Order Adding Toxic Substances to Schedule 1 to the Canadian Environmental Protection Act, 1999 (2017) (2)
PROPOSED FEDERAL REGULATION - VIA PART I OF THE GAZETTE
April 1, 2017
REGULATORY IMPACT ANALYSIS STATEMENT (This statement is not part of the Order.) Issues The Government of Canada (the Government) has conducted a screening assessment of two liquefied petroleum gases (see footnote 1) (LPGs), hereafter referred to as “the LPGs,” and has determined that the LPGs meet the definition of a substance that is toxic to human health as defined in paragraph 64(c) of the Can... (Click for more)
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Published on April 2, 2017
Order Adding Toxic Substances to Schedule 1 to the Canadian Environmental Protection Act, 1999 (2017) (2)
REGULATORY IMPACT ANALYSIS STATEMENT (This statement is not part of the Order.) Issues The Government of Canada (the Government) has conducted a screening assessment of two liquefied petroleum gases (see footnote 1) (LPGs), hereafter referred to as “the LPGs,” and has determined that the LPGs meet the definition of a substance that is toxic to human health as defined in paragraph 64(c) of the Canadian Environmental Protection Act, 1999 (CEPA). Therefore, the Government is proposing to add the LPGs to the List of Toxic Substances in Schedule 1 of CEPA. The substances are Petroleum gases, liquefied (Chemical Abstracts Service Registry Number [CAS RN] 68476-85-7); and Petroleum gases, liquefied, sweetened (CAS RN 68476-86-8). Background On December 8, 2006, the Government launched the Chemicals Management Plan (CMP) to assess and manage chemical substances that may be harmful to human health or the environment. (see footnote 2) A key element of the CMP is the Petroleum Sector Stream Approach (PSSA), which addresses approximately 160 petroleum substances that were considered to be of high priority for risk assessment, as they met the categorization criteria under subsection 73(1) (see footnote 3) of CEPA and/or were considered a priority based on other human health concerns. These petroleum substances were divided into five streams based on their use profiles. (see footnote 4) Within each stream, the substances were further divided into groups according to similarities in production and physical and chemical properties. The LPGs subject to the proposed Order Adding Toxic Substances to Schedule 1 to the Canadian Environmental Protection Act, 1999 (the proposed Order) are one of the groups in “Stream 4” of the PSSA (substances that may be present in products available to consumers). Substance description and use profile The substances assessed are petroleum and refinery gases (PRGs) that can be liquefied under pressurized or cooling conditions and are thus commonly known as liquefied petroleum gases. These LPGs are a category of light, predominantly saturated hydrocarbons and may contain unsaturated hydrocarbons, such as propene and butenes. The LPGs are produced at petroleum refining or natural gas facilities and their composition varies depending on the source of the crude oil or natural gas, the process operating conditions, and the processing units used at facilities. Therefore, the LPGs are substances referred to as “Unknown or Variable composition, Complex reaction products or Biological materials” (UVCBs). According to information submitted under section 71 of CEPA, in 2010 the total quantity of the LPGs manufactured in Canada was between 1 million and 10 million tonnes and the total imported quantity was between 10 000 and 100 000 tonnes. The common use of the LPGs for consumer applications is as a fuel (consisting primarily of propane and butane) for household heating and cooking (e.g. barbecue tanks) and automotive uses. The LPGs are often stored in cylinders, as a convenient or mobile source for small domestic appliances, such as portable space heaters, cookers, blow lamps, camping equipment and cigarette lighters. The LPGs are also used in consumer products, including as aerosol propellants inside spray cans. Industrial uses of the LPGs include their use as fuels, feedstock for chemical plants and petroleum refineries, and aerosol propellants (e.g. industrial blowing agents). Screening assessment process To determine whether the LPGs meet one or more of the criteria for a toxic substance as defined in section 64 of CEPA, a screening assessment was conducted based on available information, which included additional information submitted by industry under section 71 of CEPA. Specifically, this involves determining whether the substances are entering or may enter the environment in a quantity or concentration or under conditions that (a) have or may have an immediate or long-term harmful effect on the environment or its biological diversity; (b) constitute or may constitute a danger to the environment on which life depends; or (c) constitute or may constitute a danger in Canada to human life or health. Human health assessment results The LPGs are gases with high vapour pressures that can be released into the atmosphere in the vicinity of petroleum facilities, including refineries and natural gas processing facilities, at LPG cylinder tank filling stations (e.g. barbecue “propane” tank filling stations) and through the use of consumer aerosol products. Thus, inhalation was determined to be the primary route of exposure for the general population. This approach is consistent with the approach used to assess the site-restricted (Stream 1) and industry-restricted (Stream 2) PRGs. It is recognized that fugitive emissions of the LPGs at petroleum