Proceedings of the Standing Senate Committee on
Fisheries and Oceans
Issue 5 - Evidence
OTTAWA, Tuesday, April 1, 2014
The Standing Senate Committee on Fisheries and Oceans met this day, at 6:15 p.m., to study the regulation of aquaculture, current challenges and future prospects for the industry in Canada.
Senator Fabian Manning (Chair) in the chair.
[English]
The Chair: I welcome our guests and apologize for our delay, but it's beyond our control. We thank you for your patience. We wanted to hear from you this evening and move along with our study on aquaculture.
Before I get into the reason we're here this evening, I want to take a moment, if I could, after consultation with the deputy chair earlier. Today marks a grim anniversary in Newfoundland and Labrador. On this particular weekend 100 years ago, we lost 250 men from the SS Newfoundland and the SS Southern Cross in the great Newfoundland sealing disaster of 1914. It was a sad moment in our proud history as a seafaring people in Newfoundland and Labrador. If you want to know about this disaster, there was a great book written in 1972 called Death On the Ice by Cassie Brown. Yesterday, the National Film Board released a short film, 54 Hours. It's a very compelling explanation of what happened and it's available for anybody to see. Last night, on CBC National News, Reg Sherren did a story, and a very thought-provoking and compelling one.
Before we begin this meeting this evening, to mark this important anniversary, we will have a moment of silence in memory of the men that were lost, and the families and communities in the country that were affected by that.
[Minute of silence.]
Thank you. May their souls rest in peace.
Ladies and gentlemen, I am pleased to welcome you to this meeting of the Standing Senate Committee on Fisheries and Oceans. My name is Fabian Manning. I am a senator from Newfoundland and Labrador, and I am pleased to be chair of this committee. Before I give the floor to our witnesses, I would ask that the members of the committee introduce themselves.
Senator Raine: Senator Nancy Greene Raine from B.C.
Senator Tannas: Scott Tannas from Alberta.
Senator McInnis: Tom McInnis from Nova Scotia.
Senator Hubley: Elizabeth Hubley, Prince Edward Island.
Senator Stewart Olsen: Carolyn Stewart Olsen, New Brunswick.
Senator Beyak: Lynn Beyak, Ontario.
Senator Enverga: Tobias Enverga, Ontario
Senator Wells: David Wells, Newfoundland and Labrador.
The Chair: The committee is continuing its special study on the regulation of aquaculture, its current challenges and future prospects for the industry in Canada and is pleased to welcome Mr. Daniel Chaput, Director General, Veterinary Drugs Directorate, Health Products and Food Branch of Health Canada; John Worgan, Director, New Substances Assessment and Control Bureau, Healthy Environments and Consumer Safety Branch, Health Canada; and Jason Flint, Director of Policy and Regulatory Affairs, Pest Management Regulatory Agency, Health Canada.
Once again, I thank you for your patience this evening in waiting for us. I understand you have some opening remarks, and then we will get to questions from senators. The floor is yours.
[Translation]
Jason Flint, Director, Policy and Regulatory Affairs Division, Pest Management Regulatory Agency, Health Canada: Good afternoon, Mr. Chair, and honourable members of the committee. My name is Jason Flint. I am the Director of the Policy and Regulatory Affairs Division, Pest Management Regulatory Agency, for Health Canada. I am happy to be with you today to answer any questions you may have about the regulation of pesticides, as part of the study you conducted on the aquaculture industry in Canada.
[English]
The aquaculture industry uses both pesticides and veterinary drugs to manage disease and pest infestations. The distinction between the two may not be immediately obvious. In general, veterinary drugs are injected into an animal or added to feed, whereas pesticide is applied externally to control a pest, which in the case of aquaculture could mean adding it to water containing fish.
Pesticides in Canada are regulated under the authority of the Pest Control Products Act. Pesticides are inherently a hazardous substance, so the act requires that science-based risk assessments be conducted and restrictions be placed on how these products can be used in order to prevent unacceptable risk to human health or the environment. In addition to a thorough pre-market scientific review of all new pesticides, we conduct compliance and enforcement activities, cyclical re-evaluations of older products and removal of older pesticides from the market if they no longer meet modern scientific standards.
Similar to veterinary drugs, Health Canada also establishes maximum residue limits for pesticide residues in farmed fish so they would pose no adverse health effects even if ingested daily by humans over a lifetime.
Health Canada employs scientists from a number of different disciplines to conduct thorough assessments of pesticides proposed for use in Canada. We look at the product itself, its physical and chemical properties, its toxicity to various organisms, as well as how the product is to be used to determine if and for how long someone or something may be exposed to the pesticide. A value assessment is conducted to determine a product's efficacy, effect on host organisms, health, safety and environmental benefits and socioeconomic impact. A human health risk assessment is conducted, which considers the occupational risk to workers handling the products as well as the potential for bystander exposure. Dietary risks are also considered if the pesticide is to be used on food such as crops or farmed fish.
