Value assessment under the current Pest Control Products Act
Section 18(c) of the Pest Control Products Regulations states that the Minister shall refuse to register or
amend
the registration of a pest control product if the applicant fails to establish that the product has merit or
value for
the purposes claimed when the product is used in accordance with its label directions. The terms merit
and value are
considered to include elements described under the value assessment.
Section 9(2) of the Regulations states that the applicant shall provide the Minister with the results of
scientific
investigations respecting the effectiveness of the control product for its intended purposes and the safety of
the
control product to the host plant, animal or article in relation to which it is to be used. The Minister is
authorized
to request such further information as requested to determine merit and value.
The three main components to the value assessment process:
Efficacy Evaluation
involves assessing product performance and host tolerance to establish appropriate label claims and the lowest application frequency and rate (or rate range) required to provide effective and reliable pest control without damaging the host or crop and under a broad range of normal-use conditions.
Economics/Competitiveness Evaluation
involves examining the effect of the pest problem on the volume or quality and value of the commodity, or the efficiency of the industrial process to be treated. This includes estimating the potential economic impacts of a decision to register or not register the proposed treatment, and predicting the impact that the availability of the proposed pesticide treatment would have on the competitive position of the relevant Canadian production sector.
Consideration of the impact of availability is particularly important when the proposed treatment is already available in competing countries, the treated commodity is imported into Canada, or the treatment is not registered in countries that import the treated commodity from Canada.
Sustainability Evaluation
is a relatively new addition to the consideration of value by the PMRA. It assesses the role of the proposed treatment in pest management and the overall production systems for the commodity to be treated, including:
- compatibility with and contribution to sustainable production practices and integrated pest management,
including consideration
of pest biology and economic threshold (the population level at which an organism becomes a pest);
- comparison with alternative products and practices, including potential contribution to risk reduction (for
example, by virtue of
lower persistence, toxicity or bioaccumulation, or reduced impact on beneficial and other non-target organisms); and
- contribution to resistance management.
The direct or indirect health and environmental benefits of a product are also evaluated when relevant.
Examples of direct
benefits include the control of a disease causing organism or its vectors, or the control of an environmentally
significant
pest, such as purple loosestrife or zebra mussel. Indirect health or environmental benefits can occur in
situations where
efficacy—in terms of decrease in pest population—is less than ideal, but the product contributes to risk
reduction, resistance
management, or sustainable pest-management systems.
Value assessment contributes to the goals of reducing risk and supporting sustainability by eliminating
unnecessarily high use
rates and frequencies, ensuring that proposed risk-mitigation methods are practical, providing an objective
assessment of the economic
impact of potential regulatory decisions, identifying products that contribute to sustainable pest management
systems, and minimizing
negative impacts of products on such systems.
Efficacy review helps to avoid unnecessary pesticide exposure to users,
bystanders and the environment resulting from ineffective pesticides
or unnecessarily high use rates and application frequencies. It also
minimizes dietary exposure to pesticides by reducing the amount of pesticide
likely to remain in or on food. Efficacy evaluation protects users from
deceptive claims regarding the effectiveness of pest control products.
Economic assessment provides data on expected and experienced losses
due to pests. Such data inspire greater efforts to find mitigative measures
and, if the product is of great value to a sector, make expensive mitigative
measures more feasible. In situations where acceptability of risk is
marginal, the objective assessment of economic impacts leads to an appreciation
of the need to consider regulatory options such as restricted use patterns,
time-limited registrations and delayed cancellations. |