refining facilities will contribute to a portion of the previously estimated releases of PRGs. Since 1,3-butadiene, a toxic substance under CEPA, is recognized as a carcinogen (see footnote 5) and available evidence concluded that it could be present in the LPGs released from petroleum refining facilities, 1,3-butadiene was selected as a high-hazard component of the LPGs in order to characterize the potential exposure of the general population in Canada to the LPGs. LPGs can be released into the air from a variety of sources, but most of the releases are so small and limited in duration that they do not pose a human health concern. The only emission source releases deemed large enough to pose human health concerns are releases from petroleum refinery facilities. LPGs are contained in various fuels, including barbecue propane tanks and automotive fuels. The assessment determined, however, that any human exposure to LPGs from the use of barbecues, or at cylinder filling or automotive refuelling stations, would be low and of short duration. Similarly, exposure of individuals living in the vicinity of LPG filling stations was deemed to also be low. Exposure from these sources is not considered to pose an undue concern for human health. LPGs can also be released from the use of aerosol products, but the assessment determined that any resulting exposure from these uses would also be low and of short duration, and would not pose a human health concern. The assessment also determined that exposure to the general population during the loading, unloading, and transportation of the LPGs is not expected given the nature of the transportation systems and current regulatory and non-regulatory measures in place in Canada. (see footnote 6) The exposure source of concern, identified in the assessment, is from the production and processing of the LPGs and their contribution to petroleum and refinery gas releases and, therefore, their potential contribution to 1,3-butadiene releases from petroleum refining facilities. This may result in exposure for those living in the vicinity of petroleum refining facilities. However, based on recently received data on 1,3-butadiene concentration levels relevant to the upstream natural gas processing industry, no concerns were identified with respect to volatile emissions of PRGs, including these LPGs, from natural gas processing facilities. Based on available information on the composition of the LPGs, the carcinogenic nature of 1,3-butadiene, and high-end estimates of inhalation exposure, it was determined that potential exposure levels in Canada may pose a risk to human health for those living in the vicinity of petroleum refineries. Therefore, the screening assessment concluded that the LPGs met the criterion in paragraph 64(c) of CEPA. (see footnote 7) Ecological assessment results The ecological assessment focused on the chronic effects to terrestrial organisms via inhalation of 1,3-butadiene, the most toxic component of the LPGs, considering exposures near filling stations and petroleum facilities. The results indicate that the LPGs are not expected to be harmful to terrestrial organisms. Therefore, the assessment determined that the LPGs did not meet the environmental criteria under paragraph 64(a) or (b) of CEPA. (see footnote 8) Existing Canadian and international risk management activities In Canada, transportation of petroleum substances, including the LPGs, is regulated under the National Energy Board Act (for onshore pipelines), the Canada Shipping Act, 2001 (for ship transport), the Transportation of Dangerous Goods Act, 1992 (for truck and train transport), and the Canada Transportation Act (for train transport). (see footnote 9) The National Energy Board (NEB) is responsible for pipelines that cross provincial and international boundaries. In 2013, federal regulations affecting pipeline damage prevention such as the National Energy Board Onshore Pipeline Regulations were amended to strengthen requirements for management systems regarding safety, pipeline integrity, security, environmental protection and emergency management. The Pipeline Safety Act, which received royal assent on June 18, 2015, required that new regulations be in place by the Act’s entry into force on June 19, 2016. The updated damage prevention regulations were published in June 2016 and included modernizing regulatory language, building in damage prevention best practices and clarifying safety practices. In addition, the National Energy Board Processing Plant Regulations govern the design, construction, operation and abandonment of certain facilities used for the processing, extraction or conversion of fluids, including the LPGs. The Canada Shipping Act, 2001 deals with pollution prevention and response, including discharges of petroleum substances during marine transportation, response measures and penalties. The Transportation of Dangerous Goods Regulations, which were made under the Transportation of Dangerous Goods Act, 1992, prescribe how dangerous goods must be classified, the means of containment and safety marks that must be used as well as documentation and training requirements to increase safety during handling, offering for transport or transport. The Regulations include requirements for reporting releases or anticipated releases of dangerous goods and dangerous goods that have been lost, stolen or unlawfully interfered with. The Regulations also require an approved Emergency Response Assistance Plan (ERAP) before certain dangerous goods can be transported or imported. Under the Railway Safety