Debates of June 19th, 2024

Question No.2663—

[Steven Guilbeault, Liberal, Minister of Environment and Climate Change]

Mr. Speaker, in response to part (a), figure 5.1 reports emissions from the national inventory report of greenhouse gas sources and sinks in Canada. Livestock emissions are determined using a standard Intergovernmental Panel on Climate Change, IPCC, methodology and consist primarily of methane emissions from livestock production and manure management. The method tracks enteric methane emissions from livestock, mainly ruminants such as cattle and other ruminants, as well as methane and nitrous oxide emissions from manure management. This method is based on an internationally accepted standard, which has been modified to reflect Canadian climate, livestock types and management practices. It is further adapted based on empirical data collected from studies across Canada.

In response to part (b), data for the modeling comes primarily from the Statistics Canada census of agriculture, as well as the biennial livestock survey from Statistics Canada, which describes the population, age and gender distribution of livestock types. Additional data on livestock productivity and manure management practices come from Statistics Canada surveys, as well as from expert opinion surveys.

In response to part (c), figure 5.1 describes the emissions as of 2021. The national inventory tracks annual emissions, starting in 1990. The latest data point now available is 2022, released in early May.

In response to part (d), the data can be broken down by livestock group. Livestock groups include dairy, beef, sheep, swine and other minor animal categories for enteric methane as well as manure management emissions of methane and nitrous oxide.

In response to part (e), no, the information is for farms only. Emissions from processing facilities would be included in the industry sector.

Question No.2664—

[Jeremy Patzer, Conservative, Cypress Hills—Grasslands, SK]

With regard to Bill S-14, An Act to amend the Canada National Parks Act, the Canada National Marine Conservation Areas Act, the Rouge National Urban Park Act, and the National Parks of Canada Fishing Regulations: did any government department or agency do any consultations related to the proposed measures in the bill, and, if so, (i) who were the groups and people that were consulted, (ii) how much money was spent on the consultation process, (iii) what were the results or recommendations of the consultations, (iv) when were the consultations conducted, (v) how were the consultations conducted?

[Steven Guilbeault, Liberal, Minister of Environment and Climate Change]

Mr. Speaker, in response to parts (i), (ii), (iii), (iv) and (v), with respect to the protected areas addressed in Bill S-14, an act to amend the Canada National Parks Act, the Canada National Marine Conservation Areas Act, the Rouge National Urban Park Act, and the national parks of Canada fishing regulations, extensive consultation and engagement on the intent to expand or complete the establishment of each of these protected areas has taken place.

Within Bill S-14, there are planned expansions for seven national parks and one national park reserve and the creation of two new national parks. Much of this land is already under the control and administration of Parks Canada, and in some cases for over 20 years. As such, the consultation and engagement has been varied and dependent upon the circumstances, has been supported by local ongoing working relationships and has occurred over an extended period of time.

Specifically, regarding the creation of new protected areas, Parks Canada begins consultation and engagement with provincial and territorial governments and indigenous governments and organizations at the feasibility stage where a potential protected area site is initially selected. This consultation and engagement is critical and carries on throughout the establishment process. Consultation processes with partners, key stakeholders, provincial and territorial governments, indigenous peoples, and representatives of communities located in or near the national parks and national marine conservation areas occurred in many communities and took many forms. This includes face-to-face meetings, correspondence, community newsletters, public open houses, community participation in the development of park management plans, and other fora.

Canada has a legal duty to consult and accommodate, where appropriate, when it contemplates a project that may adversely impact upon the section 35 rights of indigenous peoples and takes these responsibilities very seriously. In fact, in a number of cases, protected areas that will be established or expanded within modern treaty areas are a requirement of land claim agreements or other agreements with modern treaty and self-government partners.

Concerning the detailed aspects of the question, Parks Canada undertook an assessment to determine the amount of information that would fall within the scope of the question. The information requested is not systematically tracked in a centralized database. In some cases, Parks Canada has had administration and control of the lands for 20years or more and the lands have been managed as though they were part of the park during this period and consultation and engagement has occurred via formal and informal means throughout the time period. Parks Canada has concluded that producing and validating a comprehensive response to the question would require a manual collection of information that is not possible in the time allotted and could lead to the disclosure of incomplete and misleading information.

Question No.2665—

[Dean Allison, Conservative, Niagara West, ON]

With regard to Health Canada's (HC) review into the presence of SV40 and other DNA elements in the Pfizer COVID-19 vaccine: (a) what were HC’s concerns regarding "SV40 enhancer-promoter sequence and other non-essential sequences in Pfizer's plasmid for their COVID-19 vaccines" as noted in email correspondences between HC, European Medicines Agency (EMA) and the Food and Drug Administration officials in August 2023 prior to an ad-hoc Cluster meeting held on August 24, 2023; (b) what did HC ask of Pfizer to mitigate the concerns in (a), and what was Pfizer's response; (c) did HC's experts review Kevin McKernan's et al. study entitled “Sequencing of bivalent Moderna and Pfizer mRNA Vaccines reveals Nanogram to Microgram Quantities of Expression Vector dsDNA per Dose”; (d) if the answer to (c) is affirmative, (i) what were HC's summary conclusions, (ii) how did HC respond to those conclusions; (e) is HC still of the position that "there is no peer-reviewed scientific literature suggesting that the SV40 promoter-enhancer itself or the other non-functional elements pose a risk to human health"; (f) if the answer to (e) is negative, what key peer-reviewed scientific literature did HC consider noteworthy; (g) is HC aware of the ability of the SV40 promoter-enhancer to bind to P53 as demonstrated by Drayman et al.; (h) if the answer to (g) is affirmative, (i) was the risk communicated to Pfizer, (ii) what was Pfizer's response; (i) if the answer to (g) is negative, will HC perform a risk analysis to human health; (j) is HC aware of the ability of the SV40 enhancer to act as a nuclear targeting sequence as demonstrated by Dean DA, Dean BS, Muller S, Smith LC. in their study entitled “Sequence Requirements for Plasmid Nuclear Import”; (k) if the answer to (j) is affirmative, was the risk communicated to Pfizer and a response requested; (I) if the answer to (j) is negative, will HC perform an independent risk analysis to human health; (m) if Pfizer's vaccine did not contain unsafe or unexpected plasmid sequences, such as SV40 promoter-enhancer, then why, on August 29, 2023, did Michael Wall state in an email to Tong Wu, "Health Canada will continue to work with international regulatory partners to achieve harmonisation regarding removal of these sequence elements from the plasmid for future strain changes"; (n) what are the "sequence elements" to which Michael Wall was referring; (o) regarding an email, on October 12, 2023, from an EMA colleague to Dr. Dean Smith at HC, which stated "We are going to discuss the matter of SV40 with Pfizer-BioNtech as well as these alleged high level of DNA in vaccines coming from these external parties. Have you taken any action? What would be your perspective?", (i) what action was taken or will be taken to address the "alleged high level of DNA" referenced in the email, (ii) has any action been taken to date, and, if so, what; (p) has HC informed (i) the Public Health Agency of Canada, (ii) Dr. Howard Njoo, (iii) Dr. Theresa Tam, (iv) Dr. Supriya Sharma, (v) the National Advisory Committee on Immunization, (vi) any or all of the provincial or territorial Chief Medical Officers, of the presence of the SV40 enhancer-promoter and DNA fragments; (q) if the answers to (p)(i) to (p)(vi) are affirmative, what were their individual responses; (r) if the answers to (p)(i) to (p)(vi) are negative, why or why not; (s) what risk assessment did HC perform to determine that SV40 promoter-enhancer is safe in an mRNA vaccine within the unique LNP delivery system; (t) what other Canadian vaccines contain SV40 promoter-enhancer sequence; and (u) what is HC's policy about SV40 promoter-enhancer being in any vaccine product?

