FEDERAL REG

SOR/2016-251: Toxic Substances to Schedule 1 to the Canadian Environmental Protection Act, 1999 — Order Adding Canadian Environmental Protection Act, 1999

REGISTRATION OF FEDERAL REGULATION - VIA PART II OF THE GAZETTE

Registered
September 24, 2016


REGULATORY IMPACT ANALYSIS STATEMENT (This statement is not part of the Order.) Issues The Government of Canada has conducted screening assessments of 40 site-restricted petroleum and refinery gases (PRGs) and 4 industry-restricted PRGs, and has determined that these 44 PRGs (see footnote 2) meet the human health criterion for toxicity as defined under paragraph 64(c) of the Canadian Environmenta... (Click for more)


Published on September 24, 2016

Bill Summary

SOR/2016-251: Toxic Substances to Schedule 1 to the Canadian Environmental Protection Act, 1999 — Order Adding Canadian Environmental Protection Act, 1999

REGULATORY IMPACT ANALYSIS STATEMENT (This statement is not part of the Order.) Issues The Government of Canada has conducted screening assessments of 40 site-restricted petroleum and refinery gases (PRGs) and 4 industry-restricted PRGs, and has determined that these 44 PRGs (see footnote 2) meet the human health criterion for toxicity as defined under paragraph 64(c) of the Canadian Environmental Protection Act, 1999 (CEPA). Therefore, the Government of Canada is adding these 44 PRGs to the List of Toxic Substances in Schedule 1 of CEPA. Previously, the 40 site-restricted PRGs and 4 industry-restricted PRGs were addressed in 2 separate proposed orders for their addition to Schedule 1 of CEPA. However, because of similar properties and human health concerns (i.e. same type of releases and risk profile) and similarities in the proposed risk management approach for these gases, they are now being addressed in a single order. (see footnote 3) Background On December 8, 2006, the Government of Canada launched the Chemicals Management Plan (CMP) to assess and manage chemical substances that may be harmful to human health or the environment. (see footnote 4) 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 were determined to present “greatest” or “intermediate” potential for exposure to individuals in Canada, and were considered to present a high hazard to human health. These petroleum substances were divided into five streams based on their use profiles. (see footnote 5) Within each stream, the substances were further divided into groups according to similarities in production and physical and chemical properties. The 44 PRGs subject to the Order Adding Toxic Substances to Schedule 1 to the Canadian Environmental Protection Act, 1999 (the Order) include 40 PRGs that were part of Stream 1 and 4 PRGs that were part of Stream 2. Description of substances and main publications The 40 PRGs from Stream 1 are site-restricted substances, which are substances that are not expected to be transported off refinery, upgrader or natural gas processing facility sites. The 4 PRGs from Stream 2 are industry-restricted substances, which are substances that may leave a petroleum-sector facility and be transported to other industrial facilities (e.g. for use as a feedstock, fuel or blending component), but that do not reach the public market in the form originally acquired. The 44 PRGs are a category of saturated and unsaturated light hydrocarbons. They are produced by petroleum facilities (i.e. refineries, upgraders or natural gas processing facilities). However, emissions of these PRGs from natural gas processing facilities are no longer being considered as an exposure scenario of concern. The composition of the 44 PRGs varies depending on the source of the crude oil, bitumen or natural gas, the process operating conditions, and the processing units used. As a result, the 44 PRGs are substances referred to as “Unknown or Variable composition, Complex reaction products or Biological materials (UVCBs).” The final screening assessments for the 40 PRGs from Stream 1 and the 4 PRGs from Stream 2 were published on the Government of Canada’s Chemical Substances Web site on June 1, 2013, and January 18, 2014, respectively. (see footnote 6) At the same time, notices were published in the Canada Gazette, Part I, signalling the intent of the Minister of the Environment and the Minister of Health (the ministers) with regards to further risk management activities. Concurrently, the risk management approach documents were published on the Chemical Substances Web site. (see footnote 7) The 2 proposed orders adding the 40 PRGs from Stream 1 and the 4 PRGs from Stream 2 to Schedule 1 of CEPA were published on February 15, 2014. (see footnote 8) These publications can be obtained from the Chemical Substances Web site 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] Screening assessment process Screening assessments were conducted for the 44 PRGs to determine whether they meet one or more of the criteria for a toxic substance as set out in section 64 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 44 PRGs can contain a number of substances with potential impacts on human health, including 1,3-butadiene and benzene, internationally recognized carcinogens and toxic substances listed under CEPA. 1,3-Butadiene is a component of particular interest because of its physical-chemical properties (e.g. volatility) and toxicological properties (e.g. carcinogenicity), and based on the available evidence, is considered present in these 44 PRGs, at a concentration that was determined to potentially pose a risk to human health. The 44 PRGs can be present in three types of petroleum facilities: petroleum refineries, natural gas processing facilities and oil sands upgraders. However, emissions of