Issues and possible approaches, Canadian Environmental Protection Act: discussion paper, chapter 2

2. Protecting Canadians from toxic substances and living organisms

• Risk Assessment
  • 2.1 Formally acknowledge vulnerable populations
• New Substances and Activities
  • 2.2 Formally expand the authority to update the Domestic Substances List
  • 2.3 Enhance the transparency of the Domestic Substances List
  • 2.4 Clarify timelines in the new substance regime
  • 2.5 Tailor authorities to address substances in products that are subject to the Food and Drugs Act
  • 2.6 Expressly allow simultaneous use of instruments
  • 2.7 Strengthen the Significant New Activity Provisions
• Risk management of Existing Substances
  • 2.8 Enable a more functional virtual elimination regime
  • 2.9 Expand the risk management “toolbox”
  • 2.10 Streamline roles for managing toxics
  • 2.11 Align the timing of the Minister’s risk management obligation with the Governor in Council decision to add a substance to Schedule 1
• Living Organisms
  • 2.12 Expand the definition of “biotechnology”
  • 2.13 Enable the appropriate department(s) to assess and manage new living organisms
  • 2.14 Miscellaneous amendments to the authorities related to living organisms in Part 6

The Chemicals Management Plan is a joint Environment and Climate Change Canada and Health Canada initiative that assesses risks from chemical substances and living organisms. It addresses chemicals and living organisms that are new to Canada as well as those that are already in commercial use in Canada (i.e., on the Domestic Substances List). In 2006, this program completed a triage (referred to in the Canadian Environmental Protection Act (CEPA) as “categorization”) of the approximately 23,000 chemicals and living organisms on the Domestic Substances List at that time, and identified 4,300 existing substances for further attention by 2020. The program is generally viewed as functioning well.

Risk Assessment

2.1 Formally acknowledge vulnerable populations

Issue

Environmental exposure to certain substances may pose greater health risks for certain more vulnerable members of society, such as children, expectant mothers and elderly persons, than for the general population, owing to physiological differences such as body size, weight, metabolism and growth rate. Assessments of risks to human health, conducted under CEPA, consider the specific vulnerabilities of these groups, including appropriate safety factors, according to available hazard, use and exposure data. However, CEPA does not formally recognize the importance of considering the vulnerabilities of certain populations as an important matter of principle when determining whether a substance is toxic or capable of becoming toxic.

Possible Approach to Address the Issue

CEPA could be amended to mention in the preamble, the importance of considering vulnerable populations in risk assessments. 

New Substances and Activities

CEPA required the Minister of ECC to create a Domestic Substances List that specified all substances that were, between 1984 and 1986: manufactured or imported in quantities of 100 kg or more, or in commerce. Any substance not on the Domestic Substances List is prohibited from being manufactured in or imported into Canada, until prescribed information is provided and the Ministers of ECC and of Health have had an opportunity to assess the substance to determine whether it is toxic, as defined in section  64 of the Act. Following this pre-market notification and assessment process, if certain criteria are met, the Minister of ECC must add the substance to the Domestic Substances List. As such, the list continues to grow over time. In addition, risk management actions can be taken if the substance is determined, or suspected, to be toxic. Similar obligations and authorities exist related to new activities associated with substances, if the Minister of ECC suspects that those activities could result in the substance becoming toxic. 

This regime relies mainly on the provisions found in the first half of Part 5 of CEPA. A parallel regime exists for new living organisms, and is found in Part 6 of the Act. The issues identified below also apply to Part 6, in addition to the specific issues related to living organisms, which are noted in items 2.12 - 2.14.

2.2 Formally expand the authority to update the Domestic Substances List

Issue

Although CEPA requires the Minister of ECC to maintain the Domestic Substances List, it does not expressly authorize the removal of a substance from the List unless it was added by error. In addition, although CEPA authorizes the Minister to collect the information necessary to determine whether a substance should be removed, it does not oblige her to do so.

