FEDERAL REG

SOR/2016-43: Potable Water on Board Trains, Vessels, Aircraft and Buses Regulations

REGISTRATION OF FEDERAL REGULATION - VIA OIC DATABASE, PRIOR TO PART II OF THE GAZETTE

Registered
March 11, 2016


REGULATORY IMPACT ANALYSIS STATEMENT (This statement is not part of the Regulations.) Executive summary Issues: There are potential public health risks to travellers associated with water supplied on board conveyances. The 1954 Potable Water Regulations for Common Carriers (PWRCC) are federal regulations that aim to mitigate these risks. The PWRCC include provisions related to water disinfection,... (Click for more)


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Published on March 11, 2016

Bill Summary

SOR/2016-43: Potable Water on Board Trains, Vessels, Aircraft and Buses Regulations

REGULATORY IMPACT ANALYSIS STATEMENT (This statement is not part of the Regulations.) Executive summary Issues: There are potential public health risks to travellers associated with water supplied on board conveyances. The 1954 Potable Water Regulations for Common Carriers (PWRCC) are federal regulations that aim to mitigate these risks. The PWRCC include provisions related to water disinfection, water quality and vessel construction that no longer reflect the latest industry or scientific standards. New regulations with modernized requirements will help ensure the continued protection of the travelling public in Canada. Description: The objective of the Potable Water on Board Trains, Vessels, Aircraft and Buses Regulations (the Regulations) is to protect the public by mitigating the risks associated with water supplied to passengers travelling on conveyances. The Regulations retain and clarify the key provisions of the PWRCC while providing updated requirements for water supplied to passengers. The Regulations are in line with recognized Canadian and international standards and industry practices, and will replace the 1954 PWRCC. They will apply to federally regulated passenger conveyances (including aircraft, trains and the following interprovincial and international conveyances: ferries, cruise ships and other passenger vessels, and buses) that are authorized to carry at least 25 passengers. The Regulations apply to water supplied on board passenger conveyances for the purposes of drinking, handwashing and oral hygiene, and for the preparation of food for passengers. Conveyance operators providing water to passengers for any of those purposes will need to ensure that it is potable and that it is provided in sufficient quantity for its intended purpose. Conveyance operators may supply water and ice from prepackaged products, a potable water system, or from potable water containers. Conveyance operators will need to take measures to ensure that the water is free from contamination when it is taken from a water supply and that it is handled in a manner that prevents the risk of contamination on board. Water will need to meet the Escherichia coli (E. coli) parameter set out in the Guidelines for Canadian Drinking Water Quality (the Guidelines), i.e. be free of E. coli. Operators will be required to sample and analyze water from on-board water systems for E. coli on a routine basis, and ensure associated records are kept and accessible for one year (or for two or three years for train operators who are taking routine potable water samples less than once per year). Conveyance operators will be required to disinfect, decontaminate, repair or replace, and flush on-board potable water systems should the water or the system be contaminated or suspected of contamination. Conveyance operators will also need to investigate the source of the suspected or confirmed contamination, assess possible contamination effects on the rest of their fleet, and ensure records about water supplies, system activities and sampling results are kept and accessible for one year. Foreign operators of conveyances with only a single stop in Canada per trip for passengers to embark or disembark (e.g. a U.S. airline operating a flight to a Canadian destination and then returning to the United States) will be excluded from the routine E. coli sampling requirements and from having to complete an assessment as to whether contamination could have affected the other conveyances in their fleet, though they will be subject to all other regulatory requirements. An earlier proposal to modernize and replace the PWRCC was published for public review in the Canada Gazette, Part I, on May 10, 2014. The Public Health Agency of Canada (the Agency) received 18 stakeholder submissions commenting on the proposal. Most stakeholders supported modernizing the PWRCC. Other comments were related to the cost and flexibility of the requirements, requested technical clarifications, and expressed concerns from foreign operators about redundancy. The Agency carefully reviewed all feedback and revised the proposal primarily in the following areas: (1) reducing the regulatory burden for conveyance operators by adding flexibility to the Schedule based on an operator’s routine disinfection frequencies, and changing record-keeping requirements to align with routine sampling frequencies; (2) clarifying several regulatory definitions and simplifying requirements for water system labelling, system disinfection and record keeping; and (3) relieving foreign operators from routine water sampling requirements and the associated record keeping with respect to conveyances that have only a single stop in Canada per trip. Changes to the regulatory proposal were based directly on feedback from stakeholders. These changes resulted in a reduction in the qualitative regulatory burden for stakeholders compared to what was presented in the Canada Gazette, Part I, in 2014, while maintaining the proposal’s public health and safety objectives. A revised proposal was published in the Canada Gazette, Part I, on June 20, 2015. The Agency received nine stakeholder submissions. Overall, comments were very supportive of the proposal and validated the revisions completed since 2014. Based on the stakeholder feedback, two technical edits were introduced to the Regulations for clarity around potable water system requirements and consistency with international requirements for sampling on train cars. In addition, the Agency updated its public guidance documents to support stakeholders who will need to understand the new regulatory requirements and be in compliance when they come into force six months after publication in the Canada Gazette, Part II. Cost-benefit statement: The main costs associated with the Regulations relate to additional water sampling and record-keeping requirements for industry compared to the PWRCC that have been in place since 1954. It is estimated that the Regulations will cost Canadian conveyance operators a total of approximately $79,000 per year. This is approximately $69,000 per year less than the cost of the proposal presented in the Canada Gazette, Part I, in 2014, and is due to the flexibility for reduced water sampling and associated record-keeping requirements that have been introduced for some operators. Costs per individual operator or conveyance are small enough that any resulting impacts passed on to Canadians through ticket price increases are expected to be negligible. It is not anticipated that there will be any incremental costs to the Government associated with the Regulations. The main benefit of the Regulations is the reduction of public health risks associated with water provided to the travelling public on board conveyances. The Regulations are expected to result in reduced cases of illness among travellers in Canada, which may contribute to reduced associated health care costs. Another benefit of the Regulations is the increased flexibility for industry to adopt new technologies, which may result in operational savings that have not been calculated at this time. Overall, the analysis demonstrates that if the Regulations prevent even 1 out of every 20 000 cases of gastrointestinal illness in Canada, the costs will be outweighed by the benefits. “One-for-One” Rule and small business lens: The “One-for-One” Rule applies to the Regulations. The annual incremental increase in administrative costs for conveyance operators resulting from the Regulations, discounted to 2012 values, is estimated to be approximately $29,000 per year (or $37,610 projected to 2016, the year the Regulations will come into force). These increased administrative costs are the result of additional record-keeping requirements related to water sampling. Consequently, the Regulations are considered an “IN” under the “One-for-One” Rule. The total costs to small businesses associated with the Regulations are beneath the threshold for the small business lens, and they are not disproportionately high compared to costs borne by larger businesses. Consequently, the small business lens does not apply. Domestic and international coordination and cooperation: The Regulations align the requirements regarding the drinking water provided to passengers on board conveyances with standards adopted in Canadian provinces and territories, as they reference the E. coli parameter set out in the Guidelines. In addition, the Regulations are comparable to standards and risk-based approaches for potable water on board conveyances outlined in World Health Organization (WHO) guidelines, as well as regulatory frameworks in place in the United States, the European Union and other international jurisdictions. The vast majority of foreign conveyance operators in Canada are already subject to sampling requirements in their own jurisdiction. Foreign operators of conveyances with only a single stop in Canada per trip are therefore excluded from the requirements for routine sampling and associated record keeping. Background Each year, millions of Canadians and international visitors travel on trains, aircraft, vessels (e.g. ferries and cruise ships), and buses. Many of these conveyances provide potable water to passengers. The Department of Health Act sets out the Minister’s mandate, which extends to the protection of public health on railways, ships, aircraft and all other methods of transportation, and their ancillary services. The PWRCC came into force in 1954 and outline requirements, for conveyance operators within federal jurisdiction, to provide to passengers water and ice that is free of pathogenic bacteria, obtained from approved sources, and stored and handled safely. Conveyance operators are required to clearly label components of the potable water system and to clean and disinfect the system at prescribed intervals using specific techniques. The PWRCC also prescribe vessel construction in relation to potable water tanks. Since the implementation of the PWRCC, industry has been adopting improved technologies for the design, construction, storage, treatment and supply of potable water on board conveyances. Industry has been requesting relief from the technical provisions of the PWRCC, as they are no longer reflective of current industry standards. A 2005 audit by the Commissioner of the Environment and Sustainable Development (CESD) recommended that Health Canada revise the PWRCC to include reference to the Guidelines, (see footnote 2) in order to reflect the latest scientific research regarding drinking water quality. Health Canada’s response to CESD acknowledged the need for updated regulations and proposed development of a comprehensive risk-based approach to public health protection on conveyances. The risk-based approach includes repealing the PWRCC and replacing them with the modernized regulatory requirements described below. Since 2006, most Canadian airline operators have voluntarily been working with Health Canada’s Travelling Public Program to develop and implement Potable Water Management Plans (PWMPs) that aim to minimize public health risks associated with potable water. PWMPs are written procedures and documentation that identify and describe the actions and measures that conveyance operators take to mitigate risks, as part of a comprehensive risk-based approach. (see footnote 3) Operators of conveyances from other transportation sectors have also been encouraged to implement PWMPs. Conveyance operators that have developed and implemented PWMPs are expected to be well-positioned for compliance with the Regulations because they