Canada Gazette, Part I, Volume 148, Number 7: Order Adding Toxic Substances to Schedule 1 to the Canadian Environmental Protection Act, 1999
February 15, 2014
Canadian Environmental Protection Act, 1999
Department of the Environment and Department of Health
REGULATORY IMPACT ANALYSIS STATEMENT
(This statement is not part of the Order.)
Canadians depend on chemical substances that are used in the manufacture of hundreds of goods, from medicines to computers, fabrics, and fuels. Unfortunately, some chemical substances can have detrimental effects on human health and/or the environment. A screening assessment conducted on four petroleum and refinery gases (PRGs) determined that they are harmful to human health, meeting the criteria as set out in paragraph 64(c) of the Canadian Environmental Protection Act, 1999 (CEPA 1999 or the Act). The four substances are
- Gases (petroleum), C3-C4 (Chemical Abstracts Service [CAS] Registry Number [RN] 68131-75-9);
- Gases (petroleum), C3-C4, isobutane-rich (CAS RN 68477-33-8);
- Gases (petroleum), C4-rich (CAS RN 68477-85-0); and
- Hydrocarbons, C1-C4, debutanizer fraction (CAS RN 68527-19-5).
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. A key element of the CMP is the Petroleum Sector Stream Approach (PSSA), under which approximately 160 petroleum substances were considered high priority for risk assessment, as they were determined to present 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 the substances' use profile. (see footnote 1) Within each stream the substances were divided into groups according to similarities in production and physical and chemical properties. The four PRGs subject to this Order form one such group in “Stream 2” of the PSSA. Stream 2 consists of industry-restricted substances that may leave a petroleum-sector facility and be transported to other industrial facilities (for example, for use as a feedstock, fuel or blending component), but that do not reach the public market in the form originally acquired.
Using information collected through surveys under section 71 of CEPA 1999 and other available sources, a screening assessment was conducted for the four PRGs to determine whether they meet one or more of the criteria set out in section 64 of CEPA 1999. Specifically, 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.
Based on the carcinogenic potential of the four PRGs, and their exposure to a small portion of the general population, the screening assessment concluded that these substances meet the criteria under paragraph 64(c) of CEPA 1999. The screening assessment found that the four PRGs did not meet the criteria as set out in paragraphs 64(a) and (b) of CEPA 1999.
The final screening assessment for the four PRGs was published on the Government of Canada's Chemical Substances Web site along with a notice published in the Canada Gazette, Part I, on January 18, 2014, signalling the intent of the Minister of the Environment and the Minister of Health (the ministers) with regard to further risk management activities. Concurrently, the proposed risk management approach document was published on the Chemical Substances Web site.
These publications can be obtained from the Chemical Substances Web site or from the Program Development and Engagement Division, Environment Canada, Gatineau, Quebec K1A 0H3, 819-953-7155 (fax), email@example.com (email).
The PRGs subject to the Order are produced by petroleum refineries, natural gas processing facilities and upgraders. The PRGs are a category of saturated and unsaturated light hydrocarbons. The composition of the PRGs varies depending on the source of the crude oil, bitumen or natural gas, as well as process operating conditions and processing units used. Therefore, these PRGs are considered to be of Unknown or Variable composition, Complex reaction products or Biological materials (UVCBs).
Canada is the first country to conduct risk assessments for complex petroleum substances. In the European Union (EU), the European Chemicals Agency (ECHA) has put petroleum and refinery gas substances on the carcinogenic, mutagenic and toxic for reproduction (CMR) list. The CMR listing is due to the PRGs potentially containing 1,3-butadiene at concentrations greater than 0.1%. In terms of risk assessment, petroleum substances are subject to registration under the EU's Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) program. In the United States, the Environmental Protection Agency (EPA) is developing an approach to identify priority chemicals, including petroleum substances, under the enhanced Chemicals Management Program, for review and assessment.
Potential releases of the substances from a petroleum facility can be either controlled or unintentional. Controlled releases are planned for safety purposes or maintenance, such as pressure relief from a venting valve. Unintentional releases of these gases may occur from processing units (e.g. compressors), valves, pipes or flanges, and tend to occur more frequently when processing equipment is not properly maintained or operated. There are some measures and industry practices in place to reduce the releases of these substances within the facilities; however, it has been recognized that, due to the higher volatility (lower boiling point) of these substances and higher mobility of gases compared with liquid substances, some unintentional release into the atmosphere may occur. Also, releases may occur during transportation of the substances between facilities.
According to information submitted under section 71 of CEPA 1999 and voluntary submissions from industry, the four PRGs can be used within a facility or may be transported to other industrial facilities and used as a feedstock or fuel or for blending into a substance leaving the facility under a different CAS RN. Three out of these four PRGs (CAS RNs 68131-75-9, 68477-33-8, and 68477-85-0) may leave a facility and be transported to other industrial facilities by pipelines or in pressurized containers by train. According to updated industry information, the fourth PRG (CAS RN 68527-19-5) is not transported to other industrial facilities.
It is recognized that a small portion of the general population may be exposed to these petroleum and refinery gases in the vicinity of petroleum facilities. Exposure to the general population during handling (loading and unloading) and transportation of these PRGs is not typically expected given the nature of the transportation systems and regulations in place to prevent or reduce any discharge during handling and transportation processes.
