Vol. 148, No. 9 — April 23, 2014

Registration

SOR/2014-91 April 11, 2014

FISHERIES ACT

Regulations Establishing Conditions for Making Regulations Under Subsection 36(5.2) of the Fisheries Act

P.C. 2014-435 April 10, 2014

His Excellency the Governor General in Council, on the recommendation of the Minister of Fisheries and Oceans and the Minister of the Environment, pursuant to subsection 36(5.1) (see footnote a) of the Fisheries Act (see footnote b), makes the annexed Regulations Establishing Conditions for Making Regulations under Subsection 36(5.2) of the Fisheries Act.

REGULATIONS ESTABLISHING CONDITIONS FOR MAKING REGULATIONS UNDER SUBSECTION 36(5.2) OF THE FISHERIES ACT

Definitions

1. (1) The following definitions apply in these Regulations.

“Act”
« Loi »

“Act” means the Fisheries Act.

“biochemical oxygen-demanding matter”
« matière exerçant une demande biochimique en oxygène »

“biochemical oxygen-demanding matter” means any organic matter that contributes to the consumption of oxygen that is dissolved in waters or sediment.

“Procedure for pH Stabilization EPS 1/RM/50”
« procédure de stabilisation du pH SPE 1/RM/50 »

“Procedure for pH Stabilization EPS 1/RM/50” means the Procedure for pH Stabilization During the Testing of Acute Lethality of Wastewater Effluent to Rainbow Trout (EPS 1/RM/50), March 2008, published by the Department of the Environment, as amended from time to time.

“Reference Method EPS 1/RM/13”
« méthode de Référence SPE 1/RM/13 »

“Reference Method EPS 1/RM/13” means the Biological Test Method: Reference Method for Determining Acute Lethality of Effluents to Rainbow Trout (EPS 1/RM/13 Second Edition), December 2000 (with May 2007 amendments), published by the Department of the Environment, as amended from time to time.

“research activities”
« activités de recherche »

“research activities” means activities during which a deposit of a deleterious substance is made for the sole purpose of acquiring scientific knowledge.

Acutely lethal

(2) For the purposes of these Regulations, a deposit is acutely lethal if, at 100% concentration, it kills more than 50% of the rainbow trout subjected to it over a 96-hour period when tested to determine lethality in accordance with Reference Method EPS 1/RM/13 and – if applicable – in conjunction with the Procedure for pH Stabilization EPS 1/RM/50.

Aquaculture, pests and invasive species

2. The power that is conferred by subsection 36(5.2) of the Act may be exercised by the Minister of Fisheries and Oceans in relation to aquaculture, to aquatic species that are a pest to a fishery or to aquatic invasive species, if the following conditions are met:

• (a) the Minister is satisfied that the Regulations are required for the proper management and control of fisheries or the conservation and protection of fish; and
• (b) the deleterious substance whose deposit is to be authorized
  • (i) is a drug whose sale is permitted or otherwise authorized, or whose importation is not prohibited, under the Food and Drugs Act,
  • (ii) is a pest control product that is registered under the Pest Control Products Act or whose use is authorized under that Act, or
  • (iii) is biochemical oxygen-demanding matter.

Aquatic research

3. The power that is conferred by subsection 36(5.2) of the Act may be exercised by the Minister of the Environment in relation to research activities if the persons authorized by the Regulations to deposit deleterious substances have processes in place or are subject to processes

• (a) to verify that
  • (i) the research activities will contribute to the development of knowledge for the purpose of managing, conserving, protecting or restoring fish populations or waters frequented by fish,
  • (ii) the research activities will be conducted under the supervision of a person who has expertise in conducting aquatic research under similar conditions, as evidenced by a substantial and relevant peer-reviewed publication record,
  • (iii) the research activities will be designed so as to
    • (A) avoid harmful effects on fish, fish habitat and the use by man of fish, other than the effects that are necessary to achieve results that are scientifically valid, and
    • (B) confine any harmful effects on fish, fish habitat or the use by man of fish to the waters in respect of which the deposit is authorized, and
  • (iv) if research activities render any waters frequented by fish unsuitable to sustain fish populations or render fish populations unsuitable for human consumption, no later than 20 years following the day on which the research activities are completed, the waters will be suitable to sustain fish populations and the fish populations will be suitable for human consumption;
• (b) to evaluate whether the research activities will be carried out in accordance with their design and to document any deviations from that design; and
• (c) to make research findings available to the public.

