FEDERAL REG

SOR/2017-113: Toxic Substance 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
June 2, 2017


REGULATORY IMPACT ANALYSIS STATEMENT (This statement is not part of the Order.) Issues The Government of Canada (the Government) conducted a screening assessment on Fuel Oil No. 2 (see footnote 2) and determined that Fuel Oil No. 2 is entering or may enter the environment in a quantity or concentration or under conditions that have or may have an immediate or long-term harmful effect on the envir... (Click for more)


Published on June 15, 2017

Bill Summary

SOR/2017-113: Toxic Substance 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 (the Government) conducted a screening assessment on Fuel Oil No. 2 (see footnote 2) and determined that Fuel Oil No. 2 is entering or may enter the environment in a quantity or concentration or under conditions that have or may have an immediate or long-term harmful effect on the environment or its biological diversity, as defined under paragraph 64(a) of the Canadian Environmental Protection Act, 1999 (CEPA). Therefore, the Government added Fuel Oil No. 2 to the List of Toxic Substances in Schedule 1 of CEPA. Background The Chemicals Management Plan (CMP) (see footnote 3) is a governmental program that assesses and manages chemical substances that may be harmful to human health or to the environment. A key element of the CMP is the Petroleum Sector Stream Approach, (see footnote 4) which addresses approximately 160 petroleum substances, including Fuel Oil No. 2, that were considered to be of high priority for risk assessment, as they met the categorization criteria under subsection 73(1) (see footnote 5) of CEPA and or were considered as a priority based on other human health concerns. Substance description and main publications Fuel Oil No. 2 is a distillate fuel oil formed by vaporizing, condensing and blending petroleum components that are obtained from the atmospheric distillation of crude oil or bitumen. (see footnote 6) Fuel Oil No. 2 is produced at refineries and upgraders in Canada, with most being produced in Eastern Canada. Fuel Oil No. 2 is used primarily as a fuel source for home heating, but is also used in medium capacity commercial/industrial burners. Based on available information, (see footnote 7) in 2006, approximately 8 billion litres of light fuel oil (the majority expected to be Fuel Oil No. 2) were produced (99%) in or imported (1%) into Canada. Of this amount, about 50% was exported, 25% was used as a fuel for home heating, 19% was used commercially/industrially (e.g. for heating and power generation), and 6% was kept in inventory. In 2011, an estimated 7% of Canadian homes (about 870 600) used Fuel Oil No. 2 as a primary source for home heating. The final screening assessment and the risk management approach document for Fuel Oil No. 2 were published on the Chemical Substances website on February 21, 2015, and a notice was published in the Canada Gazette, Part I, signaling the intent of the Minister of the Environment and the Minister of Health (the ministers) with regard to further risk management activities. On April 23, 2016, the proposed Order adding Fuel Oil No.2 to Schedule 1 of CEPA (the proposed Order) was published in the Canada Gazette, Part I. All the publications mentioned above may be obtained from the Chemical Substances website or from the Program Development and Engagement Division, Department of the Environment, Gatineau, Quebec, K1A 0H3, 1-800-567-1999 (toll-free in Canada), 819-938-5212 (fax), or by email at [email protected] Summary of the screening assessment A screening assessment was conducted on Fuel Oil No. 2 to determine whether it meets one or more of the criteria for a toxic substance, as set out in section 64 of CEPA. Specifically, this involved determining whether Fuel Oil No. 2 is 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 The human health assessment determined that the predominant route of exposure to Fuel Oil No. 2 was inhalation (from potential exposure to fuel evaporative emissions), and estimates of cancer potency for inhalation of benzene (a component of Fuel Oil No. 2 known to be carcinogenic) were used to describe the risk to human health. Based on a review of the available information, the screening assessment determined that the risk to the general population (following residential fuel storage tank leaks) and to those living in the vicinity of Fuel Oil No. 2 bulk storage facilities is considered to be low. Therefore, it was concluded that Fuel Oil No. 2 does not meet the human health criterion under paragraph 64(c) of CEPA, as it is not entering the environment in a quantity or concentration or under conditions that constitute or may constitute a danger in Canada to human life or health. Ecological assessment Determining the risk that a chemical substance poses to the environment involves the consideration of data relevant to its environmental behaviour (e.g. persistence, and