Fish Pathogen and Pest Treatment Regulations – Discussion Document

The proposed regulatory framework for Fish Pathogen and Pest Treatment states its intent is to ensure that all drugs and pest control products satisfy an environmental risk assessment prior to deposit in water frequented by fish. While the discussion paper covers broad objectives and the streamlining of related regulations, it fails to address the requirements of toxicity testing necessitated by the environmental risk assessment which lies at the heart of the proposed regulation. The Coastal Alliance for Aquaculture Reform (CAAR) has reviewed the subject document and is forwarding the following recommendations:

• The new regulation will also need to regulate the deposit of the wastes excreted by fish that have been treated with, or fed, drugs or pest control products. Testing should also address sediment health, and the risks of bioaccumulation and oxygen depletion.
• Lethality testing procedures should be conducted on marine and/or estuarine organisms.
• Toxicity testing must be conducted for chronic impacts in addition to acute impacts
• Toxicity testing must be conducted on whole product formulations for those products that may be identified as “deleterious substances”, not just the active ingredient
• All ingredients must be listed on the product label
• The risk assessment must be a transparent process
• The proposed regulation must require monitoring and specify the timing and duration of the monitoring and which substances must be monitored for
• The intent of notification must include the protection of the public
• Reporting must be direct, timely, consistent and transparent
• The framework for the new regulation should promote the use of processes, practices, products and technologies that lower environmental risk, impacts and pollution

 Strategic Question 1: Are there any changes/additions that you would like to suggest to the categories of deleterious substances listed in section 4.1?  Additional Testing Required:Ø      In order to fully regulate the deposit of fish pathogen and pest treatment products (deleterious substances), the new regulation will also need to regulate the deposit of the wastes excreted by fish that have been treated with, or fed, drugs or pest control products since these wastes will contain deleterious substances that result from the deposit of the deleterious substance and could enter water frequented by fish for a period of time lasting longer than the duration of the treatment. This is necessary in order to conform with Section 36(4)(b) of the Fisheries Act (FA). Also, considering that many of the toxic products discharged to waters may be hydrophobic and tend to bind with sediments, or may be excreted as fish feces or settle out of the water column as uneaten food particles, it is important that sediment toxicity is included in the mix of acute lethality testing parameters for the purposes of the proposed regulation. Ø      By definition, a deleterious substance is anything that is harmful to fish, if it limits the use of fish by humans (for example contamination of fish by dioxins or shellfish by E. coli), or if by going through some process of degradation, it harms the water quality (for example, oxygen-depleting wastes). A substance is also deleterious if it exceeds a level prescribed by regulation. Therefore we would expect to see in the regulation testing to ensure harmful substances are not bioaccummulative in fish tissues or other seafood products and that they do not result in oxygen depletion in over-lying waters. Finally, the discussion paper (under Part 5 Administration) states that users regulated under these proposed regulations would be expected to comply with all PCPA and F&DA requirements and product labeling. Required Changes to Toxicity Tests:Ø      The usually accepted standard for acute toxicity is, more often than not, based on the outcomes of acute lethality tests using rainbow trout, a freshwater fish. It is our view that if DFO and Environment Canada are to rely on acute lethality tests as the measure to determine whether a substance for the purposes of the proposed regulation is deemed to be deleterious then the acceptable acute lethality testing procedures should include: v     Report EPS 1/RM/10 Biological Test Method:  Acute Lethality Test using Threespine Stickleback (Gasterosteus aculeatus). July 1990, Environment Canada; and, v     Report EPS 1/RM/26 Biological Test Method: Acute Test for Sediment Toxicity to Marine or Estuarine Amphipods. December 1992. Environment Canada.  v     EPS1/RM/14 Biological Test Method: Reference Method for Determining Acute Lethality of Effluents to ‘Daphnia magna’ July 1990. Environment Canada These tests are used by Environment Canada and other investigators concerned with evaluating the effects of effluents to crustaceans and to marine and/or estuarine organisms in waters and sediments.   