La Gazette du Canada, Partie I, volume 148, numéro 7 : Order Adding Toxic Substances to Schedule 1 to the Canadian Environmental Protection Act, 1999

Le 15 février 2014

Statutory authority

Canadian Environmental Protection Act, 1999

Sponsoring departments

Department of the Environment and Department of Health

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Order.)

Background

On December 8, 2006, the Chemicals Management Plan (CMP) was announced by the Government of Canada to assess and manage chemicals 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 targeted for risk assessment and, where necessary, risk management. During the categorization of the Domestic Substances List (DSL), as the petroleum substances were determined to present “greatest” or “intermediate” potential for exposure to individuals in Canada, they were considered to present a high hazard to human health and were identified as high priorities for action.

Canada is the first national government to conduct risk assessments for complex petroleum substances. In the European Union (EU), the European Chemical Agency (ECHA) has put petroleum and refinery gas substances on the carcinogenic, mutagenic and reprotoxic (CMR) list. In terms of assessment, the EU's Registration, Evaluation, Authorisation and Restriction of Chemical substances (REACH) Program is relying on industry-developed risk assessments, which will then be reviewed by the ECHA for accuracy and completeness. Risk assessments for petroleum substances have not yet been completed under this Program. In the United States (U.S.), the Environmental Protection Agency (EPA) is developing an approach to identify priority chemicals under the Enhanced Chemicals Management Program, including petroleum substances, for review and assessment.

In Canada, approximately 160 petroleum substances were divided into five streams based on the substances' use profile. (see footnote 1) Within each stream, the substances were then further divided into groups according to similarities in production and hazard, as well as physical and chemical properties. Substances from Stream 1 are divided into four groupings. (see footnote 2) The 40 petroleum and refinery gas substances (hereafter referred to as the 40 PRG substances) subject to the Order Adding Toxic Substances to Schedule 1 to the Canadian Environmental Protection Act, 1999 (the proposed Order) compose one grouping in Stream 1.

The compositions of the 40 PRG substances vary depending on the source of crude oil, bitumen, or natural gas as well as on the process used in production. Therefore, the 40 PRG substances are considered Unknown or Variable composition, Complex reaction products or Biological materials (UVCBs). Each of the substances has a unique Chemical Abstracts Service Registry Number (CAS RN) and is listed on the DSL.

The 40 PRG substances are produced at petroleum facilities and are not expected to be transported off petroleum facility sites under their existing CAS RNs. (see footnote 3) Specifically, these substances are expected to be present in three types of petroleum facilities: (1) petroleum refineries (where crude oils are converted into finished petroleum products such as gasoline, jet fuel or base oils for lubricants); (2) natural gas processing facilities (where crude natural gases are processed into clean natural gas and other C2-C5 hydrocarbons); and (3) upgraders (where heavy crude oils or oil sand-derived bitumen are converted into lighter synthetic crude oil for further processing at a refinery).

Although the 40 PRG substances are considered site-restricted, given the physical and chemical properties of these gases (e.g. high vapour pressures), releases of these 40 PRG substances into the atmosphere can occur.

Potential releases of these substances can be characterized as either controlled or unintentional. Controlled releases occur from pressure relief valves and venting valves, for safety purposes or maintenance, and are considered part of routine operations. Exposure of the general population or the environment adjacent to a petroleum facility as a result of controlled releases is expected to be minimal.

Unintentional releases (including fugitive emissions) occur from equipment seals (e.g. compressors and storage tanks), valves, piping, flanges, etc., during the processing and handling of petroleum substances. These releases can be higher in situations of poor maintenance or operating practices. Once released, these gaseous substances will rapidly disperse in the environment in the vicinity of the facility and will separate and partition according to their physical and chemical properties. Inhalation is the primary potential route of exposure for the general population.

Screening assessment conclusions

Using information collected through mandatory surveys under the Canadian Environmental Protection Act, 1999 (CEPA 1999) and other available sources, a screening assessment was conducted on the 40 PRG substances to determine whether the substances 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

According to the final screening assessment, there is limited information on emissions associated with the 40 PRG substances as a whole. In assessing the potential for effects on human health, 1,3-butadiene was selected as a high-hazard gas component to characterize potential exposure to the general population as it is considered, based on available information, to be present in these 40 PRG substances. 1,3-Butadiene exhibits genotoxicity and has been identified by Health Canada and several international regulatory agencies (e.g. the U.S. EPA and the EU) as a carcinogen. (see footnote 4)

Based on the high-end estimates of exposure to 1,3-butadiene from PRG emissions at refineries, the screening assessment found that a small portion of the general population may be exposed to the 40 PRG substances in the vicinity of petroleum facilities. Given the carcinogenic potential of the 40 PRG substances and the uncertainties related to health effects and exposure, the final screening assessment concluded that the 40 PRG substances may constitute a danger in Canada to human life or health. As a result, the final screening assessment concluded that the 40 PRG substances meet the criteria as set out in paragraph 64(c) of CEPA 1999.