An environmental risk assessment considers factors such as how the pesticide moves through the environment, how it degrades and potential impacts on non-target organisms.
A registration under the Pest Control Products Act will only be granted if these assessments show the product can be used safely. A product must be registered before it can be imported, manufactured, sold or used in Canada. The use of an unregistered pesticide or the use of a registered pesticide in a manner that's inconsistent with its conditions of registration is prohibited.
Similar to other minor uses of pesticides, the lack of registered products for sea lice control has at times required the granting of emergency registrations to assist the aquaculture industry. Emergency registrations, similar to the Emergency Drug Release program for veterinary drugs, are used for the emergency control of infestations that can cause significant economic, environmental or health problems where there is no acceptable alternative control method available. These registrations are valid for one year and are assessed based on a single season's use.
Pest control products are granted emergency registrations in response to applications supported by the province or the federal agency involved in the direct management of the pest problem. We work closely with our federal and provincial colleagues in regulating aquaculture products to control pests. We work with the provinces on compliance and enforcement activities and draw on their knowledge of local conditions. We have consulted Fisheries and Oceans Canada and Environment Canada on the science used to characterize risks, shared our risk assessments and consulted on the proposed conditions of registration. We will continue to support our Fisheries and Oceans colleagues as the new regulations are developed under the Fisheries Act to provide legal certainty for the aquaculture industry and their use of veterinary drugs and pesticides assessed and authorized by Health Canada.
Canada has a well-developed and internationally recognized pesticide regulatory system that is dedicated to the protection of health and the environment. We are committed to working with partners in Canada and abroad to ensure that Canadians continue to benefit from efficient and effective regulation.
Thank you for your time. I would welcome any questions you may have.
[Translation]
Dr. Daniel Chaput, Director General, Veterinary Drugs Directorate, Health Products and Food Branch, Health Canada: Good evening, Mr. Chair, members of the committee. My name is Daniel Chaput, Director General of the Veterinary Drugs Directorate of Health Canada. I am happy to have the opportunity tonight to talk to you about the approval of veterinary medicines in Canada, and more specifically in the field of aquaculture.
[English]
The Veterinary Drugs Directorate of Health Canada operates under the authority of the Food and Drugs Act and regulations. It regulates the sale of veterinary drugs while the use of the drug is under provincial-territorial jurisdiction. Our mandate is to protect human and animal health and the safety of the food supply, as well as to promote the prudent use of veterinary drugs in food-producing and companion animals.
Prior to being authorized for sale in Canada, all veterinary drug applications are subject to a rigorous scientific assessment to demonstrate that the proposed product is safe for animals to be treated, is effective for its intended purpose, is manufactured according to strict quality standards; and to ensure that drugs to be used in food-producing animals do not leave potentially harmful residues. As in the case of pesticides, we set maximum residue limits for each of the intended species.
Bringing veterinary drugs to the market basically starts with the pharmaceutical company submitting an application to Health Canada with all the relevant information. Given the global nature of the pharmaceutical industry, Health Canada encourages applicants to provide as part of their submissions information on relevant foreign approvals and scientific studies in order to minimize the need to generate new information. We have information-sharing agreements with a number of international counterparts that help us to streamline the approval process without any compromise to safety.
In Canada there are 10 veterinary drugs approved for aquaculture use. The majority of them are used in feed pre- mix. Health Canada also has in place an Emergency Drug Release program aimed at addressing critical situations where access to an unapproved product is needed in a timely manner. Through this program, we allow veterinarians to obtain limited quantities of drugs not approved for sale in Canada for the emergency treatment of animals under their direct medical supervision. The manufacturer must provide adequate evidence to Health Canada that the drug poses no known health risk to the animals being treated or to humans. The veterinarian assumes full responsibility for the safety of the animals treated and for any drug residue violations in food-producing animals.
After a drug product is authorized for sale in Canada, companies are required to monitor the safety of their products. They must report to us important information such as serious side effects, also called adverse drug reactions, including any product failure. They must also report to us the studies that they have that provide new safety information, as well as any product recalls in other jurisdictions.
We also play an important role in monitoring the safety and effectiveness of veterinary drugs. We receive reports of harms from various sources such as veterinarians and pet owners. Based on the number and severity of reports received, the next step may include changes to labels, such as adding new warnings; product recall of a particular lot of the drug; or, in rare cases, removal of the drug from the market completely.
Further to all of these safety measures, compliance with and enforcement of the regulations is a shared task. The Canadian Food Inspection Agency is responsible for surveillance programs to monitor the maximum residue limits in food. Under the authority of the Food and Drugs Act, the Health Products and Food Branch Inspectorate undertakes a variety of compliance monitoring and enforcement activities, such as inspections for good manufacturing practices as well as product investigations.