To ensure that potential impacts of pesticides used to control parasites like sea lice are minimized vis-à-vis impacts to non-targets species (like crabs and prawns), we would recommend using acute lethality tests designed to assess impacts to invertebrates like water fleas (Daphnia magna) as the key indicator as to whether such substances are deemed deleterious for the purposes of the proposed regulation.  Daphnia magna are much smaller than trout and they are more quickly affected by water pollution and are a more immediate and reliable indicator that the health of an ecosystem is at risk. The sole use of the rainbow trout in acute lethality tests would mean a higher allowable level of toxic effluent since these fish can withstand greater levels of toxicity.  Because the Daphnia are at the bottom of the food chain (they consume algae and then are themselves consumed by small fish), they represent a large proportion of the food base of an aquatic ecosystem. Subsequently, the use of Daphnia in acute lethality tests would ensure that a pollution problem is addressed before an entire food web is threatened. The rainbow trout is a predator at higher levels of the chain and, therefore, any problem, as indicated by their population decline, would mean that every species below has already been affected. The United Nations and Canada currently use Daphnia in acute lethality tests to establish if a toxic substance is deleterious and the United Nations uses Daphnia for effluent standards.  Chronic Toxicity Testing Needed:Ø      It is proposed in the Discussion Paper that in order to regulate fish pathogen and pest treatment products under the FA, treatment products must first be identified as deleterious.  However, a “deleterious substance” has generally been determined by the courts (and by DFO and Environment Canada) to be a substance that is acutely toxic to fish based upon the results of a 96-Hr LC₅₀ acute toxicity test and acute toxicity is the commonly accepted standard for a deleterious substance under other Federal Fisheries Act regulations (such is the case for substances deemed deleterious under the Pulp and Paper Effluent Control Regulations, the Metal Mining Effluent Regulations and the proposed Municipal Wastewater Effluent Regulations). But toxicity can be either acute or chronic. For reasons unexplained, chronic toxicity has not yet been accepted as rendering a substance “deleterious”. A substance is deemed to exhibit acute toxicity when harmful effects occur rapidly following absorption (i.e. hours to days), whereas chronic toxicity can only be detected following long-term or repeated lower level exposure to a substance.[1] Some of the effects of chronic toxicity include genetic changes, birth defects, tumor growth, sterility, nerve damage, and reproductive failure.  For the purposes of aquaculture and the proposed regulations it is recommended that chronic impacts be captured through requirements to conduct ecotoxicity studies that test for a range of toxic effects including establishing chronically lethal endpoints for prescribed substances. This would be in keeping with the stated intentions of the proposed regulations to establish Federal aquaculture requirements for safe and responsible management of the industry and to reduce the environmental risk posed by fish pathogen and pest treatments to non-target species (like shrimp, krill, prawns, crabs and lobsters) which may be affected by chemicals used to rid fish of invertebrate parasites.   Toxicity Testing using Full Product Formulations:Ø      In Canada, pesticide registration is based almost solely on the toxicity of the “active ingredient” which is only a part of the pesticide formulation that is applied under real world circumstances.[2] The final products sold to consumers, and applied to the environment, often mix the active ingredient with multiple chemicals, any one of which could exhibit negative effects on their own, or in combination with others. Multiple studies have revealed pesticide formulations and/or surfactants that appear to be more toxic than the active ingredient (Schmuck, R, et. al, 1993; Brausch, J. et. al, 2007; Bringolf, R. et. al, 2007)[i][3][4][5]. As such, for the purposes of establishing whether product categories pertinent to the proposed regulation should be determined to be deleterious, acute and chronic testing should be conducted for the whole product (the formulation being applied) as well as the active ingredient.  Labeling:Ø      At this time, manufactures are not required to list all ingredients on a pesticide due to proprietary concerns. Until whole product formulations have undergone and passed acute and chronic toxicity testing, this cannot be justified as there may be potential adverse health or environmental impact(s) associated with some of the adjunct products. Human and environmental health must be valued over monetary profit. Therefore, it is recommended that for any and all prescribed substances under this proposed regulation, all ingredients that make up the product formulation should be listed on the product label. Strategic Question 2: Are there any changes/additions that you would like to suggest to the proposed regulatory requirements discussed in section 4.1, for example related to risk assessments, conditions of use, monitoring, emergency planning, notification, or reporting?  