Vol. 150, No. 20 — October 5, 2016

Registration

SOR/2016-251 September 23, 2016

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Order Adding Toxic Substances to Schedule 1 to the Canadian Environmental Protection Act, 1999

P.C. 2016-815 September 23, 2016

Whereas, pursuant to subsection 332(1) (see footnote a) of the Canadian Environmental Protection Act, 1999 (see footnote b), the Minister of the Environment published in the Canada Gazette, Part I, on February 15, 2014, two proposed Orders, both entitled Order Adding Toxic Substances to Schedule 1 to the Canadian Environmental Protection Act, 1999, substantially in the annexed form, and persons were given an opportunity to file comments with respect to the proposed Orders or to file a notice of objection requesting that a board of review be established and stating the reasons for the objection;

And whereas, pursuant to subsection 90(1) of that Act, the Governor in Council is satisfied that the substances set out in the annexed Order are toxic substances;

Therefore, His Excellency the Governor General in Council, on the recommendation of the Minister of the Environment and the Minister of Health, pursuant to subsection 90(1) of the Canadian Environmental Protection Act, 1999 (see footnote c), makes the annexed Order Adding Toxic Substances to Schedule 1 to the Canadian Environmental Protection Act, 1999.

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 1) is amended by adding the following in numerical order:

134 The following petroleum and refinery gases:

Coming into Force

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

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 eccc.substances.eccc@canada.ca.

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

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:

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: eccc.substances.eccc@canada.ca

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