His Excellency the Governor General in Council, on the recommendation of the Minister of Health and the Treasury Board, hereby makes the annexed Pest Control Products Fees and Charges Regulations pursuant to
section 67 of the Pest Control Products Act a, with respect to sections 1 to 9 and 11; and S.C. 2002, c. 28
section 67 of the Pest Control Products Act a and paragraph 19(1)(a) b and section 19.1 b of the Financial Administration Act c, with respect to section 10. S.C. 1991, c. 24, s. 6 R.S., c. F-11
Fees for the Examination of an Application in Respect of a Pest Control Product
Non-Application
Section 2 does not apply in respect of
an application filed by a user of a pest control product or by a user group, to amend the registration of the pest control product by adding a minor use of the product to the label, and that meets the following criteria:
some of the information that is required to accompany the application is generated either by the applicant or for the applicant by another person who is not the registrant, and
the application is accompanied by a statement by the registrant that they agree to add the new use to the label of the pest control product if the application is approved;
a request for a determination of equivalency made under section 38 of the Pest Control Products Regulations;
an application for an authorization to use a foreign product under subsection 41(1) of the Pest Control Products Regulations; and
except in the case of a type of application set out in Schedule 2 or 3, an application to register, or to amend the registration of, a pest control product whose active ingredient is
an organism that is not a microbial agent, or
any of the following substances referred to in the Food and Drug Regulations:
a food additive that is set out in column 1 of the Lists of Permitted Food Additives, as defined in subsection B.01.001(1) of those regulations,
a nutritive substance that is used, recognized or commonly sold as food or as an ingredient of food,
a vitamin, mineral nutrient or amino acid,
a flavouring preparation, natural extractive, oleoresin, seasoning or spice,
a food packaging material or any substance of which such a material is composed, or
a drug for veterinary use in animals that may be used as food for human consumption.
Fees
The fee for the examination by the Minister of an application to register a pest control product — other than a type of application set out in Schedule 2 or 3 — or to amend such a registration that includes a component set out in column 1 of Schedule 1 is the fee set out in column 2.
If an application referred to in subsection (1) includes more than one component set out in column 1 of Schedule 1, the fee is the sum of the applicable fees set out in column 2 for all of the included components.
The fee for the examination by the Minister of an application in respect of a pest control product that is a semiochemical or microbial agent for each type of application set out in column 1 of Schedule 2 is the fee set out in column 2.
If more than one type of application set out in column 1 of Schedule 2 is filed in respect of the same pest control product at the same time, the fee for the examination by the Minister is the highest of the applicable fees set out in column 2 in respect of those applications.
The fee for the examination by the Minister of an application in respect of a pest control product for each type of application set out in column 1 of Schedule 3 is the fee set out in column 2.
If more than one type of application set out in column 1 of Schedule 3 is filed in respect of the same pest control product at the same time, the fee for the examination by the Minister is the highest of the applicable fees set out in column 2 in respect of those applications.
The fee for the processing by the Minister of any of the following applications, other than an application to renew a registration, is $1,133:
an application in respect of a pest control product that is described in paragraph 1(d);
an application that includes a component set out in column 1 of Schedule 1; and
an application in respect of a pest control product that does not include any component set out in Schedule 1, that is not mentioned in Schedule 2 or 3 and for which no information other than what is already available to the Minister is required to conduct an evaluation.
The fee for the examination by the Minister of an application in respect of a pest control product, other than an application to renew a registration, that does not include any component set out in Schedule 1, that is not mentioned in Schedule 2 or 3 and that does not require an evaluation is $247.
The fee for the examination by the Minister of an application to renew the registration of a pest control product is $80.
Annual Adjustment of Fees
Every fee set out in this Part is to be increased on April 1 of each year by 2%, rounded up to the nearest dollar.
Timing of Payment
In this section, preliminary review means a review by the Minister of the information that is submitted with an application to determine whether the information is sufficient to enable the Minister to conduct an evaluation of the pest control product.
If the total fee for an application under this Part is $2,500 or less, it must be paid when the application is filed.