Concentrations of PRG components in the air surrounding petroleum facilities are not expected to be at levels that could result in harm to the environment. (see footnote 5) The screening assessment did not find that the 40 PRG substances meet the criteria as set out in paragraphs 64(a) and (b) of CEPA 1999.

The final screening assessment of the 40 PRG substances was published on the Government of Canada's Chemical Substances Web site along with a notice published in the Canada Gazette, Part Ⅰ, on June 1, 2013, signalling the intention of the Minister of the Environment and the Minister of Health (the ministers) to conduct further risk management. (see footnote 6) Concurrently, the proposed risk management approach document and the responses to comments received on the draft screening assessment report and risk management scope document were published on the Chemical Substances Web site. These reports may 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); or by email at substances@ec.gc.ca.

Issues and objectives

The screening assessment concluded that the 40 PRG substances may constitute a danger in Canada to human life or health on the basis of carcinogenicity. Given this assessment conclusion, action should be taken to ensure that control measures are available to the ministers to appropriately manage the risks posed by the 40 PRG substances.

The objective of the proposed Order is to enable the Minister to propose regulations or other risk management instruments under CEPA 1999 to manage human health risks posed by the 40 PRG substances.

Description

The proposed Order would add the 40 PRGs to Schedule 1 to CEPA 1999, thereby enabling the Minister to propose risk management instruments relating to these substances to protect human life and health.

Consultation

The ministers published a summary of the draft screening assessment for the 40 PRG substances on January 15, 2011, in the Canada Gazette, Part Ⅰ, for a 60-day public comment period. A risk management scope document outlining the preliminary options being examined for the management of these substances was also released on the same date. 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.

During the 60-day public comment period, a total of three submissions were received from two environmental non-governmental organizations (ENGOs) and one industry association. All comments were considered during the finalization of the screening assessment report.

Comments were also received from the same ENGOs and industry association on the risk management scope document for the 40 PRG substances. These were considered during the development of the proposed risk management approach document, which is also subject to a 60-day public comment period.

Below is a summary of the key comments received on the draft screening assessment of the 40 PRG substances, followed by their responses. The complete document concerning the responses to comments received is available through the Government of Canada's Chemical Substances Web site, or at the address, email address or fax number provided earlier. For cases in which comments were made questioning whether the 40 PRG substances meet the criteria set out in section 64 of CEPA 1999, due to a lack of available information or uncertainty, the Government of Canada has indicated that it will proceed to take action to protect the health of Canadians and their environment.

Summary of public comments and responses

An ENGO commented that the uncertainties surrounding the utilization of representative structures for modelling the persistence and bioaccumulation of the 40 PRG substances is concerning.

Response: Data on the specific composition of individual PRG substances were not available. Using analogues and representative structures to conduct risk assessment is a recognized approach. The representative structures provide information on the toxicity, persistence and bioaccumulation potentials of the 40 PRG substances. Uncertainties associated with this procedure are acknowledged in the final assessment.

An industry association commented that 1,3-butadiene is not present in all 40 PRG substances and that CAS RNs are not common to all refiners. However, the screening assessment was underpinned by the assumption that each of these gases is present at all facilities and that they all contain significant amounts of 1,3-butadiene.

Response: The 40 PRG substances are considered to be complex combinations of petroleum hydrocarbons. The composition of the 40 PRG substances varies depending on the source of crude oil, bitumen or natural gas, as well as on the process operating conditions and the processing units involved. As specific and detailed information regarding the composition of the 40 PRG substances was not available, conservative assumptions about their compositions were made to protect public health.

An industry association commented that the assumption of a fixed ratio of benzene to 1,3-butadiene is not supported to estimate fugitive emissions, the dataset for the releases of 1,3-butadiene was too small to be used to estimate emission potential, and the limited ambient air monitoring data for 1,3-butadiene do not suggest the presence of 1,3-butadiene at appreciable levels.