Possible Approach to Address the Issue

CEPA could be amended to add an explicit authority to remove a substance from the Domestic Substances List when it is not in commerce. This would result in the substance becoming subject to the new substance pre-market notification and assessment requirements, should someone wish to manufacture or import it into Canada following deletion from the List. As such, the removal should involve a transparent process, with opportunity for public comment. An obligation could also be put on the Minister to collect the information necessary to periodically update the Domestic Substances List.

2.3 Enhance the transparency of the Domestic Substances List

Issue

To protect confidential business information, a notifier of a new substance or living organism can request that its name be kept confidential, and appear as a “masked name” on public documents, such as the Domestic Substances List. However, there are cases when disclosure of the name may be desirable, in particular, when compliance by the broader regulated community depends on knowledge of the substance or living organism being regulated.

Possible Approach to Address the Issue

CEPA could be amended to explicitly require the disclosure of names when risk management instruments are in place for the substance or living organism (e.g., when it is added to the Domestic Substances List with the requirement that the Government must be notified of new uses). The Ministers could also be formally authorized to release a name after five years, after proponents have had the opportunity to demonstrate that it should remain confidential.   

2.4 Clarify timelines in the new substance regime

Issue

The new substances provisions in Part 5 of CEPA prohibit the manufacture or import of new substances unless information is provided to the Minister in order for that new substance to be assessed for potential health or environmental risks, and an assessment period has expired. During the assessment period, the Minister can formally request additional information, which “pauses” the assessment period. However, if the Minister requests clarifications of submitted information, the assessment period is not “paused”. As a result, the assessment period could expire (allowing the substance to enter Canada) before the Minister receives the clarifications required to make an informed decision.

Possible Approach to Address the Issue

CEPA could be amended to expressly allow the assessment period to be “paused” if the Minister requests clarifications related to submitted information.

2.5 Tailor authorities to address substances in products that are subject to the Food and Drugs Act

Issue

Subsections 81(1) to 81(4) of CEPA require the notification and assessment of new substances and new uses of existing substances. CEPA recognizes that other Acts may provide equivalent pre-market notification and assessment regimes that are better suited for certain new substances. If such a regime is listed on Schedule 2 of CEPA, the substances subject to it are exempt from the above-noted requirements in CEPA. For example, new animal feeds and new pesticides are assessed and managed through the Feeds Act and Pest Control Products Act respectively. This allows the departments with the relevant expertise to determine whether these substances are safe for use in Canada.

However, in certain cases, the appropriate departments do not have legislation with equivalent pre-market notification, assessment and management regimes. For example, substances that are used or intended to be used in products regulated under the Food and Drugs Act (FDA) are subject to the new substance requirements in CEPA. This has resulted in a number of issues:

• CEPA does not always formally provide for the tailoring necessary for the new substance regime to apply to substances in products subject to the FDA. For example, certain foods and substances that originate in nature do not pose a risk to the environment, and should be exempted from pre-market notification and assessment. However, the regime in CEPA does not expressly allow for such exemptions. 
• Section 83 of CEPA requires the Minister of ECC and the Minister of Health to both assess information to determine whether a new substance is toxic or capable of becoming toxic. However, for substances in certain products regulated under the FDA, the assessment process could be streamlined if the Minister of Health was solely responsible.

Another issue relates to the administrative “In-commerce List” which comprises substances in products subject to the FDA that entered Canada between January 1, 1987 and September 13, 2001. These substances were subject to an assessment of safety and efficacy under the FDA, and are currently being prioritized under the Chemicals Management Plan for risks which they may pose to human health and the environment. However, their status in relation to the New Substances provisions of CEPA remains an issue. 

Possible Approach to Address the Issue

CEPA could be amended, in the following ways, to address these issues:

• Explicitly allow for exemptions related to notification and information provisions for certain classes of new substances, such as substances in FDA regulated products that are originating in nature.
• Provide an express authority to the Governor in Council to designate the Minister of Health as the minister solely responsible for section 83 assessments of new substances in specified products regulated under the FDA.
• Formally authorize the Minister of ECC to add substances on the “In-commerce list” to the Domestic Substances List, with any restrictions necessary to account for uses that have not yet been assessed. This would provide regulatory certainty for industry with respect to the status of these substances.

