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Aquatic biotechnology regulation

Learn about aquatic biotechnology regulations, risk assessment, published orders, guidance documents and notification forms.

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Overview

Scientists from Fisheries and Oceans Canada (DFO) contribute to regulating fish products of biotechnology through research and scientific advice.

We also helped put into effect the New Substances Notification Regulations (Organisms) under the Canadian Environmental Protection Act, 1999, by:

This is done in partnership with Health Canada, and Environment and Climate Change Canada.

Acts and regulations

The Canadian Environmental Protection Act, 1999, provides the authority to address pollution problems:

The act is administered by Health Canada, and Environment and Climate Change Canada. It ensures all new living organism products of biotechnology are assessed for their potential to harm the environment and human health. The measures target these products prior to their import into or manufacture in Canada.

New substances

The New Substances Notification Regulations (Organisms) specify the information you need to submit if a living organism isn't on the domestic substances list. This includes:

Fish products of biotechnology on the domestic substances list don't require notification unless they're proposed for a significant new activity.

We may issue a notice if we suspect that a significant new activity may result in the fish becoming toxic.  

You must provide additional information on the product if you intend to:

The additional information will allow us to assess the new activity's potential environmental and human health risks.

The regulations don't apply to:

Risk assessment decisions

You must provide the information requested in Schedule 5 of the New Substances Notification Regulations (Organisms) at least 120 days prior to importing or manufacturing your product.

We use this information to conduct a risk assessment to determine if the product is toxic. If we suspect that a fish product of biotechnology is toxic, our government partners may impose control measures, such as:

Published orders for biotechnology

The Canada Gazette publishes new substance biotechnology orders of regulatory decisions, including:

Guidance documents

For individuals responsible for complying with regulations, we've prepared:

Notification forms

The new substances notification form (PDF, 809 KB) aids in:

For help in completing and submitting the forms, contact us by:

Informing us that you've made a submission

If you send in a regulatory submission to the minister for Environment and Climate Change Canada, we encourage you to notify us as well. You can do this by providing a copy of the new substances notification form to:

Director, Biotechnology and Aquatic Animal Health Sciences Branch
Fisheries and Oceans Canada
200 Kent St, 12E-236
Ottawa ON  K1A 0E6

If you have any questions, contact us by:

Frequently asked questions

AquaBounty – Risk Assessment

Q1: What did Fisheries and Oceans Canada examine in the environmental risk assessment?
Answer:

The environmental risk assessment consisted of an exposure assessment and an environmental hazard assessment.

The exposure assessment examined the physical, biological, and geographical aspects of the proposal for the potential for AquAdvantage® salmon to enter and reproduce in the Canadian environment, should they escape containment. The environmental hazard assessment examined the potential impacts that escaped AquAdvantage® salmon could pose to the natural environment, including to wild Atlantic salmon.

The environmental risk assessment integrated the conclusions of the exposure assessment and the environmental hazard assessment. The Department concluded, with reasonable certainty, that the proposal poses low risk to the Canadian environment.

Q2: What did Fisheries and Oceans Canada examine in the indirect human health assessment?
Answer:

The indirect human health assessment focused on potential human contact with the fish in the environment, should they escape containment. It did not examine human food consumption.

The indirect human health assessment examined whether AquAdvantage® salmon is associated with increased levels of toxins or allergens that could impact human health as a consequence of contact in the environment. It also examined the potential for AquAdvantage® salmon to act as a carrier of human pathogens.

The Department concluded, with reasonable certainty, that the proposal poses low risk to indirect human health.

Q3. What do the levels of certainty mean?
Answer:

Each risk component is associated with a level of certainty. The level of certainty reflects the availability and quality of sound information and data that is associated with a particular conclusion.

A high certainty level means that the conclusion was derived from high quality data on key parameters and considerations. A lower certainty level means that the conclusion was derived from more limited data with more knowledge gaps and/or greater reliance on expert opinion.

Q4: Can the salmon escape the Canadian facility? What about the facility in Panama?
Answer:

The exposure assessment examined the possibility of the salmon escaping from the Canadian facility and while being transported to Panama. The Department also examined the possibility of salmon escaping in Panama and swimming back into Canadian waters.

The Department found that in all cases, suitable physical and operational containment measures are in place to prevent AquAdvantage® salmon from entering the Canadian environment.

For example, in the Canadian facility, there are three to six redundant mechanical barriers in place, for each potential exposure pathway, to prevent escapes. Similar mechanical barriers are in place at the facility in Panama.

The Department concluded, with reasonable certainty, that the likelihood of AquAdvantage® salmon escaping from the Canadian facility is negligible.

The Department concluded, with reasonable certainty, that there is a low likelihood of AquAdvantage® salmon escaping from the facility in Panama. It also concluded, with high certainty, that the likelihood of fish returning to Canadian waters from Panama is negligible.

Q5: Who peer-reviewed the risk assessment?
Answer:

As is the case with all of the Department's science advice, the environmental and indirect human risk assessment of AquAdvantage® salmon underwent a rigorous national peer review process.

The peer review meeting consisted of scientific experts from Fisheries and Oceans Canada, Health Canada, and Environment Canada, as well as external scientists with relevant expertise. A consensus was reached amongst peer review participants on the Department's risk assessment conclusions and science advice.

A summary of the risk assessment (CSAS ScR - 2013/023) is available online.

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