Other subject matters

4. The power that is conferred by subsection 36(5.2) of the Act may be exercised by the Minister of the Environment in relation to any other subject matter if the following conditions are met:

• (a) the deleterious substance to be deposited, its deposit or the work, undertaking or activity that results in the deposit is authorized under federal or provincial law, or is subject to guidelines issued by the federal or provincial government, and is subject to an enforcement or compliance regime;
• (b) the federal or provincial law or guidelines set out conditions that result in a deposit that is not acutely lethal and contains a quantity or concentration of deleterious substance that when measured in the deposit, or in the relevant waters frequented by fish, satisfies
  • (i) the recommendations of the Canadian Water Quality Guidelines for the Protection of Aquatic Life that were published in 1999 by the Canadian Council of Ministers of the Environment, as amended from time to time, or the recommendations that were derived from those guidelines on their site-specific application, as amended from time to time, or
  • (ii) the recommendations of any peer-reviewed guidelines that are established for the purpose of protecting aquatic life and adopted by a federal or provincial body; and
• (c) the effects of such a deposit on fish, fish habitat and the use by man of fish have been evaluated in accordance with generally accepted standards of good scientific practice.

Additional conditions

5. The power that is conferred by subsection 36(5.2) of the Act may be exercised if

• (a) the proposed Regulations are published in the Canada Gazette at least 30 days before the day on which they are made; and
• (b) before the proposed Regulations are published, the Minister of Fisheries and Oceans or the Minister of the Environment, as applicable, provides the President of the Treasury Board with an estimate of the costs of their implementation.

Coming into force

6. These Regulations come into force on the day on which they are registered.

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Regulations.)

Issues

The pollution prevention provisions in the Fisheries Act (hereinafter referred to as the “Act”) include a general prohibition on the deposit of deleterious substances in water frequented by fish unless authorized by federal regulations made either under the Act or under another Act of Parliament. As a result of limited tools available under the Act to authorize deposits, activities that are already well managed in a way that is protective of water frequented by fish may nevertheless not be in compliance with the prohibition.

For example, industrial deposits that are managed by a federal or provincial permitting program may be in compliance with permit requirements while still being prohibited under the Act because there is no federal regulation allowing such deposits. As a result, there is some uncertainty within industries because their activities, though in compliance with other federal or provincial regulatory controls, are not authorized under the Act. This uncertainty could pose a challenge to some industries in that it could discourage investment decisions or delay business development.

In addition, there has been limited flexibility to authorize research activities that provide useful information to support the purposes of the pollution prevention provisions of the Act. Research of this nature conducted at the ecosystem scale, as opposed to a laboratory setting, may require the carefully controlled and monitored release of deleterious substances into water frequented by fish. The Act does not provide a specific mechanism to enable such research activities and to set conditions for the protection of fish and fish habitat under the general prohibition. In contrast, the Species at Risk Act and the Migratory Birds Convention Act, 1994, provide for the permitting of research activities in similar situations.

Under the Act, the deposit of deleterious substances must be authorized through regulations wherein appropriate conditions for the protection of fish, fish habitat and the use of fish can also be established. Recent amendments to the pollution prevention provisions within the Act have introduced a new authority to develop ministerial regulations authorizing the deposit of certain deleterious substances when such deposits meet specific conditions. This new authority provides another tool that can be used under the Act to effectively manage deposits of deleterious substances in water frequented by fish and potentially reduce regulatory duplication. These ministerial regulations would also provide some clarity for stakeholders on regulatory requirements in the situations described above. Ministerial regulations will not replace the current use of Governor in Council (GIC) regulations to control the deposit of deleterious substances under the Act where these GIC regulations are appropriate. However, before this ministerial authority can be exercised, the GIC must make regulations that set out conditions on the use of this new authority.

Background

Subsection 36(3) of the Act (the general prohibition) prohibits the deposit of deleterious substances in water frequented by fish unless authorized by federal regulations made either under the Act or under another Act of Parliament. The Minister of Fisheries and Oceans is accountable to Parliament, for the most part, for the administration and enforcement of the Act. However, the Minister of the Environment is accountable to Parliament for the administration and enforcement of the provisions of the Act related to the deposit of deleterious substances, in particular, subsections 36(3) to (6), except as they relate to aquaculture, aquatic invasive species and aquatic pests, which remain the responsibility of the Minister of Fisheries and Oceans. These areas of responsibility are established through an Order in Council published in the Canada Gazette, Part II, Vol. 148, No. 6, on March 12, 2014 (www.gazette.gc.ca).

