Environmental domoic acid test

From: Innovation, Science and Economic Development Canada

The Canadian Food Inspection Agency is seeking to develop a portable test to detect environmental domoic acid in marine waters. The intent is to have the capacity to inform harvesters of risk and advance scientific capacity to examine environmental triggers of toxin production and accumulation in marine foods (not for regulatory or Canadian Shellfish Sanitation Program purposes).

Challenge sponsor:
Canadian Food Inspection Agency (CFIA)

Funding mechanism:
Grant

Opening date:
December 13, 2022

Closing date:
January 31, 2023, 14:00 Eastern Daylight Time

Prospective applicants should refer to the Innovative Solutions Canada Grant Instructions and Procedures document.

Challenge

Problem statement

Domoic acid is a significant concern to consumers of marine foods, given acute poisoning can be life threatening, and with the impact of low doses being cumulative over time, can cause cognitive disability and illness. This and other biotoxins are of particular interest to Indigenous Peoples, for whom marine foods are a significant part of the diet and in remote communities where food insecurity creates greater reliance on marine foods. Using portable tests to establish detections of toxin at the harvest site, would help to avoid exposure of contaminated marine foods in areas with recent or current toxin detections. This enhances food safety initiatives and saves resources associated with food safety investigations, recall, and costly product destruction activities.

Scientific data is required to develop targeted risk based monitoring options for geographic areas or products not currently served by existing programs. The relationships between toxins in the marine environment, environmental conditions that precipitate toxin production, and product specific uptake and accumulation of toxin are key to creating efficient and effective future programs.

A solution is needed to gather data in real time for use in remote marine environments in order to advance the science and address expanding food safety and security needs for foods impacted by harmful algal blooms and changing oceans.

Desired outcomes and considerations

Essential (mandatory) outcomes

The proposed solution must:

have robust capacity to operate and produce results under varied temperature conditions (i.e. between 5 and 35 degrees Celsius).
be of a size and weight that makes the unit portable by a single individual for field use.
have the ability to detect domoic acid in marine waters; including measuring toxin contained within associated phytoplankton, and measuring toxin present in solution in the absence of vegetative cells.
provide a reliable qualitative signal with minimal probability of false positives and false negatives (<5%) indicating toxin presence when concentrations exceed 100 picograms/ml.
not be cost prohibitive for the intended end user. Cost of testing should not exceed that of devices currently on the market for product testing (not exceeding $200/test).

Additional outcomes

The proposed solution should:

provide a reliable secondary or alternate qualitative signal when toxin presence exceeds 1000 picograms/ml.
provide a reliable signal, the intensity of which increases in correlation to increased toxin concentrations.
be suitable for signaling toxin presence in tissue or products extracted from marine foods.

Background and context

At present, the only existing option for biotoxin testing in Canada is to send samples to a CFIA laboratory. Mussels are commonly used as a sentinel species for sampling and informing shellfish safety programs, but are not necessarily representative of other marine foods in terms of toxin accumulation and depuration. Harvest waters are often closed out of an abundance of caution due to the resource challenges associated with sampling multiple species for multiple toxins to provide food safety assurance. Biotoxin monitoring is limited to shellfish in a geographic area that can reasonably be served by the program given logistical challenges of getting samples to a CFIA lab. The need for infrastructure, expensive analytical instruments (which cost hundreds of thousands of dollars), and highly skilled labor challenges additional laboratories to take on current testing methods.

The proposed solution is a device intended for monitoring on a routine and ongoing basis (daily) to gather data in real time to signal toxin presence for informing harvest considerations, and for advancing science objectives such that correlations can be made between quantified phytoplankton presence, toxin levels internal to phytoplankton and in solution, and establishing trends with relevant environmental conditions.

A monitoring device would help to inform food harvest decisions and enable data collection where there are concerns of domoic acid, including where persistent low levels may be of significance given regular consumption of marine foods in areas where regulatory standards for product are being met.

Scientific study and additional data are required to create opportunities for additional food safety programs and monitoring. Understanding environmental conditions that trigger toxin production may support more targeted monitoring programs and make resources available for additional testing and method development. A precise understanding of specie specific toxin uptake creates opportunities to focus monitoring on products and areas of specific risk.