[Translation]
Mr. Chair, members of the committee, this concludes my overview of Health Canada's role in the approval of veterinary medicines. Thank you for your attention. I would now be happy to answer your questions.
John Worgan, Director, New Substances Assessment and Control Bureau, Healthy Environment and Consumer Safety Branch, Health Canada: Good evening, Mr. Chair, members of the committee. As you know, my name is John Worgan and I am the Director of the New Substances Assessment and Control Bureau for Health Canada. I am happy to be with you today to answer any questions you may have on the assessment of substances under the Canadian Environmental Protection Act, as they concern your study of the aquaculture industry in Canada.
The Canadian Environmental Protection Act or CEPA, is an important pillar of federal legislation when it comes to the environment in Canada. The law aims to protect Canadians and the environment against pollution and exposure to chemicals.
[English]
While Environment Canada administers the Canadian Environmental Protection Act, both Environment Canada and Health Canada jointly assess and manage the risks associated with harmful substances under this act. This is achieved in several ways, including the new substances regime that requires a pre-manufacture or pre-import notification and assessment of substances considered new to Canada in accordance with the New Substances Notification Regulations — or NSNR — of CEPA. Under CEPA, substances are considered new if they are not on the domestic substances list. This list, created in 1994, includes substances in commerce in Canada between 1984 and 1986 as well as new substances introduced to Canadian commerce since that time that meet specified conditions.
A new substance is subject to the NSNR unless the substance is subject to another federal act that has equivalent notification and assessment requirements. Since assessments of veterinary drugs under the Food and Drugs Act do not consider the potential impact on the environment, new veterinary drugs are subject to the NSNR. Under a memorandum of understanding between Environment Canada and Health Canada, Health Canada conducts these assessments.
The NSNR requires manufacturers or importers of new substances to notify the government of the manufacture or import to provide required data. These data requirements set out in the regulations are tiered based on the type and quantity of the new substance.
Upon receipt of the notification, a science-based risk assessment is conducted to determine whether the substance is likely to be harmful to the environment or to human health. This assessment must be completed within strict timelines as set out in the regulations. As part of our assessment, we consider the physical and chemical properties of the substance, its proposed quantity and uses, its behaviour in the environment, and its impact on various mammalian and aquatic organisms. When the assessment identifies a potential risk or concern, CEPA provides authority to take measures to minimize the risk.
Additionally, as part of the Chemicals Management Plan, a number of existing affordable pharmaceuticals will be subject to a screening assessment. This assessment occurs in the absence of any notification, but like the assessment of a new substance, when it identifies a potential risk of concern, appropriate risk management actions are taken.
We have and will continue to work closely with our federal colleagues in the development of new regulations under the Fisheries Act to ensure the appropriate application of veterinary drugs in aquaculture.
Mr. Chair and members of the committee, this concludes my summary on the role of Health Canada in assessing the potential environmental impacts of veterinary drugs used in aquaculture. I would welcome any questions that you might have.
The Chair: Thank you, witnesses, for your opening remarks. We'll begin the questions.
Senator Hubley: Welcome this evening and thank you for your presentations.
You may or may not know that in British Columbia we have been looking at the aquaculture industry. We had heard that one of the leading issues in front of them was the fact that the regulatory framework, both provincially and federally, is cumbersome. As I listened to your presentation, I underlined the New Substances Notification Regulations, the Canadian Environmental Protection Act, Environment Canada and Health Canada, the Food and Drugs Act, and the Chemicals Management Plan. I think we heard there were 70 issues that the aquaculture industry had to satisfy before they could go. It seemed to me that there were impediments in that process that could be improved upon.
In light of this framework that we feel was complex, cumbersome and costly, to what extent are Health Canada and the PMRA involved in improving the regulatory framework pertaining to aquaculture?
Dr. Chaput: I guess my main point is that there is recognition that it is a complex situation. There has been a lot of work between Health Canada and a number of other departments, mainly the Department of Fisheries and Oceans, to work on this regulatory amendment to try to streamline the regulatory approach as much as possible.
Having said that, this remains a complex matter. For example, when it comes to veterinary drugs, at the end of the day, prior to a drug being used on the market, we need to make sure it is safe for the users and safe for the consumers. That remains. But there is a lot of work being done between the various departments to improve the situation, including DFO.
Mr. Flint: We have been working with the Department of Fisheries and Oceans as they look forward to revising the regulations they have and put in place regulations to deal with section 36 of the Fisheries Act. There is a prohibition under section 36 for depositing deleterious substances, sometimes under which pesticides can be classified.
They put into Canada Gazette Schedule 1 some Governor-in-Council regulations back in February, and they have a new designation order out, which defines the roles of DFO and Environment.