already have plans in place to manage and minimize public health risks associated with potable water supplied to passengers. It should be noted that on April 1, 2013, the Travelling Public Program moved from Health Canada to the Public Health Agency of Canada. This change has not affected the Travelling Public Program’s operations. The Agency remains committed to modernizing the PWRCC to help ensure the continued protection of the travelling public in Canada. Issues The health of Canadians and international visitors would be at risk if they were exposed to contaminated water on board conveyances. The PWRCC that are currently in place aim to mitigate risks associated with water supplied to passengers while travelling on conveyances. However, the PWRCC include provisions related to water disinfection, water quality and vessel construction that no longer reflect the latest industry or scientific standards. New regulations with modernized requirements are being implemented to help ensure the continued health protection of the travelling public in Canada. Objectives The objective of the Regulations is to protect the public by mitigating risks associated with water supplied to passengers travelling on conveyances. The Regulations are also intended to modernize requirements for potable water and ice supplied to passengers on board conveyances. Description The Regulations, made pursuant to subsection 11(1) of the Department of Health Act, apply to operators of trains, vessels, aircraft, and buses that are authorized to carry at least 25 passengers and that are within federal jurisdiction. They do not apply to conveyances that are part of an urban transit system, conveyances passing through Canada with no stops, or vessels that start and end their travels in the same province but may pass through another province or another country without stopping. The Regulations do not oblige conveyance operators to provide water to passengers, but they set out requirements for when operators choose to provide water for drinking, handwashing, oral hygiene and food preparation, and when they provide ice for drinks or for cooling foods intended for passengers. The Regulations require conveyance operators to ensure that water and ice are potable and provided in sufficient quantity for passenger needs and for food preparation on board. Water and ice need to be supplied to passengers from an on-board potable water system, or as bottled water and prepackaged ice. Water may also be supplied from a small potable water container, such as a coffee pot or water jug, provided it is a refillable container that is constructed, maintained, stored, moved and handled to help prevent contamination, and that it is readily moveable by one person. Water supplied from an on-board potable water system or potable water containers needs to meet bacteriological parameters for E. coli, as specified in the Guidelines (i.e. no E. coli can be detected in the potable water). (see footnote 4) Prepackaged water and ice are already subject to the requirements of the Food and Drugs Act, (see footnote 5) and Division 12 of the Food and Drug Regulations. (see footnote 6) Conveyance operators will be required to take measures to ensure that water and ice are free from contamination at the time they are taken from water supplies and handled to help prevent contamination during loading onto the conveyance. Vessels that produce potable water on board will be able to load contaminated water (such as seawater, or water drawn from a lake) provided that the water is loaded while the vessel is moving outside the limits of a port or harbour, and that the water is decontaminated before being provided to passengers. Conveyance operators will need to take measures to minimize the risk of contamination when water is handled on board. For example, conveyance operators could use individual-sized bottles or disposable cups when dispensing water to passengers, and could use an ice scoop or tongs to handle ice. Components of on-board potable water systems need to be easily identifiable in order to avoid confusion with other systems on board (such as grey water or wastewater systems). Each storage tank and filling connection needs to have a label identifying it as potable water. To monitor the level of E. coli in water from on-board potable water systems, conveyance operators will be required to sample and analyze water on board for E. coli on a routine basis, at sampling sites specified in the Schedule of the Regulations. Sampling frequencies are based on public health risk and vary by type of conveyance. Conveyance operators will be able to select among different sampling and disinfection frequencies that afford flexibility based on the frequency of routine disinfection activities. Sampling is a tool used to verify that water supplies are potable or to identify contamination that needs to be addressed. Routine disinfection and flushing of on-board potable water systems is a protective health measure that can prevent contamination from developing or persisting. Disinfection and sampling activities complement each other, and operators that conduct more frequent disinfection and flushing will not have to complete water sampling as frequently. Analysis of water samples needs to be conducted in accordance with Part 9000 of the Standard Methods for the Examination of Water and Wastewater. (see footnote 7) Conveyance operators will be required to disinfect and flush potable water systems any time water sampling confirms the presence of E. coli. They will also be required to disinfect, decontaminate, repair or replace and flush potable water systems any time there are grounds to believe the water may have been contaminated with E. coli or another contaminant. Taking water samples will be required in order to complete analysis to ensure that the E. coli, or any other suspected or confirmed contamination, has been removed. Conveyance operators will also be required to investigate the source of contamination and assess possible impacts on any other conveyance within the operator’s fleet. Conveyance operators will be required to keep or have access to a record that specifies where and when water samples have been taken, the type of analysis completed, and the results. Conveyance operators will also need to keep or have access to a record that includes the date, time and description of system disinfection, decontamination, repair or replacement and flushing, as well as any other corrective measures. Conveyance operators will need to keep a record of any investigations related to suspected or confirmed contamination, and a record of the assessment of whether any other conveyances in their fleet were affected. Conveyance operators will be required to ensure that all records are kept and readily accessible for examination by a designated inspector for a period of one year (or for two or three years for records of routine sampling and disinfection on board trains for operators taking routine potable water samples less than once per year). The vast majority of foreign conveyance operators in Canada are already subject to sampling requirements in their own jurisdiction. Consequently, foreign conveyance operators will be excluded from the requirements for routine sampling and associated record keeping for conveyances that have only a single stop in Canada per trip for passengers to embark or disembark. They will also be excluded from the record keeping associated with investigating suspected or confirmed contamination of a water system and the assessment of impacts on the operator’s fleet, as this would likely take place outside of Canada and beyond the scope of regulatory authority conferred by the Department of Health Act. All foreign conveyance operators will remain subject to the other requirements of the Regulations, including the provision of water to passengers that is free from contamination, taking measures to prevent contamination when loading and serving water, maintaining on-board potable water systems, and keeping, or having access to, records about corrective measures taken. Furthermore, foreign conveyances operating in Canada for extended trips with multiple stops for passengers to embark or disembark, such as cruise ships travelling along Canada’s coasts, remain subject to all regulatory requirements including routine sampling. The Regulations specify that the Minister of Health will inform conveyance operators of the results of statutory inspections and water samples taken on board conveyances, which is already a practice of the Public Health Agency of Canada. The Regulations will repeal and replace the PWRCC and will come into force six months after the day they are published in the Canada Gazette, Part II. Regulatory and non-regulatory options considered In addition to the approach described above, the following options were considered. Status quo As described in the “Background” section, the PWRCC contain provisions related to water disinfection and vessel construction that no longer reflect the latest industry or scientific standards. The PWRCC do not reference the E. coli parameter in the Guidelines and are not consistent with the latest scientifically accepted standards for drinking-water quality. Updating the PWRCC requirements is therefore expected to better protect the health of the travelling public. For these reasons, maintaining the status quo as a viable option was rejected. Voluntary option As indicated above, PWMPs have been implemented by most conveyance operators in the airline sector. Conveyance operators in other sectors are developing and increasingly adopting similar plans. PWMPs provide flexibility for conveyance operators to choose the most appropriate actions and measures to meet the Guidelines’ parameter for E. coli; however, a voluntary approach would not necessarily result in all conveyance operators adopting and implementing PWMPs to mitigate risks associated with potable water provided to passengers. Further, adopting a voluntary approach lacks a compliance and enforcement mechanism and would not include mandatory corrective measures from an operator should the potable water or the potable water system of a conveyance be contaminated. Given the potential public health risks to travellers associated with water supplied on board conveyances, a voluntary approach was not deemed sufficient and was rejected. Benefits and costs The Public Health Agency of Canada identified and analyzed the key costs and benefits of the Regulations. The analysis included impacts of the Regulations on industry, consumers, the Government and Canadians. This analysis was based on a projected scenario that is believed to represent the most likely outcome of the regulatory change. Efforts were made to provide a quantitative and monetized analysis; however, due to limitations with data availability, it was not possible to quantify and monetize all expected impacts of the Regulations. Qualitative assessments are provided in instances when quantification or monetization was not possible. Results of the analysis undertaken are summarized below. Additional details on the analysis conducted and the underlying data are available on request. Analytical framework The cost-benefit analysis identifies and quantifies, to the extent possible, the incremental costs and benefits of the Regulations by comparing the Regulations to the status quo. Implementing the Regulations will require little or no upfront capital costs, so the only significant costs are expected to be the annual compliance and administrative costs. Costs on a per-conveyance basis are assumed to be fairly constant over time. Therefore, the total costs associated with the Regulations are expected to increase proportionately to any increase in the total number of conveyances operating in Canada over time. The benefits of the Regulations are dependent on the number of passengers. This is also expected to increase over time proportionately to any increase in the number of conveyances operating in Canada. Since costs and benefits are both dependent almost exclusively on the number of conveyances operating in a given year, the benefit-to-cost ratio is expected to be relatively constant over time. The period of time covered by this analysis, therefore, would not affect the determination as to whether total benefits are larger than total costs. For consistency with other elements