Dermal Absorption Testing of Existing and New Priority Chemicals under the Chemicals Management Plan

Advance Contract Award Notice (ACAN) Title: Dermal Absorption Testing of Existing and New Priority Chemicals under the Chemicals Management Plan Solicitation Number: 1000199005 1. The Purpose and Explanation of an ACAN An Advance Contract Award Notice (ACAN) allows Health Canada to post a notice for no less than fifteen (15) calendar days, indicating to the supplier community that a goods, services or construction contract will be awarded to a pre-identified contractor. If no other supplier submits, on or before the closing date, a Statement of Capabilities that meets the minimum requirements identified in the ACAN, the Contracting Authority may then proceed to award a contract to the pre-identified contractor. 2. Rights of Suppliers Suppliers who consider themselves fully qualified and available to provide the services or goods described in this ACAN may submit a Statement of Capabilities demonstrating how they meet the advertised requirement. This Statement of Capabilities must be provided via e-mail only to the contact person identified in Section 12 of the Notice on or before the closing date and time of the Notice. If the Bidder can clearly demonstrate they possess the required capabilities, the requirement will be opened to electronic or traditional bidding processes. 3. Proposed Contractor Charles River Laboratories Edinburgh Limited, Elphinstone Research Centre, Tranent Edinburgh, EH33 2NE, UK 4. Definition of Requirements or Expected Results The main objective of the requirement is to test the dermal absorption capabilities of identified priority substances in support of risk assessment activities under the CMP. The ultimate goal of the study is to generate data to derive the dermal absorption rate, amount and/or fraction for the specified chemicals. The study data and results provided by the Contractor will be evaluated by Health Canada for accuracy, appropriate quality assurance/quality control (QA/QC) measurements employed, and reporting standards.  The Government of Canada has committed to the safe management of chemical substances through its CMP, a three-phased initiative which provides a triaged approach to chemical management. Categorization of the Domestic Substances List (DSL) was completed in 2006, and 4,300 substances were identified for further evaluation under the CMP. With CMP Phases 1 and 2 complete, risk assessments of some 2,800 chemicals have been completed and risk management and ongoing monitoring strategies initiated. Yet much work remains if Canada is to fulfil the commitments it made to complete the assessment of all CMP priority chemicals by 2020. This work will support Health Canada's assessment of the potential human health effects and exposure of the specified chemical substances under the CEPA 1999.  The Contractor shall conduct dermal absorption testing of chemicals and provide the results to the Scientific and Technical Authority at Health Canada. The timing will be subject to the specific requirements of the project, as determined exclusively by Health Canada. In each report the Contractor will provide evidence that the method used has been validated and that the data are supported by appropriate quality assurance procedures.  The contractor will be required to complete dermal absorption testing of chemical substances #1 to 3 (see list below) by January 2019 (substances #1-2) and December 2018 (substance #3). Health Canada anticipates that dermal absorption testing of other priority substances may potentially be required in subsequent option years (option year #1 April 2019-March 2020; option year #2 April 2020-March 2021).  1. Citral (CAS RN 5392-40-5) 2. Alpha-pinene (CAS RN 80-56-8) 3. 2,2,4-Trimethyl-1, 3-pentanediol diisobutyrate (TXIB) (CAS RN 6846-50-0) 5. Minimum Requirements Any interested supplier must demonstrate by way of a Statement of Capabilities that it meets the following minimum requirements: a) Good Laboratory Practice (GLP) Compliance The bidder is required to be GLP compliant as recognized by the respective national GLP compliance monitoring authority.  The technical proposal must include a copy of the relevant documentation or GLP compliance statement from the respective national GLP compliance monitoring authority. A list of national monitoring authorities: http://www.oecd.org/chemicalsafety/testing/linkstonationalwebsitesongoodlaboratorypractice. htm b) Performance, reliability and reproducibility The bidder is required to demonstrate the performance, reliability and reproducibility of the test methodology in the performing laboratory. This can be demonstrated by showing the historical results for reference substances such as caffeine, benzoic acid or testosterone assessed at regular intervals as specified in the OECD TG 428 and providing documents to demonstrate participation in inter-laboratory comparison or proficiency-testing programs. c) Ability to acquire and handle radiolabelled chemicals for testing The bidder is required to demonstrate the ability to acquire and handle radiolabelled chemicals for testing. The technical proposal must include appropriate documentation such as proof of appropriate licences and permits acquired to handle the radioactive materials, quotations from a vendor capable of synthesising radiolabelled chemicals for the chemicals 1-4 listed under the section 1.4 of statement of work. d) Ready access to human skin and Research Ethics Board approval The bidder is required to demonstrate the ready access to human skin. The bidder is required to submit a document to demonstrate that they have acquired the necessary approvals from their Research Ethics Board (REB) committee to conduct testing on human skin. e) Experience with testing human skin integrity The bidder is required to demonstrate experience with appropriate methodology to test the skin integrity as specified within SCCS 2010. f) Recent Dermal Absorption Testing Experience The bidder must demonstrate recent (within last 2 years) experience performing in vitro   dermal absorption testing using human skin. The proposal must include appropriate description of projects conducted within last 2 years as well as references (maximum of 1000 words). References should include at least the person’s name, title, telephone number and/or e-mail. 6. Reason for Non-Competitive Award Section 6 of the Government Contracts Regulations contains four exceptions that permit the contracting authority to set aside the requirement to solicit bids. For the proposed procurement, the following exception applies: (d) Only One Person or Firm is capable of performing the contract. In 2016, Health Canada posted a RFP towards finding a suitable laboratory capable of providing dermal absorption testing services. Charles River Laboratories Edinburgh Limited won the bid and was awarded a contract in 2016 and in 2017. In last two years, Charles River has completed two individual studies with Health Canada and has provided dermal absorption data for a total of 8 chemicals. To our knowledge, there are no other laboratories capable of providing similar chemical dermal absorption testing services. In addition, for the purposes of maintaining consistency across the experiments and reporting standards, we would like to award the contract to Charles River Laboratories Edinburgh Limited. 7. Applicable trade Agreements and Justification for Limited Tendering or the Procurement Strategy for Aboriginal Business This requirement is subject to the North American Free Trade Agreement (NAFTA), the World Trade Organization – Agreement on Government Procurement (WTO-GPA) and the Canadian Free Trade Agreement (CFTA). The requirement is being directed to the proposed supplier as permitted under the following sections of the above trade agreements: Article 513 b) of the Canadian Free Trade Agreement (CFTA)