potential to bioaccumulate in organisms or biomagnify in food webs), its ecotoxicity and exposure to the substance by potentially affected non-human organisms from the major known sources of release to the Canadian environment. Conclusions regarding risk to the environment take into consideration existing controls in place and are based in part on an estimation of environmental concentrations resulting from releases and the potential for these concentrations to have a negative impact on non-human organisms and/or environmental health. (see footnote 8) Fuel Oil No. 2 can be released (spilled) to the environment during its production, formulation, transportation and use. As part of the ecological assessment, to determine potential ecological harm (e.g. impact on survival, growth and reproduction) associated with this substance, concentrations of Fuel Oil No. 2 in the environment were compared to concentration levels at which the substance may cause ecological harm. To estimate the concentration of Fuel Oil No. 2 in the Canadian environment, data on spills reported to the Government from 2000 to 2009 were used. The analysis determined that at least 200–300 spills of Fuel Oil No. 2 occur each year on land, at least half of which are of sufficient volume to result in soil concentrations that could be harmful to the environment. (see footnote 9) Due to the limited reporting requirements to the Government, this information likely underestimates the number of spills on land nationally. Based on the available information presented in the final screening assessment on the frequency and magnitude of spills, it is concluded that Fuel Oil No. 2 may cause harm to organisms in areas adjacent to sources of release because spills have been identified as harmful to freshwater, marine, and terrestrial organisms, but it does not compromise the broader integrity of the environment. It is therefore concluded that Fuel Oil No. 2 meets the environmental criterion for a toxic substance under paragraph 64(a) of CEPA, as it is entering the environment in a quantity or concentration that have an immediate or long-term harmful effect on the environment or its biological diversity, but it does not meet the criterion under paragraph 64(b) of CEPA. Existing control measures in Canada and abroad Fuel Oil No. 2 can be released to the environment during its production, formulation, transportation and use. In Canada, there is already an extensive regulatory regime for the management of Fuel Oil No. 2 with respect to pollution prevention and response (including discharges), prevention of incident (when dangerous goods are imported, handled, offered for transport or transported), and storage. (see footnote 10), (see footnote 11), (see footnote 12) Many of the storage measures, including those in Manitoba, Newfoundland and Labrador, Ontario, and Prince Edward Island, include requirements for the construction, installation, maintenance, or repair of residential storage tanks for Fuel Oil No. 2. In other provinces and territories, including British Columbia, the Northwest Territories, Nova Scotia, and Nunavut, guidance regarding residential heating fuel storage is available for homeowners. Some municipalities have bylaws requiring permits and inspection for the installation, removal or repair of home heating oil systems. In the United States, there are several regulations pertaining to refineries and to the transportation of substances that may pose a flammability or explosion hazard, substances that include Fuel Oil No. 2. (see footnote 13), (see footnote 14) In Europe, there are principles set on industrial emissions and regulations addressing the transportation of Fuel Oil No. 2. (see footnote 15), (see footnote 16) Also, there are regulations addressing the control of pollution. (see footnote 17) Objectives The objective of the Order Adding a Toxic Substance to Schedule 1 to the Canadian Environmental Protection Act, 1999 is to enable the Government to propose risk management instruments under CEPA to manage potential environmental risks associated with Fuel Oil No. 2, should such instruments be deemed necessary. Description The Order will add Fuel Oil No. 2 to Schedule 1 of CEPA. “One-for-One” Rule The “One-for-One” Rule does not apply, as the Order will not impose any administrative burden on business. Small business lens The small business lens does not apply, as the Order will not impose any compliance or administrative costs on small business. Consultation On June 1, 2013, the Government published a summary of the draft screening assessment for Fuel Oil No. 2, in the Canada Gazette, Part I, for a 60-day public comment period, proposing that Fuel Oil No. 2 meets the criterion under paragraph 64(a) of CEPA. Only one comment regarding the presence and level of benzene in Fuel Oil No. 2 was received and a response was published in the Regulatory Impact Analysis Statement (see footnote 18) for the proposed Order. (see footnote 