2.6 Expressly allow simultaneous use of instruments

Issue

During the assessment period, where the substance is suspected of being toxic, or capable of becoming toxic, paragraphs 84(1)(a)-(c) provide that the Minister may a) permit the manufacture or import of the substance, with conditions, b) prohibit the manufacture or import of the substance, or c) request additional information. Subsection 84(2) prohibits the manufacture or import of the substance when additional information has been requested. However, in certain cases, it may be beneficial to expressly allow the controlled manufacture/import of a substance while also requesting the notifier to provide additional information.

Possible Approach to Address the Issue

CEPA could be amended to formally allow additional information to be requested using paragraph 84(1)(c) at the same time as allowing controlled manufacture/import under paragraph 84(1)(a) (i.e., to allow an exception to the prohibition in subsection 84(2) if the manufacture or import is permitted under paragraph 84(1)(a)).

2.7 Strengthen the Significant New Activity Provisions

Issue

The Significant New Activity (SNAc) provisions prohibit new activities associated with a substance, unless information is provided to the Minister in order for that new activity to be assessed for potential health or environmental risks. A number of issues have been identified related to these provisions:

• When the Minister publishes a SNAc notice for substances or living organisms not on the Domestic Substance List, CEPA requires every person who transfers the substance or living organism to notify all persons to whom the substance or living organism is transferred of the obligation to comply with the SNAc notice. However, a similar downstream notification requirement is not explicitly provided for SNAc notices issued for substances that are on the Domestic Substance List.
• The Minister can vary the significant new activities identified in a significant new activity notice, but is not expressly authorized to vary other information such as data requirements and timeframes for submission.
• Some substances on the Domestic Substances List are subject to the CEPA requirements concerning significant new activities. CEPA does not expressly provide the authority to use interim risk management measures such as Ministerial conditions and prohibitions to manage risks identified when a proponent notifies the Ministers of a proposed significant new activity with respect to these substances.

Possible Approach to Address the Issue

CEPA could be amended, in the following ways, to address these issues:

• To provide explicitly for a downstream notification requirement for significant new activities regarding substances that are on the Domestic Substance List, similar to that for substances not on the Domestic Substances List. This provision may need to be tailored to take into account the specific circumstances of substances on the Domestic Substances List.
• Explicitly allow Minister to vary any part of a significant new activity notice (not just the new activities). Such an amendment could clarify that any information in a notice may be modified.
• Expressly allow Ministerial conditions and prohibitions to be used for Domestic Substances List substances.

Risk management of Existing Substances

Substances on the Domestic Substances List are referred to as existing substances, to distinguish them from newsubstances that are not yet in commercial use in Canada. If the results of a risk assessment for a substance show that the substance is toxic under CEPA, risk management actions may be undertaken. In certain cases, this is an obligation for existing substances. Along with regulations, a variety of other instruments can be used to risk manage toxic substances. This is known as the risk management toolbox. Having a wide selection of tools allows the departments to select the risk management action that will be the most effective and efficient at controlling the risk. Provisions related to risk management instruments are found throughout CEPA. In certain cases, there are timeframes and requirements for action with respect to risk management, which are set out in Part 5.

Some substances may also be managed through controls on exports, administered  through  the Export Control List, which operates under Part 5 of CEPA, Schedule 3 and related regulations.

2.8 Enable a more functional virtual elimination regime

Issue

CEPA’s virtual elimination regime - established to address substances that are persistent, bioaccumulative, and toxic (PBT) - requires that certain PBT substances be added to a Ministerial Virtual Elimination List (in addition to Schedule 1), and that a Ministerial release limit regulation and virtual elimination plans be developed for each substance. However, this largely duplicates the risk management requirements that already exist by virtue of adding the substance to Schedule 1.

In addition, the regime requires that a “level of quantification” be developed for each substance added to the Virtual Elimination List. However, this restricts the use of the current provisions to substances that can be measured while they are being released into the environment (e.g., point source releases), thereby preventing the Government from adding to the Virtual Elimination List those PBT substances that are released diffusely.