Now, for the enforcement of section 36, we will deal with the Department of Fisheries and Oceans officers rather than Environment Canada on compliance activities. We have been working closely with them to make sure that as those changes happen, we continue to work with our colleagues at the Department of Fisheries and Oceans for compliance.
As well, we have relationships with all the provinces we work in. When we work on complaints and enforcement activities, we rarely work alone; we generally work with Environment Canada, DFO or the provinces to try to ensure that we are not duplicating efforts or creating confusion by having competing systems.
Mr. Worgan: To reiterate the same message within the CEPA area under the Chemicals Management Plan, we have been cooperating with DFO and Environment Canada in looking at the revised regulatory regime. Under the Chemicals Management Plan, we have a lot of interaction between various players.
So even though the system may appear cumbersome, we have ongoing interaction with our partners at the veterinary drugs program, at PMRA and at Environment Canada. We are working closely together on this file.
Senator Hubley: This question is for clarification. In some of the presentations, you refer to animals and things of that nature. Do you consider aquaculture a farming-of-fish activity or do you consider aquaculture a fishing activity?
Dr. Chaput: We consider aquaculture a farming-of-fish activity. That is for animals and aquatic animals.
Senator McInnis: You say that, and I know you are not Fisheries, but the Superior Court of British Columbia ruled in British Columbia at least that aquaculture is the fishery; it is not farming. Do you want to clarify your remarks?
Dr. Chaput: I guess I will talk from the perspective of a regulator of veterinary drugs. When we have, for example, an application from a company for a drug to be used in aquaculture, we apply the same requirements as we would for a drug to be used on a territorial animal. The same requirements have to be met in terms of proving the safety, efficacy and quality of that product. That is the parallel that I would make, whether or not it is farming. From a regulatory perspective, it is the same requirements.
Senator McInnis: Across the country?
Dr. Chaput: Yes, the same requirements.
Senator Wells: I gather you all work closely together; is that right?
Dr. Chaput: Yes.
Mr. Flint: Yes.
Mr. Worgan: Yes.
Senator Wells: If I direct a question at someone and see you looking at each other, I can figure it might be better answered by someone else.
I have a question about agricultural runoff. Most or all runoff eventually ends up in the ocean. Is consideration given to pesticides from agricultural uses that run off into the ocean that may have affect fish farms? Is there a consideration?
Mr. Flint: Not fish farms, particularly, but to fish in general. If you apply a pesticide to a field, for example, and then runoff goes into a natural water course, we would be looking at the potential impact it could have on naturally occurring fish, not just fish farms — anything in the environment there.
Senator Wells: With regard to the studies that I believe Mr. Worgan referenced regarding not-yet-approved or unapproved pesticides or drugs, who provides those studies — the manufacturer, the end user or are they independent? Where do those studies come from?
Mr. Worgan: In the case of new substances for the environmental assessment of drugs, it would be the notifier, which is either the importer or the manufacturer, who would be required to provide the data that are prescribed in the regulations. There are specific studies that are asked for that get assessed by our evaluation teams, and they are provided by the notifier.
Senator Wells: Tell me what the notifier is.
Mr. Worgan: The notifier is the importer or the manufacturer.
Senator Wells: How do we know the veracity of the findings of those studies? Are they independent studies provided by them, or are they done in-house?
Mr. Worgan: It could be a combination of things. For example, if we were doing a reassessment of a veterinary drug and its impact on the environment, not only would we take a look or consider the studies that had been done by industry that are providing that, but we would also take a look at whatever else was out there in the public domain. That could be published literature or assessments done by other regulatory agencies.
In any event, our scientists do very rigorous reviews of the available information in order to make a determination as to whether or not the substance would be harmful to the environment.
Senator Wells: Would that also include that which is harmful to the food product that is being ``aquacultured''?
Dr. Chaput: In terms of the safety for the food products, this would be under the mandate of the Food and Drugs Act and regulations. This something we would look at. John's comments in terms of the origin of the study would also apply in our case. It would either come from the manufacturer, public literature or often from our international counterparts with which we have a number of confidential information sharing agreements.
Senator Hubley: I have a supplementary on Senator Wells' question, which I would like to reiterate. If you okay a product that can be applied to a crop on land — a pesticide — is that also cleared for whether it would or would not endanger a fish species in the water?
Mr. Flint: To clarify, are you asking if it could be applied in water?
Senator Hubley: No, if there was a runoff. In other words, are the pesticides that are applied to crops also safe, or is it an issue that they must be safe for fish in the wild?
Mr. Flint: The intention is that you put in mitigation measures to prevent them from actually entering the water. Ideally the pesticide should stay on the field. When we approve the use of a product in a terrestrial use, generally there would be buffer zones to create a separation between the water and the edge of the farmer's field to allow the pesticide not to enter the water. That is preferred. We put in mitigation measures to prevent that.