Response: Monitoring data were summarized and used to provide context to ambient 1,3-butadiene levels in Canada. No measured and limited estimated quantitative data on emissions of 1,3-butadiene from Canadian petroleum facilities were identified. Emission rates for 1,3-butadiene were derived by calculating ratios of facility-wide benzene to 1,3-butadiene emissions, and applying those ratios to the measured emission rates of benzene from a Canadian refinery. Benzene emissions were taken to be a measure of substance throughput in refinery facilities. Two ratios of benzene to 1,3-butadiene were derived from established emissions inventories, specifically the Canadian National Pollutant Release Inventory (NPRI) and the U.S. EPA's Toxics Release Inventory (TRI) which were submitted to authorities by industry. The TRI database contains data from 65 U.S. refineries and was used to expand the dataset and increase confidence in the numbers presented. Therefore, a range of derived emission rates was presented using all available data and associated variations to reflect conservative estimates of the potential for fugitive emissions.

An industry association commented that the margin of exposure was believed to be very conservative and not supported by studies in occupational epidemiology and community health. It was recommended that the high-end estimate of exposure be reduced, thus increasing the margin of exposure.

Response: All available information is evaluated and considered during screening assessments and forms the basis of decisions. Government evaluators examine lines of evidence and seek additional scientific advice and review from experts when proposing conclusions. The final screening assessment recognizes that there is uncertainty regarding the margin of exposure. However, given the state of knowledge regarding the 40 PRG substances' hazard and exposure levels, the Government of Canada has determined that it is appropriate to be conservative to protect the health of Canadians.

An ENGO commented that no monitoring and release data were provided in the draft screening assessment report for the 40 PRG substances as a whole.

Response: Monitoring a complex combination of petroleum hydrocarbons, as defined by a PRG CAS RN as a whole, is technically challenging given the CAS RN description which typically includes the process equipment involved and the location. Normally, only the individual constituents of concern can be monitored using standard techniques. Additionally, these monitoring results cannot be unambiguously attributed to the release of any specific CAS RN from a facility. The limited availability of data is acknowledged in the uncertainties section of the final screening assessment.

An ENGO commented that emissions of other hazardous components of site-restricted PRGs should be considered, beyond 1,3-butadiene.

Response: Detailed quantitative information regarding the composition of the 40 PRG substances and the nature of the fugitive releases, or health effects information for the 40 PRG substances, was not available. 1,3-Butadiene was selected as a high hazard component. Health effects of other components are summarized in the assessment report.

“One-for-One” Rule

The proposed Order is not expected to have any impact on industry that could result in administrative costs. Therefore, the “One-for-One” Rule is not applicable.

Small business lens

The proposed Order would enable the ministers to propose risk management measures with respect to the 40 PRG substances, but would not impose any compliance requirements on businesses, including small businesses. Thus, no costs would be imposed on small businesses. Therefore, the small business lens would not apply to this proposed Order.

Rationale

The 40 PRG substances are produced at petroleum facilities such as refineries, upgraders, and natural gas processing facilities. Although they are not expected to be transported off petroleum facility sites, unintentional releases occur during processing and handling of petroleum substances. Once released, these PRG substances can disperse in the environment in the vicinity of the facility where limited exposure to the general population may occur. Components of the 40 PRG substances including 1,3-butadiene are recognized to be carcinogenic. Given these findings, the screening assessment concludes that the 40 PRG substances meet the criteria set out in paragraph 64(c) of CEPA 1999.

The following measures can be taken after an assessment is conducted under CEPA 1999:

Adding the 40 PRG substances to Schedule 1 to 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 addition of the 40 substances to Schedule 1 to CEPA 1999 does not result in any incremental impacts (benefits or costs) on the public or industry, since there are no compliance 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 40 PRG substances to Schedule 1 of CEPA 1999, thereby allowing the ministers to publish proposed regulations or instruments respecting preventive or control actions no later than June 2015 and finalize them no later than December 2016. 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 risks posed by the 40 PRG substances.

Contacts

Danie Dubé
Program Development and Engagement Division
Environment Canada
Gatineau, Quebec
K1A 0H3

Substances Management Information Line
Telephone: 1-800-567-1999 (toll-free in Canada)
Telephone: 819-953-7156 (outside of Canada)
Fax: 819-953-7155
Email: substances@ec.gc.ca

Michael Donohue
Risk Management Bureau
Health Canada
Ottawa, Ontario
K1A 0K9
Telephone: 613-957-8166
Fax: 613-952-8857
Email: michael.donohue@hc-sc.gc.ca

PROPOSED REGULATORY TEXT

Notice is hereby 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 substances@ec.gc.ca.

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

JURICA ČAPKUN
Assistant Clerk of the Privy Council

ORDER ADDING TOXIC SUBSTANCES TO SCHEDULE 1 TO THE CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

AMENDMENT

1. Schedule 1 to the Canadian Environmental Protection Act, 1999 (see footnote 7) is amended by adding the following:

The following petroleum and refinery gases:

COMING INTO FORCE

2. This Order comes into force on the day on which it is registered.

[7-1-o]