Federal Regulation of Pest Control Products
For Use in Aquaculture
Health Canada
Pest Management Regulatory Agency
Outline
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PMRA responsibilities related to aquaculture
PMRA Regulatory Process
Environmental Assessment Approach
Compliance and Enforcement of Pest Control
Products Act (PCPA)
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Pesticide Regulation and Aquaculture
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Products which are applied to water or topically applied to
animals or structures used in aquaculture for pest control
purposes are considered pesticides and are covered under the
PCPA.
Products which are administered in feed or injected into animals
are considered Veterinary Drugs and are covered under the
Food and Drugs Act (FDA) and the Canadian Environmental
Protection Act (CEPA).
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Pest Management Regulatory Agency
Branch of Health Canada
Role: Federal Regulation of pest control products
Responsibility: Administration of the Pest Control Products Act which
regulates the sale, manufacture, use and importation of pest control
products
Mission/Mandate:
Protect the health and environment of Canadians and support Canadian
competiveness by regulating pesticides and their use in an effective
and transparent manner
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Pesticide Regulation in Canada:
Distribution of Legislative Responsibilities
Federal
• Regulation of New Pesticides
• Re-evaluation of Existing Products
• Compliance and Enforcement of PCPA
Provincial
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Transportation, sale, use, storage and disposal
Training, certification and licensing
Further restrictions/conditions on use
Compliance and Enforcement Activities
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Regulatory Process
• For pesticides to be used or imported to in Canada,
they must be registered
• The registration process requires that :
• Applicants must submit data required by the Minister
• Submissions undergo a pre-market science based risk
assessment
• Risks from proposed uses to human health, the environment
and value must be acceptable
• The Minister establishes the conditions of registration
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Federal Regulatory Mechanisms to Enable
the Sales/Use of Pesticides in Canada
• Research Authorizations - can be granted to conduct
research related activities with pest control products
• Registration of technical actives and end-use
products
• Emergency Registration
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Registration of a Pesticide
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Decision of the federal Minister of Health
Based on acceptable risk:
• Reasonable certainty of no harm to health, future generations and
the environment from use or exposure when used according to
label directions
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Requires public consultation for regulatory decisions on new
actives or major new uses
• done on line via PMRA Public Registry
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Registration enables the sales/use of a pesticide in Canada
• Allows use under conditions of registration as specified on the
label. Use in a manner not specified is illegal
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Emergency Registration
 Sponsor: Province or Federal Department/Agency involved in
direct management of the pest problem
• Criteria:
 Pest outbreak occurs that can cause significant economic,
environmental or health problems;
 No effective product or application method registered in Canada for
the control of the pest; and,
 No effective alternative control method available.
 Technical active already registered for use in Canada
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Registration granted for up to one year
Conditions & Restrictions may be applied
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Science Based Risk Assessments
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Data requirements are determined by PMRA to allow characterization
and identification of potential risks
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Health Evaluation: toxicology and epidemiology; occupational and
bystander; dietary exposure
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Environmental Assessment: environmental toxicology, environmental
chemistry and fate (including persistence and bioaccumulation)
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Value Assessment: efficacy, sustainability competitiveness
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These form key inputs to risk management and regulatory decision
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Environmental Risk Assessment Framework
Hazard Assessment
Exposure Assessment
Environmental Chemistry
Use Pattern
Acute and Chronic Toxicity
Bioaccumulation
Risk Characterization
Integration of Exposure and Effects
Identify environmental concerns
Risk Management - Risk
Mitigation Options
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Response
Key Concepts - Dose Response
Dose
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Key Concepts - Toxicity (hazard)
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Measures of toxicity are a function of two factors:
• Dose (how much)
• Duration (how long)
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The shorter the exposure, the greater the dose needed to get an
effect
Results of toxicity tests expressed as a concentration and
exposure period (eg. 48h LC50)
Also related to a particular exposure media (eg seawater,
sediment, etc)
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Key Concepts - Risk
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Risk is a function of both hazard (toxicity) and exposure
Most chemicals have the potential to cause adverse effects at
high enough doses but there is usually a dose – a low enough
exposure - below which no effects will occur
Generally, as the amount of exposure increases, so does the
risk of effects
This is why risk assessments put such a strong emphasis on
estimating both the amount and duration of exposures
Risk assessments match up what we know about hazard with
how exposure is expected to occur
Used to identify potential concerns and risks
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Key Concepts - Risk
Hazard
Exposure
Risk
Receptor
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Risk Mitigation
• Measure(s) which can be used to limit exposure will
help decrease risk
• No or limited exposure
no or limited potential
for effects
• Conditions/restrictions for registrations
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Application rates
Frequency of application
Timing of application
Method of application
PPE
Type of Product Registration (eg: Restricted)
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HC - PMRA Compliance and Enforcement
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PMRA’s Compliance and Enforcement Program supports the Agency’s
primary objective of protecting the health of Canadians and their
environment from unacceptable risks associated with the use of pest control
products.