[Yasir Naqvi, Liberal, Parliamentary Secretary to the Minister of Health]

Mr. Speaker, the health and safety of Canadians are Health Canada’s top priority, and before the initial authorization of the Pfizer-BioNTech vaccine, COMIRNATY, the department completed a rigorous scientific review of the product’s safety, efficacy and quality. Following authorization, Health Canada remained active in discussions with international partners in assessing the quality, safety and efficacy of all COVID 19 vaccines.

Health Canada also collaborates with international partners; the Public Health Agency of Canada, PHAC; the National Advisory Committee on Immunization, NACI; and provincial/territorial public health authorities in monitoring the safety of vaccines authorized for use in Canada. The risk-based decisions made by Health Canada on the COVID-19 mRNA vaccines are based on sound scientific evidence and are also in line with those of other countries, international guidelines, sound regulatory principles, and good regulatory practices.

Health Canada is aware of concerns surrounding SV40. In July 2023, through clarification requests, Health Canada evaluated the presence of the SV40 promoter-enhancer sequence in the plasmid used to prepare the Pfizer-BioNTech COVID-19 vaccine, COMIRNATY, as well as in residual DNA as a manufacturing impurity in the final vaccine product. Clarification requests are routinely issued during submission review to seek clarifications on various aspects of the file. Health Canada submitted a clarification request to Pfizer seeking additional information related to the SV40 sequences. Pfizer provided a reply to address all of Health Canada’s questions. Please note that communications between Health Canada and manufacturers related to the manufacturing and control of a vaccine are considered confidential business information that cannot be disclosed.

As previously indicated, the presence of a fragment of the SV40 sequence is not the same as the presence of the whole virus itself. The SV40 promoter-enhancer sequence fragment is inactive and has no functional role. The presence of the SV40 promoter-enhancer sequence in the COVID-19 vaccines is considered as low risk, as the levels of this residual DNA fragment are consistent with international regulators and are below the WHO recommended limit of 10 ng/dose.

To date, over three billion doses of COMIRNATY have been administered worldwide, including over 69 million doses in Canada: https://health-infobase.canada.ca/covid-19/vaccine-administration/. No safety signals related to the residual SV40 DNA fragment have been detected. When new safety issues are confirmed by the department, Health Canada takes action, which may include communicating new risks to Canadians and health care professionals or changing the recommended use of the product.

Question No.2666—

[John Nater, Conservative, Perth—Wellington, ON]

With regard to the government's appointment of Catherine Blewett to be Secretary of the Treasury Board, effective February 6, 2024: (a) since February 6, 2024, broken down by month, how many days did the Secretary work in person at the Treasury Board Secretariat's main office at 90 Elgin Street in Ottawa; and (b) is the Secretary exempt from the government's requirement that employees are to work in the office for at least two days per week?

[Anthony Housefather, Liberal, Parliamentary Secretary to the President of the Treasury Board]

Mr. Speaker, the direction on prescribed presence in the workplace applies to all public servants, including deputy heads. In addition to setting a minimum number of days in the office, currently 2-3 days/week or 40-60% of an employee’s schedule, the direction allows for certain exemptions in exceptional cases, for example for medical reasons. Ms. Blewett has been under medical care since March 11, 2024. Her presence at TBS’ office is as follows: February 6 to 29, 13 days; March, 7 days; April, 0 days; May 1 to 2, 0 days.

Question No.2667—

[Robert Gordon Kitchen, Conservative, Souris—Moose Mountain, SK]

With regard to Exhibit 5.8 of the Commissioner of the Environment and Sustainable Development's report entitled "Agriculture and Climate Change Mitigation-Agriculture and Agri-Food Canada" and the performance targets related to climate change mitigation in place for the Agricultural Clean Technology program: (a) what were the 193 new technologies adopted based on 141 performance reports; (b) what did the performance reports say about the adoption of these technologies; and (c) what were the 352 approved projects based on 141 performance reports?

[Lawrence MacAulay, Liberal, Minister of Agriculture and Agri-Food]

Mr. Speaker, in response to part (a), rhe 193 new technologies adopted were to replace or upgrade the existing technology on farm or in the food-processing facility with technology that showed promise to generate measurable emission reductions categories under the program’s three priority areas.

The area of green energy and energy efficiency covers improvements that enable better management of energy-intensive agricultural processes, such as more energy-efficient technology for grain drying and grain handling; more energy-efficient facility heating systems; replacing fossil fuels or fossil fuel-derived energy with renewable energy such as solar electricity or biomass fuel.

The area of precision agriculture covers technology that contributes to more precise, and therefore reduced, input use, such as variable rate application technologies and GPS, auto-steering, guidance systems that optimize fertilizer and seed placement, reducing inputs and the number of passes in the field; subsurface or injection technologies that reduce fertilizer and water inputs and soil disturbance; - precision feed technologies that optimize livestock digestion and reduce methane production; precision harvesting equipment that reduces fossil fuel inputs.

The area of bioeconomy solutions covers using agricultural waste and by-products to generate energy or create bioproducts, such as anaerobic digesters and manure or compost management technologies.