Senator Hubley: I certainly agree it is preferred, but that is not always the case. That is why I was wondering if any importance was given to the fact that what goes on the land has the possibility of ending up elsewhere and doing damage.
Mr. Flint: It is considered.
Senator Stewart Olsen: Gentlemen, I have some questions on pesticides. How are they administered as a general rule? We have the open pens and we also have closed containment. I can see closed containment being easier, but how do you administer the pesticides in open pens?
Mr. Flint: They are being administered in a couple of ways. One, they can skirt or tarp around the pen to create a temporary containment while the pesticide is applied. Also, for some products they use well boats where they transfer the fish from the pen into the boat where they are being treated, and then they put the fish back in the pen after the treatment has occurred.
Senator Stewart Olsen: I have one other question on pesticides and that is on the study of the effects. Does Health Canada or anyone sample the fish that have been treated at harvest before they go to market?
Mr. Flint: The Canadian Food Inspection Agency is responsible for residues on the food. They are responsible for the marketplace sampling. We do some sampling of fish as part of inspection programs. We look at compliance. We will take samples before the harvest.
Senator Stewart Olsen: No, I am talking specifically about those who have been approved to use pesticides. Is special attention paid to the harvest of fish that have been treated with pesticides?
Mr. Flint: They are just part of the Canadian Food Inspection Agency's residue monitoring programs. They would look at it the same way as any other fruits, vegetables, meat products that would be available to the Canadian consumer.
Senator Stewart Olsen: We can assure consumers of that even if there were pesticides, then? What kind of pesticides do you use? Give me a couple of examples and names.
Mr. Flint: There are really only two at the moment that are being used. Salmosan is one brand name; the chemical is azamethiphos and the other one is hydrogen peroxide.
Senator Stewart Olsen: That is right, we heard about that. This would be a surface application, not ingested?
Mr. Flint: It is applied to the water and the fish are in the water.
Senator Stewart Olsen: Someone mentioned drugs in their feed. What kind of drugs would you put in fish feed?
Dr. Chaput: As I said, there are about 10 drugs approved. A lot of them are anti-parasitic. One is to treat sea lice, and the commercial name is SLICE. That is very typical. There are also a few antibiotics to treat bacteria.
Senator Stewart Olsen: Are studies done in the same way for fish that have been treated before they go to market? Are these fish examined and monitored?
Dr. Chaput: The fish that are treated with vet drugs or pesticides are subject to the Canadian Food Inspection Agency routine monitoring program, so they are sampled, as is the case for foods, vegetables and other food commodities.
Senator Stewart Olsen: You say they are regular. I just don't know what you mean by regular inspections.
Dr. Chaput: The CFIA samples thousands of various food commodities a year. It is basically done on a random basis to assess the level of compliance of the food supply with the maximum residue limits. They publish a report on an annual basis, which typically sees a high compliance rate. These reports are always available on their website.
Senator Stewart Olsen: Can you assure the Canadian public who are buying farmed fish that this is basically a safe product as approved by Health Canada?
Dr. Chaput: I would say there are a number of regulatory controls in place to ensure the safety of this fish.
Senator Stewart Olsen: I hear you.
Dr. Chaput: And I do eat them, frankly.
Senator Stewart Olsen: Thank you.
Senator Enverga: As you develop your policies and regulations with regard to pesticides and those kinds of things, have you been talking with other countries, like Norway or Chile, in formulating these particular policies and exchanging information with regard to what kind of chemicals you will put in the water? Do you have such cooperation?
Mr. Flint: Yes. We work more broadly on pesticides. We work with OECD countries with respect to pesticide regulations. We have standardized protocols and testing methods in the way we assess them. A limited number of products are used in aquaculture in areas such as Norway, Chile and Scotland. We have had meetings with some of the regulatory authorities in these countries to figure out how they have approached these challenges. Again, there are only a limited number of chemicals that are actually used worldwide.
The conditions can also vary from country to country. The Bay of Fundy, for example, is very different than deep- water pens that are located perhaps off the coast of Newfoundland or north of Scotland or in Norway. We are looking at the differences there as well.
Mr. Worgan: On the new substance side for aquaculture specifically, we also collaborate closely with other regulatory agencies through OECD, as well as the USEPA. For example, if there are evaluations done by another regulatory agency, that's something we would take into account when we work through our own evaluations. We have that close contact with other regulatory agencies overall.
Senator Enverga: I understand that there is inland aquaculture. Do you differentiate between inland and ocean aquaculture? Do you handle both or only one particular part of aquaculture?
Mr. Flint: We are approving products for use in contained areas or in a marine environment. Either could be approved. I don't think we differentiate between the two. Aquaculture is one particular use category that we would look at.