Changes to 4.1: Ø      The proposed regulations must state that, in order to satisfy the Responsible Minister, the risk assessment must be a transparent process. Public review of and input into an environmental risk assessment including all data provided by drug or pest control product manufacturers must be enshrined in the proposed regulation. No deleterious substances should be approved for deposit in water frequented by fish until there is a full public assessment of all ensuing impacts both acute and chronic. The Need for Monitoring:Ø      The proposed regulation must require monitoring and specify the timing and duration of the monitoring and which substances must be monitored for. The proposed regulation will need to specify which waters or places or classes thereof into which these deleterious substances are authorized to be deposited in order to conform with Section 36(5)(b) of the Fisheries Act. This implies specific spatial boundaries where these deposits are authorized. Monitoring requirements must include not only these specified spatial boundaries but also the waters beyond so as to ensure that these substances are not being deposited beyond the specified waters or places (far-field effects). Required Notification:Ø      The concept paper states that the proposed regulations would require notification of planned treatment, emergency response planning, record keeping, and reporting on information related to fish pathogen and pest treatment. And that information collected would guide in decision-making, assist with ongoing evaluation of risk assessments in changing environments, and provide a basis for compliance and enforcement planning. However, currently, it is proposed that a person who deposits or orders the deposit of a prescribed substance through contracting or through the provision of veterinary prescriptions, (that is to say, CFIA or DFO officials, a veterinarian, a provincial employee, or an aquaculture facility owner) would be required to notify the Responsible Minister in writing. There is no other requirement to notify anyone else. The intent of notification must include more than just assisting with enforcement planning. The intent must include the protection of the public who may access the waters or the public resources there in at the time these deleterious substances are being deposited or are present in the aquatic environment. The proposed regulation must require public notification at any location where treatment with a fish pathogen or pest treatment product is occurring and for a period of time that includes the time it takes for monitoring to indicate that there is no longer a risk to the public or the aquatic environment. Strategic Question 3: Are there any changes/additions that you would like to suggest for the reporting requirements discussed in section 4.1? For example, when should the reporting occur, how frequently, in what format, what should be the scope of information collected, etc.  Ø      Reporting must be direct, timely, consistent and transparent. The reports for each deposit must be sent directly to the Responsible Minister from the persons who deposit or order the deposit of the prescribed substances and not through a third party (that is to say, an industry organization or contractor) in a format (electronic or otherwise) that specifies:o        the specific area of the deposit (site), o       the quantity of the substance deposited, o       the method by which the substance was administered, o       the date upon which the deposit commenced and o       the duration that the deposit occurred. This format for reporting should be consistent for all persons who deposit or order the deposit of a prescribed substance. Information contained in all reports to the Minister must be publicly available upon request for all deposits made into public waters.    This transparent sharing of monitoring data will assist in the evaluation of the science-based environmental risk assessments and will further inform and improve decision making. Strategic Question 4: Are there any changes/additions that you would like to suggest to the proposed regulatory requirements for non-chemical methods of fish pathogen and pest treatment?  Ø      Based upon the rationale to lessen environmental impacts (Part 2: Policy Rationale for Regulatory Measures) and the context of pollution prevention and reduction of overall risk (Part 3: Federal Regulatory Principles and Process), we would expect that the framework for the new regulation will be arranged in such a way as to not only discourage the use of those processes, practices, products and wastes therefrom that are deemed by environmental risk assessment to pose higher risks but also to promote the use of processes, practices, products and technologies (such as closed containment technologies) that place an impermeable barrier between the aquatic environment and the species targeted for those processes, practices, products and wastes thereby lowering environmental risk, impacts and pollution.