National Program with Regional Inspection Staff
Regionally based Staff
According to the PCPA and its regulations:
• All products must be registered prior to
– Import
– Sale
– Use
• All registered products must be used according to approved labelled
uses and conditions
HC - PMRA Compliance and Enforcement
Compliance Activities: Compliance Promotion, Monitoring
Inspections and Compliance Verification/Surveillance Inspections.
Enforcement is any action that is taken to induce, encourage or
compel compliance. Options that are available include:
• education letter;
• administrative monetary
penalty (AMP) or warning;
• compliance order
• prosecution;
• amend, suspend or cancel
registration;
• voluntary recall;
• seizure and detention;
• seizure and forfeiture; and
• denial of entry into Canada.
HC - PMRA Compliance and Enforcement
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The PMRA generally follows an established conformity
continuum used by many compliance and enforcement officials.
This continuum ranges from conformity through education to
responses to situations of non-compliance.
The PMRA considers whether there is
knowledge/understanding, intent and the ability to comply with
regulatory requirements. The following factors are also
considered:
– the history of compliance, evidence of corrective action already taken;
– the degree of actual harm or potential harm as a result of noncompliance; and
– the level of response necessary to achieve and maintain continuing
compliance.
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Fines under the PCPA
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In regards to AMPs the maximum fine is up to $6000 per violation
In regards to disobeying compliance orders the liability is as follows:
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a) "on summary conviction, to a fine of not more than $200,000 or to imprisonment for
a term of not more than six months, or to both; or
b) "on conviction on indictment, to a fine of not more than $500,000 or to imprisonment
for a term of not more than three years, or to both
The above liability applies to all offences except where wilfulness or
recklessness lead to a risk of imminent death or serious bodily harm to
another person, risk of substantial harm to the environment or harm to
the environment in which case the liability is:
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a) not more than $300,000/six months or both for summary conviction or
b) not more than $1,000,000/3 years or both as detailed in s.68(4) PCPA.
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Collaborative Effort
HC - PMRA works in collaboration with its partners responsible for
the environment and aquaculture/fisheries to:
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Maximize efficiency and inspection coverage for use of products.
Execute salmon-farm inspection blitzes.
Analyze salmon samples in conjunction with Environment Canada sampling
program.
Work cooperatively with all partners to examine and respond to potential
non-compliance issues.
Be aware of industry treatment and regulatory inspection strategies and
emerging issues.
Useful Links:
• Pest Control Products Act
Link to PCPA
• PMRA Website
http://www.hc-sc.gc.ca/pmra
•Regulatory Data Requirements for Aquaculture
Data Requirements I Data Requirements II
•PMRA Public Registry
Public Registry
•PMRA Consultations
Consultations
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For Further Information:
E-mail: pmra.infoserv@hc-sc.gc.ca
Telephone: 613-736-3799
Toll-free: 1-800-267-6315
Facsimile: 613-736-3798
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