of the Regulatory Impact Analysis Statement, a 10-year time horizon has been adopted for this analysis. A discount rate of 7% is used for estimating the present value (base year: 2016) of the monetized impacts over time. (see footnote 8) In-house conveyance data were used as key data and information sources. Data were verified by industry stakeholders through consultation in 2013 and revised based on stakeholder submissions received during the 2014 and 2015 public review periods. Key assumptions All conveyance operators will assume costs related to understanding the new Regulations, but these costs are believed to be negligible. The size of the conveyance industry will remain stable over 10 years. While there is some uncertainty about this simplifying assumption, as noted above, the magnitude of both the costs and benefits depend on the number of conveyances. Any increase in the size of the industry will result in a proportionate increase in both costs and benefits, and will therefore not have a significant impact on the net present value. Conveyance operators will choose whether or not to provide water or ice to passengers or for food preparation on board, and how to do so. Buses that are authorized to carry 25 or more people, and that are used for interprovincial or international travel, are captured by the Regulations. Most bus operators, however, do not provide water from a potable water system to their passengers, so they will not be required to conduct routine water sampling as per the Regulations. As a result, no incremental costs are expected to be carried by bus operators, and they are excluded from the cost-benefit analysis calculations below. Conveyance operators providing water to passengers by way of a potable water system will maintain current practices for water sampling and system disinfection if they are currently meeting one of the options of the Schedule, and will not face additional compliance costs. As per the Schedule, operators may select from different routine sampling frequencies, depending on how frequently they routinely disinfect the on-board potable water systems. Operators of conveyances that are not already meeting one of the frequencies for sampling set out in the Schedule could choose to take additional samples to meet the regulatory requirements or alternatively, they could increase disinfection activities. Given that disinfecting and flushing a potable water system takes longer and is generally more costly than taking additional water samples, it is assumed that operators will choose to increase water sampling instead of increasing disinfection and flushing frequency, as this would be the less expensive approach to reach compliance with the Regulations. Table 1: Incremental cost-benefit statement (see footnote 9) This table shows the Incremental cost-benefit statement. Base Year Final Year Total (Undiscounted) Present Value (at 7% Discount Rate) 2016 2025 Total (Undiscounted) Present Value (at 7% Discount Rate) A. Quantified costs (CAD 2012) A. Quantified costs (CAD 2012) A. Quantified costs (CAD 2012) A. Quantified costs (CAD 2012) A. Quantified costs (CAD 2012) Industry costs Industry costs Industry costs Industry costs Industry costs Compliance costs: water sampling $41,154 $41,154 $411,540 $289,052 Administrative costs: record keeping $37,610 $37,610 $376,100 $264,156 Total $78,764 $78,764 $787,640 $553,208 B. Benefits — Qualitative impacts B. Benefits — Qualitative impacts B. Benefits — Qualitative impacts B. Benefits — Qualitative impacts B. Benefits — Qualitative impacts Health care system and human health Reduced rates of illness as a result of reducing passengers’ exposure to contaminated water supplies on board conveyances will lead to improved public health, improved quality of life and reduced health care costs. Reduced rates of illness as a result of reducing passengers’ exposure to contaminated water supplies on board conveyances will lead to improved public health, improved quality of life and reduced health care costs. Reduced rates of illness as a result of reducing passengers’ exposure to contaminated water supplies on board conveyances will lead to improved public health, improved quality of life and reduced health care costs. Reduced rates of illness as a result of reducing passengers’ exposure to contaminated water supplies on board conveyances will lead to improved public health, improved quality of life and reduced health care costs. Industry Performance-based regulatory design will enable potential cost savings through flexibility to adopt new technologies. Performance-based regulatory design will enable potential cost savings through flexibility to adopt new technologies. Performance-based regulatory design will enable potential cost savings through flexibility to adopt new technologies. Performance-based regulatory design will enable potential cost savings through flexibility to adopt new technologies. Costs Compliance costs (e.g. costs for water sampling and analysis) and administrative costs (e.g. collecting information and record keeping) will be carried by conveyance operators to comply with the Regulations. The federal government will assume negligible implementation costs associated with communicating to stakeholders about the Regulations. The Government is already completing risk-based inspections and reporting back to conveyance operators, in line with the Regulations. Consequently, the new activities associated with the Regulations will be accommodated with existing resources without an increase in workload. Compliance costs for Canadian industry When the Regulations come into force, conveyance operators will assume incremental compliance costs associated with the requirements for sampling and laboratory analysis of potable water quality. Other requirements of the Regulations, including taking measures to ensure water and ice supplies are free of contamination at the time they are taken from supplies, preventing contamination during loading and handling of water, and requirements related to the design, construction, and operation of on-board potable water systems, are not new. They modernize and update provisions in the PWRCC. Therefore, conveyance operators are not expected to assume any incremental compliance costs related to these requirements. It is estimated that on average, activities related to water sampling will cost $46.75 per water sample. This includes labour costs (15 minutes per sample at $47/hour), sampling and analysis costs ($25 per sample), and courier costs ($10 per sample). Data from the Public Health Agency of Canada indicates that there are currently almost 1 200 conveyances (aircraft, cruise ships, expedition vessels, ferries and trains) operated by 41 Canadian businesses that will need to be compliant with the Regulations. Considering the level of adoption of PWMPs (which include routine sampling and disinfection procedures) and the current level of compliance with the PWRCC, the Agency estimates that operators of approximately 300 conveyances will need to implement additional water sampling to comply with the frequency set out in the Schedule. Operators of the approximately 900 remaining conveyances are not expected to assume any incremental compliance costs associated with the water sampling requirements of the Regulations since they are either currently sampling and analyzing their potable water at one of the required frequencies set out in the Schedule, providing only prepackaged water to passengers on board or not providing potable water at all. The costs for each conveyance depend upon the frequency of sampling and the number of individual samples taken as part of each sampling process. The requirements vary by sector and use of the conveyance, and operators may adopt reduced routine sampling if they frequently disinfect their on-board potable water systems. Rail operators will be required to take two routine samples from each train car, and will have the flexibility to select one of the following as per the Schedule: 1) taking samples from each train car, once per year; 2) taking samples from each train car once every two years, with disinfection of the on-board potable water system three times per year; or 3) taking samples from each train car once every three years, with disinfection of the on-board potable water system four times per year. Operators of aircraft and vessels without sleeping accommodations (including most ferries operating in Canada between provinces or internationally) will be required to sample up to four times per year, taking two samples each time. Operators that routinely disinfect their potable water systems will be subject to reduced routine sampling requirements, sampling on-board water supplies either once or twice per year (depending on how frequently the on-board potable water system is disinfected and flushed), and taking two samples each time. Operators of vessels with sleeping accommodations for passengers (including cruise ships, expedition vessels and some ferries operating in Canada), and any other vessels that draw water from lakes or oceans and convert it to potable water on board, will be required to sample their water once per month, taking four samples each time. These vessels do not typically operate year round, and will only be required to sample their water systems while operating. Taking into consideration the cost per sample and the number of additional samples required each year for all Canadian operators to meet the frequency set out in the Schedule, the estimated total incremental compliance costs to undertake the water sampling and analysis for all conveyance operators in Canada is approximately $41,154 per year. (see footnote 10) This represents a 51% reduction (difference of $43,277) to annual compliance costs compared to those in the proposal presented in the Canada Gazette, Part I, in 2014, which had an estimated incremental compliance cost for Canadian industry of $84,431 per year. The reduced cost is a result of modifications to the Regulations that increase flexibility for operators to select from different sampling options depending on the frequency of routine disinfection of the on-board potable water system. With the introduction of the modified Schedule, fewer operators need to increase sampling to comply with the Regulations. The cost per sample has not changed, but the total number of new samples required per 12-month period is significantly reduced, while health protection for travellers is maintained since operators will still need to disinfect and flush their systems routinely, which helps prevent contamination from developing or persisting within a water system. The breakdown by individual sector is shown in the table below. Note that the cost-benefit analysis was validated by comments received from industry based on the proposal prepublished in the Canada Gazette, Part I in 2015, and has not been revised since then. Based on stakeholder comments received in 2015, the Agency revised the Regulations to include a new sampling and disinfection option for rail operators in the Schedule, introducing an additional option for sampling train cars once every 36 months (with disinfection and flushing of the on-board potable water system at least once every three months). This is in addition to the Schedule’s provisions for rail operators who may also select train car sampling every 12 or 24 months, depending on routine disinfection practices. This additional flexibility does not affect the cost-benefit analysis for the Regulations as many Canadian rail operators are seasonal. Seasonal rail operators will not be eligible to select routine sampling at 24 or 36 month intervals, because they will be required to disinfect, flush and sample their train cars at least annually, after returning train cars to service after not being used for a season. Other operators that run rail service year round are not currently disinfecting and flushing their train cars at the frequencies needed to opt for the 36-month routine sampling frequency. It is still assumed that Canadian rail operators will take additional samples to meet the 12-month sampling requirement rather than introduce additional disinfection and flushing procedures. In the future, Canadian operators may adjust their practices and select a different sampling and disinfection frequencies, but this analysis is based on incremental costs