For these reasons, only two substances have been added to the Virtual Elimination List, even though about 20 meet the criteria.

Possible Approach to Address the Issue

CEPA could be amended to create a more functional virtual elimination regime for managing persistent, bioaccumulative and toxic substances, with the following elements:

• Schedule 1 is divided into 2 parts:
  • Part 1: Virtual Elimination List
  • Part 2: Other toxic substances
• Following an assessment, a substance may be added to either Part of Schedule 1 (not both)
• Substances added to Part 1 (the Virtual Elimination List) must be risk managed with one of two possible instruments:
  • A regulation under CEPA or another federal Act; or
  • Addition to the Toxic Substances with Restricted Activities List (see 2.9 below)
• Exemption for substances that are critical to human or animal health
• This would involve removal of the following elements: the definition of virtual elimination, the level of quantification, virtual elimination plans, Ministerial release limit regulations, and the Ministerial virtual elimination list.

2.9 Expand the risk management “toolbox”

Issue

For most existing substances that are found toxic, section 91 of CEPA requires a preventive or control instrument or regulation to be proposed by the Minister of ECC within 24 months, and section 92 requires that instrument or regulation to be finalized 18 months later. Although CEPA provides for the use of a wide range of preventive or control instruments and regulations to manage risks from toxic substances, additional express authorities would formally enable the government to manage each risk as effectively as possible.

• Performance Agreements are entered into according to the existing Policy Framework for Environmental Performance Agreements. They are flexible instruments with core design criteria negotiated among parties to achieve specified environmental results. They stipulate clear and measurable performance standards and include effective accountability mechanisms. However, as they are not expressly mentioned in CEPA, these agreements do not formally allow the Minister of ECC to discharge the obligations under sections 91 and 92.
• The obligation on the Minister of ECC is to publish a regulation or instrument under CEPA. In some cases, however, another federal act may be the best placed act to manage the risks associated with a toxic substance. For example, measures provided under the Canada Consumer Product Safety Actmay be better suited than CEPA to manage the risks of some substances found in certain types of consumer products.
• In some situations, the current activities associated with a toxic substance do not pose a risk, but potential future activities might. The addition of a new instrument (Toxic Substances with Restricted Activities List) would explicitly allow risk management to focus on only these potential new uses.
• All CEPA instruments and regulations are currently formally limited in their ability to control risks arising from products that do not originally contain a toxic substance, but release it during use (as mentioned in item 1.7 above). For example, portable fuel containers may not be made of toxic materials, but they can release VOCs while they are storing fuel if they are not properly constructed.

Possible Approach to Address the Issue

CEPA could be amended to formally expand the toolbox in CEPA as follows:

• Performance agreements: Expressly allow performance agreements between either the Minister of Health or the Minister of ECC and another party, to fulfill the risk management obligation.
• Best Placed Act: Formally allow a regulation or instrument made under another Act to fulfill the risk management obligations under CEPA
• Toxic Substances with Restricted Activities (TSRA) List: Create a list under the Act, and expressly allow the Governor in Council to add a toxic substance to this list, and specify the activities associated with the substance that are prohibited. The Governor in Council would also have the authority to modify the list (remove substances, add and remove activities, etc.)
• All instruments & regulations: Ensure they can cover products that may release a substance (as mentioned in item 1.7 above).  

2.10 Streamline roles for managing toxics

Issue

The obligation to propose a risk management regulation or instrument for certain toxic substances (described above), rests solely with the Minister of ECC. However when risk management of a substance is entirely led by the Minister of Health, the accountability to meet the legislated timeframes arguably should expressly rest with the Minister of Health.

In addition, section 93 regulations for toxic substances are made by the Governor in Council (GiC) upon recommendation of both the Minister of ECCC and of Health. However, in certain cases, this adds unnecessary administrative process.

Possible Approach to Address the Issue

CEPA could be amended to formally allow the Minister of Health to be responsible for the sections 91 and  92 obligations to develop a preventive or control instrument or regulation for a toxic substance, in the following two circumstances:

• when the risk management will be entirely led by the Minister of Health using a CEPA instrument that the Minister of Health has authority to develop unilaterally (i.e., section 55 guidelines or code of practice); and
• when the development of the preventive or control instrument or regulation will be entirely led by the Minister of Health under a Health Canada Act such as the Canada Consumer Product Safety Act or the Food and Drugs Act (see item 2.9 re: Best Placed Act proposal).