As part of the Jobs, Growth and Long-term Prosperity Act, a number of amendments were made to the Act, including changes to the pollution prevention provisions. It is important to underscore that these amendments did not change the scope of the pollution prevention provisions of the Act. For instance, the long-standing prohibition against depositing deleterious substances into water frequented by fish continues to apply to all waters frequented by fish. One of the amendments to the Act introduced the ability to use ministerial regulations to authorize the deposit of certain deleterious substances under certain conditions. Otherwise, deposits could only be authorized with GIC regulations.

The authority to develop ministerial regulations improves the ability of Environment Canada and Fisheries and Oceans Canada to more efficiently and effectively manage their respective responsibilities under the Act. However, the GIC must first establish conditions for making ministerial regulations.

Objectives

The overall objective of the Regulations Establishing Conditions for Making Regulations under Subsection 36(5.2) of the Fisheries Act (hereinafter referred to as “the Regulations”) is to establish the conditions under which each Minister may make regulations authorizing the deposit of deleterious substances into water frequented by fish for matters under their respective responsibilities. The Regulations will permit the responsible Minister to make ministerial regulations regarding the deposit of deleterious substances following the conditions set out in the Regulations. For example, ministerial regulations would be an efficient means for authorizing deposits that have been determined to be lower-risk and that are already well controlled by a recognized federal or provincial instrument or processes outside the Act or where such deposits are for the purpose of research that supports the objectives of the Act. It is important to reiterate that the Regulations themselves do not authorize deposits.

Description

Made under the authority of subsection 36(5.1) of the Act, the Regulations establish conditions for the making of ministerial regulations under subsection 36(5.2) of the Act. The Regulations, in and of themselves, do not authorize any deposits. The Regulations establish three separate sets of conditions for the making of ministerial regulations which would authorize deposits, depending on the subject matter of such ministerial regulations.

Under the first set of conditions, the Minister of Fisheries and Oceans may develop ministerial regulations that authorize deposits of deleterious substances related to aquaculture, and the management of/or control of aquatic pests, and aquatic invasive species if the following conditions are met:

• The Minister is satisfied that the ministerial regulations are required for the proper management and control of fisheries or the conservation and protection of fish; and
• The deleterious substance whose deposit is to be authorized
  • (i) is a drug whose sale is permitted or otherwise authorized or whose importation is not prohibited under the Food and Drugs Act,
  • (ii) is a pest control product that is registered under the Pest Control Products Act or whose use is authorized under that Act, or
  • (iii) is biochemical oxygen demanding matter.

Under the second set of conditions, the Minister of the Environment may develop ministerial regulations that authorize deposits of deleterious substances for the purpose of aquatic research if the following conditions are met:

• The persons authorized to deposit have processes in place or are subject to processes to verify that
  • (i) the research will contribute to the development of knowledge for the management, conservation, protection or restoration of aquatic ecosystems, and
  • (ii) the research is conducted under the supervision of a qualified person;
• The persons authorized to deposit have processes in place or are subject to processes that result in the findings from research activities being made available to the public;
• The persons authorized to deposit have processes in place or are subject to processes to ensure that research activities are designed and executed to
  • (i) avoid harmful effects other than what is required to obtain valid scientific results, and
  • (ii) contain effects to waters within the boundary for which the authorization is given; and
• The persons authorized to deposit have processes in place or are subject to processes for natural or assisted remediation within 20 years directly following project completion in the event deposits render
  • (i) the aquatic environment unsuitable for sustaining fish populations, or
  • (ii) fish populations unsuitable for human consumption.

Under the third set of conditions, the Minister of the Environment may develop ministerial regulations that authorize deposits of deleterious substances already managed by federal and/or provincial regulating authorities if the following conditions are met:

• The deleterious substance, the deposit or the source of the deposit is managed under a federal or provincial law or guidelines that establish conditions such that:
  • (i) the whole deposit is not acutely lethal (see footnote 1) to fish;
  • (ii) the deleterious substances meet the Canadian Water Quality Guidelines for the Protection of Aquatic Life (CWQG), their site-specific application or science-based guidelines that offer protection similar to the CWQG adopted by a federal or provincial body in the deposit, or in the relevant water frequented by fish;
  • (iii) the deleterious substance, the deposit or the source of the deposit is subject to an enforcement and/or compliance regime; and
  • (iv) the effects on fish, fish habitat and the use by man of fish associated with the deposit have been evaluated, in accordance with generally accepted standards of good scientific practice.

The following conditions apply to each of the three separate sets of conditions described above:

• Ministerial regulations must be published in the Canada Gazette, Part I, for a minimum 30-day public comment period; and
• Before publishing the ministerial regulations, the Minister must provide the President of the Treasury Board with an estimate of the costs of their implementation.