The following is a breakdown of the 193 adopted clean technologies that were included in the commissioner of the environment and sustainable development’s report: 39% in grain drying and handling; 21% in precision agriculture; 18% in solar adoption; 5% in biomass heating; and 17% in “other”, which includes a combination of the various technologies outlined above.

In response to part (b), at an aggregate level, the performance reports provided information confirming that the clean technologies were being adopted as planned and are achieving the projects’ anticipated greenhouse gases emissions reduction results. In addition, the reports provide information on efficiencies gained and results achieved at a granular level. They also detail a number of challenges and unforeseen circumstances that affected the adoption and use of these technologies. For example, supply chain issues, labour shortages, and other COVID-related challenges contributed to delays in adoption for some producers. Furthermore, unforeseen circumstances such as unseasonably wet or dry conditions were also noted in a number of performance reports. This led to some results falling short of targets, and some exceeding them.

In response to part (c), please see “Database: Agricultural Clean Technology Program projects” at Canada.ca for a cumulative listing of all projects approved and announced as of March 7, 2024, under the agricultural clean technology program, adoption stream and research and innovation stream.

Note that the number of approved projects was 352 as of January 2024, when this program information was provided for the commissioner of the environment and sustainable development’s report.

Question No.2668—

[Cheryl Gallant, Conservative, Renfrew—Nipissing—Pembroke, ON]

With regard to Health Canada's (HC) signing of the contract with Pfizer on October 26, 2020, and the subsequent release of the Pfizer mRNA COVID-19 vaccine to the Canadian public: (a) was HC aware of a presentation made to the Vaccines and Related Biological Products Advisory Committee on October 22, 2020, where Dr. Steve Anderson at the US Food and Drug Administration's Center for Biologics Evaluation and Research, presented "Plans for Monitoring COVID-19 Vaccine Safety and Effectiveness"; (b) if the answer to (a) is affirmative, did HC review the presentation deck, specifically slide #16, which identified a working list of 22 "possible adverse event outcomes", including acute myocardial infarction, stroke, myocarditis, pericarditis and death; (c) if the answer to (a) is negative, at what point did HC become aware of this presentation material or these serious adverse events of special interest; (d) once HC was in possession of this information, where and when did HC publish this list of 22 "possible adverse event outcomes" for the purpose of informing (i) the general public, (ii) medical physicians and hospitals, (iii) the media; (e) how did HC plan to independently and actively monitor these 22 "possible adverse event outcomes"; (f) did the initial Pfizer monograph posted on HC's website on December 9, 2020, and the ones posted thereafter identify any of these 22 "possible adverse event outcomes"; (g) when Pfizer vaccines were first being administered in early 2021, did HC require the sponsor to include a package insert in each mRNA vaccine vial containing a fully printed monograph of the product's ingredients and side effects including the identified 22 "possible adverse event outcomes" for both the consumer and the health professional to ensure full, informed consent; (h) if the answer to (g) is negative, (i) why was this not required, (ii) how was full, informed consent achieved at the time of vaccination; (i) did HC plan to actively monitor and publish the 1,291 "serious adverse events (SAEs) of special interest" which were contained in the Appendix of Pfizer's report of April 30, 2021, entitled "5.3.6 CUMULATIVE ANALYSIS OF POST-AUTHORIZATION ADVERSE EVENT REPORTS OF PF-07302048 (BNT162B2) RECEIVED THROUGH 28-FEB-2021" to ensure medical awareness of these potential SAEs; (j) if the answer to (i) is affirmative, (i) how were the SAEs monitored, (ii) what information was gathered; and (k) if the answer to (i) is negative, why are the 1,291 SAEs of special interest being monitored by the US Food and Drug Administration and not by HC?

[Yasir Naqvi, Liberal, Parliamentary Secretary to the Minister of Health]

Mr. Speaker, Health Canada’s mandate is to help Canadians maintain and improve their health. The health and safety of Canadians is Health Canada’s top priority, and the department exercises stringent regulatory oversight over health products, including vaccines. Health Canada received Pfizer’s submission seeking authorization to its Pfizer-BioNTech COVID-19 Vaccine on October 9, 2020, available at https://www.canada.ca/en/health-canada/news/2020/12/health-canada-authorizes-first-covid-19-vaccine0.html. The department is not a signing authority of purchasing contracts for health products, including COVID-19 vaccines.

Before a vaccine is approved in Canada, the Department conducts a rigorous scientific review of its safety, efficacy and quality. Submissions typically contain extensive data regarding the vaccine's safety, efficacy and quality, including results of pre-clinical and clinical studies, details on manufacturing processes, and information on adverse events following immunization, or AEFI. An authorization is only issued when benefits of the vaccine outweigh the risks of its use.

Following authorization, Canada has a robust and well-established vaccine safety surveillance system involving Health Canada, Public Health Agency of Canada, or PHAC, provinces and territories, and vaccine manufacturers. Health Canada continues to monitor the safety profile of health products once they are on the Canadian market, to help ensure that the benefits of the product continue to outweigh the risks. The safety profile of these products is monitored by reviewing safety information submitted by manufacturers as well as considering safety information from international regulators. When new safety issues are confirmed by the Department, Health Canada takes action, which may include communicating new risks to Canadians and healthcare professionals or changing the recommended use of the product.

In response to (a) to (e), Health Canada is aware of the referred presentation regarding FDA “Plans for Monitoring COVID-19 Vaccine Safety and Effectiveness”, which occurred at the Vaccines and Related Biologic Products Advisory Committee, or VRBPAC, held on October 22, 2020, including the slide #16 of the 22 “possible adverse event outcomes.” Since the authorization of the first COVID-19 vaccines in Canada on December 9, 2020, Health Canada has been monitoring possible adverse events including these 22 “possible adverse event outcomes.”