A device that reliably detects and measures toxins in the marine environment would significantly advance opportunities for academia, industry and other agencies to conduct meaningful monitoring and advance food safety initiatives and research.

The following links speak to the challenges of domoic acid monitoring using current methods and the need for scientific advance in understanding this food safety risk in the marine environment.

Marine Biotoxin Workshop (October 24-25, 2016) – Recommendations, Evaluation and Presentation Summaries

Changing Trends in Paralytic Shellfish Poisonings Reflect Increasing Sea Surface Temperatures and Practices of Indigenous and Recreational Harvesters in British Columbia, Canada (October 14, 2021)

Maximum grant value and travel

Multiple grants could result from this Challenge.

Phase 1:

The maximum funding available for any Phase 1 Grant resulting from this Challenge is : $150,000.00 CAD
The maximum duration for any Phase 1 project funded by a grant resulting from this Challenge is up to 6 months
Estimated number of Phase 1 grants: 2

Phase 2:

The maximum funding available for any Phase 2 Grant resulting from this Challenge is : $500,000.00 CAD
The maximum duration for any Phase 2 project funded by a grant resulting from this Challenge is up to 24 months
- Note: Only eligible businesses that have completed Phase 1 could be considered for Phase 2.
Estimated number of Phase 2 grants: 1

Note: Selected companies are eligible to receive one grant per phase per challenge.

This disclosure is made in good faith and does not commit Canada to award any grant for the total approximate funding. Final decisions on the number of Phase 1 and Phase 2 awards will be made by Canada on the basis of factors such as evaluation results, departmental priorities and availability of funds. Canada reserves the right to make partial awards and to negotiate project scope changes.

Travel

No travel is anticipated. The kick-off meeting and final review meeting will have the flexibility of being a video or teleconference.

Kick-off meeting

Teleconference/videoconference

Progress review meeting(s)

Teleconference/videoconference

Final review meeting

Teleconference/videoconference

All other communication can take place by telephone, or videoconference.

Eligibility

Solution proposals can only be submitted by a small business that meets all of the following criteria:

for profit
incorporated in Canada (federally or provincially)
499 or fewer full-time equivalent (FTE) employees^{Footnote *}
research and development activities that take place in Canada
50% or more of its annual wages, salaries and fees are currently paid to employees and contractors who spend the majority of their time working in Canada^{Footnote *}
50% or more of its FTE employees have Canada as their ordinary place of work^{Footnote *}
50% or more of its senior executives (Vice President and above) have Canada as their principal residence^{Footnote *}

Evaluation criteria

The applicant must complete the Challenge Stream Electronic Submission Form with a degree of information sufficient to enable Canada's assessment of the proposal against the criteria and the Evaluation Schema. The information must demonstrate how the proposal meets the criterion.

Part 1: Mandatory Criteria

Proposals must meet all mandatory criteria identified by achieving a "Pass" in order to proceed to Part 2. Proposals that do not meet all mandatory criteria will be deemed non-responsive and given no further consideration.

Mandatory Criteria

(Applicant's proposal must address)

Question 1 a: Scope

Describe the proposed solution and demonstrate how it responds to the challenge. Include in your description the scientific and technological basis upon which the solution is proposed and clearly demonstrate how the solution meets all of the Essential (Mandatory) Outcomes (if identified) in the Desired Outcomes section in the Challenge Notice.

Evaluation Schema (Mandatory - Pass/Fail)

Pass

The Applicant's proposed solution is clearly articulated, within the scope for the challenge and addresses all Essential (Mandatory) Outcomes (if identified) in the Challenge Notice.

Fail

The proposed solution is articulated as out of scope for the challenge.
OR
The proposal does not clearly demonstrate how the proposed solution addresses all Essential Outcomes listed in the challenge.
OR
The proposed solution is poorly described and does not permit concrete analysis.
OR
There is little to no scientific and/or technological evidence that the proposed solution is likely to meet the challenge.

Question 2: Current Technology Readiness Level (TRL)

Indicate the current TRL of the proposed solution. (Drop Down Menu of the Challenge Stream Electronic Submission Form)

Describe the research and development activities that have taken place to bring the proposed solution to the stated TRL.