“One-for-One” Rule

The “One-for-One” Rule does not apply to the Regulations as there is no change in administrative costs to business.

Small business lens

The Regulations do not impose any incremental costs on industry, including small businesses, as the Regulations guide ministerial actions. As a result, the small business lens does not apply to the Regulations.

Rationale

The Regulations are required in order to enable the use of a new ministerial authority under the Act to make regulations. The Regulations establish the conditions under which the appropriate Minister may make ministerial regulations. However, where a situation satisfies the conditions in the Regulations, this does not constitute an authorization by itself, nor does it compel the Minister to develop ministerial regulations.

Before a ministerial regulation is developed, the appropriate minister must first conduct an assessment to determine if the conditions contained in the Regulations are met and the use of ministerial regulations could be enabled. In addition, the minister must publish ministerial regulations in the Canada Gazette, Part I, for a minimum 30-day public comment period. As per the Cabinet Directive on Regulatory Management, a Regulatory Impact Analysis Statement (RIAS) summarizing the analysis undertaken to design regulatory proposals would also be published in the Canada Gazette. This means that the public will be consulted on the development of individual ministerial regulations which propose to authorize deposits and that other requirements of the federal regulatory process will be completed.

Ministerial regulations provide an additional tool to manage classes of activities, waters, and deleterious substances that are already effectively controlled by other federal and/or provincial law or guidelines in a manner that prevents pollution or research activities that contribute to the development of knowledge around pollution prevention for water frequented by fish. Such ministerial regulations could also allow for additional controls to the deposit of deleterious substances as appropriate (e.g. monitoring standards and reporting requirements). The ministerial regulations would provide regulatees with added legal certainty that they would not be subject to the general prohibition in cases where they are in compliance with an assessed regime that has recognized environmental controls or are conducting research that supports the pollution prevention provisions of the Act. In turn, they allow the ministers to authorize these lower-risk activities in an efficient manner in order to focus resources on activities that pose greater risks to water frequented by fish.

As an example, the Experimental Lakes Area is a dedicated research facility for ecosystem-scale experimental investigations and long-term monitoring of ecosystem processes. The research at this facility is relevant and useful in implementing the pollution prevention provisions of the Act. However, the operator of the facility would require an authorization under the Act to support the ongoing conduct of research. Therefore, this facility is a good candidate for ministerial regulations. Accordingly, the Experimental Lakes Research Activities Regulations were published in the Canada Gazette, Part I, on February 15, 2014, for a 30-day public comment period. These ministerial regulations would authorize deposits of deleterious substances related to research activities at the Experimental Lakes Area in order to provide the necessary regulatory framework for continued operation of the Experimental Lakes Area. However, they can only be finalized upon completion of the Regulations.

For deposits related to aquaculture, aquatic invasive species and aquatic pests, future ministerial regulations would provide an additional tool to manage the deposit of deleterious substances that are well managed, including those substances that are already regulated at the federal level. These ministerial regulations would also provide regulatees with the assurance that they would not be subject to the general prohibition in cases where they have been assessed to be in compliance with an existing federal or provincial law or guidelines that otherwise allows for the use of these substances in water.

For example, biochemical oxygen demanding matter is managed by federal or provincial aquaculture regulators with respect to marine finfish farms and land-based aquaculture facilities. Health Canada conducts pre-manufacture and pre-import assessments of the potential environmental risk of drugs under the New Substances Notification Regulations of the Canadian Environmental Protection Act. With respect to pest control products, Heath Canada’s Pest Management Regulatory Agency (PMRA) conducts extensive evaluation to determine whether the product is acceptable in terms of safety, merit and value. In addition to evaluating products for impact on human health and safety, the PMRA also evaluates data on the environmental chemistry and toxicology of products, as well as their environmental fate thus what happens to the pesticide once it enters the environment. To address environmental concerns that may arise from the intended use of a product, the PMRA can place restrictions on use that would reduce risks. This could include label statements outlining buffer zones, timing and frequency of applications, rate at which the product can be applied, etc. A decision to register a product will be made only if there is sufficient scientific evidence to show that the product does not pose unacceptable health or environmental risks and that it serves a useful purpose.

Ministerial regulations do not replace the use of GIC regulations to control the deposit of deleterious substances under the Act, such as is necessary for the management of effluent from wastewater systems, mines, and pulp and paper mills. GIC regulations will continue to be used where such regulations are the most appropriate option to manage pollution risks (e.g. deposits that are not currently managed by another regulatory body or where there is a need to impose several conditions on the deposit) and in all cases where the regulations would impose significant new costs.