compared to existing practices. While there are no cost-savings for Canadian operators directly related to the new sampling flexibility, it will help align requirements for Canadian operators with those in place in the United States. Major passenger rail operators in the U.S. are required to sample their fleet of train cars on a three-year cycle, and to routinely disinfect on-board potable water systems every three months. Table 2: Incremental compliance costs This table shows the incremental compliance costs. Sector Number of Conveyance Operators Number of Conveyances Number of Samples per 12-Month Period Required for Each Conveyance (see note 1) Cost per Sample Number of New Samples Required (see note 2), (see note 3) Total Annual Cost Total Annual Cost Projected to 2016 Rail 5 462 0–2 $46.75 222 $10,379 $10,729 Airlines 29 691 2–8 $46.75 568 $26,554 $27,341 Vessels without sleeping accommodations 4 9 2–8 $46.75 40 $1,870 $1,928 Vessels with sleeping accommodations 3 3 12 (see note 4) $46.75 24 $1,122 $1,156 Total 41 1 165 N/A $46.75 854 $39,925 $41,154 Notes: Note 1 As per the Schedule, operators may select from different routine sampling frequencies, depending on how frequently they routinely disinfect the on-board potable water systems. Note 2 The number of new samples per sector is based on Public Health Agency of Canada data about industry PWMPs and existing practices around routine water sampling and disinfection. It was assumed that operators already meeting one of the frequencies for sampling set out in the Schedule will maintain existing practices and no new samples were estimated. Note 3 The most demanding routine sampling requirement was used to calculate the additional costs for conveyances not already meeting one of the frequencies presented in the Schedule (e.g. two samples per year per train car, eight samples per year per aircraft or vessel without sleeping accommodations). It is assumed that operators will select increasing water sampling, which can be completed in just a few minutes, rather than increasing the frequency of routine disinfection and flushing activities, which will generally require removing the conveyance from operation. Note 4 Operators of vessels with sleeping accommodations are required to take at least four water samples each month when the vessel is operational. As most vessels with sleeping accommodations (including cruise ships, expedition vessels, and some ferries) operate just a few months per year in Canada, an average of 12 samples per year for each conveyance will be required. The largest share of the expected compliance costs will be borne by the airline industry, due to the large number of impacted conveyances and the number of samples (up to eight) per plane that are required per year. The rail industry also accounts for a large proportion of the costs. The vast majority of the conveyances for which costs will be incurred are owned and operated by medium or large companies. Of the 277 conveyances expected to be impacted, only 10 are owned by small companies. These include four train cars, five airplanes, and one ferry. Total costs to small businesses under the Regulations will be an estimated $2,618 per year (or $262 per conveyance). Over a 10-year time horizon, the total compliance costs of the Regulations, for all affected conveyance operators, will be $411,540 in undiscounted costs. Discounting future costs at 7% per year, the total present value of compliance costs would be $289,052. Administrative costs to Canadian industry The Regulations will require conveyance operators to compile, store, and provide access to records about water supplies, water sampling results, disinfection, decontamination and flushing activities, and investigations into suspected or confirmed water contamination for a period of one year. The other regulatory requirements (including provision of water free from contamination and requirements related to the design, construction, and operation of on-board potable water systems) are not new. They modernize and update provisions in the PWRCC. Therefore, operators are not expected to bear incremental costs related to these requirements. The Regulations will require conveyance operators to record and maintain water sampling results for all conveyances under their operation (i.e. approximately 1 200 conveyances in total). Conveyance operators will, therefore, have increased administrative costs associated with all of the conveyances they operate, not just those conveyances for which water sample frequency needs to be increased. Aircraft, train and ferry operators with PWMPs are already keeping records of water sampling; however, these records may not be easily accessible for examination for one year. This analysis assumes that in order to implement the Regulations, all conveyance operators in the airline, train and ferry sectors, even conveyance operators with PWMPs, will bear incremental administrative costs associated with recording water sampling results. This analysis assumes that for each sample collected, approximately 15 minutes will be needed to record the results. Assuming a labour cost of $47 per hour, administrative costs will be $11.75 per sample collected. The frequency of sample collection and the number of samples collected each time will depend on the frequency of routine disinfection. In-house data from the Travelling Public Program was used to estimate annual costs per conveyance, based on each individual operator’s current practices for routine water sampling and disinfection and information in industry PWMPs. For example, if an airline is currently disinfecting on-board potable water systems every 90 days and taking two samples per year, the cost of record keeping for those two samples has been estimated. An airline operator who currently completes no routine disinfection of an on-board potable water system will be required to add an additional eight samples per aircraft per year, so costs of recording eight water samples have been estimated. No costs for record-keeping requirements beyond water sampling (i.e. measures to ensure water taken from supplies are free from contamination, flushing and disinfection activities, potable water system repairs and replacements, records from investigating possible contamination) have been estimated. Almost all conveyance operators are already meeting these requirements, or will be able to do so with little or no change to existing procedures. Most conveyance operators already keep records about water supply loading procedures, disinfection and flushing activities. They also keep records about special corrective measures, such as flushing, disinfection, decontamination, repairs and replacements, as well as investigations into possible contamination of water on board. Almost all the remaining conveyance operators have access to such records through subcontractors, such as water haulers. Since existing industry practices are sufficient to meet these requirements, no associated incremental administrative costs have been estimated. The total administrative costs associated with the Regulations are estimated to be $37,610 per year. (see footnote 11) Details of this calculation, and the costs by sector, are shown below. This represents a 41% reduction ($25,934 less) to annual administrative costs compared to the proposal presented in the Canada Gazette, Part I, in 2014, which had an estimated incremental compliance cost to Canadian industry of $63,544 per year. With the introduction of the modified sampling frequencies, the total number of samples necessary in a 12-month period is reduced, since many operators will be able to adopt reduced sampling frequencies given their routine disinfection practices. The cost per sample for record keeping has not changed, but the total number of records required per 12-month period is significantly reduced. The health of travellers will continue to be protected, as operators will still need to disinfect and flush their systems routinely, to help prevent contamination from developing or persisting within a water system. Table 3: Incremental administrative costs This table shows the incremental administrative costs. Sector Number of Conveyance Operators Number of Conveyances Number of Samples per 12-Month Period Required for Each Conveyance (see note 5) Total Number of Samples to be Recorded per 12-Month Period (see note 6) Cost per Sample Total Annual Cost Total Annual Cost Projected to 2016 Rail 5 462 0–2 486 $11.75 $5,711 $5,906 Airlines 29 691 2–8 2 498 $11.75 $29,352 $30,342 Vessels without sleeping accommodations 4 9 2–8 72 $11.75 $846 $874 Vessels with sleeping accommodations 3 3 12 (see note 7) 40 $11.75 $470 $484 Total 41 1 165 N/A 3 096 $11.75 $36,378 $37,610 Notes: Note 5 As per the Schedule, operators may select from different routine sampling frequencies, depending on how frequently they routinely disinfect the on-board potable water systems. Note 6 The total number of samples per sector is based on Public Health Agency of Canada data about industry PWMPs and existing practices around routine water sampling and disinfection. It was assumed that operators already meeting one of the frequencies for sampling set out in the Schedule will maintain existing practices, and record-keeping costs for current practices were estimated for those conveyances. For conveyances not already meeting one of the frequencies presented in the Schedule, the most demanding routine sampling requirement was used to calculate the additional costs (e.g. two samples per year per train car, eight samples per year per aircraft or vessel without sleeping accommodations). Note 7 Operators of vessels with sleeping accommodations are required to take at least four water samples each month when the vessel is operational. As most vessels with sleeping accommodations (including cruise ships, expedition vessels, and some ferries) operate just a few months per year in Canada, an average of 12 samples per year for each conveyance will be required. As with compliance costs, the bulk of the administrative costs are borne by the airline sector, with the rail sector accounting for most of the remaining costs. The administrative burden imposed by the Regulations will impact five small businesses that operate a total of four train cars, five airplanes, and one ferry. Total administrative costs for these five small businesses will be $658 per year (or $66 per conveyance). Over a 10-year time horizon, the total administrative costs of the Regulations, for all affected conveyance operators, will be $376,100 in undiscounted costs. Discounting future costs at 7% per year, the total present value of compliance costs will be $264,200. Total costs to domestic industry The Regulations impose an estimated $41,154 per year on industry for compliance costs, and an estimated $37,610 per year for administrative costs, for total costs of $78,764 per year to Canadian industry. This represents a 47% reduction from the $147,975 per year that was estimated for Canadian industry to meet the regulatory requirements in the Regulations proposed in the Canada Gazette, Part I, in 2014. When a 7% discount rate is applied, the present value of all costs to industry, over the next 10 years, is estimated to be $553,208. These expected costs to industry represent a very small fraction of the total costs of operating conveyances in Canada. Conveyance operators that will be affected by the Regulations have costs and revenues that are estimated to be over $25 billion per year, and they transport millions of passengers every year. The Regulations are estimated to cost less than one thousandth of one percent of total operating costs for the transportation industry, or less than one cent per passenger. Therefore, the Regulations are not expected to have any significant impact on the competitiveness or profitability of Canadian conveyance operators. Costs to international industry The analysis above includes only Canadian-owned conveyance operators. The Public Health Agency of Canada estimates that 117 international companies operate 505 passenger conveyances in Canada at any time (most of which are airplanes); these conveyances will be subject to the Regulations. Foreign stakeholders advised the Agency through comment submissions that, in addition to ensuring compliance with the regulatory proposal for conveyances operating in Canada at any time, they