19) This comment was considered, but did not alter the conclusion in the assessment that Fuel Oil No. 2 poses a risk to the environment, but not to human health. On the same date, a risk management scope document outlining the preliminary options being examined for the management of this substance was released on the Chemical Substances website. (see footnote 20) Prior to the publication of the draft screening assessment and the risk management scope document, the Department of Environment and the Department of Health had informed provincial and territorial governments through the National Advisory Committee of CEPA (CEPA NAC) of their release and public comment period. No comments were received from CEPA NAC. (see footnote 21) On February 21, 2015, the Government published the final screening assessment and the risk management approach document for Fuel Oil No. 2 on the Chemical Substances website (see footnote 22) and on April 23, 2016, the proposed Order adding Fuel Oil No. 2 to Schedule 1 of CEPA was published in the Canada Gazette, Part 1 for a 60-day public comment period. No comments were received on the proposed Order. Rationale Fuel Oil No. 2 is a distillate fuel oil produced at refineries and upgraders in Canada and is primarily used as a fuel source for home heating, but it is also used in medium capacity commercial/industrial burners. Fuel Oil No. 2 may be released (spilled) to the environment during its production, formulation, transportation and use. Based on an analysis of estimated concentration levels at which the substance may cause harm to aquatic and terrestrial environments and the estimated frequency, volume and impact of spills in Canada, it was determined that Fuel Oil No. 2 meets the criteria for a toxic substance under paragraph 64(a) of CEPA. One of the following three measures can be taken after a screening 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. Based on the available evidence, which includes data received from industry and the conclusions of the screening assessment, the Government determined that choosing options 1 or 2 is not appropriate to manage potential ecological risk associated with Fuel Oil No. 2 in Canada. Therefore, option 3, which recommends that the substance be added to the List of Toxic Substances in Schedule 1 of CEPA, is the option chosen by the Government. The addition of Fuel Oil No. 2 to Schedule 1 of CEPA will not result in any incremental impacts (benefits or costs) on the public or industry, since the Order will not impose any compliance requirements on stakeholders. Accordingly, there will be no administrative burden imposed on small businesses or businesses in general. In accordance with the Cabinet Directive on the Environmental Assessment of Policy, Plan and Program Proposals, a strategic environmental assessment was completed. (see footnote 23) Implementation, enforcement and service standards The Order will add Fuel Oil No. 2 to Schedule 1 of CEPA, thereby enabling the Government to propose risk management instruments respecting preventive or control actions. In the case of Fuel Oil No. 2 an instrument must be finalized no later than August 2018. This is within the prescribed limit of 42 months following the Minister’s original proposal to recommend that Fuel Oil No. 2 be added to the List of Toxic Substances in Schedule 1 of CEPA. The proposal was published on February 21, 2015, at the same time as the final screening assessment report for this substance. Developing an implementation plan or a compliance strategy, or establishing service standards, is not considered necessary without any specific risk management proposal. As the Order does not include a specific risk management proposal, there is no requirement for implementation, enforcement, or service standards. An appropriate assessment of implementation, compliance and enforcement is being undertaken during the development of the final instrument to manage risks posed by Fuel Oil No. 2. 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 Fuel Oil No. 2 Chemical Abstracts Service Registry Number (CAS RN): 68476-30-2. The CAS RN is the property of the American Chemical Society, and any use or redistribution, except as required in supporting regulatory requirements and/or for reports to the Government when the information and the reports are required by law or administrative policy, is not permitted without the prior, written permission of the American Chemical Society. Footnote 3 For more information on the Chemical Management Plan, please visit: http://www.chemicalsubstanceschimiques.gc.ca/plan/index-eng.php. Footnote 4 For more information on the Petroleum Sector Stream Approach, please visit: http://www.chemicalsubstanceschimiques.gc.ca/petrole/index-eng.php. Footnote 5 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 6 The composition of Fuel Oil No. 2 can vary depending on the source of crude oil or bitumen; therefore, this substance is considered to be of