A Proposed Regulatory Regime to Manage the Release of Aquaculture Substances

(formerly known as the Fish Pathogen and Pest Treatment Regulations)

Public Consultation Presentation February 2012

Download PDF version (625 KB)

Table of Contents

• A Proposed New Regulatory Regime
• Regulatory Issues Being Addressed
• Prior Initiatives Informing the Regulatory Regime
• Scope of Regulatory Initiative
• Regulatory Regime Principles
• Related Regulatory Programming Already Exists
• Integration of Regulatory Programming
• Proposed Regime Elements
• Element 1: Environmental Risk Assessment
• Element 2: Mitigation
• Element 3: Compliance
• Proposed Delivery Model
• Design of Proposed Fisheries Act Regulations
• Proposed Timelines
• For Discussion
• Annex - Acronyms

A Proposed New Regulatory Regime

• Federal and Provincial governments are committed to sustainable aquaculture in Canada – enabling development while ensuring protection of fish and fish habitat.
• Some aquaculture husbandry activities have the potential to affect water quality, fish, and/or fish habitat, if not properly managed.
• These animal husbandry activities are critical to animal welfare, but environmental effects must be considered and appropriately managed.
• There are a number of government environmental management measures in place that contribute to ensuring environmentalrisks resulting from these activities are low.

Regulatory Issues Being Addressed

• The establishment of an overall regulatory regime is being considered, given that:
  • Environmental risks related to these activities are currently being managed, but by a variety of regulators; a mechanism for overall coordination could better ensure measures are integrated and effective in managing risk;
  • The Fisheries Act contains provisions that may limit certain aquaculture activities, even when the environmental risks are low; and
  • While Fisheries Act regulations have not been developed to manage all activities that may present similar risks, there has been substantial public focus on aquaculture activities.

Prior Initiatives Informing the Regulatory Regime

• Environment Canada (EC) published guidelines on environmental assessment of marine finfish aquaculture projects in 2001.
• Fisheries and Oceans (DFO) published an interim guide to the application of section 35 of the Fisheries Act to marine salmonid cage aquaculture in 2002.
• The Pest Management Regulatory Agency (or its predecessor) has been involved in the regulation of pesticide use in aquaculture, under the Pest Control Products Act, since the early 1990s, and published guidance on Integrated Pest Management approaches for sea lice control in 2003.
• Regulation of fish pathogen and pest treatments, and feed and feeding were considered as part of the development of the Pacific Aquaculture Regulations.
• A discussion document on potential fish pathogen and pest treatment regulations was posted on the Department's website in August, 2010.
• A Notice of Intent to Regulate was published in Canada Gazette on November 5, 2011.

Scope of Regulatory Initiative

• DFO, working with regulatory partners, is considering establishing a regulatory regime to manage some or all of the following activities:
  • The deposit into fish bearing waters of:
    • Substances used to treat fish for pathogens and pests (example pesticides and drugs); and
    • Materials, such as settleable solids and biological oxygen demand (BOD) matter related to aquaculture activities.
  • Mechanical destruction of pests and biofouling organisms (e.g. tunicates) through means such as power washing.
  • Activities by the Canadian Food Inspection Agency (CFIA), under the Health of Animals Act, to control or eradicate fish diseases. With the new regulations and program in place, sections 32, 35, and 36 of the Fisheries Act would be regarded as adequately addressed for the scope of the managed activities.
• The intention is that the regulatory regime will address related provisions of the Canadian Environmental Protection Act (1999) Disposal at Sea requirements for environmental protection.

Regulatory Regime Principles

• In designing the regulatory regime, the following principles are being applied:
  • Fish populations, fish habitat, and use of fish must be protected;
  • Government management regimes support sustainable activities and development in rural communities;
  • Investment in risk assessment and mitigation should be commensurate with the level of risk; and
  • Programming is to build on existing regulatory structures to the greatest extent possible, to be fiscally responsible, and to minimize regulatory burden.
  • Initiative is to encompass Disposal at Sea principles of the Canadian Environmental Protection Act (1999) and the 1996 Protocol to the Convention on the Prevention of Marine Pollution by Dumping of Wastes and Other Matter.