will need to ensure compliance for all conveyances in their fleets to ensure scheduling flexibility for future travel or in case of disruptions, when one conveyance must be substituted for another. This would have extended the impact of the Regulations to thousands of conveyances worldwide. However, as per changes introduced since the version published in the Canada Gazette, Part I, in 2014, the foreign airplanes, ferries and most railways operating in Canada have only a single stop in Canada per trip for passengers to embark or disembark (for example a U.S. airline operating a flight to a Canadian destination and then returning to the United States), so they will not be subject to the routine sampling requirements of the Regulations. As a result, they are not expected to bear incremental costs associated with the Regulations. Foreign conveyance operators will remain subject to all other regulatory requirements, such as providing passengers with water that is free from contamination, taking measures to prevent contamination when loading and serving water, maintaining on-board potable water systems, and keeping or having access to records of corrective measures taken. No costs for these requirements have been estimated, since almost all operators already meet them as per the existing requirements of the PWRCC and regulatory requirements in the jurisdictions where they are registered, or will be able to do so with few or no changes to existing procedures. Operators of foreign conveyances that travel between two or more points in Canada in a single trip will be subject to all requirements of the Regulations, including routine water sampling and record-keeping provisions. This will affect most cruise ships operating in Canada as they travel between multiple points in Canada (for example making stops at several ports in the Maritimes or along Canada’s Pacific coast). This analysis assumed that international cruise ship operators are already meeting requirements of the Regulations as per the requirements of the Public Health Agency of Canada’s Cruise Ship Inspection Program, (see footnote 12) which are harmonized with requirements of the U.S. Centers for Disease Control and Prevention (CDC) Vessel Sanitation Program. (see footnote 13) Cruise ship operators are therefore not expected to bear any incremental costs to comply with the Regulations. These regulatory requirements will also apply to a small number of trains that enter Canada from the United States and have multiple stops here. U.S. registered rail operators are not expected to bear any incremental costs to comply with the Regulations when operating in Canada, as they are already subject to comparable requirements under the U.S. Environmental Protection Agency’s (EPA) Federal Safe Drinking Water Act, and other requirements set out by the EPA for individual operators through legally binding agreements known as Administrative Orders of Consent. The Regulations are not expected to affect the decisions of international carriers to operate in the Canadian marketplace, to result in any noticeable impact on international ticket prices, or to have any impact on the scale of international conveyance operations in Canada. Costs to consumers Consumers travelling on conveyances are not expected to be adversely impacted by the Regulations. Costs to conveyance operators will be small enough that any resulting costs passed on to consumers in the form of higher ticket prices are expected to be negligible. Costs to Government The federal government will incur negligible implementation costs associated with communicating with stakeholders about the Regulations. The federal government is already completing inspection and sampling activities and reporting back to conveyance operators, in line with the Regulations. Consequently, the new activities associated with the Regulations will be accommodated with existing resources and there will be no increase in workload for inspectors. Benefits The Regulations will maintain the objective of the PWRCC and are expected to benefit Canadians as described below. Health benefits It is expected that the increased water-sampling and record-keeping requirements outlined in the Regulations will lead to the improved safety of water used on conveyances in Canada, thereby reducing the risk of illness for the travelling public. Canadians will benefit from improved public health standards related to water on conveyances, including those that have not yet implemented PWMPs. Specifically referencing the E. coli parameter of the Guidelines and requiring operators to take corrective measures and investigate any suspected or confirmed on-board water contamination will help mitigate risks associated with potable water supplied to passengers on board conveyances and help reduce public exposure to this pathogen. For travellers and the Canadian population, the Regulations are expected to contribute to reduced rates of gastrointestinal illness. Gastrointestinal illness in Canada is a widespread problem that imposes significant costs on the medical system and on the productivity of Canadian workers. Precise estimates of the incidence of this illness or the burden to the health care system and the Canadian economy are difficult to obtain, since most cases of gastrointestinal illness do not receive treatment by a physician. Some studies suggest that for every case of gastrointestinal illness that is reported, there are over 300 unreported cases. (see footnote 14) The Public Health Agency of Canada estimates that Canadians experience an average of 1.3 episodes of gastrointestinal illness per person per year, for a total of 42 million cases per year in Canada. (see footnote 15) The Public Health Agency of Canada estimates that the economic costs of this illness may be about $88 per case, for total economic costs of $3.7 billion per year in Canada. There is no information about the number of cases of gastrointestinal illness resulting from exposure to contaminated water on board conveyances, so it is not possible to precisely quantify and monetize the health benefits of reduced illness attributable to the Regulations. However, if even a small fraction of all gastrointestinal illnesses are related to water consumption on board conveyances, then the health benefits of the Regulations could be significant. For example, if the Regulations prevent even 1 out of every 20 000 cases of gastrointestinal illness in Canada, then the economic benefits will be approximately $185,000 per year, based on the costs of illness reported by the Public Health Agency of Canada. Benefits to industry The Regulations are tailored to provide industry with the flexibility to adopt modern or new technology for potable water system design, construction and operation, including methods of disinfection and frequency of sampling and disinfection that suit conveyance operators’ particular circumstances. The associated benefits are expected to reduce the cost of investment and the time needed for disinfection activities. The Regulations will complement the PWMPs that have already been developed and implemented by many Canadian conveyance operators. Furthermore, vessel operators will no longer bear the administrative costs of submitting ships’ potable water system plans to the Minister, which is a requirement of the PWRCC currently in place. Benefits to Government In addition to addressing the recommendation of the CESD, referencing the E. coli parameter of the Guidelines supports consistency with water regulations in Canadian provinces and territories that also use the Guidelines to inform their respective water regulations. “One-for-One” Rule As noted above, the Regulations are expected to result in an increase in administrative costs to Canadian industry of $37,610 per year. Assuming that 2016 is the first year in which administrative costs will be imposed as a result of these Regulations, the total present value costs, discounted at 7% per year, of these Regulations over the 10-year period from 2016 to 2025 will be $264,156. This is considered the “IN” under the “One-for-One” Rule. On the day of their coming into force, the Regulations will repeal and replace the PWRCC. The repeal of the PWRCC will offset the implementation of the Regulations, satisfying the second element of the “One-for-One” Rule that requires a regulator to remove a regulation each time they introduce a new regulation that imposes new administrative burden on business. Small business lens The total costs to small businesses associated with the Regulations are beneath the threshold for the small business lens and are not disproportionately high compared to costs borne by larger businesses. Consequently, the small business lens does not apply. The total costs to small business resulting from the Regulations (both compliance and administrative) are estimated to be just under $3,300 per year. Costs associated with the Regulations are dependent upon the number of conveyances owned by each operator and their sampling and disinfection practices. Individual small businesses will have lower costs, because they operate fewer conveyances, but their costs per conveyance will be comparable to the costs for larger businesses (and dependent on the frequencies of sampling and disinfection practices, which may be selected by operators as per the Schedule, depending on operational requirements). Therefore, the Regulations will not impose costs on small businesses that are disproportionate relative to the costs for larger conveyance operators. Consultation The need for modernized regulatory requirements to mitigate public health risks associated with potable water provided to passengers on board conveyances was discussed for many years by the conveyance industry as well as the federal government and international partners. Pre-consultations Health Canada held discussions with stakeholders and partners during the development of the Regulations. Industry Health Canada held preliminary consultations with conveyance industry stakeholders during two days in October 2011. The first day was held with representatives from the airline industry, including representatives from industry associations and flight kitchens. The second day included representatives from rail, ferry, cruise ship and small vessel companies and industry associations. During these meetings, Health Canada outlined its intentions to proceed with modernizing the PWRCC in line with recognized Canadian and international standards. Overall, industry showed support for the initiative and expressed the view that the adoption of standards consistent with other regulatory authorities would be very beneficial in order for the industry to remain competitive. There was also strong support for performance-based regulations rather than prescriptive provisions that do not give the industry the flexibility to adopt new technologies as they arise. In January 2013, Health Canada met with airline, rail, bus, cruise ship, and ferry associations and conveyance operators to present the requirements of proposed Regulations and solicit feedback. In general, industry stakeholders were very supportive of the proposed Regulations, including the flexibility to adopt disinfection processes and technologies that are results-based. Some issues were raised during the consultations. Below is a summary of the key comments as well as the Public Health Agency of Canada’s response, which was reflected in the regulatory proposal published in the Canada Gazette, Part I, in May 2014. The airline and rail industries noted that the projected costs of water sampling to industry under the proposed Regulations were underestimated. The costs were subsequently adjusted to include labour and courier costs and are reflected in the cost-benefit statement above. The airline and rail industries were concerned with the record-keeping requirements to document source water and time of uploading water onto aircraft. In response to these concerns, the proposal was revised so that industry is required to have a record of the date, place and source of water being loaded on board a conveyance, but not the time. The Public Health Agency of Canada reiterated that industry will not be required to implement brand new record-keeping systems, and the Agency revised the proposed Regulations to remove the requirement that records be available on board conveyances. Rather, the