Senator Enverga: Through your experience, which is better — freshwater aquaculture or saltwater aquaculture? I see that sea lice is one of the major problems for aquaculture. I can't imagine that there would be sea lice in fresh water.
Dr. Chaput: This is a bit outside of our sphere. Our concern is usually to make sure that the products used are safe and effective. On this other question, I don't think we can speak to it.
Senator Enverga: You wouldn't be handling that kind of information? If not, then my next question is with regard to antibiotics.
I am on the Standing Senate Committee on Social Affairs, Science and Technology and we are studying medicines and how organisms develop their own traits so that the chemicals will no longer affect them. Does that happen normally in organisms in aquaculture?
Dr. Chaput: Some antibiotics are used in aquaculture, and they have to be used under veterinary oversight to ensure that the use is judicious and does not infer an unnecessary risk.
My colleague reminds me that some vaccines are also approved for aquaculture, which basically have resulted in a decrease in the use of antibiotics. That is an alternative to antibiotics.
Senator McInnis: I get the impression that there is a lot of confusion with respect to aquaculture generally. It has a great future and, as my colleague mentioned, there are better than 60 departments and agencies that touch aquaculture.
You alluded to section 36 of the Fisheries Act and regulations. About 14 years ago, Fisheries and Oceans said that they wanted to put regulations in place that would control the placing of deleterious substances in the water. Of course, it was picked up by Environment and Sustainable Development in an audit. In 2011 they reported and said that it is clear that in Canada there is no standard procedure for public reporting of antibiotics, therapeutants or other chemical use.
You mentioned that the executive council approved — I'm not sure what they approved. It wasn't regulations, was it? I don't think you said that. What did they approve? A policy or something?
Mr. Flint: There was a publication in the Canada Gazette Part 1 of Governor-in-Council regulations that would allow for the Minister of Fisheries and Oceans to develop ministerial regulations to authorize the deposition of pesticides and veterinary drugs for the purposes of aquaculture.
Senator McInnis: They gave him permission to bring about regulations?
Mr. Flint: The last time that the Fisheries Act was changed, section 36(5) got a bit of a change where there is now a two-step process. The Governor-in-Council would explain the conditions under which the minister could now develop regulations to do certain things to authorize the deposition. It's now a two-step process, and the Governor-in-Council regulations have already been proposed and consulted on. They were proposed back in February. That's the first step. The Minister of Fisheries and Oceans would have to then propose ministerial regulations specifically authorizing the deposition of pesticides and veterinary drugs for aquaculture.
Senator McInnis: So we're going to get regulations?
Mr. Flint: That is what they tell me at Fisheries and Oceans.
Senator McInnis: You know why it's confusing? You just made the comment here, Mr. Chaput, that SLICE is used to treat sea lice. Yet in this Canadian Aquaculture R&D Review 2013, they say the opposite. They say, and I can do no better than quote:
Over the past few years sea lice populations in Chile, northern Europe, and now New Brunswick, Canada, have begun to exhibit resistance to the in-feed treatment SLICE . . . . Since it was introduced in 2000, SLICE was so highly effective that it quickly became the only available treatment used against sea lice in Canada. However, treatment failures were first observed in 2008 and now SLICE resistance has completely removed the effective use of the drug in NB.
They have now asked Pfizer Inc. to develop a vaccine because there's nothing on the market that treats sea lice.
As a committee, we're trying to get to the bottom of some of this stuff. We are not druggists or technical people, but we read these things and I get differing views. Do you want to comment on that?
Dr. Chaput: I would say that this is a quickly evolving situation. Whenever you start using vet drugs, resistance starts to build. If you don't have alternatives, resistance will build even quicker.
SLICE is still used in some areas in B.C., I think. That's why the importance of access to alternatives. I was talking about vaccines earlier. This is quickly evolving and alternatives are key in this.
SLICE, as I said, was used a lot. It's used less today but still used. The resistance aspect is inherent to the use of these products; eventually you'll get resistance if you don't have what one would call integrated sea lice management, for example, where you have a variety of products you can use to treat the disease.
Senator McInnis: Health Canada would be involved in any approval process of any new vaccine?
Dr. Chaput: The vaccines are approved by the Canadian Centre for Veterinary Biologics, which is part of the Canadian Food Inspection Agency. This is regulated under the Health of Animals Act.
Senator McInnis: As I understand it, you can approve on an emergency basis. Say, for example, I'm a veterinarian with one of the aquaculture companies and I contact you and I have an emergency situation. You can approve a drug to be utilized, despite the fact it's not permitted to be sold in Canada; is that correct?
Dr. Chaput: Yes, we can approve a drug to be used for emergency reasons, based on some criteria. We still need basic information that will ensure the safety of the use of the drug from a food-safety perspective but also for the animal, the fish. There is a program in place, which is common to all drugs and pesticide regulators, but there is still a review done. Often it's based on international information.