In addition, Health Canada and the PHAC have been actively monitoring and reviewing AEFI reports. All AEFI reports submitted by provincial and territorial public health authorities and federal departments are captured in the Canadian Adverse Events Following Immunization Surveillance System, or CAEFISS, which is managed by PHAC. In addition, the Canada Vigilance Program, or CVP, managed by Health Canada, receives AEFI reports from manufacturers, Canadian hospitals, healthcare professionals and consumers. Information about AEFIs reported in Canada, including some of the 22 “possible adverse event outcomes” is published on the Government of Canada’s website. It is important to note that these reports do not necessarily imply that a relationship between the adverse event and the vaccine has been established. However, they are an important information source supporting ongoing safety monitoring. Additional information is also available on the following public websites: COVID-19 Vaccine safety and side effects, at https://www.canada.ca/en/public-health/services/diseases/coronavirus-disease-covid-19/vaccines/safety-side-effects.html#a5; Vaccine safety and possible side effects, at https://www.canada.ca/en/public-health/services/vaccination-children/safety-concerns-side-effects.html; Health Product InfoWatch, at https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/health-product-infowatch/published-newsletters.html#a1; Pfizer-BioNTech Comirnaty COVID-19 Vaccine, at https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/drugs-vaccines-treatments/vaccines/pfizer-biontech.html; and Regulatory Decision Summary of Pfizer-BioNTech Comirnaty COVID-19 Vaccine, at https://covid-vaccine.canada.ca/info/regulatory-decision-summary-detailTwo.html?linkID=RDS00730.

In response to (f) to (i), as part of the regulatory requirements, a product monograph is publicly released at the time of a vaccine’s authorization. The product monograph is developed and managed by the manufacturer. The content, wordings, and format are carefully reviewed by Health Canada to ensure that it is prepared in accordance with the Product monograph guidance documents and notices, found at Canada.ca. Updates of the product monograph are summarized in the Post-Authorization Activity Table (PAAT) at https://covid-vaccine.canada.ca/info/paat-SBD00510-comirnaty-en.html for Comirnaty.

A product monograph is a factual, scientific document on the drug product that, devoid of promotional material, describes the properties, claims, indications, and conditions of use for the drug, and that contains any other information that may be required for optimal, safe, and effective use of the drug. It is used to inform physicians, pharmacists, dentists, nurses, other healthcare professionals, and patients about the appropriate use of the product.

A package insert is also required at the time of a vaccine’s authorization. As noted above for the Canadian Product Monograph, at the time of authorization, the safety information included in package inserts was based on the available safety data from clinical trials. Furthermore, Health Canada is responsible for ensuring that the product monograph and package inserts are updated over time to adequately reflect the risks associated with the vaccines that are authorized in Canada. Health Canada-approved information is used by the appropriate bodies (e.g., provincial and local public health authorities, etc.) to guide recommendations, vaccine use, as well as information provided to vaccine recipients.

In response to (j) to (k), the referred report of 1,291 "serious adverse events (SAEs) of special interest" which were contained in Pfizer's report of April 30, 2021, entitled "5.3.6 CUMULATIVE ANALYSIS OF POST-AUTHORIZATION ADVERSE EVENT REPORTS OF PF-07302048 (BNT162B2) RECEIVED THROUGH 28-FEB-2021", was prepared by the manufacturer, Pfizer, for the US FDA. Health Canada reviewed safety reports submitted by the manufacturer including data from the referred report. The information reviewed did not identify new safety concerns and was consistent with the known safety profile of COMIRNATY. Outcomes of Health Canada’s safety reviews for COMIRNATY, as well as subsequent reviews, are available online at the Post Authorization Activity Table for COMIRNATY at https://covid-vaccine.canada.ca/info/post-authorization-activity-table.html?linkID=SBD00510.

To date, the benefits of these vaccines continue to outweigh their known risks.

Question No.2669—

[Dean Allison, Conservative, Niagara West, ON]

With regard to the post-market surveillance used by Health Canada (HC) to monitor for safety concerns regarding the novel COVID-19 vaccine products: (a) have HC, the Public Health Agency of Canada (PHAC), Statistics Canada or any other federal agency or entity, department, or third-party agency used databases such as the Institute for Clinical Evaluative Sciences, the Ontario Health Data Platform or any other databases that collect real­time data to determine an individual's date of medical diagnoses, including death; (b) if the answer to (a) is affirmative, what are the anonymized individual results for the following new onset diagnoses, from December 1, 2020, to the present date, cross referenced with the date of receipt of COVID- 19 vaccine, the age by 5-year increments, the gender, and the province or territory of residence, (i) cerebral infraction, (ii) cerebral hemorrhage, (iii) sudden infant death syndrome, (iv) seizure, (v) acute myocarditis, (vi) pericarditis, (vii) transverse myelitis, (viii) miscarriage, (ix) Bell's palsy, (x) pancreatic cancer, (xi) esophageal cancer, (xii) anaphylaxis, (xiii) myocardial infraction, (xiv) breast cancer, (xv) pulmonary embolism, (xvi) deep vein thrombosis, (xvii) thrombocytopenia, (xviii) pulmonary hypertension (xix) lymphoma, (xx) ruptured aortic aneurysm, (xxi) cellulitis, (xxii) Guillain Barre syndrome, (xxiii) stillbirth, (xxiv) encephalopathy due to vaccination, (xxv) encephalopathy, (xxvi) sudden death, (xxvii) preeclampsia, (xxviii) premature birth, (xxix) multiple sclerosis, (xxx) hysterectomy, (xxxi) vasculitis; (c) what are the quarterly incidence rates of the diagnoses in (b) categorized by (i) age with 5-year increments, (ii) gender, (iii) province or territory of residence from January 1, 2014, to November 30, 2020; (d) if the answer to (a) is negative, what are the quarterly incidence rates of the diagnosis in (b) from December 1, 2020, to the present day, categorized by (i) age with 5-year increments, (ii) gender, (iii) province or territory of residence; (e) if the answer to (a) is affirmative, has this data been used to compare rates of medical diagnosis between never COVID-19 vaccinated individuals and others based on the number of COVID-19 injections received; (f) if the answer to (a) is affirmative, has this data been used to determine the length of time between receipt of a COVID-19 vaccine and the medical diagnosis or death, and, if so, what are the ranges of time; (g) if the answer to (a) is affirmative, will the raw data be released to independent researchers; (h) if the answer to (a) is negative, will the government make the raw anonymized data public; (i) if the answer to (a) is negative, what plans are either in place or planned to complete such an analysis in order to validate adverse event reporting systems that may be outdated for the COVID-19 vaccine products; (j) have there been any communications from or between HC, the PHAC, Statistics Canada, or any other federal agencies or their representatives about the Institute for Clinical Evaluative Sciences, the Ontario Health Data Platform, or any other similar database sources that capture receipt of COVID-19 vaccine(s) or booster(s) and clinical outcomes to monitor for safety signals; (k) if the answer to (j) is affirmative, which government agencies or out-sourced third parties were involved, and, for each, (i) what are the communications, (ii) who directed these communications, (iii) what were the dates of these communications, (iv) what was included in these communications, (v) what were the conclusions of these communications?