these PRGs from natural gas processing facilities are no longer being considered as an exposure scenario of concern. (see footnote 9) Under typical operating conditions, controlled releases of the 44 PRGs are normally collected in a closed system, and usually go to a flare system for combustion. However, in some instances (e.g. to relieve pressure) they may be vented directly to the atmosphere. In addition, unintentional (fugitive) releases (e.g. leaks) occur from compressor seals, processing valves, flanges, pressure relief valve seals, and loading operations. Fugitive releases tend to occur more frequently when processing equipment is not properly maintained or operated, and could go undetected or unfixed for periods of time ranging from days to months. It has been determined that a small portion of the general population may be exposed to these petroleum and refinery gases in the vicinity of certain petroleum facilities. Based on available information on the composition of the 44 PRGs, the carcinogenic nature of 1,3-butadiene, and high end estimates for inhalation exposures, it was determined that potential exposure levels in Canada may pose a risk to human health for those living in the vicinity of certain facilities. Therefore, the screening assessments concluded that the 44 PRGs met the criterion under paragraph 64(c) of CEPA. Ecological assessment results The estimated concentrations of PRG components in the air surrounding petroleum facilities or near other sources of release are not expected to be at levels that could result in harm to the environment. The screening assessments for the 44 PRGs determined that these substances are not a concern to the environment in Canada, and therefore did not meet the environmental criteria under paragraphs 64(a) or (b) of CEPA. Alignment with other jurisdiction on the assessment results In the European Union, the European Chemical Agency has identified petroleum and refinery gases containing 1,3-butadiene at concentrations greater than 0.1% as carcinogens. Therefore, based primarily on classifications by international agencies, the critical human health effect for the initial identification of these substances as priorities for assessment was carcinogenicity. 1,3-Butadiene was then selected as a high hazard component of PRGs to characterize the potential exposure to the general population. Objectives The objective of the Order Adding Toxic Substances to Schedule 1 to the Canadian Environmental Protection Act, 1999 is to enable the Minister of the Environment (the Minister) to propose risk management instruments under CEPA to manage the human health risks posed by the 44 PRGs. Description The Order adds the 44 PRGs to Schedule 1 of CEPA (the List of Toxic Substances). “One-for-One” Rule The “One-for-One” Rule does not apply to the Order because it does not impose any requirements on industry that would result in administrative burden. Small business lens The Order will not add compliance or administrative burden on small business; therefore, the small business lens does not apply. Consultation Screening assessment of 40 substances in Stream 1 On January 15, 2011, the ministers published a summary of the draft screening assessment for the 40 PRGs from Stream 1 in the Canada Gazette, Part I, for a 60-day public comment period. (see footnote 10) Three submissions were received: two from environmental non-governmental organizations (ENGOs) and one from an industry association. All comments were considered during the finalization of the screening assessment report. (see footnote 11) On June 1, 2013, the ministers published a summary of the final screening assessment for the 40 PRGs from Stream 1 in the Canada Gazette, Part I. (see footnote 12) Screening assessment of 4 substances in Stream 2 On April 28, 2012, the ministers published a summary of the draft screening assessment report for the 4 PRGs from Stream 2 in the Canada Gazette, Part I, for a 60-day public comment period. (see footnote 13) No comments were received. On January 18, 2014, the ministers published a summary of the final screening assessment report for the 4 PRGs from Stream 2 in the Canada Gazette, Part I. (see footnote 14) Prepublication of the proposed orders in the Canada Gazette, Part I On February 15, 2014, 2 proposed orders adding the 40 PRGs from Stream 1 and the 4 PRGs from Stream 2 to Schedule 1 of CEPA were published for a 60-day public comment period. No comments were received. However, an industry association submitted additional information after the comment period that led to reducing the uncertainties about upstream natural gas processing facilities as a potential source of exposure. Where applicable, this information will also be considered, in consultation with stakeholders, during the development of any risk management instrument and in future assessments of similar substances. 