Evaluation Schema (Mandatory - Pass/Fail)

Pass: The Applicant has demonstrated that the proposed solution is currently between TRLs 1 and 6 (inclusive), and provided justification by explaining the research and development (R&D) that has taken place to bring the solution to the stated TRL.

Fail: The Applicant has not provided sufficient evidence to demonstrate that the current TRL is between 1 to 6 (inclusive) including:

There is insufficient/no evidence provided for TRL judgment.
The solution involves the development of basic or fundamental research.
The solution is demonstrated at TRL 7 or higher.
Insufficient/unclear/no justification explaining the R&D that took place to bring the solution to the stated TRL.
The explanation simply paraphrases the description of a given TRL level.

Question 3a: Innovation

Demonstrate how the proposed solution meets one or more of the ISC definitions of innovation below:

An invention^{Footnote *}, new technology or new process that is not currently available in the marketplace.
Significant modifications to the application of existing technologies/components/processes that are applied in a setting or condition for which current applications are not possible or feasible.
An improvement in functionality, cost or performance over an existing technology/process that is considered state-of-the-art or the current industry best practice.

Evaluation Schema (Mandatory – Pass/Fail)

Pass:

The Applicant has demonstrated that the proposed solution meets one or more of the ISC definitions of innovation.

Fail:

Applicant has not provided sufficient evidence to demonstrate that the proposed solution meets any of the ISC definitions of innovation; OR
Applicant has demonstrated that the proposed solution is an incremental improvement, "good engineering", or a technology that would go ahead in the normal course of product development (i.e. the next version or release).

Question 3b: Advance on State of the Art

Describe in detail the competitive advantages and level of advancement over existing technologies. Where appropriate, name existing technologies as well as potential substitutes or competitors.

To demonstrate this, proposals should include the following information:

Improvements (minor or major) over existing technologies or substitutes. Use direct comparison.
How the proposed innovation will create competitive advantages in existing market niches or market spaces.

Evaluation Schema (Mandatory Criteria – Pass/Fail + Points)

0 points/Fail:

The Applicant has not demonstrated that the proposed solution advances the state-of-the-art over existing technologies, including available competing solutions; OR
The proposed solution improves minimally upon the current state of the art, though not sufficiently enough to create competitive advantages in existing market niches; OR
The stated advancements are described in general terms but are not substantiated with specific, measurable evidence.

5 points/Pass:

The Applicant has demonstrated that the proposed solution offers one or two minor improvements to existing technologies, including available competing solutions, that have potential to create competitive advantages in existing market niches.

12 points/Pass:

The Applicant has demonstrated that the proposed solution offers three or more minor improvements to existing technologies, including available competing solutions, that together are likely to create competitive advantages in existing market niches; OR
The Applicant has demonstrated that the proposed solution offers one significant improvement to existing technologies that is likely to create competitive advantages in existing market niches

20 points/Pass:

The Applicant has demonstrated that the proposed solution offers two or more significant improvements to existing technologies, including available competing solutions that are likely to create competitive advantages in existing market niches and could define new market spaces; OR
The Applicant has demonstrated that the proposed solution can be considered a new benchmark of state of the art that is clearly ahead of competitors and that is likely to define new market spaces

Part 2: Point-Rated Criteria

Proposals must meet the overall minimum pass mark of 50% to be deemed responsive. Proposals that do not achieve the minimum pass mark will be declared non-responsive and given no further consideration.

Point-Rated Criteria

(Applicant's proposal to address)

Question 1b: Scope

Demonstrate the scientific and technological basis of how the proposed solution addresses the Additional Outcomes (if identified) in the Desired Outcomes section in the Challenge Notice. If no Additional Outcomes are identified in the Challenge Notice, text entered in this section will not be considered.

If no Additional Outcomes are identified in the Challenge Notice, Applicants will receive 10 points.

Evaluation Schema (Point-Rated)

Insufficient or no information provided to demonstrate that the solution will address any of the Additional Outcomes. 0 points
Information provided clearly demonstrates that the solution will address some (<50%) of the Additional Outcomes. 3 points
Information provided clearly demonstrates that the solution will address most (50% or more) of the Additional Outcomes. 6 points
Information provided clearly demonstrates that the solution will address all (100%) of the Additional Outcomes. 10 points

Question 4: Phase 1 Science and Technology (S&T) Risks

Describe potential scientific and/or technological risks to the successful development of the proof of feasibility and how they will be mitigated in Phase 1.