The Regulations will only allow ministerial regulations to be developed with respect to the deposits of the above-mentioned substances which are already subject to assessment processes or governed by various acts, regulations, guidelines, directives and by-laws to ensure the protection of human health, safety, and the environment. Additional measures may also be included in future ministerial regulations authorizing these deposits including requirements to further minimize harm to fish and fish habitat, consideration of alternatives, monitoring and reporting activities.  Any such ministerial regulations will be available for public comment prior to being made.

Implementation, enforcement and service standards

The Regulations come into force on the day on which they are registered. There is no enforcement associated with the Regulations as they apply to the Minister of Fisheries and Oceans, and the Minister of the Environment, rather than to direct regulatees or the public at large.

The general provisions of section 36 of the Act will continue to apply and be enforced. Further, future ministerial regulations will have an enforcement and compliance plan that would work with the enforcement provisions already established in the Act.

Consultation

The Regulations set out the conditions under which the ministers may make ministerial regulations for the control of deposits that are low risk and well managed. The Regulations do not in themselves authorize the deposit of deleterious substances. The Regulations also do not impose any costs or burden on stakeholders as they apply to the Minister of Fisheries and Oceans and the Minister of the Environment rather than to regulatees or the public at large. Therefore, a limited consultation approach was taken. Any regulations developed in the future for the purpose of authorizing deposits of deleterious substances, whether a ministerial regulation or a GiC regulation, that could impose costs or burden on stakeholders would be subject to separate consultations.

Pre-consultations were held with provincial/territorial representatives and key stakeholders. There were no major issues identified as a result of these pre-consultations.

The proposed Regulations were published in the Canada Gazette, Part I, on February 15, 2014, for a 30-day public comment period. In addition, 130 stakeholders including provincial and municipal governments, Aboriginal groups, industry associations, and environmental groups were notified in writing that the proposed Regulations were available for comment in the Canada Gazette.

A total of 4 385 submissions were received and taken into consideration during the 30-day public comment period. Parties who submitted comments included provincial governments, Aboriginal groups, research organizations, academics, law firms, industry associations, industry, environmental non-governmental organizations, and members of the public. The majority of these submissions were generated through an online petition facilitated by an environmental group.

Of the total submissions received, 72 individual submissions were received which referred to many elements of the proposed Regulations as well as the RIAS published with the proposed Regulations on February 15, 2014. A summary of the comments received during the above-mentioned consultations and how they have been addressed are as follows:

General

Purpose of the Regulations

There were a number of comments received from the general public, industry associations, environmental non-governmental organizations, and a research organization related to the overall purpose and scope of the proposed Regulations. The commenters questioned the rationale provided for the proposed Regulations and suggested that the use of ministerial regulations would weaken existing controls and oversight of the deposit of deleterious substances in waters frequented by fish. Furthermore, the commenters questioned whether there were examples of activities that would benefit from a ministerial regulation.

Response: Environment Canada and Fisheries and Oceans Canada have considered these views and maintain that ministerial regulations will provide an efficient means for authorizing lower-risk deposits that are already well controlled by recognized instruments and for the purpose of authorizing research activities. As in the case of using a GIC regulation to authorize deposits, when using a ministerial regulation, the federal government remains responsible for the implementation and enforcement of the ministerial regulation as well as the pollution prevention provision of the Act. Furthermore, the conditions in the Regulations have been established such that ministerial regulation would authorize deposits in a manner that is protective of fish, fish habitat and use by man of fish. As a result of comments received, this RIAS provides a more detailed explanation of the purpose of the Regulations than described in the RIAS of the proposed Regulations published in the Canada Gazette, Part I, including an example of a proposed ministerial regulation related to aquatic research.

Development of ministerial regulations

Several comments were received from members of the public, provinces, industry associations, academic, and environmental non-governmental organizations questioning how ministerial regulations would be developed, including whether they would be based on a scientific assessment of risks, and whether the conditions set out in the proposed Regulations would be subject to a compliance and enforcement regime. One comment specifically recommended the inclusion of a condition prescribing the Minister to review the adequacy of ministerial regulations within a given time limit.