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 the draft and final screening assessment reports, risk management scope and approach documents and public comment periods. No comments were received from CEPA NAC for any of the publications. Rationale The 44 PRGs subject to the Order can be produced and used within a petroleum facility or may be transported to other industrial facilities but are not fuels or products sold to the general public. Although wide-spread exposure to the general population is not expected, it has been determined that a small portion of the general population may be exposed to these 44 PRGs in the vicinity of facilities. Due to the carcinogenicity of the high hazard components of the 44 PRGs and the potential exposure to a small portion of the general population, the screening assessments concluded that the 44 PRGs meet the criterion under paragraph 64(c) of CEPA. One of the following measures must be proposed after an assessment is conducted under CEPA: taking no further action with respect to the substance; adding the substance to the Priority Substances List for further assessment; or 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 addition of the 44 PRGs to Schedule 1 of CEPA enables the Minister to propose risk management instruments to manage potential risks posed by the 44 PRGs, and is therefore the preferred option among the three alternatives. The implementation of virtual elimination is not applicable for these substances. The addition of these 44 PRGs to Schedule 1 of CEPA would not result in any incremental impacts (benefits or costs) on the public or industry, since the Order does not include any regulatory requirements. Accordingly, there is no compliance or administrative burden imposed on small businesses or businesses in general. The Minister will assess the costs and benefits and consult with the public and other stakeholders during the development of any risk management instrument for these substances. Implementation, enforcement and service standards The Order adds the 44 PRGs to Schedule 1 of CEPA, thereby allowing for developing and publishing regulations or instruments under CEPA. 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: 1-800-567-1999 (toll-free in Canada) 819-938-3232 (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] Footnote a S.C. 2004, c. 15, s. 31 Footnote b S.C. 1999, c. 33 Footnote c S.C. 1999, c. 33 Footnote 1 S.C. 1999, c. 33 Footnote 2 A complete list of the 44 substances, including Chemical Abstracts Service Registry Numbers (CAS RNs), is available at http://www.chemicalsubstanceschimiques.gc.ca/petrole/group-1/index-eng.php and http://www.chemicalsubstanceschimiques.gc.ca/petrole/group-2/index-eng.php. Footnote 3 The proposed orders for the 40 PRGs from Stream 1 and the 4 PRGs from Stream 2 are available at http://www.gazette.gc.ca/rp-pr/p1/2014/2014-02-15/html/reg3-eng.php and http://www.gazette.gc.ca/rp-pr/p1/2014/2014-02-15/html/reg4-eng.php, respectively. Footnote 4 More information on the CMP is available at http://www.chemicalsubstanceschimiques.gc.ca/plan/index-eng.php. Footnote 5 Details on the five streams of the PSSA are available at http://www.chemicalsubstanceschimiques.gc.ca/petrole/index-eng.php. Footnote 6 The final screening assessments for the 40 PRGs from Stream 1 and the 4 PRGs from Stream 2 are available at http://www.ec.gc.ca/ese-ees/default.asp?lang=En&n=08D395AD-1 and http://www.ec.gc.ca/ese-ees/default.asp?lang=En&n=D5D72B57-1, respectively. Footnote 7 The risk management approach documents for the 40 PRGs from Stream 1 and the 4 PRGs from Stream 2 are available at http://www.ec.gc.ca/ese-ees/default.asp?lang=En&n=62D588DD-1 and http://www.ec.gc.ca/ese-ees/default.asp?lang=En&n=480A9D82-1, respectively. Footnote 8 The proposed orders for the 40 PRGs from Stream 1 and the 4 PRGs from Stream 2 are available at http://www.gazette.gc.ca/rp-pr/p1/2014/2014-02-15/html/reg3-eng.php and http://www.gazette.gc.ca/rp-pr/p1/2014/2014-02-15/html/reg4-eng.php, respectively. Footnote 9 An industry association submitted additional information after the comment period, this information was analysed and led to reducing the uncertainties on natural gas processing facilities as a potential source of exposure to 1,3-butadiene that may pose a risk to human health. Therefore, volatile emissions of petroleum and refinery gases from natural gas processing facilities are no longer being considered as an exposure scenario of concern. This has been taken into account as risk management actions are developed. Emissions from oil sands upgraders and petroleum refineries are still of concern because of potential risks to human health. Footnote 10 On the same date, a risk management scope document outlining the preliminary options being examined by the Government of Canada for the management of the 40 PRGs from Stream 1 was also published in the Chemical Substances Web site. Comments were received and where applicable, the information will be considered, in consultation with stakeholders, during the development of a risk management instrument and future assessments of similar substances. Footnote 11 Detailed responses to comments received were posted on the Chemical Substances Web site, as well as a summary of key comments, and the Minister’s responses were published in the Canada Gazette, Part I, on February 15, 2014. For more information, please see http://www.ec.gc.ca/ese-ees/default.asp?lang=En&n=9F26C372-1 and http://www.gazette.gc.ca/rp-pr/p1/2014/2014-02-15/html/reg3-eng.php. Footnote 12 A risk management approach document outlining the options being examined for the management of the 40 PRGs from Stream 1 was also released and subject to a 60-day public comment period. Three comments were received: two from industry associations and one from a petroleum company. Where applicable, the received information will be considered, in consultation with stakeholders, during the development of a risk management instrument and future assessments of similar substances. Footnote 13 A risk management scope document outlining the preliminary options being examined for the management of the 4 PRGs from Stream 2 was also released and subject to the 60-day public comment period. No comments were received. Footnote 14 A risk management approach document outlining the options being examined for the management of the 4 PRGs from Stream 2 was also released and subject to a 60-day public comment period. No comments were received.

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