Act, the Railway Safety Management System Regulations, 2015 require companies to establish a safety management system for the purpose of achieving the highest level of safety in railway operations. Railway operations may include the transport of various products, including dangerous goods such as petroleum substances. The Liquefied Petroleum Gases Bulk Storage Regulations, made under the Canada Transportation Act, set out standards for the placement of storage tanks as well as additional requirements for storage equipment, inspection, safety considerations and emergency guidelines. The Consumer Chemicals and Containers Regulations, 2001, made under the Canada Consumer Product Safety Act, contain information with regards to the labelling of pressurized containers, such as spray cans and LPG cylinder tanks. (see footnote 10) Provincial requirements such as Alberta’s Directive 060: Upstream Petroleum Industry Flaring, Incinerating, and Venting, British Columbia’s Flaring and Venting Reduction Guideline, and Saskatchewan’s Upstream Petroleum Industry Associated Gas Conservation Directive regulate the intentional releases of petroleum gases (including the LPGs) through flaring, incinerating and venting activities at well sites, facilities and pipelines. In addition, the Canadian Association of Petroleum Producers’ Best Management Practice for Fugitive Emissions Management and the Canadian Council of Ministers of the Environment’s Environmental Code of Practice for Measurement and Control of Fugitive Volatile Organic Compound Emissions from Equipment Leaks are incorporated in some provincial facility operating permits for the control of fugitive emissions of petroleum substances. In the United States, several regulations pertaining to limiting the emissions from refineries and natural gas processing facilities have been developed under the National Emission Standards for Hazardous Air Pollutants program of the Clean Air Act. In September 2015, the United States Environmental Protection Agency (EPA) issued a final rule that will further control air emissions from petroleum refineries, including a requirement for facilities to monitor emissions around their fence lines. In Europe, the Directive on Industrial Emissions (Integrated Pollution Prevention and Control), which entered into force in 2013, sets out the main principles for the permitting and control of installations based on an integrated approach and the application of best available techniques. Operators of industrial installations conducting activities covered by the Directive (including refineries) are required to obtain an environmental permit from the national authority in their country. Publication and conclusions The final screening assessment for the LPGs was published on the Government’s Chemical Substances website, along with a notice of intent published in the Canada Gazette, Part I, on February 25, 2017. The notice stated that the Minister of the Environment and the Minister of Health (the ministers) have concluded that the LPGs meet one or more of the criteria set out under section 64 of CEPA and recommended the addition of these substances to Schedule 1 of CEPA. (see footnote 11) Objectives The objective of the proposed Order Adding Toxic Substances to Schedule 1 to the Canadian Environmental Protection Act, 1999 is to enable the Government to propose risk management instruments under CEPA, should such instruments be deemed necessary to manage the human health risks associated with the LPGs. Description The proposed Order adds the LPGs to Schedule 1 of CEPA (the List of Toxic Substances). “One-for-One” Rule The “One-for-One” Rule does not apply, as the proposed Order would not impose any administrative burden on business. Small business lens The small business lens does not apply, as the proposed Order would not impose any compliance or administrative costs on small business. Consultation On October 11, 2014, the ministers published a summary of the draft screening assessment report for the LPGs in the Canada Gazette, Part I, for a 60-day public comment period. (see footnote 12) On the same date, the risk management scope document outlining the preliminary options being examined for the management of the substances was released on the Chemical Substances website. (see footnote 13) During the 60-day public comment period, submissions were received from industry associations and other stakeholders. All comments were considered during the finalization of the screening assessment report. A table summarizing the complete set of comments received and the Government’s responses is available on the Chemical Substances website. (see footnote 14) Prior to these publications, the Department of the Environment and the Department of Health had informed provincial and territorial governments through the National Advisory Committee of CEPA (CEPA NAC) of the release of these documents and public comment period. No comments were received from CEPA NAC. (see footnote 15) Overview of public comments and responses Comments received focused on the methodology used to determine human exposure, data gaps and uncertainties in the assessment. Concerns raised regarding methodology centred on the tools used to model exposure to and emissions of the LPGs. Stakeholders indicated that modelling tools used were outdated, conservative and only took into account 1,3-butadiene as the component of concern of the LPGs. Government officials responded that the models, studies and technologies used to estimate exposure were considered appropriate as they are used by the U.S. EPA, National Aeronautics and Space Administration (NASA), as well as European refineries. Even though conservative values were used, uncertainties in the exposure are communicated in the assessment, and a model sensitivity analysis was included. 