Evaluation Schema (Point-Rated)

Insufficient or no information provided to demonstrate that the Applicant has considered potential risks and mitigation strategies and/or information provided contains significant gaps. 0 points
Information provided demonstrates that the Applicant has considered some potential risks and associated mitigation strategies but there are minor gaps in risks and/or associated mitigation strategies. 5 points
Information provided clearly demonstrates that the Applicant has sufficiently considered the risks and defined associated mitigation strategies. 10 points

Question 5: Phase 1 Project Plan

Demonstrate a feasible Phase 1 project plan by completing the table.

Indicate if any milestones and activities will be completed concurrently
Indicate the estimated exit TRL at the completion of Phase 1. (Drop Down Menu of the Challenge Stream Electronic Submission Form)

Evaluation Schema (Point-Rated)

Insufficient or no information provided to demonstrate a feasible project plan for Phase 1 and/or the project plan exceeds the maximum duration indicated in the Challenge Notice. 0 points
Project plan for Phase 1 is conceivably feasible but not clearly demonstrated and/or includes gaps. 10 points
Information provided clearly demonstrates a feasible project plan for Phase 1. 20 points

Question 6: Phase 1 Project Risks

Describe potential project risks to the successful development of the proof of feasibility and how they will be mitigated in Phase 1.

Applicants should address the following risks, as applicable:

Human Resources
Financial
Project Management
Intellectual Property
Other project-related risks

Note to Applicants: S&T risks should not be included in this section. Question 4 addresses S&T risks.

Evaluation Schema (Point-Rated)

Insufficient or no information provided to demonstrate that the Applicant has considered potential risks and mitigation strategies and/or information provided contains significant gaps. 0 points
Information provided demonstrates that the Applicant has considered some potential risks and associated mitigation strategies but there are minor gaps in risks and/or associated mitigation strategies. 5 points
Information provided clearly demonstrates that the Applicant has sufficiently considered the risks and defined associated mitigation strategies. 10 points

Question 7: Phase 1 Implementation Team

Demonstrate how the project implementation team has the required management and technological skill sets and experience to deliver the project plan for Phase 1 by completing the table. A member of the implementation team can have more than one role.

Evaluation Schema (Point-Rated)

Insufficient or no information provided to demonstrate that the project team has the required management and technological skill sets and experience to deliver the Phase 1 project plan. 0 points
Information is provided but there are minor gaps in required management and/or technological skill sets and/or experience to deliver the Phase 1 project plan. 10 points
Information provided clearly demonstrates that the project team has the required management and technological skill sets and experience to deliver the Phase 1 project plan. 20 points

Question 8: Inclusivity

If your business were to receive funding from Innovative Solutions Canada, describe what actions (e.g., recruitment strategy, internships, co-op placements, etc.) might be taken in Phase 1 to support the participation of under-represented groups (e.g., women, youth, persons with disabilities, Indigenous people, visible minorities) in the research and development of the proposed solution. Each Applicant in their response to this question must focus only on describing relevant programs, policies, or initiatives that it currently has in place or would put in place to support the R&D effort in Phase 1.

Note: Do not provide any personal information of individuals employed by your company or that of your subcontractors in the response.

Evaluation Schema (Point-Rated)

No description and/or concrete examples of actions provided that would be taken to encourage greater participation of under-represented groups. 0 points
A description and concrete examples of actions to encourage greater participation of under-represented groups provided.5 points

Question 9: Phase 1 Financial Proposal

Demonstrate a realistic financial proposal for the Phase 1 project plan by completing the table.

Evaluation Schema (Point-Rated)

Insufficient information provided and/or information provided significantly lack credibility. Does not demonstrate a realistic financial proposal for the Phase 1 project plan. 0 points
Information is provided but some costs lack credibility and/or are unclear for the Phase 1 project plan. 7.5 points
Information provided contains credible elements to clearly demonstrate a realistic financial proposal for the Phase 1 project plan. 15 points

Question 10: Phase 1 Financial Controls, Tracking and Oversight

Describe the financial controls, tracking and oversight that will be used to manage the public funds throughout Phase 1. Applicants should indicate if an individual or firm will be managing the public funds and provide their credentials and/or relevant experience.