This is where these confidentiality agreements that I was talking about earlier are so critical for us so that we can, for example, talk to the FDA or to our European colleagues about drug X and share the information so that we can make the right decision to ensure that this drug will be safe.
Senator McInnis: You would be aware of Cooke Aquaculture in New Brunswick and what they used. Was that approved?
Dr. Chaput: I cannot talk to any specifics. What I can tell you is that we have a request for emergency drug release, both in the aquaculture world but also for terrestrial animals. This is part, really, of any regulatory framework. I couldn't talk specifically to this situation.
Senator McInnis: There is no litigation. They settled out of court. I'm wondering if it's possible for something to be approved, but you're saying it is not; is that correct? You would review it and you would look at international standards and so on?
Dr. Chaput: Under the Emergency Drug Release program you would, yes.
Mr. Flint: It's the same situation for pesticides. The use of pesticides in New Brunswick has increased over the last few years because of the resistance built up to SLICE. That's what has created the need for these products. Again, there are currently two products that are being used legally in New Brunswick, which will hopefully help mitigate resistance to the pesticides that we're using.
Senator McInnis: One final question: If you had the say, if you were in charge, what would you do to make the treatment of these animals more fluid, more effective and more corralled, if I could use that word? Or is everything just fine?
Dr. Chaput: I would say there's always room for improvement. I would summarize by saying that ``integrated pest management'' is one of the key ways of dealing with these, a series, a variety, whether it's pesticides, vet drugs or vaccines, so you minimize the building of resistance in the system.
Senator Raine: I have questions about how it works, and I think many people do. When I look at this industry, I can see that how you site the fish farms is your first defence against the need for pesticides and the need for therapeutants, because if you have a properly sited fish farm you probably have a lot of things going for you in terms of the quality of the water and the flushing of the water.
I remember a couple of years ago we studied lobster, and there was an indication that there was some impact on the lobster at certain phases with the downstream flow of pesticides being used in fish farms. If that's part of the analysis, are you doing tracing with dyes to see where the residue goes from the fish farms and how it impacts other fish and aquatic life? Is that part of what you do or is that someone else's job?
Mr. Flint: That is part of what we look at with respect to the approval of the pesticide. Dye dispersion studies are done to show what would happen when you have a contained pen that's been treated with a pesticide and you remove the containment. The pesticide is then released into the ocean, in which case we do look at what happens — it does disperse and become diluted. Immediately after the pens are opened, there is a risk outside the pen to particularly juvenile lobster that may be swimming in the water for a short period of time after the tarps have been released. The biology of the lobster is similar to the biology of the sea lice that we are trying to control on the fish.
Senator Raine: The timing of the treatments is part of the prescription, if you like, for the use of these products, so that it's in the life cycle of the other aquatic life?
Mr. Flint: It's based on the life cycle of the sea lice, so you are looking at the infestation. You need a certain level of infestation before you apply it. You have to have a veterinarian to indicate that it is ready to be applied. You also have a permitting process run by the provinces, so you need to get a provincial permit if you are going to apply any pesticide to water. You need a plan and to keep records of what you are doing.
You are required to follow the conditions of registration on the label which would indicate how much pesticide you can add and how long you're supposed to keep the fish exposed to it. All the directions for use would be on the label, and it's a legal requirement that you follow those directions.
Senator Raine: Can you describe the difference between SLICE and hydrogen peroxide?
Mr. Flint: SLICE is a veterinary drug, so it would be administered in the feed the fish are given, in which case the veterinary drug in the system would cause the sea lice to die and fall off, whereas generally the fish are immersed in water which hydrogen peroxide is added to, and the sea lice drop off the fish because of the shock of the hydrogen peroxide that's administered. The hydrogen peroxide doesn't necessarily kill all of the sea lice, but it causes them to drop off the fish.
Senator Raine: That's the one administered in the water as opposed to in the feed?
Mr. Flint: In the water. Most frequently it's used in a well boat. All the fish are removed from the pen and put into a special boat that has containment for the fish. Then they increase the concentration of hydrogen peroxide in the water to such a level that the sea lice will drop off, and then they put the fish back in the pen, having had the sea lice removed.
Senator Raine: They scoop up the sea lice at the bottom of the boat.
Senator Beyak: There was a report done by Health Canada in 2003, well over 10 years ago, that enumerated the four ways that you make the sites better to prevent sea lice in salmon. Is there a more recent study, and how is the balance between those preventative measures and the use of therapeutants?
Mr. Flint: I think you're referring to work done in 2003 with the salmon producers that looked at how integrated pest management could be used. It was a combination of using the veterinary drugs and pesticides to control sea lice; so there was work done back in 2003.