Article 1016, 2(b) of the North American Free Trade Agreement (NAFTA Article XV, 1b of the World Trade Organization – Agreement on Government Procurement (WTO-AGP)

8. Ownership of Intellectual Property The Contractor will own the IP “Intellectual Property” (IP) includes patents, copyright, industrial design, integrated circuit design, topography, plant breeders’ rights, or any rights subject to protection under the law as trade secrets and confidential information. Current Treasury Board “Policy on Title to Intellectual Property Arising Under Crown Procurement Contracts” states that IP ownership developed under government contracts will remain with the Contractor. 9. Period of the Proposed Contract The contract period shall be from date of contract award until the 31st of March, 2019. There will be 2 possible option years. Should the first option year be exercised, the expected completion date for that option year is the 31st of March, 2020. Should the second option year be exercised, the expected completion date for that option year is the 31st of March, 2021. 10. Estimated Value of the Proposed Contract The estimated value of the proposed contract is $200,000.00 including all applicable taxes, plus 2 one year option periods worth an additional $400,000.00 per year. Total potential value of the contracts $1,000,000.00. 11. Closing Date and Time The Closing Date and Time for accepting Statements of Capabilities is June 1st, 2018, 2PM EDT. 12. Contact Person All enquiries must be addressed by e-mail to: Name: Cathy JonesE-Mail: cathy.jones@canada.ca