV Check box that information is considered confidential* Check box that security measures are in place* Estimate value economic value to you or your competitors Estimate material financial loss to you or material financial gain to your competitors Provide R&D costs (optional) Part V Calculate fee Part VI Sign declaration
  11. 11. dell tech laboratories ltd. 11 PART I
  12. 12. dell tech laboratories ltd. 12 Parts II & III
  13. 13. dell tech laboratories ltd. 13 Part IV * Only need to attestation on the form but substantiating evidence is required to be submitted upon request from Health Canada.
  14. 14. dell tech laboratories ltd. 14 Part IV Complete only one of 3A or 3B
  15. 15. dell tech laboratories ltd. 15
  16. 16. dell tech laboratories ltd. 16 HOW to complete Form (Suppliers) (Part VII) Protected information Generic Chemical Identity for ingredients claimed as CBI List Specific Chemical Identity (Proper, common ) for all ingredients CAS # for all ingredients % concentration of all ingredients The name of an the toxicological study that may identify the ingredient
  17. 17. dell tech laboratories ltd. 17 HOW do I create a Generic Chemical Identity? The objective is to mask part or all of the chemical name while at the same time retain identity of the general class or structure so that it can still be connected to hazard information disclosed on the Safety Data Sheet. Proper Chemical Name Generic Chemical Identity Hydrochloric acid Inorganic Acid Sodium Xylene sulphonate (Sodium methylbenzene sulphonate Alkylarylsulphonate (salt) 2,2,3,3,4,4,5,5,6,6,6-undecafluoro-N,N- bis(2-hydroxyethyl)hexanamide Polyhalo-N-bis(hydroxylalkyl) alkanamide Proprietary chelate Trade secret Colourant Surfactant emulsifier solvent Long chain hydrocarbon containing sulphur & nitrogen Acceptable Examples Unacceptable examples
  18. 18. dell tech laboratories ltd. 18 HOW to complete Form (Employers) (Part VII) Protected information Generic Chemical Identity for ingredients claimed as CBI List Specific Chemical Identity (Proper, common ) for all ingredients CAS # for all ingredients % concentration of all ingredients The name of an the toxicological study that may identify the ingredient Name of the product Information that would identify the supplier
  19. 19. dell tech laboratories ltd. 19 HOW IS IT REVIEWED? How does WHMD review the application? 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
  20. 20. dell tech laboratories ltd. 20 3 Choices for a Non-Compliant SDS #1: Make edits, and resubmit with “compliance undertaking” within 30 days #2: Do not make the edits, Health Canada will publish an order that the changes be made. #3: Appeal the decision. 2000$ application fee for appeals.
  21. 21. dell tech laboratories ltd. 21 WHEN ? Can I start using the HMIRA # ? As soon as you get it When do I need to update the SDS? When you get the HMIRA# and date filed When you get the HMIRA # and date granted. Do I need to renew? Every 3 years or when the formula changes (You will get a new HMIRA#) Should I submit a renewal 30 days before expiry
  22. 22. dell tech laboratories ltd. 22 Dell Tech Laboratories Joe McCarthy Senior Regulatory Affairs Specialist 519-858-5024 jmccarthy@delltech.com http://delltech.com/product-safety-group/

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