Identification of Microbial Mixtures (English title revised)

September 24, 2019 Attachment 1 has been added. The document contains questions and answers related to the Challenge. The English title of this challenge has been revised to match the French. ******************************************************* August 27 2019 The closing date has been changed to October 18 2019 ********************* This Challenge Notice is issued under the Innovative Solutions Canada Program (ISC) Call for Proposals 002 (EN578-170003/C). For general ISC information, Bidders can visit the ISC website. Please refer to the Solicitation Documents which contain the process for submitting a proposal. Steps to apply: Step 1: read this challenge Step 2: read the Call for Proposals Step 3: propose your solution here CHALLENGE TITLE: Identification of Microbial Mixtures CHALLENGE SPONSOR: Health Canada (HC) Funding Mechanism: Contract MAXIMUM CONTRACT VALUE: Multiple contracts could result from this Challenge. The maximum funding available for any Phase 1 Contract resulting from this Challenge is $150,000.00 CAD (plus tax) including shipping, travel and living expenses, as applicable, for up to 6 months. The maximum funding available for any Phase 2 Contract resulting from this Challenge is $1,000,000.00 CAD (plus tax) including shipping, travel and living expenses, as applicable, for up to 24 months. Only eligible businesses that have completed Phase 1 could be considered for Phase 2. This disclosure is made in good faith and does not commit Canada to contract for the total approximate funding. TRAVEL:   For Phase 1 it is anticipated that up to five (5) meetings will require the successful bidder(s) to travel to the location identified below: Kick-off meeting Ottawa, ON Progress Review Meetings One (1) to three (3) design/progress review meetings by teleconference/videoconference Final Review Meeting Ottawa, ON Problem Statement Summary Health Canada (HC) is seeking a method to accurately identify and characterize micro-organisms found in microbial mixtures, and predict their interactions that could mask or enhance adverse effects with a view to determining risks to the environment and human health. Problem Statement Micro-organisms and microbial mixtures have the capacity to perform novel and complex tasks in a diverse array of biotechnology applications, many of which support the goals of sustainability. The testing required under the regulations for assessment can be expensive. When multiple micro-organisms are used together in a mixture, the cost of testing becomes prohibitive to the small-medium enterprises that represent the majority of notifiers. Companies have requested the option to conduct testing on the microbial mixture, but it is unknown how interactions between micro-organisms in the mixture during testing could affect prediction of an adverse effect subsequent to environmental release. Lack of suitable test methodologies and novel approaches to determine the adverse effects of microbial mixtures also puts pressure on the program to provide timely guidance to notifiers to meet the regulatory requirements or to assess the notifications within regulated timelines, which prevents Canadian companies from bringing products to the market. The solution will equip HC with complete information needed to conduct the risk assessment of biotechnology-derived products containing microbial mixtures, and meet its operational and regulatory responsibility. It would enable HC to provide informed guidance to notifiers on cost-effective, reliable test methods required to fulfill the regulatory requirements prior to the manufacture or import of microbial mixtures into Canada. Desired Outcomes and Considerations Essential (Mandatory) Outcomes The solution must be a cost-effective*, robust and reliable** method to: (i) identify members of microbial mixtures; (ii) characterize their stability and population dynamics; and (iii) predict possible interactions among the micro-organisms in the mixture (e.g. using omic approaches such as genomics, transcriptomics, proteomics, etc.), that may mask or enhance adverse effects (e.g. pathogenicity, toxicity) in humans.

Cost-effective*- Current cost estimate is about $150K per micro-organism for accurate identification and characterization of micro-organisms in microbial mixtures, and conducting pathogenicity/toxicity testing for one micro-organism with Good Laboratory Practices (GLP). The solution must aim to reduce these testing costs significantly and make it affordable for SMEs. Robust and reliable**- The solution must provide a well-constructed method with demonstrated sensitivity (capable of identifying wide range of target micro-organisms in the mixture with threshold of detection limits defined), specificity (capable of distinguishing different micro-organisms in the mixture at least to species level) and reproducibility (reliable for any microbial mixtures containing different micro-organisms.

Additional Outcomes N/A Background and Context There is an increasing demand to enrich natural microbial consortia and formulated microbial mixtures. These complex microbial products often display an enhanced adaptability to complex nutrient substrates and tolerance to environmental stressors. The capacity of microbial mixtures to perform novel and complex tasks has diverse biotechnology applications, many of which support the goals of sustainability (e.g. contaminated site remediation, production of hydrogen fuels, biofuels, biogas or bioplastics, or replacement of harmful substances in products such as cleaners, complete waste recycling for space missions). In order to comply with the New Substances Notifications Regulations (Organisms) [NSNR (Organisms)], notifiers intending to manufacture or import micro-organisms contained in such products are required to submit data from tests supporting the taxonomic identity and characterization of micro-organisms in these mixtures as well as to determine their potential to cause adverse effects (pathogenicity, toxicity, etc.) to humans and the environment. The testing required under the regulations for assessment can be expensive for companies. When multiple micro-organisms are employed together in a mixture, the cost of testing quickly becomes prohibitive to the small-medium enterprises (SMEs) that represent the majority of our notifiers. In addition, there currently exist no tests or models to predict the fate or complex interactions between multiple micro-organisms in various environments, including conditions found in human body. Lack of suitable test methodologies and novel approaches to determine the adverse effects of complex microbial mixtures also place an increasing demand on the Department’s capability to provide timely guidance to notifiers to meet the NSNR (Organisms) requirements or to assess the notifications within regulated timelines. The goal of this research is to develop a cost-effective, robust and reliable automated method to identify members of microbial mixtures and consortium, characterize their stability and population dynamics, and predict possible interactions between individual micro-organisms of the mixture (e.g. using OMIC approaches such as genomics, transcriptomics, proteomics, etc.) that may mask or enhance adverse effects (pathogenicity, toxicity, allergenicity, hypersensitivity, etc.) in humans. The outcomes from the challenge will empower the program with cutting-edge science-based methods and tools to assess complex microbial mixtures and consortia, as well, provide informed guidance to biotechnology industry stakeholders on cost-effective, reliable test methods and help them to meet the regulatory requirements of the NSNR (Organisms). This challenge will particularly benefit the small-medium enterprises, as they will have the option of using alternative methods to test microbial mixtures that are less expensive than testing individual microbial constituents present in the mixtures. ENQUIRIES All enquiries must be submitted in writing to TPSGC.SIC-ISC.PWGSC@tpsgc-pwgsc.gc.ca no later than ten calendar days before the Challenge Notice closing date. Enquiries received after that time may not be answered.