Related Regulatory Programming Already Exists

• As noted previously, there are already a wide range of regulatory measures in place in Canada to manage aquatic environmental risks related to activities within the scope of this proposed regime; these include:
  • Federal measures under the Pest Control Products Act, Food and Drugs Act combined with the Canadian Environmental Protection Act, Health of Animals Act, and the Fisheries Act.
  • Aquaculture measures (DFO under the Fisheries Act in British Columbia, and provinces elsewhere) covering areas such as:
    • Integrated fish health and pest management;
    • Management of organic deposition; and
    • Requirements to provide site-specific data, such as currents, habitat, etc.
  • Provincial regulation related to pesticide use and veterinary practice.
• Information on the Pest Management Regulatory Agency's regulatory regime, DFO's aquaculture regulatory regime in British Columbia, and New Brunswick's Integrated Pest Management Plan is available as accompanying documents to this presentation on the DFO website.

Integration of Regulatory Programming

• In order to ensure that program management is integrated across the various individual regulatory regimes, DFO and its partners are considering establishing a program oversight and coordination process as outlined below:

• New regulations under the Fisheries Act will provide the regulatory integration to underpin the program.

Proposed Regime Elements

Regulatory partners have identified that the regulatory regime needs to encompass the following elements:

• Environmental Risk Assessments (ERAs), informed by applicant information and data, and government science advice, using a robust, science-based risk assessment framework;
• Imposition of environmental mitigation measures on use, as appropriate; and
• Compliance and enforcement of mitigation measures.

Element 1: Environmental Risk Assessment

• The following general, science-based risk assessment framework is expected to be used, with processes expected to be Canadian Environmental Protection Act (CEPA) equivalent:
  • Hazard identification and characterization
  • Exposure assessment and characterization
  • Risk assessment and characterization
  • Risk Mitigation/Management
• The environmental risk assessment element would be implemented as follows:
  • For pesticides, by the Pest Management Regulatory Agency (PMRA); consideration of environmental impacts on fish and fish habitat, as well as terrestrial ecology, as may be applicable
  • For drugs, by HC Environmental Assessment Unit; and
  • For all other activities, by DFO under the Fisheries Act.

Element 2: Mitigation

• Environmental risk assessment processes are typically expected to identify ways to mitigate environmental uncertainty or risks to an acceptable level.
• Mitigation measures for this initiative are expected to typically fall into one of the following categories:
  • Reporting on level of activity (e.g., annual use of therapeutants by facility);
  • Establishment of maximum thresholds, through dosage and/or maximum accumulation;
  • Special conditions on use to reduce risks of impacts and/or volume of product required (e.g., related to weather or application conditions);
  • Integrated management measures to reduce inputs (e.g., for therapeutants - alternative approaches to treatment; in general - husbandry measures, such as fallowing, density of animals; timing of smolt entry); and
  • Monitoring programs.
• Mitigation is expected to be established consistent with environmental risk assessment outcomes. Note that not all mitigation categories may be relevant to all activities at all times, and that the extent of mitigation will typically be a factor of the level of risk.

• Mitigation measures would be imposed through mechanisms as follows:
  • Reporting on level of activities, as a requirement of new Fisheries Act regulations;
  • For pesticides, through product label conditions under the Pest Control Products Act, as set by the Pest Management Regulatory Agency in areas such as:
    • Establishment of maximum thresholds, through dosage and/or maximum accumulation;
    • Special conditions on use to reduce risks of impacts and/or volume of product required (e.g., related to weather or application conditions); and
    • Monitoring programs under some situations, particularly emergency registrations.
  • For other aspects of pesticide management, by aquaculture regulators through their respective regimes;
  • For all other activities, all mitigation would be imposed by aquaculture regulators through their respective regimes.

Element 3: Compliance

• Compliance would be the responsibility of the regulatory authority setting mitigation.
• Achieving compliance involves a combination of identifying compliance issues, encouraging and promoting compliance, inspecting for compliance, and investigations.
• Enforcement response tools include:
  • For the Pest Management Regulatory Agency - education; warnings; product detention; administrative penalties up to $4,000; and, depending on the specifics of the situation of non-compliance and the enforcement approach taken, maximum prison terms from six months to three years, and maximum fines from $200,000 to $1,000,000;
  • For Fisheries and Oceans - education; warnings; compliance orders; prosecutions with fines up to $500,000 or imprisonment up to two years; and
  • Provincial aquaculture regulatory regimes (vary by province and legislation) – permits and licensing.
• While Environment Canada would have no enforcement responsibilities under this proposed regulatory regime, they maintain the lead for s.36 of the Fisheries Act, for activities outside these regulations.