A critical effect for the initial categorization of these substances was carcinogenicity, based primarily on classifications by international agencies. (see footnote 2) Based on available information on the composition of the four PRGs, it was considered appropriate to focus on the emissions of a specific component found in all four industry-restricted PRGs. Similarly to in the approach taken for the site-restricted petroleum and refinery gases, 1,3-butadiene was selected as a high hazard component to characterize potential exposure to the general population. (see footnote 3) It was determined that margins between high-end estimates of exposure to 1,3-butadiene and estimates of cancer potency for inhalation exposure to 1,3-butadiene are considered potentially inadequate to address uncertainties related to health effects and exposure. Given the screening assessment conclusion, the Government of Canada determined that action should be taken to ensure that control measures are available to the ministers to appropriately manage the risks posed by the four PRGs.
The objective of the proposed Order Adding Toxic Substances to Schedule 1 to the Canadian Environmental Protection Act, 1999 is to enable the ministers to propose risk management instruments under CEPA 1999 to manage potential human health risks posed by the four PRGs.
The proposed Order would add the four PRGs to Schedule 1 (the List of Toxic Substances) of CEPA 1999.
The proposed Order would not trigger the “One-for-One” Rule. The proposed Order is an enabling instrument which allows the ministers to propose risk management measures with respect to the four substances; therefore, it is not expected to have any impact on industry that could result in administrative costs.
Small business lens
The small business lens does not apply to this proposed Order, as there are no costs imposed on small businesses. The proposed Order would enable the ministers to propose risk management measures with respect to the four substances, but does not impose any compliance requirements on businesses, including small businesses.
The ministers published a summary of the draft screening assessment for the four PRGs in the Canada Gazette, Part I, on April 28, 2012, for a 60-day public comment period. A proposed risk management scope document outlining the preliminary options being examined for the management of these substances was also released on the same date. During the 60-day public comment period, no submissions were received.
Prior to these publications, Environment Canada and Health Canada had informed provincial and territorial governments through the National Advisory Committee of CEPA 1999 (CEPA NAC) of the release of the draft screening assessment report, risk management scope document and public comment period. No comments were received from CEPA NAC.
As described in the “Substance descriptions” section, the four PRGs can be consumed within a petroleum facility or may be transported to other industrial facilities (for example to be used as a feedstock or fuel or for blending into other substances). Exposure to the general population during handling (loading and unloading) and transportation of these PRGs is not expected given the efficient nature of the transportation systems and risk management measures in place to prevent or reduce any potential release into the environment. However, it is recognized that a small portion of the general population may be exposed to these PRGs in the vicinity of petroleum facilities. 1,3-Butadiene, a component considered to be present in all of these four PRGs, is recognized to be carcinogenic. Given these findings, the screening assessment concluded that the four PRGs subject to this Order meet the criteria set out in paragraph 64(c) of CEPA 1999.
One of the following measures must be proposed after an assessment is conducted under CEPA 1999:
- 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 1999, and where applicable, implement virtual elimination.
Adding the four PRGs to Schedule 1 of CEPA 1999 enables the ministers to propose risk management instruments to manage risks posed by these substances, and is therefore the preferred option among the three alternatives.
The proposed addition of the four PRGs to Schedule 1 of CEPA 1999 would not result in any incremental impacts (benefits or costs) on the public or industry, since the proposed Order does not include any regulatory requirements. Accordingly, there is no compliance or administrative burden imposed on small businesses or businesses in general. The ministers will assess the costs and benefits and consult with the public and other stakeholders during the development of risk management proposals for these substances.
Implementation, enforcement and service standards
The proposed Order would add the four PRGs to Schedule 1 of CEPA 1999, thereby requiring the ministers to publish proposed regulations or instruments respecting preventive or control actions no later than January 2016 and to finalize them no later than July 2017. Developing an implementation plan or a compliance strategy, or establishing service standards, is not considered necessary without any specific risk management proposal. An appropriate assessment of implementation, compliance and enforcement will be undertaken during the development of proposed instruments to manage the risks posed by these PRGs.
Program Development and Engagement Division
Substances Management Information Line:
1-800-567-1999 (toll-free in Canada)
819-953-7156 (outside of Canada)
Michael Donohue Risk Management Bureau
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 sent by mail to the Executive Director, Program Development and Engagement Division, Department of the Environment, Gatineau, Quebec K1A 0H3, by fax to 819-953-7155 or by email to firstname.lastname@example.org.
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, February 6, 2014
Assistant Clerk of the Privy Council
ORDER ADDING TOXIC SUBSTANCES TO SCHEDULE 1 TO THE CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999
1. Schedule 1 to the Canadian Environmental Protection Act, 1999 (see footnote 4) is amended by adding the following:
The following petroleum and refinery gases:
- (a) gases (petroleum), C3-C4 (a complex combination of hydrocarbons — obtained from the distillation of products that result from the cracking of crude oil — consisting of hydrocarbons primarily with three or four carbon atoms, predominantly of propane and propylene, and boiling in the range of approximately -51°C to -1°C);
- (b) gases (petroleum), C3-C4, isobutane-rich (a complex combination of hydrocarbons — obtained from the distillation of saturated and unsaturated hydrocarbons having carbon numbers generally in the range of C3 through C6, predominantly butane and isobutane — consisting of saturated and unsaturated hydrocarbons primarily with three or four carbon atoms, predominantly isobutane);
- (c) gases (petroleum), C4-rich (a complex combination of hydrocarbons — obtained from the distillation of products that result from a catalytic fractionation process — consisting of aliphatic hydrocarbons having carbon numbers in the range of C3 through C5, predominantly C4); and
- (d) hydrocarbons, C1-C4, debutanizer fraction (a complex combination of hydrocarbons — obtained from a debutanizing process — having carbon numbers in the range of C1 through C4).
COMING INTO FORCE
2. This Order comes into force on the day on which it is registered.