Response: Environment Canada and Fisheries and Oceans Canada have assessed these comments and made changes in the RIAS. The details of these changes are specified below:

• In order for the Minister of Fisheries and Oceans or the Minister of the Environment to be able to make ministerial regulations, an assessment must be completed to ensure the conditions of the Regulations are met. The conditions in the Regulations have been established to build on existing risk assessment processes and tools (e.g. substance-based risk assessment conducted under the Pest Control Products Act or the evaluation of the risk of exposure to substances as part of water quality guidelines). Furthermore, the Minister making the regulations could establish further controls on the deposit of substances, as appropriate, if specific risks are identified. The RIAS has been updated to explain that an assessment of the conditions of the Regulations will occur prior to the development of ministerial regulations.
• When using ministerial regulations, the federal government will continue to remain responsible for the pollution prevention provisions, for verifying compliance with the ministerial regulation and, if applicable, enforcing compliance measures.
• The periodic review of regulations is a key element of the Cabinet Directive on Regulatory Management which confirms a “life cycle” approach to regulation making. The life cycle approach recognizes that attention must be given not only to regulatory development and analysis but also to the implementation, evaluation, and review of regulations. As part of this approach, implementation of any ministerial regulations would be reported on annually as part of the annual report to Parliament on the administration and enforcement of the fisheries protection and pollution prevention provisions of the Fisheries Act.

Terminology used in the Act

Members of the public and environmental non-governmental organizations questioned some of the terminology used in the proposed Regulations, including the definition of “deleterious substances,” “fisheries” and “drugs.”

Response: The Regulations apply definitions of “deleterious substances (see footnote 2)” and “fishery (see footnote 3)” as they are found within the Act. The term “drug (see footnote 4)” applies as it is defined in the Food and Drugs Act.

Gender inclusive language

A member of the public requested more gender inclusive language in paragraph 4(c) of the proposed Regulations, which refers to the effects of a deposit on fish, fish habitat and the use by man of fish.

Response: Environment Canada and Fisheries and Oceans Canada have considered this comment and concluded that it is necessary to ensure that the Regulations remain consistent with the Act. Therefore, this change has not been made to the Regulations. If the terminology used in the Act is amended in the future, the Regulations may be changed accordingly.

Requirement for a Regulatory Impact Analysis Statement for ministerial regulations

Members of the public, industry associations, and a research organization requested that the proposed Regulations require the Minister to publish a RIAS when publishing ministerial regulations in the Canada Gazette.

Response: The Cabinet Directive on Regulatory Management applies to regulations made by GIC and ministers alike, and requires federal regulators to publish a RIAS in the Canada Gazette, summarizing the analysis undertaken to design a regulatory proposal. Furthermore, the Regulations require any ministerial regulations to be prepublished in the Canada Gazette, Part I, for a minimum 30-day public comment period. Stakeholders would therefore have an opportunity to review a RIAS and provide formal comment on any ministerial regulations.

Equivalency

Members of the public, a provincial government, and environmental non-governmental organizations suggested that equivalency agreements would be a more appropriate approach than ministerial regulations in cases where deposits were already being managed by provincial and/or federal authorities.

Response: An equivalency agreement can be established in cases where both provincial laws and federal regulations, under the Act, are in place. With an equivalency agreement, the GIC may declare that the Fisheries Act regulations stand down in that province; the province becomes the sole regulator. Moreover, ministerial regulations would be pursued where federal regulations do not currently exist with respect to a given class of activities, waters, and deleterious substances. Moreover, where there are ministerial regulations in place the federal government remains responsible for the implementation and enforcement of the ministerial regulation as well as the pollution prevention provisions of the Act.

Ministerial regulations for the purposes of aquaculture, aquatic pests and aquatic invasive species (section 2)

Deposits of drugs, pest control products

Members of the public, industry (fishery) organizations and environmental non-governmental organizations expressed concerns, via an online petition, over the use of pest control products and drugs in aquaculture facilities or in the control of aquatic invasive species and the potential effects on fish, fish habitat and aquatic ecosystems generally. Some identified the need for robust environmental risk assessments or aquatic impact assessments for products authorized for use by the Food and Drugs Act or the Pest Control Products Act in order to minimize the resulting effects on fish, fish habitat and aquatic ecosystems generally.

Response: Fisheries and Oceans Canada considered this comment and notes that Health Canada’s Healthy Environments and Consumer Safety Branch conducts pre-manufacture and pre-import assessments of the potential environmental risk of drugs under the New Substances Notification Regulations of the Canadian Environmental Protection Act. In addition, environmental risk assessments and associated product label restrictions related to pesticides (including pest control products and antifouling products) are enabled through the Pest Control Products Act and its regulations. If environmental risks cannot be appropriately managed to prevent harm to fish and fish habitat, pest control products may not be authorized. If risks emerge that were not predicted, then the product can be reassessed for use and the registration amended as necessary. Any future ministerial regulations developed pursuant to the Act with respect to aquaculture activities, aquatic invasive species and aquatic pests could place additional conditions on the deposit of deleterious substances, including, for example, future ministerial regulations to address deposits of deleterious substances in aquaculture facilities may specify standardized monitoring or may include annual reporting requirements to facilitate compliance and enforcement monitoring.