[Yasir Naqvi, Liberal, Parliamentary Secretary to the Minister of Health]

Mr. Speaker, with regard to (a) to (g), the Public Health Agency of Canada, or PHAC, does not have access to provincial or territorial databases like the Ontario Health Data Platform that provide an individual-level information such as medical diagnoses or date of deaths. Similarly, PHAC does not have access to databases managed by the Institute for Clinical Evaluative Sciences.

Canada has a robust and well-established surveillance system to monitor for safety concerns for COVID-19 vaccines authorized in Canada, which involves monitoring by Health Canada, PHAC, provinces and territories, and vaccine manufacturers. Health Canada continues to monitor the safety profile of health products once they are on the Canadian market, to help ensure that the benefits of the product continue to outweigh the risks. The safety profile of these products is monitored by reviewing safety information submitted by manufacturers as well as considering safety information from international regulators and from adverse events following immunization, or AEFI, reports from healthcare professionals and consumers. When new safety issues are confirmed, Health Canada takes action, which may include communicating new risks to Canadians and healthcare professionals or changing the recommended use of the product.

In addition, Health Canada and the PHAC have been actively monitoring and reviewing AEFI reports. All AEFI reports submitted by provincial and territorial public health authorities and federal departments are captured in the Canadian Adverse Events Following Immunization Surveillance System, or CAEFISS, which is managed by PHAC. In addition, the Canada Vigilance Program, or CVP, managed by Health Canada, receives AEFI reports from manufacturers, Canadian hospitals, healthcare professionals and consumers. Information about AEFIs reported in Canada, including the reporting rates, is published on the Government of Canada’s website. In addition, the anonymized reports received from the CVP of Health Canada, including suspect AEFIs reported directly to the CVP, are available at https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-database.html. It is important to note that these reports do not necessarily imply that a relationship between the adverse event and the vaccine has been established. However, they are an important information source supporting ongoing safety monitoring.

Building on the existing robust pharmacovigilance system, Health Canada introduced strategies to enhance regulatory surveillance measures for COVID-19 vaccines. For example, terms and conditions in the document “Guidance for market authorization requirements for COVID-19 vaccines”, found at canada.ca, have been imposed on manufacturers to quickly request and gather critical safety and effectiveness information in order to mitigate risks during the product lifecycle. These enhanced regulatory surveillance measures enabled Health Canada to request additional risk monitoring activities and post-market studies, namely post-authorization studies on safety and effectiveness. These measures also provided tools for Health Canada to detect and evaluate emerging safety information on the benefit-risk balance of COVID-19 vaccines. As noted before, should there be new safety issues, Health Canada will take appropriate action(s).

With regard to (h), PHAC does not possess or have access to datasets with this type of information.

With regard to (i), Health Canada and PHAC have a robust vaccine safety surveillance system in place that engages healthcare professionals, vaccine manufacturers, and provincial and territorial health authorities. PHAC receives and reviews AEFI reports from provinces and territories, as submitted by health care providers through CAEFISS). The information provided by CAEFISS is complemented by the Canada Vigilance Program, Health Canada’s post-market surveillance program that collects and assesses reports of suspected adverse events to health products marketed in Canada. Manufacturers are required to report serious adverse events to Health Canada as the national regulatory authority, as well as submit regular summaries of global safety information. AEFI reports are monitored continuously by PHAC and Health Canada. Any new or unusual adverse events, or changes in trends or severity of specific events would trigger an investigation, including an in-depth medical review and risk assessment. As safety issues are investigated, Health Canada will take appropriate action as needed.

With regard to (j), PHAC is aware of provincial and territorial databases that include information about vaccinations and clinical outcomes following vaccination, among many other topics. However, PHAC receives AEFI reports from all provincial and territorial governments. For the purposes of adverse events following immunizations, provincial and territorial governments make the determination of the appropriate data sources for clinical and vaccination data necessary to generate and validate those reports that are submitted to PHAC for the purposes of surveillance.

Part (k) is not applicable.

Question No.2670—

[Dean Allison, Conservative, Niagara West, ON]

With respect to Health Canada's (HC) review into the presence of SV40 and other DNA elements in the Pfizer COVID-19 vaccine: (a) in July 2023, what was the basis for an Issue Analysis Summary (IAS) for the SV40 promoter agreed to by Drs Co Pham, Tong Wu and Michael Wall; (b) in July 2023, what was the rationale for HC to submit #1 Clarifax request to Pfizer and (i) what was the outcome of this request, (ii) did the response from the sponsor to #1 Quality Clarifax address all of HC's questions and concerns, and, if negative, what was missing, (iii) did Pfizer provide a complete justification for the SV40 sequences, (iv) did Pfizer provide an updated fully annotated table of functional elements of the plasmid, (v) did Pfizer include non-functional elements of the plasmid in the annotated table specifically addressing any unexpected open reading frames and other sequence elements, (vi) if the answer to (iii), (iv) and (v) is affirmative, what were the results, (vii) if the answer to (iii), (iv) and (v) is negative, what was HC's response; (c) with respect to the quantitative assay used to measure the residual DNA in order to confirm the presence of the SV40 promoter-enhancer, did HC confirm with Pfizer (i) the amplicon size used, (ii) the appropriateness of the primers used; (d) if the answer to (c) is affirmative, what was Pfizer's response; (e) if the answer to (c) is negative, has HC independently verified the total amounts of residual DNA, the appropriateness of the primers, and the amplicon size used by Pfizer to measure the residual DNA in the XBB.1.5 vials; (f) with respect to Pfizer's response in #1, #2 and #3 Quality Clarifaxes, did Pfizer provide the requested information on the fragment size analysis by December 1, 2023; (g) if the answer to (f) is affirmative, what were the results; (h) if the answer to (f) is negative, what was HC's response; (i) concerning the residual plasmid DNA in the drug substance, (i) did Pfizer provide the requested information on the characterization of residual circular DNA plasmid by December 1, 2023, (ii) did Pfizer provide the requested information on the risk of replication in bacterial cells by December 1, 2023, (iii) did HC at any time request information on the risk of replication in mammalian cells; (j) if the answer to (i)(i), (i)(ii) and (i)(iii) is affirmative, what were the results; (k) if the answer to (i)(i), (i)(ii), and (i)(iii) is negative, what was HC's response; (I) did HC request that Pfizer repeat the analyses for fragment size distribution and residual DNA for any of Pfizer COVID-19 vaccines (i.e., original or bivalent); (m) if the answer to (l) is affirmative, what were the findings; (n) if the answer to (l) is negative, why not; (o) did HC independently verify the quantity of residual DNA, the size distribution and the presence of SV40 sequences in the XBB.1.5. vaccine, or any other COVID-19 vaccine submitted by Pfizer for review; (p) at any time, did Pfizer ever suggest that the regulatory sequence elements in question were functional with respect to the manufacturing process, and, if so, what was the function; (q) at any time, did Plizer ever suggest that regulatory sequence elements in question were functional following inoculation into humans; and (r) if the answer to (p) is affirmative, what and when did Pfizer inform HC?