I do not believe we have done anything since then with respect to integrated pest management, or looked at or revisited how that can be done. In 2003, the resistance to SLICE was not an issue, and that was the primary way of controlling the sea lice at that time.
Senator Enverga: Because you are one of the regulatory boards or agencies and you use substance assessment, what kind of monitoring do you do to ensure everybody is doing their job? Do you have any monitoring implemented?
Mr. Worgan: On the CEPA side, the compliance and enforcement aspect under CEPA is with Environment Canada; so if monitoring were done it would be through them. However, we also have some research that we are conducting under our Chemical Management Plan. At this time we're not doing anything related to aquaculture, but we are looking at pharmaceuticals in the environment writ large and looking at their fate and potential toxicity. So at some point in the future it is possible, as we work through our prioritization exercise every year, that some of the vet drugs used in aquaculture could rise to the surface and be considered for research. At this time, we're not conducting specific research.
Senator Enverga: No monitoring. How about the others?
Mr. Flint: For the pesticides there are some compliance enforcement activities, so there are inspections that are done on facilities. It was done at one point in conjunction with Environment Canada, who had responsibility for section 36.
Going forward it will be with Fisheries and Oceans compliance people that will do inspections. We also do inspections with provincial pesticide authorities because they have some responsibility there. There is responsibility for recordkeeping by the facility operator. Also, if there is any evidence of environmental problems — for example, unusual morbidity or mortality of fish — those could be reported to us. We have an incident-reporting program similar to veterinary drugs. If it is suspected that a pesticide may be involved in an incident that may cause the death of fish, we would get an incident report from the province, the manufacturer or the public indicating there is a suspected problem that has resulted from that, in which case we can look at that and investigate it as well.
Senator Enverga: You do some on-the-spot investigation?
Mr. Flint: For the last three years we have been doing inspections of aquaculture facilities in the Atlantic provinces where the pesticides are being used; we have been doing that in conjunction with Environment Canada. Every spring there is usually a blitz of inspections done on the aquaculture facilities in Eastern Canada.
Senator Enverga: I know you are putting it in containment like a boat, but have you implemented some rules about the disposal of those chemicals? Where do they throw it out?
Mr. Flint: It depends what it is. Hydrogen peroxide is very nice because it breaks down to oxygen and water. Given a short period of time, there is really nothing there with respect to residue and it just gets dumped right back into the ocean.
With Salmosan, which is used often in tarp pens, there is a period of time during which it is dispersed, but it gets dispersed into the ocean, to a concentration where it wouldn't have any impact.
Senator Enverga: But that would mean returning all the lice. You said it never kills the lice, so you return it back to the ocean?
Mr. Flint: The lice get returned to the ocean quite often, yes.
Senator McInnis: Senator Raine alluded to this. I'm not sure what involvement you would have in this, but there are a couple of components. One is depth of the water and the other is currents. There are approvals of some of these farms in as little as 13 metres of water in Eastern Canada. Some of the ones we have seen out West are 400 feet deep, tremendous current, of course. If we were making a recommendation, how important is that?
Dr. Chaput: Unfortunately, this is something that's outside of our sphere.
Senator McInnis: Let me give you one that might involve you. It has been said by one of the presenters who came before our committee that the fish that come from the hatchery could be diseased. We also were told by a doctor, I believe, that each fish is vaccinated and that there is a close watch after they enter the sea water for parasites. What involvement do you have in that?
Dr. Chaput: I think this touches more on aquaculture practices. I stand to be corrected, but our involvement doesn't cover this part of aquaculture.
Senator McInnis: You don't have anything to say about what they are injecting them with?
Dr. Chaput: Yes, we do. If they are injecting them, for example, with vet drugs, they will have to come to us to get pre-market approval.
Senator McInnis: So that would be your involvement?
Dr. Chaput: Yes. But in terms of the overall, broader aquaculture practices, this goes beyond.
Senator McInnis: Does Health Canada have R&D funds?
Mr. Worgan: As I had mentioned, under the Chemicals Management Plan for CEPA, we have funds for a variety of different things: human health, research and monitoring. We also have a limited number of dollars that we set aside every year for the study of pharmaceuticals in the environment, not necessarily related to aquaculture, but pharmaceuticals, just speaking generally about drugs in the environment: their environmental fate as well as potential impact. So we do a limited amount of that with other government departments that conduct the research for us.
Senator McInnis: Do you partner with universities as well?
Mr. Worgan: In the recent past we have not, but it is something we are considering for the future.
The Chair: I would like to thank our witnesses for this evening. You have provided some great information for us in the continuation of our study.
Before I adjourn the meeting, I want to advise senators that the clerk will be preparing a summary of our visit to British Columbia and distributing it to all senators, especially for those who did not have the opportunity to travel with us, to give you some idea of what we experienced in British Columbia. He will do that in the next week or so and pass it on to you.
(The committee adjourned.)