revised proposal required conveyance operators to ensure that records are made accessible for examination upon request (e.g. for the purposes of an inspection or an investigation of potential public health risk associated with the water supply). Some airline and rail stakeholders also raised concerns about the frequency of sampling required, suggesting this would be logistically challenging. Given the risks and the flexibility offered in the proposal with disinfection technology, routine water sampling based on risk is required to help ensure the water supply remains safe from a public health perspective. Therefore, the proposed Regulations were not changed at the time. Other Canadian jurisdictions Transport Canada and the Labour Program of Employment and Social Development Canada (formerly Human Resources and Skills Development Canada) have been consulted throughout the regulatory process and are supportive of the Regulations. During the summer and fall of 2011, the regulatory proposal was presented to the Council of Chief Medical Officers of Health (CCMOH), which represents all provincial and territorial public health authorities. Health Canada also held informal discussions with provincial and territorial partners. There was general support for the proposal among the CCMOH and the provincial and territorial partners. Consultation on proposed Regulations in the Canada Gazette, Part I, 2014 The proposed Regulations and the accompanying Regulatory Impact Analysis Statement were prepublished in the Canada Gazette, Part I, (see footnote 16) followed by a 75-day public comment period from May 10, 2014, to July 24, 2014. During the comment period, the Public Health Agency of Canada reached out to industry stakeholders, the CCMOH, other Canadian health and transportation authorities as well as international partners to provide information on the proposal and discuss how the proposed Regulations would be implemented. The Agency received 18 letters with comments and suggestions during the public comment period from the following sectors: Canadian and international conveyance industry operators and associations, public health authorities, and federal government representatives. Overall, most stakeholders expressed support for the regulatory objectives and suggested that modernizing the PWRCC is overdue. Other stakeholder comments on the proposal related to flexibility and cost, technical clarifications, and redundancy for foreign operators. Comments are summarized below along with responses from the Agency. Flexibility and cost In general, there was support for the flexibility provided for operators to select appropriate methods of disinfection based on their operational requirements, and allowing industry to adopt new technologies as they arise. There were some comments requesting additional options for water sampling frequency and testing sites. The Public Health Agency of Canada revised the Schedule’s sampling sites to ensure its applicability for conveyances with different water system configurations on board. The added flexibility for routine sampling is intended to alleviate some industry concerns about the costs of implementing the proposed Regulations, while ensuring on-board water systems remain safe through the regular disinfection and analysis of water supplies. One stakeholder noted that the proposed Regulations would not allow operators to bring jugs of water, tea or coffee on board for service to passengers, which is a common practice for aircraft and rail operators. The Public Health Agency of Canada added a new provision to allow operators to carry water on board in a small container, provided it is a refillable container that is readily moveable by one person, and is constructed, maintained, stored, moved and handled to help prevent contamination. The Public Health Agency of Canada also reviewed the record-keeping provisions. The cost to record every water upload was a significant concern to several stakeholders. The Public Health Agency of Canada replaced that requirement with a performance-based requirement for operators to maintain a record about investigations into any suspected or confirmed contamination of water on board, and to take measures to address the source of contamination. The Public Health Agency of Canada clarified the requirements regarding water supplies that can be loaded onto conveyances, and revised the requirement to keep records accessible from 36 months to 12 months, to align with international industry requirements. This will not compromise public health investigations into suspected risks undertaken by operators or the Public Health Agency of Canada, since such investigations would be completed within days or weeks. The Public Health Agency of Canada did not revise the cost-benefit analysis to add training costs related to the proposed Regulations, as suggested by two commenters. Operators are already subject to staff training costs associated with the PWRCC, and after negligible costs to all operators to understand the new requirements, significant incremental training costs associated with the Regulations are not anticipated. Technical clarifications The Public Health Agency of Canada clarified some technical requirements of the Regulations by simplifying the requirements for the labelling of water systems, revising the definition for contamination, adding a definition for disinfection, and clarifying circumstances that would require sampling beyond routine sampling (i.e. in the cases of suspected or confirmed contamination, and before a new system is placed into operation). The Public Health Agency of Canada also clarified the requirements for what supplies of water could be served to passengers on board, and revised requirements for vessels that produce potable water on board to align with requirements in place for cruise ships operating internationally. Some stakeholders suggested that the water sampling and monitoring requirements of the proposed Regulations should be expanded to address the chemical parameters of on-board water supplies. However, passenger conveyances are not equivalent to community water systems, which require more stringent routine water monitoring because users may be exposed to potable water from community water systems over a period of years. As per the Guidelines for Canadian Drinking Water Quality, chemical and radiological substances may be found in some drinking water supplies, but these are generally only a concern if they are present above guideline levels and there is exposure over the longer term. Travellers typically have a limited exposure time to water supplied on passenger conveyances, ranging from hours to a few days. The greatest risk associated with water supplied to passengers on board conveyances is therefore from acute exposure to microbiological contamination, which is why the routine sampling targets E. coli. Note that any time contamination is suspected or confirmed, whether it is microbiological, chemical, physical or radiological, the Regulations require operators to respond and disinfect, decontaminate, repair or replace the water system. Redundancy for foreign operators Several foreign stakeholders raised concerns with Canada’s jurisdiction to regulate international operators, and possible redundancy with other international requirements. For example, foreign airlines are already subject to requirements for potable water in the jurisdictions where they are registered. In the United States, airlines are subject to the Environmental Protection Agency’s Aircraft Drinking Water Rule and European airlines must adhere to the European Union’s Directive on the quality of water intended for human consumption (98/83/EC). Other airlines adhere to industry standards, such as the International Air Transport Association (IATA) drinking water standards. The Public Health Agency of Canada reviewed all proposed regulatory requirements in light of concerns raised by foreign stakeholders. The vast majority of foreign operators are already subject to routine water sampling requirements in their home jurisdictions. For example, fewer than 4% of all flights in Canada are arriving from or departing for countries that are not covered by Canadian, U.S. or European requirements for water on aircraft. (see footnote 17) Many of these flights are operated by airlines within IATA, and operators follow IATA’s voluntary guidelines for water handling and operating on-board potable water systems, including routine water sampling. To reduce duplication, burden and cost for the majority of foreign air carriers operating in Canada, the Agency revised the proposal by removing the requirement for foreign operators of conveyances that have only a single stop in Canada per trip from the routine water sampling and associated record-keeping requirements of the Regulations. Provisions related to safe water supplies, potable water systems, water quality, water quantity, water handling, disinfection, corrective measures and follow-up will continue to apply to all operators of passenger conveyances in Canada, whether they are Canadian or foreign. The Public Health Agency of Canada will retain the authority to take water samples and complete public health inspections and investigations on board all passenger conveyances operating in Canada within federal jurisdiction. Stakeholder recommendations adopted The feedback received from stakeholders was carefully considered by the Public Health Agency of Canada. Recommendations to improve the Regulations that were submitted by stakeholders following publication in the Canada Gazette, Part I, in 2014, and adopted by the Agency include the following. Revisions that impact flexibility and cost Introducing flexibility to serve water brought on board in small containers, in addition to water provided from an on-board potable water system, or as prepackaged water and ice. Reducing the period that records need to be kept and accessible from 36 to 12 months. Revising sampling sites for conveyances subject to routine sampling to ensure applicability for conveyances with different configurations. Adding flexibility for operators to select a water sampling frequency that meets operational requirements and links to frequency of flushing and disinfection activities. Technical clarifications Introducing a definition for disinfection while maintaining performance-based disinfection requirements that can evolve over time as new technologies are introduced. Clarifying the definition for contamination to align more closely with accepted definitions for potable water as per the Guidelines for Canadian Drinking Water Quality. Clarifying requirements for water supplies, so that operators can select an appropriate potable water supply and take measures to ensure that water is free from contamination at the time it is taken from the supply, and handled to prevent contamination during loading and when on board. Revising the requirements for vessels that produce potable water on board to align them with requirements in place for cruise ships operating internationally. Simplifying labelling requirements for on-board potable water systems while maintaining the requirement that potable water systems be clearly distinguishable from other systems on board in order to prevent contamination. Clarifying requirements for when systems must be flushed and disinfected before being placed into operation or after they are returned to operation, and when verification sampling of the water supply is required. Replacing requirements for operators to keep records of all water upload activities with requirement for a plan or process allowing them to trace back possible contamination and take appropriate measures to mitigate potential public health risks. Revisions that impact foreign carriers Clarifying the regulatory scope to exclude conveyances travelling through Canada without stopping. Removing requirements for operators of foreign conveyances with a single stop in Canada per trip to conduct routine water sampling and associated record-keeping. Overall, stakeholders have been supportive of the objectives of this regulatory proposal, and have expressed constructive comments that have informed many of the specific approaches and requirements. Revisions as they are presented above would result in a substantial reduction in the qualitative regulatory burden for stakeholders compared to that as