1,3-Butadiene was chosen to represent the highest health concern for exposure to the LPGs due to its potential presence in the LPGs and due to its carcinogenicity. Furthermore, data for other components of the LPGs was unavailable for modelling. Stakeholders also pointed to the uncertainty regarding the actual presence of 1,3-butadiene in the LPGs. The Government has solicited compositional data from industry stakeholders, including levels of 1,3-butadiene that may be present in the LPGs. Data relevant to the upstream natural gas processing industry were recently received, and the assessment was updated based on this information. Due to a lack of specific compositional data from Canadian refineries and upgraders and multiple lines of evidence indicating the potential presence of 1,3-butadiene in petroleum and refinery gases (including the LPGs), it was assumed within the assessment that all petroleum and refinery gases (including the LPGs) produced by these facilities potentially contain 1,3-butadiene. Furthermore, modelling was used to estimate potential risks of exposure for general populations to the LPGs from nearby petroleum refineries and upgraders. Stakeholders commented that a risk management instrument to address Volatile Organic Compounds (VOCs) emission reductions should be developed through a single initiative, and that any future plans to manage VOCs should be compared with results achieved under existing voluntary measures such as industry codes of practice. The Government responded that a single regulatory initiative to address all PRGs, including the LPGs, was under consideration and would take into consideration results achieved under existing voluntary measures. The regulation would focus on additional practices and technologies, or the improved implementation of existing requirements for reducing fugitive emissions from petroleum facilities. Rationale Potential releases of the LPGs include releases within refineries from activities associated with their production and processing, transportation between industrial facilities, and consumer uses. The assessment determined that the exposure to the general population from activities related to their transportation and consumer uses are not a concern to human health; however, it was determined that a small proportion of the general population living in the vicinity of petroleum facilities may be exposed to the LPGs. Therefore, due to the carcinogenicity of high hazard components of the LPGs (e.g. 1,3-butadiene) and the potential exposure of those living in the vicinity of petroleum facilities, the screening assessment concluded that the LPGs met the criterion under paragraph 64(c) of CEPA. One of the following measures must be proposed after an assessment is conducted under CEPA: 1. taking no further action with respect to the substance under the authority of CEPA; 2. adding the substance to the Priority Substances List; or 3. recommending that the substance be added to the List of Toxic Substances in Schedule 1 of CEPA and, where applicable, recommending the implementation of virtual elimination. The proposed addition of the LPGs to Schedule 1 of CEPA enables the Minister of the Environment (the Minister) to propose risk management instruments to manage the human health risks posed by the LPGs, and is therefore the preferred option among the three alternatives. The implementation of virtual elimination is not applicable for the LPGs. The proposed addition of the LPGs to Schedule 1 of CEPA would not result in any incremental impacts (benefits or costs) on the public or industry, since the proposed Order would not impose any compliance or administrative requirements on stakeholders and thus, there would be no compliance or administrative burden imposed on small businesses or businesses in general. If further risk management instruments are deemed necessary for the LPGs, the Minister will assess the costs and benefits and consult with the public and other stakeholders during the development of any risk management instrument to address potential human health concerns associated with the LPGs in Canada. In accordance with the Cabinet Directive on the Environmental Assessment of Policy, Plan and Program Proposals, a strategic environmental assessment was completed. (see footnote 16) Implementation, enforcement and service standards The proposed Order would add the LPGs to Schedule 1 of CEPA, thereby allowing for developing and publishing regulations or instruments under CEPA if such actions are deemed necessary. Developing an implementation plan, a compliance strategy or establishing service standards are not considered necessary for this Order. Contacts Greg Carreau Program Development and Engagement Division Department of the Environment Gatineau, Quebec K1A 0H3 Substances Management Information Line: Telephone: 1-800-567-1999 (toll-free in Canada) Telephone: 819-938-5144 (outside of Canada) Fax: 819-938-5212 Email: [email protected] Michael Donohue Risk Management Bureau Department of Health Ottawa, Ontario K1A 0K9 Telephone: 613-957-8166 Fax: 613-952-8857 Email: [email protected] PROPOSED REGULATORY TEXT Notice is given, pursuant to subsection 332(1) (see footnote a) of the Canadian Environmental Protection Act, 1999 (see footnote b), that the Governor in Council, on the recommendation of the Minister of the