Wild fisheries

Industry (fishery) organizations expressed concerns that authorizing the use of drugs and pesticides in aquaculture facilities is being enabled at the expense of the fishing industry.

Response: Fisheries and Oceans Canada supports a sustainable and economically prosperous wild fisheries and aquaculture-based fisheries. There have been no changes to the long-standing prohibition on the deposit of deleterious substances; the deposit of deleterious substances can and has been authorized under the Act by regulation. The regulation of deleterious substances with respect to aquaculture is shared between the federal and provincial/territorial governments. The federal government, through various statutes, regulates certain aspects, e.g. the Act includes authorities related to fisheries protection and pollution prevention; the Food and Drugs Act provides for environmental assessments and approval for sale drugs, the Pest Control Products Act provides for the registration of pest control products, the new substances provisions of the Canadian Environmental Protection Act, 1999, address environmental risks related to drug and pesticide products and, the Canada Shipping Act, 2001, includes provisions with respect to pollution from vessels and floating platforms. Generally, provincial/territorial jurisdictions have environmental protection legislation and regimes that include elements addressing water quality, the use of pesticides, and other substances that may be used in aquaculture facilities. Overall, given the suite of federal and provincial legislation in place to regulate the deposit of deleterious substances with respect to aquaculture facilities, future ministerial regulations to address deposits of deleterious substances in aquaculture facilities will work within the scope of the management regimes already in place, allowing for the most efficient application of measures to support all fisheries activities. Proposed regulations of this nature will be published in the Canada Gazette, Part I, for a public comment period.

Ministerial regulations for the purpose of aquatic research (section 3)

Use of ministerial regulations for research activities

Members of the public, industry associations, and environmental non-governmental organizations questioned whether there was a need to allow for the use of ministerial regulations to authorize research activities or whether these activities could be authorized using GIC regulations.

Response: Environment Canada considered these comments and maintains that ministerial regulations are a more efficient means to address research needs. This ministerial-level approach is consistent with other acts such as the Species at Risk Act and the Migratory Birds Convention Act, 1994.

Aquatic research activities: Definition and remediation timeline

Members of the public, academics, environmental non-governmental organizations, and a research organization expressed concern that the requirement to have processes in place for natural or assisted remediation within 20 years following completion of the project was too long. These groups suggested that the definition of “research activities” be amended to exclude monitoring time as part of the 20-year remediation requirement. Additionally, members of the public, academics, research organizations and environmental non-governmental organizations also raised concerns that the definition of “research activities” was too broad and could be considered to include monitoring undertaken by industrial sectors as part of some of the requirements of the Pulp and Paper Effluent Regulations and the Metal Mining Effluent Regulations.

Response: Environment Canada has assessed these comments and, to address both of these concerns, revised the Regulations to amend the definition of “research activities” to exclude monitoring activities and to clarify that the activities in question are solely for the purposes of the development of scientific knowledge. As a result, the time frame for natural or assisted remediation is now 20 years after the last deposit of deleterious substances. Reducing this time limit even further would preclude valuable research on natural recovery rate, as commonly done in aquatic research projects.

Ministerial regulations for deposits of deleterious substances already managed by provincial and/or federal regulating authorities (section 4)

Rationale for conditions

A number of comments were received from members of the public, industry associations, environmental non-governmental organizations, a law firm, and an academic expressing concern that ministerial regulations could lead to more pollution and questioning the rationale for the conditions contained in section 4 of the proposed Regulations.

Response: Environment Canada established the conditions to be protective of fish and fish habitat as explained in the following rationale for each condition contained in section 4

• the requirement that the deleterious substance, deposit, or activity is authorized under federal or provincial law or guidelines and is subject to an enforcement or compliance regime is meant to limit the use of ministerial regulations to cases where there is a regulator actively managing the instrument, verifying compliance with the instrument and, if applicable, enforcing compliance measures;
• the requirement that the effluent not be acutely lethal is meant to limit the use of ministerial regulations to cases where a regulator has an instrument that establishes conditions that avoid mortality of fish exposed temporarily to the effluent;
• the requirement to satisfy the recommendations of the Canadian Water Quality Guidelines for the Protection of Aquatic Life or equivalent guidelines is meant to limit the use of ministerial regulations to cases where a regulator has an instrument that establishes conditions that protect fish and fish habitat from chronic effects; and
• the requirement that the effects of such a deposit on fish, fish habitat and the use by man of fish have been evaluated in accordance with generally accepted standards of good scientific practice is meant to limit the use of ministerial regulations to cases where the effects on fish and fish habitat have been documented or assessed. This will confirm the expected level of environmental protection and handle the uncertainty from unknown substances in the deposit, unknown interactions among substances, or impact of toxicity modifying factors in the receiving environment.