originally presented in the proposed Regulations in the Canada Gazette, Part I, in 2014, while maintaining the public health and safety objectives of the proposal. Consultations on proposed Regulations in the Canada Gazette, Part I — 2015 Given the technical nature and extent of revisions to the regulatory proposal in consideration of comments received during the prepublication in the Canada Gazette, Part I, in 2014, a revised version was published in the Canada Gazette, Part I, on June 20, 2015, for a 75-day public review period. This allowed stakeholders to see how the regulatory proposal evolved from previous versions and how comments received from stakeholders were incorporated. During the comment period in 2015, the Agency contacted industry, health and transportation authorities, as well as international partners to advise them of the opportunity to review the proposed Regulations and submit comments to the Agency for consideration. Three information sessions (via webinar) were held with Canadian industry stakeholders in July and August 2015. These sessions were well attended, and the 20 participants represented all major Canadian conveyance operators and industry associations, as well as several small- and medium-size industry stakeholders. The Agency also delivered presentations at industry forums and held follow up calls and email exchanges with interested parties. The Agency received nine submissions with comments and suggestions during the Canada Gazette, Part I, 2015 public comment period from the following sectors: Canadian industry operators and association (3), foreign operators and associations (4), provincial health authorities (1) and water disinfection companies (1). Overall, the comments were very supportive of the proposed Regulations and validated the revisions completed since 2014. Conveyance industry stakeholders recognized and appreciated how revisions to the proposal addressed their initial concerns and reduced burden to industry. Comments are summarized below along with responses from the Agency. Flexibility, cost and redundancy for international operators One stakeholder requested an additional option for water sampling frequencies on train cars to align Canadian requirements with those put in place in the United States in 2015. As a result, the Public Health Agency of Canada revised the Schedule for rail sampling frequency and added a new rail sampling option: sampling each train car at least every 36 months subject to routine disinfection and flushing of the on-board potable water system once every three months, which aligns with requirements for major U.S. rail operators. The associated record-keeping provisions of the Regulations have also been revised to align with the new sampling option. The Agency did not revise the cost-benefit analysis to add training costs related to the proposed Regulations, as suggested by one commenter: operators are already subject to staff training costs associated with the PWRCC. After negligible costs to all operators to understand the new requirements, significant incremental training costs associated with the Regulations are not anticipated. This is consistent with how the Agency responded to a similar comment raised during the 2014 Canada Gazette, Part I, comment period. The Agency also did not revise the cost-benefit analysis to adjust and increase costs associated with water sampling of Canadian conveyances, as suggested by one international industry stakeholder based on that stakeholder’s experience implementing new potable water requirements for conveyances in the United States. As per the Canadian Cost Benefit Analysis Guide, (see footnote 18) this cost-benefit analysis was based on estimated costs to Canadian industry stakeholders. Estimated costs were revised to reflect feedback from Canadian industry in 2013 and 2014 and validated by Canadian industry feedback in 2015. Two stakeholders were concerned with the costs and expectations around investigating impacts of contamination on other conveyances in an operator’s fleet. The Agency recognizes that it will not always be possible to identify the source of contamination. However, operators are expected to have standard operating procedures for conducting investigations, including assessment of any impacts on the rest of their fleet (for example exposure to contamination of multiple conveyances from a single water upload point and contamination trends on a specific conveyance model). This requirement builds on industry’s existing Potable Water Management Plans and is an important step to identifying risks to potable water safety, so that they can be resolved and prevented from recurring. Technical clarifications One stakeholder noted that the definition for “potable water system” may have inadvertently prevented an operator from using water from a potable water system for firefighting or cleaning. As a result, the definition was revised and the word “solely” was removed for clarity. One stakeholder suggested that water sampling and monitoring requirements of the proposed Regulations should be expanded to address total coliforms, as well as chemical parameters of on-board water supplies. This comment was not adopted by the Agency. As outlined above in the Agency’s response to similar comments received in 2014, the proposal focuses on E. coli sampling which represents an acute risk to travellers. Other microbiological and chemical parameters may represent a risk over the longer term, or with extended exposure to the water on board. One stakeholder requested that the Schedule be adjusted to minimize sampling requirements for conveyances that disinfect water once it is on board a conveyance (when it is being stored on board a conveyance after being loaded from the water supply). This is known as secondary disinfection, and is already a practice encouraged by the Agency through technical guidance documents as one means of reducing risk associated with water served to passengers on board conveyances. However, secondary disinfection does not replace the requirement for routine sampling on board, which is necessary to validate that the on-board potable water system and supply are free from contamination, existing processes for preventing and removing contamination are effective and no corrective actions are required. Of note is that operators that correctly adopt secondary disinfection should experience a reduction in any suspected or confirmed contamination, so they are less likely to be impacted by requirements for corrective actions and verification sampling associated with contamination. Three stakeholders requested clarification for some technical points covered in the proposal. The Agency will provide additional guidance in its program documentation regarding: sufficient water supply, selecting a source of water that is free from contamination, water sampling protocols for industry and for the Agency environmental health officers, as well as best practices for operators to assess risks to their fleet for contamination events, and how the Agency can support public health investigations. Stakeholder recommendations adopted The feedback received from stakeholders was carefully considered by the Agency. Recommendations to improve the Regulations that were submitted by stakeholders following publication in the Canada Gazette, Part I, in 2015, and adopted by the Agency are as follows: Clarifying the definition for “potable water system” to ensure operators could continue using water from the system for activities that do not inherently require potable water. Adding an additional rail sampling frequency in the Schedule to align with U.S. requirements, and updating record keeping requirements accordingly. Updating the Public Health Agency of Canada technical guidance documents to provide additional information about sufficiency with respect to potable water, sources of potable water, water sampling protocols as well as investigations by operators into contamination events. Regulatory cooperation The Regulations have been drafted to align with Canadian guidance documents related to drinking water and with international regulations and guidance documents related to potable water on board conveyances. The Public Health Agency of Canada has incorporated a reference in the Regulations to the stringent parameter for E. coli established in the Guidelines. This enhances national coordination, because the Guidelines are developed by the Federal-Provincial-Territorial Committee on Drinking Water, which includes membership from all 10 provinces and 3 territories as well as the federal government. All Canadian jurisdictions use the Guidelines to inform their own potable water regulations and standards, and all have adopted the Guidelines’ parameter for E. coli. The Regulations support cooperation between federal departments. Transport Canada has implemented occupational health and safety provisions related to the drinking water provided to the crew of aviation, (see footnote 19) maritime (see footnote 20) and rail (see footnote 21) conveyances within federal jurisdiction. The Regulations include similar provisions related to potable water on board conveyances, but apply to water for passengers. The Regulations are not designed to meet a commitment under the Joint Action Plan for the Canada–United States Regulatory Cooperation Council. However, in recognition of the shared border and significant international travel between Canada and the United States, the regulatory proposal was discussed with the U.S. Environmental Protection Agency (EPA) and the U.S. Food and Drug Administration (FDA), and reviewed against relevant American legislation that applies to passenger conveyances and demonstrated substantive similarities for requirements intended to ensure that water served to passengers is safe and reliable. The U.S. Safe Drinking Water Act and the National Primary Drinking Water Regulations apply to all public or semi-public drinking water systems, including those on interstate conveyances, through the Aircraft Drinking Water Rule (promulgated in October 2009). The Aircraft Drinking Water Rule contains requirements for airlines to analyze drinking water for E. coli and total coliforms, conduct routine disinfection and flushing of potable water systems, maintain records, and complete routine reporting. The U.S. EPA sets out similar requirements for rail operators through Administrative Orders of Consent. The U.S. FDA regulates drinking water systems on board interstate conveyances and related servicing facilities (Part 1250 - Interstate Conveyance Sanitation). The FDA interstate regulations include provisions for regular cleaning and disinfection to achieve microbiological standards as well as specific provisions relating to backflow prevention in potable water systems. The Public Health Agency of Canada also shared the regulatory approach with the World Health Organization (WHO) and the International Civil Aviation Organization (ICAO). The Regulations contain similar requirements to those in the document entitled Guide to Hygiene and Sanitation in Aviation (see footnote 22) published by the WHO. The document includes provisions for aircraft drinking water systems, including selection of a safe source of water, uses of potable water on board, provisions for bottled water, application of drinking water guidelines (including guidelines on E. coli) and routine monitoring. Many international airlines use this document to support the implementation of their PWMPs. The Public Health Agency of Canada continues to advocate for strong water safety regulations for conveyances globally, and is working with international partners to share information about industry and government activities, standards and compliance systems around the world. Operators of foreign conveyances that operate in Canada are currently subject to the PWRCC. They will remain subject to the Regulations, and will be required to maintain the same public health standards for water supplied to passengers as Canadian operators, including requirements around keeping water from supplies that are free of contamination, and addressing any suspected or confirmed contamination. However, the requirement for routine sampling would have represented a new burden to foreign operators in Canada, as it is not required under the PWRCC. Since the vast majority of foreign conveyances operating in Canada