Unknown or Variable composition, Complex reaction products of Biological materials (UVCB). Footnote 7 Statistics Canada (2008a) provided information on the supply, movement and energy demand of “light fuel oil” (which includes all distillate fuel types for power burners, Fuel Oil No. 2, Fuel Oil No. 3, furnace fuel oil, gas oils and light industrial oils in Canada). Footnote 8 Using available data on the toxicity of the substance to organisms in water, sediment, soil, and/or air, predicted “no-effect concentrations” are then determined. The predicted no-effect concentration is the highest concentration of the substance that is unlikely to cause harm, in terms of impact on survival, reproduction, growth, etc., to non-human organisms. Footnote 9 For detail information on the assessment, please see the final screening assessment at http://www.ec.gc.ca/ese-ees/CA593523-4175-4FC0-8546-A8A9482FF242/FSAR_PSSA-S3_FO%20No.%202_EN.pdf. Footnote 10 For more information on pollution prevention, please see the Ballast Water Control and Management Regulations at http://laws-lois.justice.gc.ca/PDF/SOR-2011-237.pdf and the Vessel Pollution and Dangerous Chemicals Regulations at http://laws-lois.justice.gc.ca/PDF/SOR-2012-69.pdf. Footnote 11 For more information on prevention of incident when dangerous goods are imported, handled, offered for transport or transported, please see the Transportation of Dangerous Goods Act, 1992 at http://laws-lois.justice.gc.ca/PDF/T-19.01.pdf. Footnote 12 For more information on the storage of Fuel Oil No. 2, please see the Storage Tank Systems for Petroleum Products and Allied Petroleum Products Regulations at http://laws-lois. justice.gc.ca/PDF/SOR-2008-197.pdf and the National and Provincial Fire Codes at http://www.nationalcodes.nrc.gc.ca/eng/nfc/index.html. Footnote 13 For more information on regulations pertaining to refineries in the United States, please see the Web page of the National Emission Standards for Hazardous Air Pollutants (NESHAP) program of the Clean Air Act at https://www3.epa.gov/airtoxics/petrefine/petrefpg.html. Footnote 14 For more information on the transportation of substances that may pose a flammability or explosion hazard, please see the Federal Hazardous Materials Regulations of the U.S. Department of Transportation at http://www.ecfr.gov/cgi-bin/text-idx?SID=a0ad26de397e21351d14d32b4b95f428&tpl=/ecfrbrowse/Title49/49CIsubchapA.tpl. Footnote 15 For more information on the principles set on industrial emissions, please see the Directive on Industrial Emissions at http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32010L0075&from=EN. Footnote 16 For more information on the regulations addressing the transportation of Fuel Oil No. 2, please see the European Agreement Concerning the International Carriage of Dangerous Goods by Road at http://www.unece.org/fileadmin/DAM/trans/danger/publi/adr/ADRagree_e.pdf and the Regulation concerning the International Carriage of Dangerous Goods by Rail at http://www.otif.org/fileadmin/user_upload/otif_verlinkte_files/07_veroeff/03_erlaeut/rpex99-rid-e.pdf. Footnote 17 For more information on measures regarding the control of pollutions in Europe please see the Control of Pollution (Oil Storage) (England) Regulations 2001 at http://www.legislation.gov.uk/uksi/2001/2954/pdfs/uksi_20012954_en.pdf a guidance note for the Water Environment (Oil Storage) (Scotland) Regulations 2006 at http://www.scotland.gov.uk/Resource/Doc/ 1057/0029448.pdf and the Control of Pollution (Oil Storage) Regulations (Northern Ireland) 2010 at http://www.legislation.gov.uk/nisr/2010/412/pdfs/nisr_20100412_en.pdf. Footnote 18 The Regulatory Impact Analysis Statement is a summary of the expected impact of a regulatory initiative that addresses each of the requirements of the federal government’s regulatory policy. For more information, please see: http://www.tbs-sct.gc.ca/rtrap-parfa/riaswg-grrier/riaswg-grrier-eng.pdf. Footnote 19 Please see the comment and Government’s response to this comment, in the "Consultation" section of the Regulatory Impact Analysis Statement for Fuel Oil No. 2, at http://gazette.gc.ca/rp-pr/p1/2016/2016-04-23/html/reg1-eng.php. Footnote 20 For more information on the risk management scope document, including comments received during the 60-day public comment period and Government’s responses to these comments, please see: http://www.ec.gc.ca/ese-ees/A4D03268-EAF2-4CEF-82BC-B9F52D06C407/PC%20Table_PSSA-S3_FO%20No.%202_ EN.pdf. Footnote 21 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 22 For updated information on what are the actions the Government is taking with respect to the risk management of Fuel Oil No. 2, please see the Public Summary of Fuel Oil No. 2 at http://www.chemicalsubstanceschimiques.gc.ca/petrole/group-3/fuel_oil-no2-eng.php. Footnote 23 For more information, please see: http://www. chemicalsubstanceschimiques.gc.ca/plan/sea-ees-eng.php.

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