[Yasir Naqvi, Liberal, Parliamentary Secretary to the Minister of Health]

Mr. Speaker, in response to (a) to (r), the health and safety of Canadians are Health Canada’s top priority. The department exercises stringent regulatory oversight over vaccines, and conducts a rigorous scientific review of their safety, efficacy and quality prior to authorization. In July 2023, Health Canada evaluated the presence of the SV40 promoter/enhancer sequence in the plasmid used to prepare the Pfizer-BioNTech COVID-19 vaccine, or COMIRNATY, as well as in residual DNA as a manufacturing impurity in the final vaccine product. Clarification requests are routinely issued during submission review to seek clarifications on various aspects of the file. Health Canada submitted a clarification request to Pfizer seeking additional information related to the SV40 sequences. Pfizer provided a reply to address all of Health Canada’s questions. Please note that communications between Health Canada and manufacturers related to the manufacturing and control of a vaccine are considered confidential business information that cannot be disclosed.

The residual plasmid DNA levels measured by the manufacturer, using approved validated methods, were provided to Health Canada and was consistently below the limit of 10 nanograms per human dose. In addition, all COMIRNATY commercial vaccine batches, released in Canada, complied with the quality requirements approved by Health Canada, including the requirements for residual DNA. An Issue Analysis Summary, or IAS, was initially considered to document the process but was later deemed to be unnecessary as the residual DNA content in the final product was consistently below the limit of 10 nanograms per human dose, which is in line with the World Health Organization’s recommendation concerning residual DNA in biological drugs.

The presence of residual plasmid DNA in the mRNA COVID-19 vaccines is considered a manufacturing impurity and does not change the safety assessment of these vaccines by Health Canada.

Question No.2672—

[Cathay Wagantall, Conservative, Yorkton—Melville, SK]

With respect to Canada’s Vaccine Injury Support Program (VISP): (a) how many claims have been filed to the program from December 8, 2020, to present day, broken down by age group; (b) how many of those claims have been approved, broken down by age group; (c) of the approved claims, what have been the diagnoses and their frequencies, broken down by age group, date approved, and the corresponding COVID-19 vaccines that were administered; (d) of the approved claims, what are the percentages of Canadians who received (i) the AstraZeneca COVID-19 vaccine, (ii) the J&J COVID-19 vaccine, (iii) any COVID-19 vaccine produced by Pfizer-BioNTech, (iv) any COVID-19 vaccine produced by Moderna, (v) a combination of COVID-19 vaccines; (e) how many persons have received compensation to date through the VISP; (f) what is the total compensation to date given to vaccine-injured Canadians; (g) what is the age of the youngest person who received funding support approval through the VISP, and their associated diagnosis; (h) for all death claims, (i) what is the total number of death claims that have been filed to VISP, (ii) of the total, what have been the underlying causes of death, aside from the vaccine and their frequencies, (iii) how many filed death claims have been approved by the VISP and their corresponding diagnosis and vaccine status; (i) did the VISP require autopsies prior to approving a death claim; (j) if the answer to (i) is affirmative, what immunohistochemistry requirements does the VISP specify for these autopsies; (k) when denied, how many persons have appealed their claim and how many have been successful; (l) regarding the determination of causality of the adverse event in relation to a COVID-19 vaccine, (i) what is the standard criteria, (ii) does the Medical Review Board take into consideration the Bradford Hill criteria; (m) what are the professional qualifications of each member on the Medical Review Board; and (n) who are the professionals on the Medical Review Board?

[Yasir Naqvi, Liberal, Parliamentary Secretary to the Minister of Health]

Mr. Speaker, the Pan-Canadian Vaccine Injury Support Program, or VISP, provides financial support to people in Canada in the rare event that they experience a serious and permanent injury as a result of receiving a Health Canada authorized vaccine, administered in Canada, on or after December 8, 2020. The program also provides death benefits and support for funeral expenses in the rare case of a death as a result of receiving a Health Canada authorized vaccine.

The Pan-Canadian VISP was launched on June 1, 2021, and is being administered independently by OXARO, formerly known as Raymond Chabot Grant Thornton Consulting Inc., with funding from the Public Health Agency of Canada, or PHAC. This program is available for people who were vaccinated in all provinces except Quebec. PHAC is not involved in individual cases, including in the determination of decisions regarding causality or compensation.

As the independent administrator, OXARO operates at arm’s length from PHAC and oversees all aspects of claims intake and assessment. OXARO is responsible for providing periodic public reporting on program statistics. Public reporting began on December 1, 2021, and data on the pan-Canadian VISP is updated twice a year. Latest public reporting can be found at https://vaccineinjurysupport.ca/en/program-statistics. The latest reporting shows the program statistics as of December 1, 2023. The next update will be available in June 2024.

The province of Quebec continues to administer its longstanding Vaccine Injury Compensation Program, or VICP, for people vaccinated in that province, with federal funding. Information on Quebec’s VICP, including program statistics as of March 31, 2023, can be found at https://www.quebec.ca/en/health/advice-and-prevention/vaccination/vaccine-injury-compensation-program#c3895.

In response to questions (a), (b), (e), (f), and (k), as of OXARO’s last public report on December 1, 2023, OXARO had received 2233 claims; approved 138 claims by Medical Review Board; received 102 claims of appeals; approved 6 appeals; and paid $11.236 million in financial support to eligible claimants.

As of Quebec’s last public report on March 1, 2023, since 1988, Quebec had received 410 claims; approved 56 claims; received 92 claims of appeals; approved 9 appeals; and paid $9.397 million in financial support to eligible claimants.

These program statistics, including the claims received, claims approved and appeals, can also be found on the OXARO website. Information on Quebec’s Vaccine Injury Compensation Program, for those vaccinated in Quebec, can be found on the Quebec provincial website.