Clarifying federal and provincial roles

Members of the public and environmental non-governmental organizations expressed concerns, via an online petition, that the federal government was offloading its responsibility to manage pollution under the Act to the provinces.

Response: The purpose of the Regulations is to set the conditions that allow the Minister to authorize deposits where those conditions are met. The Regulations, in and of themselves, do not authorize any deposits. Once a ministerial regulation is in place, the federal government would remain responsible for the implementation and enforcement of that ministerial regulation as well as the pollution prevention provisions of the Act. In addition, any federal or provincial law or guidelines that would be considered as part of the assessment for a ministerial regulation must be subject to an enforcement or compliance regime.

Acute lethality definition

A research organization, industry associations, environmental non-governmental organizations, and members of the public commented that the proposed definition of “acutely lethal” would not always be effective in avoiding acute effects on “fish” as defined in the Act as including eggs, sperm, spawn, larvae, spat and juvenile stages of fish, shellfish, crustaceans, and marine animals. Moreover, they indicated that this test was less sensitive to certain pollutants compared to other existing tests and would not apply in the case of deposits that have a medium to high salinity.

Response: The 96-hour rainbow trout test that is used to determine if an effluent is acutely lethal is an industry benchmark in water pollution management and is consistent with existing effluent regulations under the Act (e.g. Pulp and Paper Effluent Regulations, Metal Mining Effluent Regulations, and the Wastewater Systems Effluent Regulations). The test is used to determine the toxicity of pollutants and is a good standard for determining the acute lethality of deposits in a comparable and consistent manner. Nonetheless, ministerial regulations could include additional controls to the deposit of these substances, as needed, for the protection of fish, fish habitat and use by man of fish.

Application of the Canadian Water Quality Guidelines for the Protection of Aquatic Life

A research organization, environmental non-governmental organizations, a law firm, and members of the public raised concerns that the proposed Regulations do not specify how or where in the relevant water frequented by fish the requirement to satisfy the Canadian Water Quality Guidelines for the Protection of Aquatic Life, or similar peer-reviewed guidelines, would be determined. The comments received suggest that this could lead to uncertainty about the level of environmental protection that would result from ministerial regulations.

Response: The Canadian Water Quality Guidelines for the Protection of Aquatic Life, or similar peer-reviewed guidelines, were included as conditions in section 4 in order to address potential sublethal (i.e. chronic) effects to fish exposed to deposits of deleterious substances. Environment Canada has considered these comments and intends to assess the water quality guidelines in the waters frequented by fish close enough to the deposit, or at a sufficiently high ratio of deposit in the waters, for the protection of fish, fish habitat and use by man of fish. In determining such a distance or ratio, Environment Canada will take into account what provinces and other jurisdictions do in that regard, including its own internal risk assessments of chemical products. Moreover, the application of paragraph 4(c) [evaluation of the effects] will ensure that the Minister has the necessary information in assessing whether the application of paragraph 4(b) is consistent with the protection of fish, fish habitat and the use by man of fish.

Contacts

Peter Ferguson
Manager
Legislation and Regulatory Affairs
Fisheries and Oceans Canada
Mail Station 14S020
200 Kent Street
Ottawa, Ontario
K1A 0E6
Fax: 613-993-5204
Email: ER-RH@dfo-mpo.gc.ca

Stéphanie Johnson
Director
Forestry Products and Fisheries Act Division
Environmental Stewardship Branch
Environment Canada
351 Saint-Joseph Boulevard
Gatineau, Quebec
K1A 0H3
Fax: 819-420-7384
Email: FPFA-PFLP@ec.gc.ca

• Footnote a
  S.C. 2012, c. 19, s. 143(2)
• Footnote b
  R.S., c. F-14
• Footnote 1
  An effluent is acutely lethal if, at 100% concentration, it kills more than 50% of the rainbow trout subjected to it over a 96-hour period when tested in accordance with the reference method.
• Footnote 2
  See section 34 of the Fisheries Act.
• Footnote 3
  See section 2 of the Fisheries Act.
• Footnote 4
  See section 2 of the Food and Drugs Act.