Evaluation Schema (Point-Rated)

Insufficient or no information provided to demonstrate the Applicant's ability to manage public funds in Phase 1. 0 points
Information provided is vague and/or contains gaps. The Applicant has some controls, tracking and/or oversight in place to manage the public funds in Phase 1. 5 points
Information provided clearly demonstrates that the Applicant has strong financial controls, tracking and oversight to manage public funds in Phase 1. 10 points

Question 11: Phase 2 Overview

Demonstrate a realistic overview for the prototype development plan if selected to participate in Phase 2.

Responses should include:

key tasks
estimated cost for materials
human resources
project risks and mitigation strategies

Note: A more detailed proposal will be requested if selected to participate in Phase 2.

Evaluation Schema (Point-Rated)

Insufficient or no information provided to demonstrate that the Applicant has contemplated a realistic overview for the Phase 2 prototype development. 0 points
Information provided demonstrates a conceivably realistic overview for Phase 2 prototype development, however there are gaps and/or the strategy is vague. 6 points
Information provided demonstrates that the Applicant has a clear and realistic overview. 12 points

Question 12: Commercialization Approach

Demonstrate a realistic overall commercialization approach/business model that can successfully take the technology/service to market, and how the technology/service will help you develop and sell other products.

Responses should include:

Target markets (excluding Government of Canada)
Non-ISC funding sources
Transition to a commercially-ready product or service
Any other indicators of commercial potential and commercial feasibility

Note: A more detailed proposal will be requested if selected to participate in Phase 2.

Evaluation Schema (Point-Rated)

Insufficient or no information provided to demonstrate that the proposed solution has commercial potential. 0 points
Some information provided to demonstrate that the proposed solution has commercial potential, however there are gaps in the commercialization approach. 6 points
A realistic commercialization approach is provided that demonstrates that the proposed solution has commercial potential. 12 points

Question 13: Resulting Benefits to Canada

Describe the benefits that could result from the commercialization of the proposed solution. Applicants should consider the potential benefits using the following three categories and provide justification for each claim:

Innovation Benefits: Expected contribution towards the enhancement or development of new industrial or technological innovations within your firm. Responses could include: potential spillover benefits, creation of intellectual property, impact on productivity of the new technology, etc.
Economic Benefits: Forecasted impact on the growth of Canadian firms, clusters and supply chains, as well as its expected benefits for Canada's workforce. Responses could include: number of jobs created, number of high-paying jobs, investment in Canada's economy, etc.
Public Benefits: Expected contribution to the broader public to the degree that the solution is expected to generate social, environmental, health, security or other benefits to Canada. Responses could include: solution-related environmental benefits, solution-related accessibility benefits, and solution-related impact on Indigenous communities.

Evaluation Schema (Point-Rated)

Innovation Benefits

Benefit not identified or insufficient claim of benefit. 0 points

Benefit has marginal increment or limited justification. 1 point

Benefit is significant and well justified. 2 points
Economic Benefits

Benefit not identified or insufficient claim of benefit. 0 points

Benefit has marginal increment or limited justification. 1 point

Benefit is significant and well justified. 2 points
Public Benefits.

Benefit not identified or insufficient claim of benefit. 0 points

Benefit has marginal increment or limited justification. 1 point

Benefit is significant and well justified. 2 points

Questions and answers

All incoming questions regarding this specific challenge should be addressed to solutions@canada.ca.

All enquiries must be submitted in writing no later than ten calendar days before the Challenge Notice closing date. Enquiries received after that time may not be answered.

You can also consult the Frequently asked questions about the Innovative Solutions Canada Program.

A glossary is also available.

Is it necessary to detect domoic acid at 100 picograms/ml with the proposed solution or can sample preparation techniques to purify domoic acid from phytoplankton be utilized?

Sample preparation may be acceptable where procedures remains consistent with the challenge’s mandatory outcomes (specifically be of a size and weight that makes the unit portable by a single individual for field use).