Proposed Delivery Model

Design of Proposed Fisheries Act Regulations

• Proposed new regulations would permit activities under the Fisheries Act, so long as:
  • There is an annual report on all activities subject to these regulations; and
  • The activities are carried out in a manner that conforms with:
    • For pesticides:
      • Health Canada's product labels; and
      • Aquaculture regulators requirements for integrated pest management and site information;
    • For drugs:
      • Aquaculture Regulators* requirements for integrated fish health management, feed management, and site information
    • For materials such as settleable solids and BOD matter:
      • Aquaculture regulators' requirements for management
    • For mechanical destruction of pests and biofouling organisms:
      • Aquaculture regulators' requirements for management
• Accountability, coherent application, and transparency would all be objectives sought through the regime's program oversight structure.

* Aquaculture Regulators are DFO in British Columbia and provinces in other parts of the country.

Proposed Timelines

• External policy consultations are expected to be start February 2012:
  • On-line, downloadable presentation with questions for feedback via email; and
  • Limited number of multi-stakeholder and First Nations face-to-face meetings and teleconferences.
• Publication of draft regulations in Canada Gazette I in late spring, 2012 with a consultation period.
• Canada Gazette II publication of final regulations, targeted for fall 2012.

For Discussion

1. Are there any changes, deletions, or additions that you would like to suggest to the categories of activities proposed to be managed under this regulatory regime:

• The deposit into fish bearing waters of:
  • Substances used to treat fish for pathogens and pests (e.g. pesticides and drugs); and
  • Materials, such as settleable solids and BOD matter related to aquaculture activities.
• Mechanical destruction of pests and biofouling organisms (e.g. tunicates) through means such as power washing.
• Activities by CFIA under the Health of Animals Act to control or eradicate fish diseases.

2. We have listed a number of principles used in developing the proposed regulatory regime. Are there any changes, deletions or additions that you would propose?

• Fish populations, fish habitat, and use of fish must be protected;
• Government management regimes support sustainable activities and development in rural communities;
• Investment in risk assessment and mitigation should be commensurate with the level of risk;
• Programming is to build on existing regulatory structures to the greatest extent possible, to be fiscally responsible and to minimize regulatory burden; and
• Initiative is to encompass Disposal at Sea principles of CEPA (1999) and the 1996 Protocol to the Convention on the Prevention of Marine Pollution by Dumping of Wastes and Other Matter.

3. Are there any changes, deletions, or additions that you would like to suggest to the proposed mitigation areas? Please explain why you believe these changes would better support sustainable use of our resources, considering environmental protection, economic use of our resources, and social factors (e.g. jobs, values, and recreation). The ones listed include:

• Reporting on level of activity (e.g., annual use of therapeutants by facility);
• Establishment of maximum thresholds, through dosage and/or maximum accumulation;
• Special conditions on use to reduce risks of impacts and/or volume of product required (e.g., related to weather or application conditions);
• Integrated management measures to reduce inputs (e.g., for therapeutants, alternative approaches to treatment; for feed, maximizing food conversion, in general, husbandry measures such as fallowing, density of animals; timing of smolt entry); and
• Monitoring programs.

4. In your opinion, does the program delivery approach (slide 14) sufficiently support accountability to Canadians? If not, what would you add, change, or delete, and why?

5. Are there any other comments that you would like to provide?

Annex - Acronyms

• BC – British Columbia
• BOD – biological oxygen demand
• CEPA – Canadian Environmental Protection Act (1999)
• CFIA – Canadian Food Inspection Agency
• CG – Canada Gazette
• DAS – Disposal at Sea
• DFO – Fisheries and Oceans Canada
• EAU – Environmental Assessment Unit
• ERA – environmental risk assessment
• FA – Fisheries Act
• FHM – fish health management
• HC – Health Canada
• IPM/FHM – integrated pest management
• MOU – memorandum of understanding
• PAR – Pacific Aquaculture Regulations
• PCPA – Pest Control Products Act
• PMRA – Pest Management Regulatory Agency
• RASR – Release of Aquaculture Substances Regulations
• RASRR – Release of Aquaculture Substances Regulatory Regime
• SS – settleable solids

Related Information

The following documents provide background information on how pesticides are currently managed by the Government of Canada, on the role of Health Canada’s Pest Management Regulatory Agency as well as on DFO’s role as the aquaculture regulator in British Columbia.

• Frequently Asked Questions
• Federal Regulation of Pest Control Products For Use in Aquaculture
• New Brunswick Integrated Pest Management Plan for Sea Lice
• Sea Lice Monitoring Program for Marine Salmon Aquaculture Sites in New Brunswick
• Aquaculture regulation in British Columbia

Need more information?

Email:  fpptr-rtppp@dfo-mpo.gc.ca

Mail:    RASRR-RRLSA Consultations
          Aquaculture Management Directorate
          Fisheries and Oceans Canada
          200 rue Kent St, STN 8N177
          Ottawa, ON
          K1A 0E6