Consideration could also be given to amending CEPA to streamline the process for putting regulations in place to manage a substance.

2.11 Align the timing of the Minister’s risk management obligation with the Governor in Council decision to add a substance to Schedule 1

Issue

Section 91 states that the Minister must propose a preventive or control instrument or regulation for certain toxic substances within 24 months of making a recommendation to the Governor in Council to add that substance to the List of Toxic Substances. Subsection 90(1) specifies that the Governor in Council may (or may not) choose to add the substance to Schedule 1. This creates a possible problem because some risk management regulations and instruments are only available for substances that are listed on Schedule 1, but the obligation to risk manage the substance applies, even if the Governor in Council decides not to list the substance on Schedule 1.

Possible Approach to Address the Issue

CEPA could be amended to trigger the obligation to develop the instrument or regulation for a substance when the Governor in Council decides to add the substance to Schedule 1.

Living Organisms

Living organisms, such as micro-organisms, are used in a growing range of products such as adhesives and detergents, and for purposes such as bioremediation and biomass conversion. New living organisms are subject to analogous pre-market notification and assessment requirements to chemicals. Existing living organisms can also be assessed, added to Schedule 1 if they are determined to be toxic, and risk managed if needed. This program relies mainly on Part 6 and Schedule 4, but could also use Part 5 for risk management.

2.12 Expand the definition of “biotechnology”

Issue

The current definition of “biotechnology” refers to the “application of science and engineering in the direct or indirect use of living organisms”. This definition lacks clarity.  

Possible Approach to Address the Issue

CEPA could be amended to clarify the definition of biotechnology.  

2.13 Enable the appropriate department(s) to assess and manage new living organisms

Issue

The Government must assess the environmental and health risks of all new products of biotechnology before they are introduced into Canada. As for new substances, the default situation is for these assessments to be performed by ECCC and Health Canada under CEPA. Recognizing that other departments or agencies may be better placed to address certain living organisms, CEPA can stand-down in favour of other Acts that contain an equivalent assessment regime, if they are listed on Schedule 4. However, in certain cases, the departments with the relevant expertise do not have statutes with equivalent pre-market notification regimes.

Possible Approach to Address the Issue

CEPA could be amended to formally allow the Governor in Council to designate another Minister -whose department or agency has the appropriate mandate, expertise and stakeholder relationships for a given living organism- as responsible for, and having the authority under CEPA to assess and manage, specific products of biotechnology.  

2.14 Miscellaneous amendments to the authorities related to living organisms in Part 6

Issues

There are a few issues that present challenges in the administration of Part 6 of CEPA:

• The Ministers of ECC and Health have authority to make guidelines on the interpretation and application of the provisions of Part 5 of CEPA, but this authority is missing for Part 6.
• A person must provide certain information to the Minister before manufacturing, importing or using a new living organism. The Minister can waive information requirements in certain circumstances, for example if the information is not required to determine toxicity, or if the living organism will be manufactured at a location where it will be contained in a way that protects the environment and human health. However, the provisions do not expressly allow for information requirements to be waived for a person importing a living organism in a manner and to a location where it will be contained in a way that protects the environment and human health.
• Paragraph 115(1)(b) provides authority to make regulations dealing with the effective and safe of use of living organisms with respect to their use in pollution prevention, but this is narrower than it needs to be (i.e., living organisms are also often used in environmental remediation and protection).

Possible Approach to Address the Issue

CEPA could be amended to address these issues as follows:

• Ensuring that the section 69 authority to make interpretive guidelines explicitly applies to Part 6 (as well as Part 5).
• Updating waiver provisions to formally allow for waiving of information when a living organism is imported in a manner and to a location where it will be safely contained.
• Broaden language in paragraph 115(1)(b) to better reflect biotechnology uses in environmental protection applications.