In response to questions and sub-questions (a) broken down by age group, (b) broken down by age group, (c) what have been the diagnoses and their frequencies, broken down by age group, date approved, and the corresponding COVID-19 vaccines that were administered, (d), (g), (h), (i) and (j), the implementation model used by the Government of Canada, a contribution agreement subject to the Policy on Transfer Payments, means that OXARO’s work occurs independently and at arm’s length from PHAC. As a result, PHAC does not request nor receive any information regarding individual claims received by OXARO nor data related to demographics, types of vaccines, or the nature of vaccine injuries.

In response to questions (l), (m) and (n),with regards to the physicians conducting the medical board reviews and assessment process followed, OXARO has advised PHAC that they ensure the medical experts hold both a valid license with their respective College of Physicians and a valid Canadian Medical Protective Association membership across Canada. Depending on the nature of the injury, the team of medical experts assembled to review a claim can include specialists, such as cardiologists and neurologists. This is done to provide a comprehensive analysis of each claim. Medical review boards use a causality assessment process developed by OXARO that is based on accepted industry practices and the World Health Organization’s guidance on the causality assessment of an adverse event following immunization.

Question No.2675—

[John Williamson, Conservative, New Brunswick Southwest, NB]

With regard to the government’s announcement on August 12, 2021 to invest $1.44 billion into Telesat’s advanced low Earth orbit (LEO) satellite constellation, Telesat Lightspeed: (a) what are the details of government purchases or sales of Telesat equity or shares since the announcement, including, for each, the (i) date, (ii) total price or amount, (iii) type of transaction (bought or sold), (iv) number of shares or percentage of equity, (v) share price, if applicable; and (b) what is the government’s current equity stake in Telesat in terms of value, percentage of equity, and number of shares?

[François-Philippe Champagne, Liberal, Minister of Innovation]

Mr. Speaker, the terms of the 2021 agreement-in-principle were never finalized and have since been superseded. As such, the government has not disbursed any funds or received any equity for Telesat’s Lightspeed Low Earth Orbit satellite project.

Since then, both Telesat’s and the Government’s plans have been updated. The government remains in discussions with Telesat regarding a potential investment in the project.

Question No.2683—

[Kyle Seeback, Conservative, Dufferin—Caledon, ON]

With regard to the recently announced emissions cap on Canada's oil and gas sector: (a) what assessments has the Government of Canada made regarding the economic impact on Gross Domestic Product and Export amounts, by dollar, for Canada; (b) has the government analyzed and reviewed the potential impact to Canadian firms that export energy products, and, if so, what are the details; (c) has the government considered the potential economic fallout in terms of job losses across the energy sector, at the provincial and territorial level, and, if so, what were the findings; (d) prior to the announcement of the emissions cap, did the government engage in any public relations or briefings with non-government organizations (NGO), the United Nations, and any sub-directorates of the United Nations at the ministerial level, and, if so, what was the nature of those discussions and the result of those discussions; (e) did the government procure any NGO or outside-of-government entities or actors to raise the subject within the Canadian media sphere, and, if so, who was involved and how much money was spent on these endeavors; and (f) what are the financial and contractual details of all memorandums and briefing notes, scope documents and economic impact analysis about the emissions cap that were sent to, or received by, the Minister of Export Promotion, International Trade and Economic Development, the Minister of the Environment and Climate Change, and the Minister of Finance, as well as any relevant ministerial offices and other involved ministers, deputy ministers, assistant deputy ministers regarding the emissions cap policy file, from 2016 to 2024?

[Steven MacKinnon, Liberal, Leader of the Government in the House of Commons]

Mr. Speaker, the Government of Canada has committed to cap and reduce greenhouse gas, or GHG, emissions from the oil and gas sector at a pace and scale necessary to contribute to Canada’s 2030 climate goals, to achieve net-zero GHG emissions by 2050, and in a way that allows the sector to compete in the emerging net-zero global economy. As the country’s largest source of GHG emissions and the only major source that continues to grow, decarbonizing the oil and gas sector is critical to achieving Canada’s emission targets. The sector is also an economic powerhouse, proven innovator, and source of good jobs. The emissions cap will help decarbonize oil and gas production to make Canada a highly efficient producer supplying global demand and ensure the sector is on a path to net-zero by 2050. The emissions cap is an integral piece of the Government of Canada’s roadmap to support the decarbonization of oil and gas production.

On July 18, 2022, the government published a discussion paper outlining two regulatory options to cap GHG emissions from the oil and gas sector: a new national GHG emissions cap-and-trade system, and modifications to existing carbon pricing systems. The discussion document sought feedback on the two options, and generated a significant response. Environment and Climate Change Canada, or ECCC, received over 150 submissions from provinces and territories, indigenous organizations, industry, environmental non-governmental organizations, and academics, as well as over 25,000 comments from members of the public. Feedback on the discussion paper has informed the government’s approach on this important policy.

In addition to the formal comment period, the Government of Canada has held a significant number of information webinars and bilateral meetings with various partners and interested parties. Information gathered and feedback received during this engagement has been taken into consideration in the design of the proposed regulatory approach.

On December 7, 2023, the Government of Canada published a regulatory framework to cap and cut emissions in the oil and gas sector for a 60-day public comment period. The government received 107 formal written submissions from provinces and territories, indigenous organizations, industry, environmental non-governmental organizations, and academics, as well as over 35,000 comments from members of the public. Feedback on the regulatory framework is being used to inform the development of proposed regulations.

The Government of Canada plans to publish proposed regulations in 2024 in Part I of the Canada Gazette for a 60-day public comment period. The impacts of the policy will be assessed as part of the regulatory process and published in the regulatory impacts analysis statement that accompanies the proposed regulations. Formal written comments will also be sought on the proposal at that time. Publication of the final regulations is targeted for 2025, with the first reporting obligations starting as early as 2026 and full system requirements phased in between 2026 and 2030.

The Government of Canada has not procured any non-government organizations or outside-of-government entities or actors to raise the subject within the Canadian media sphere. The government has not put in place any contracts to support analysis related to the oil and gas emissions cap.