Environment and the Minister of Health, pursuant to subsection 90(1) of that Act, proposes to make the annexed Order Adding Toxic Substances to Schedule 1 to the Canadian Environmental Protection Act, 1999. Any person may, within 60 days after the date of publication of this notice, file with the Minister of the Environment comments with respect to the proposed Order or a notice of objection requesting that a board of review be established under section 333 of that Act and stating the reasons for the objection. All comments and notices must cite the Canada Gazette, Part I, and the date of publication of this notice, and be addressed to the Executive Director, Program Development and Engagement Division, Department of the Environment, Gatineau, Quebec K1A 0H3 (fax: 819-938-5212; email: [email protected]). A person who provides information to the Minister of the Environment may submit with the information a request for confidentiality under section 313 of that Act. Ottawa, March 23, 2017 Jurica & #268;apkun Assistant Clerk of the Privy Council Order Adding Toxic Substances to Schedule 1 to the Canadian Environmental Protection Act, 1999 Amendment 1 Item 134 of Schedule 1 to the Canadian Environmental Protection Act, 1999 (see footnote 17) is amended by striking out “and” at the end of paragraph (z.17) and by adding the following after paragraph (z.18): (z.19) petroleum gases, liquefied (a complex combination of hydrocarbons — obtained from the distillation of crude oil — consisting of hydrocarbons having carbon numbers predominantly in the range of C3 through C7 and boiling in the range of approximately -40°C to 80°C); and (z.20) petroleum gases, liquefied, sweetened (a complex combination of hydrocarbons — obtained by subjecting liquefied petroleum gases to a sweetening process to convert mercaptans or to remove acidic impurities — consisting of hydrocarbons having carbon numbers predominantly in the range of C3 through C7 and boiling in the range of approximately -40°C to 80°C). Coming into Force 2 This Order comes into force on the day on which it is registered. [13-1-o] Footnote 1 For transport and storage, gases are typically compressed into a liquid. The industry standard is to call them liquefied petroleum gases (LPGs). Footnote 2 For more information on the CMP, please see http://www.chemicalsubstanceschimiques.gc.ca/plan/index-eng.php. Footnote 3 73(1) The Ministers shall, within seven years from the giving of Royal Assent to this Act, categorize the substances that are on the Domestic Substances List by virtue of section 66, for the purpose of identifying the substances on the List that, in their opinion and on the basis of available information, (a) may present, to individuals in Canada, the greatest potential for exposure; or (b) are persistent or bioaccumulative in accordance with the regulations, and inherently toxic to human beings or to non-human organisms, as determined by laboratory or other studies. Footnote 4 For more details on the five streams of the PSSA, please see http://www.chemicalsubstanceschimiques.gc.ca/petrole/index-eng.php. Footnote 5 In the European Union, the European Chemical Agency has identified petroleum and refinery gases (including the LPGs) containing 1,3-butadiene at concentrations greater than 0.1% as carcinogens. Footnote 6 For a detailed summary of current risk management measures in Canada related to the LPGs, please see the risk management approach document on the Chemical Substances website. Footnote 7 For more information on the human health assessment of the LPGs, please see the final screening assessment report on the Chemical Substances website. Footnote 8 For more information on the ecological assessment of the LPGs, please see the final screening assessment report on the Chemical Substances website. Footnote 9 For more information on the risk management activities associated with the LPGs, please see the risk management approach at http://www.ec.gc.ca/ese-ees/E1A72137-AB1B-4F6E-BE89-4E201BB785F4/EN_RM%20Stream%204%20LPG%202016%2002%2020s.pdf. Footnote 10 Required information that must be displayed on these containers help consumers know about proper handling for safe use. Footnote 11 The final screening assessment and other related publications can be obtained from the Chemical Substances website or from the Program Development and Engagement Division, Department of the Environment, Gatineau, Quebec K1A 0H3; 819-938-5212 (fax); or by email at [email protected] Footnote 12 For more information, please see the Canada Gazette, Part I, Vol. 148, No. 41 (October 11, 2014): http://www.gazette.gc.ca/rp-pr/p1/2014/2014-10-11/html/notice-avis-eng.php#nb1. Footnote 13 For more information on the Risk Management for the LPGs, please visit the Chemical Substance website. Footnote 14 For more information, please see http://www.chemicalsubstanceschimiques.gc.ca/petrole/group-4/index-eng.php#a41. Footnote 15 Section 6 of CEPA provides that the CEPA NAC be the main intergovernmental forum for the purpose of enabling national action and avoiding duplication in regulatory activity among governments within Canada. This Committee has a Department of the Environment and a Department of Health representative, a representative of each of the provinces and territories, as well as up to six representatives of Aboriginal governments. Footnote 16 For more information, please see: http://www.chemicalsubstanceschimiques.gc.ca/plan/sea-ees-eng.php. Footnote a S.C. 2004, c. 15, s. 31 Footnote b S.C. 1999, c. 33 Footnote 17 S.C. 1999, c. 33
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