are already required to meet routine sampling, record-keeping and reporting requirements in their country of registration, operators of foreign conveyances with a single stop in Canada per trip will be excluded from some of the routine sampling and record-keeping requirements of the Regulations. This is similar to the exemptions granted to Canadian conveyance operators when they are operating internationally. For example, Canadian airlines that fly in and out of the United States do not need to comply with the U.S. EPA’s Aircraft Drinking Water Rule or its sampling and reporting requirements. The Public Health Agency of Canada will continue to maintain regulatory oversight for foreign conveyances operating in Canada. For example, the Public Health Agency of Canada will complete water sampling on foreign conveyances in Canada as part of its regulatory oversight activities. Water sampling will be risk-based, and conveyances will be targeted based on factors such as regulatory oversight in their country of registration, staff knowledge and training, historical compliance and water system capacity. The Public Health Agency of Canada will take compliance and enforcement actions as needed in order to help ensure the continued protection of the travelling public in Canada. Rationale Given the potential public health risks to travellers associated with water supplied on board conveyances, federal regulatory requirements will benefit from modernization to help support the continued public health protection of the travelling public in Canada. A voluntary approach through industry adoption and implementation of PWMPs was considered as an alternative to the Regulations; however, a voluntary approach would not ensure that every conveyance operator adopts and implements a PWMP to mitigate the risks associated with potable water provided to passengers. Further, adopting a voluntary approach lacks an enforceability mechanism necessary for the Government to require corrective measures from an operator should the potable water or the potable water system of a conveyance become contaminated. Given the potential public health risks to travellers associated with water supplied on board conveyances, a voluntary approach was not deemed sufficient. The Regulations will modernize the regulatory requirements for mitigating risks associated with potable water provided to passengers on board conveyances. The Regulations provide flexibility for conveyance operators to choose appropriate water systems and disinfection practices, while requiring them to ensure that the water provided to passengers is free from E. coli. Referring to the stringent parameter for E. coli of the Guidelines in the Regulations enhances national coordination, because the Guidelines are used by all Canadian provinces and territories to inform their respective potable water regulations and standards. In light of these considerations, developing modernized regulations was determined to be the best option to mitigate the risks associated with water supplied to passengers on board conveyances. Health Canada and the Public Health Agency of Canada consulted with industry associations and conveyance operators in the airline, rail, ferry, bus and cruise ship sectors. Health Canada and the Public Health Agency of Canada also consulted provincial, territorial and international partners and stakeholders. Overall, there was support for the regulatory initiative, and the views expressed were taken into consideration during the development of the Regulations. A cost-benefit analysis of the impacts of implementing the Regulations indicated that in order to meet the regulatory requirements, conveyance operators will bear compliance and administration costs totalling approximately $79,000 per year to Canadian industry. The impact on industry is not expected to result in any negative spillover effect on related economic activities. Incremental costs to small businesses will not disproportionately affect them. Negligible costs are expected for Government and other stakeholders. Implementation of the Regulations is expected to contribute to the reduction of the number of cases of gastrointestinal illness in Canada, through the management of the risks associated with exposure to contaminated water supplies during travel on board passenger conveyances. Industry will also benefit from the Regulations, which allow greater flexibility than the PWRCC in the provision of water on board, including the design, construction, operation, disinfection and sampling of potable water systems. Overall, the Regulations are expected to result in benefits that exceed costs. Implementation, enforcement and service standards Implementation The Regulations will come into force six months after the day on which they are published in the Canada Gazette, Part II. Before the Regulations come into force, the federal government will work with industry and other federal government departments and agencies to raise stakeholder awareness of the regulatory requirements and facilitate their smooth introduction. This will include the early communication of revised existing industry guidelines to reflect the regulatory requirements, and the development of additional tools for stakeholders (e.g. supporting templates and how-to guidelines for stakeholders) over time. The Public Health Agency of Canada will continue to work with industry stakeholders to help ensure their PWMPs or water management operations will comply with the Regulations. The Agency will also respond to all inquiries from stakeholders and the public. Enforcement The enforcement approach for the Regulations will include conducting inspections and water sampling of conveyances. The frequency of inspections and water sampling will be determined through a risk assessment process, resulting in a greater emphasis on conveyances that pose a higher public health risk to passengers. Follow-ups and re-inspections will be conducted to address specific areas of non-compliance should they be observed and measures will be taken by environmental health officers or medical officers within the Public Health Agency of Canada when necessary. When regulatory compliance is not achieved, enforcement action may be taken under subsection 11(2) of the Department of Health Act, which states that any person who contravenes a regulation made under the Act is guilty of an offence punishable on summary conviction. Under section 787 of the Criminal Code, this carries a maximum penalty of six months of imprisonment, a fine of $5,000, or both. Service standards The Public Health Agency of Canada will respond to enquiries related to the Regulations in a timely manner, within five business days of receiving the inquiry; communicate the results of an inspection to the conveyance operator within five business days of completing the inspection; and communicate the results of microbiological water sampling analysis to the conveyance operator within five business days of receiving the results from a laboratory. (see footnote 23) Performance measurement and evaluation Conveyance operators that provide water to passengers will be required to comply with the Regulations. Compliance will be assessed through scheduled and unscheduled inspections of conveyances, verification of water sampling, audits of operators’ plans and procedures, review of water sampling results for E. coli and verification of records related to on-board potable water systems and water supplied to passengers. Contact Sara Strawczynski Senior Policy Analyst Travelling Public Program Public Health Agency of Canada 100 Colonnade Road Postal locator: 6201C Ottawa, Ontario K1A 0K9 Telephone: 613-716-9059 Fax: 613-952-8189 Email: [email protected] Footnote a S.C. 1996, c. 8 Footnote 1 C.R.C., c. 1105 Footnote 2 The Guidelines can be found online at http://www.hc-sc.gc.ca/ewh-semt/water-eau/drink-potab/guide/index-eng.php. The Guidelines are established based on comprehensive reviews of the known health effects associated with contaminants, as well as exposure levels and the availability of treatment and analytical technologies. The Guidelines are regularly updated to ensure standards reflect the latest scientific knowledge and practices. Footnote 3 The PWMPs are developed by industry based on guidance provided by the Public Health Agency of Canada in A Guide to Developing Management Plans for Conveyances (Health Canada, 2011), available on request by contacting the Public Health Agency of Canada at [email protected] Footnote 4 The Regulations do not refer to sampling for total coliforms because this is not specified as a parameter for water quality in potable water systems in the Guidelines; however, the Minister of Health still encourages industry to sample water for total coliforms, because it remains a useful early indicator of potential contamination within water supplies. Footnote 5 Food and Drugs Act, available online at http://laws.justice.gc.ca/PDF/F-27.pdf. Footnote 6 Food and Drug Regulations, available online at http://laws-lois.justice.gc.ca/eng/regulations/c.r.c.,_c._870/page-135.html#h-94. Footnote 7 The Standard Methods for the Examination of Water and Wastewater is published jointly by the American Public Health Association, the American Water Works Association and the Water Environment Federation. Footnote 8 The policy impact period is the present value (PV) of the proposal in 2012 dollars over 10 years, from 2016 to 2025. A 7% discount rate was used to calculate this value, as per the Treasury Board Secretariat’s cost-benefit analysis guide, available online at http://www.tbs-sct.gc.ca/rtrap-parfa/analys/analystb-eng.asp. Footnote 9 The cost-benefit statement represents costs for Canadian operators. Costs for international companies that transport passengers in Canada were analyzed separately, and implications are included below. Footnote 10 Costs are based on an estimated 854 new samples per year, which will be necessary for Canadian operators to reach compliance with the Schedule. Estimates are based on consultations with industry carried out in 2013 and have been revised based on feedback from the 2014 Canada Gazette, Part I, public review period. Footnote 11 Costs are based on an estimated 3 096 samples per year, with administrative requirements of 15 minutes per sample, at a labour cost of $47 per hour. Estimates are based on consultations with industry carried out in 2013 and were revised based on feedback received during the public review period following publication of the proposed Regulations in the Canada Gazette, Part I, in 2014. Footnote 12 Details about the Public Health Agency of Canada’s Cruise Ship Inspection Program are available online at www.hc-sc.gc.ca/hl-vs/travel-voyage/general/ship-navire-eng.php. Footnote 13 Details about the U.S. CDC Vessel Sanitation Program are available online at www.cdc.gov/nceh/vsp/. Footnote 14 Majowicz et al., “Estimating the under-reporting rate for infectious gastrointestinal illness in Ontario,” in Canadian Journal of Public Health, May 2005. Footnote 15 Thomas et al., “Burden of acute gastrointestinal illness in Canada, 1999–2007: Interim summary of NSAGI activities,” Canada Communicable Disease Report, May 2008, Volume 34, Number 05. Footnote 16 Canada Gazette, 2014. http://www.gazette.gc.ca/rp-pr/p1/2014/2014-05-10/html/reg2-eng.php. Footnote 17 Statistics Canada. 2012. Distribution of aircraft movements at airports with NAV CANADA towers and flight service stations, by type of operation (Text table 2 — Air Carriers), http://www.statcan.gc.ca/pub/51-209-x/2011001/t017-eng.htm. Footnote 18 Treasury Board of Canada Secretariat (2007). Canadian Cost-Benefit Analysis Guide: Regulatory Proposals. Available online at https://www.tbs-sct.gc.ca/rtrap-parfa/analys/analys-eng.pdf. Footnote 19 Aviation Occupational Health and Safety Regulations (SOR/2011-87). Footnote 20 Maritime Occupational Health and Safety Regulations (SOR/2010-120). Footnote 21 On Board Trains Occupational Safety and Health Regulations (SOR/87-184). Footnote 22 World Health Organization, Guide to Hygiene and Sanitation in Aviation, 3rd edition, Geneva, 2009. Footnote 23 Additional details about the Travelling Public Program’s service standards are available on the Agency’s Web site at the following address: http://www.phac-aspc.gc.ca/cepr-cmiu/ophs-bssp/quar/tpp-ppv-eng.php.

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