Question No.2685—

[Tony Baldinelli, Conservative, Niagara Falls, ON]

With regard to the Treasury Board Secretariat (TBS) hybrid workforce model for the federal public service: (a) has the TBS ever sought the opinion of the Office of the Privacy Commissioner of Canada regarding the concern for and risk of privacy and data breaches of sensitive and confidential information of Canadian citizens that may be caused with malicious intent such as a cyberattack, accident, or negligence, and, if so, when was the opinion sought and what was the opinion; and (b) is the TBS aware of any privacy and data breaches that have occurred with federal workers operating off-site since March 16, 2020, as a result of working from home on unsecured networks, devices, software, or hardware, and, if so, what are the details of each breach including for each the (i) date, (ii) department or agency involved, (iii) summary of what occurred, (iv) number of individuals whose information was impacted, (v) type of information breached, (vi) length of time until the breach was resolved, (vii) details on if and how those whose information was breached were notified, (viii) date on which the Privacy Commissioner was notified, if applicable?

[Anthony Housefather, Liberal, Parliamentary Secretary to the President of the Treasury Board]

Mr. Speaker, with regard to (a), in the context of the hybrid work model for the federal public service, the Information and Privacy Policy Division of the Treasury Board Secretariat, or TBS, engaged the Office of the Privacy Commissioner of Canada, or OPC, on Access to Information and Privacy Implementation Notice 2020-01: Guidance on delays resulting from measures to mitigate the impact of novel Coronavirus, or COVID-19, on federal workplaces, in March 2020; and the implementation of departmental verification processes that support the irection on prescribed presence in the workplace, in February 2023.

TBS did not consult the OPC specifically on the concern for and risk of privacy and data breaches of sensitive and confidential information of Canadian citizens that may be caused with malicious intent such as a cyberattack, accident, or negligence.

With regard to (b), Appendix A to the TBS Policy on Privacy Protection provides for the following definitions:

Privacy breach means the improper or unauthorized access to, creation, collection, use, disclosure, retention, or disposal of personal information.

Material privacy breach means a privacy breach that could reasonably be expected to create a real risk of significant harm to an individual. Significant harm includes bodily harm, humiliation, damage to reputation or relationships, loss of employment, business or professional opportunities, financial loss, identity theft, negative effects on the credit record and damage to or loss of property.

As per section 4.2.8 of the Policy, heads of government institutions or their delegates are responsible for reporting material privacy breaches to TBS and to the OPC after making efforts to contain, assess and mitigate the breach. Consequently, as per sections 5.2.6 and 5.3.4 of the policy, respectively, TBS and the Privacy Commissioner of Canada are responsible for receiving and reviewing material privacy breach reports.

While TBS centrally tracks certain details related to material privacy breach reports submitted by federal institutions subject to the Privacy Act, it does not track the employee’s work location at the time of the breach. TBS does not centrally track or otherwise receive any details related to non-material privacy reaches.

Question No.2686—

[Leslyn Lewis, Conservative, Haldimand—Norfolk, ON]

With regard to the Known Traveller Digital Identity (KTDI) project announced by the government in January 2018 and the successor pilot on Digital Travel Credentials (DTCs): (a) what is the current status of both projects; (b) why was the decision made to not resume the KTDI; (c) how was the data, including personal data, that was obtained through the KTDI used; (d) was the data, including personal data, that was obtained through the KTDI retained, and, if so, by whom, including the country, territory, organization, and company details, including (i) which types of data were retained, (ii) where is the data stored; (e) what is the nature of the government's involvement, including its agencies, in the new DTC project; (f) what is the World Economic Forum’s involvement in the new project, if any; (g) who are the project partners; (h) what is the end date of the DTC project; (i) how many Canadian travellers opted into the project to date; (j) for travellers who have been participating in the project, what type of data was shared with (i) the government, (ii) third parties; (k) what third parties received the data in (j)(ii); (l) what specific technologies is the government testing, and what are the parameters around that testing; (m) what (i) benefits of, (ii) problems with, the technologies have been identified to date; and (n) what are the total government expenditures related to the KTDI and DTC projects since 2018, broken down by type of expenditure?

[Pablo Rodriguez, Liberal, Minister of Transport]

Mr. Speaker, in regard to (a), Transport Canada, or TC, officially ended its participation in the Known Traveler Digital Identity, or KTDI, project in April 2023. The KTDI Project never launched.

The Digital Travel Credentials, or DTC, pilot project launched on January 7, 2024, and ended on March 31, 2024.

In regard to (b), the KTDI project was delayed indefinitely due to the COVID-19 pandemic in March 2020. In April 2023, TC and the Kingdom of the Netherlands notified the World Economic Forum that they had officially ended their participation due to resource constraints, travel restrictions and competing priorities.

In regard to (c), as the KTDI project was never officially launched, no data was obtained.

In regard to (d), as the KTDI project was never launched, no data of any type was retained or stored.

In regard to (e), TC facilitated the DTC pilot project with KLM Royal Dutch Airlines, or KLM, and the Kingdom of the Netherlands by assisting KLM in receiving a ministerial exemption order from Public Safety Canada for sections 4 and 4.1 of the Secure Air Travel Regulations to allow their use of facial recognition technology in a live pilot to verify the identity of participating passengers at the boarding gate for flights destined to the Kingdom of the Netherlands.

A condition of the ministerial exemption was for KLM to ensure that all passenger participation in the DTC pilot project be voluntary.

In regard to (f), the World Economic Forum was not involved in any capacity with KLM’s DTC pilot project.

In regard to (g), the DTC pilot project partners were KLM, the Kingdom of the Netherlands, and the Montreal-Trudeau International Airport where the live pilot was hosted in Canada for departing flights.

In regard to (h), the DTC pilot project concluded on March 31, 2024.

In regard to (i), as TC did not collect any data from the DTC pilot project, the total number or citizenship of the passengers who volunteered for the pilot is unknown.

In regard to (j) (i) and (ii), no data from the DTC pilot project has been shared with TC, and no data was shared with Canadian third parties, such as the Montreal-Trudeau International Airport.

In regard to (k), no third parties received data.

In regard to (l), TC did not conduct testing as the DTC pilot project was industry-run by KLM in partnership with the Kingdom of the Netherlands.

In regard to (m), as the DTC pilot project was run by KLM, its results, including (i) benefits of, and (ii) problems with the technology, are commercially proprietary. Further information may be available from KLM and the Kingdom of the Netherlands.

In regard to (n), during the length of TC’s participation in the KTDI project, TC’s expenditures totalled $399,938 on salaries and $238,627 on other operating costs.

There are no government expenditures by TC in relation to the DTC pilot project run by KLM and the Kingdom of the Netherlands.