10% must be paid when the application is filed;
25% is payable on receipt of a notice from the Minister that the application has been accepted for a preliminary review; and
65% is payable on receipt of a notice from the Minister that the application has been accepted for evaluation.
The preliminary review and the evaluation begin on receipt of the relevant payments.
Fee Reduction
The following definitions apply in this section.
actual gross revenue means the amount that the person who makes an application to register a pest control product referred to in subsection 2(1) collects during the fee verification period from the sales in Canada of that product. (recettes brutes réelles)
anticipated gross revenue means the amount that the person who makes an application to register a pest control product referred to in subsection 2(1) expects to collect during the fee verification period from the sales in Canada of that product. (recettes brutes prévues)
fee verification period, in respect of a pest control product for which an application for a fee reduction is approved under subsection (3), means the period that begins on the day on which the pest control product is first sold in Canada as a registered pest control product or as an active ingredient in a registered pest control product and that ends three years after that day. (période de vérification des droits)
sales in Canada means
in the case of an application to register an active ingredient, the sales in Canada of all pest control products that contain that active ingredient and that became registered during the fee verification period;
in the case of an application to register a pest control product that is not an active ingredient, the sales in Canada of that product during the fee verification period; and
in the case of more than one application that includes a common component set out in Schedule 1 and that is filed at the same time to register pest control products that contain the same active ingredient, the sales in Canada of those pest control products during the fee verification period. (ventes au Canada)
A person who files an application to register a pest control product referred to in subsection 2(1) may apply at the same time to the Minister for a reduction of the fee.
The Minister must approve a fee reduction if the following conditions are met:
the person provides to the Minister with their application
a statement signed by an individual who is designated by the person for the purpose that indicates the person’s anticipated gross revenue and that certifies that the fee is greater than 10% of that anticipated gross revenue, and
information that establishes that that fee is greater than 10% of the person’s anticipated gross revenue; and
the Minister determines, on the basis of the information provided under paragraph (a) and any other information that is available to the Minister, that the fee is likely to be greater than 10% of the person’s actual gross revenue.
If the Minister approves a fee reduction, the fee that is payable at the end of the fee verification period is the lesser of
the total fee payable under this Part, and
the higher of
10% of the fee referred to in paragraph (a), and
10% of the actual gross revenue, based on the records of the sales in Canada provided to the Minister in accordance with subsection (6).
10% of their anticipated gross revenue, and
10% of the total fee payable under this Part.
Within 60 days after the end of the fee verification period, the person must provide the Minister with the records of the sales in Canada, prepared in accordance with generally accepted accounting principles and certified by the individual responsible for the person’s financial affairs.
If the Minister determines, on the basis of any information that is available to him or her, that the certified records of the sales in Canada are not adequate to determine the person’s actual gross revenue, the Minister may require that the person provide records of the sales in Canada that have been audited by a qualified independent auditor.
If there is any inconsistency between the certified records and the audited records, the fee is to be based on whichever records show the higher amount of sales in Canada.
Annual Charge
A registrant must pay each year, in respect of every pest control product that is registered in their name on April 1 of the year, an annual charge that is the lesser of
$3,600, and
4% of the actual gross revenue during the registrant’s preceding fiscal year, but not less than $100.
The annual charge is payable
on receipt of a notice from the Minister requiring payment; or
in four equal quarterly payments, the first of which is payable on receipt of a notice from the Minister requiring payment.
When the annual charge is paid under paragraph (1)(b), the registrant must, when paying it in full or when making the first quarterly instalment, provide the Minister with the records of the sales in Canada for the fiscal year referred to in that paragraph, prepared in accordance with generally accepted accounting principles and certified by the individual responsible for the registrant’s financial affairs.
If the Minister determines, on the basis of any information available to him or her, that the certified records are not adequate to calculate the annual charge, the Minister may require that the registrant provide records of the sales in Canada that have been audited by a qualified independent auditor.
If there is any inconsistency between the certified records and the audited records, the calculation of the annual charge is to be based on whichever records show the higher amount of sales in Canada.
Repeal and Coming into Force
Repeal
[Repeal]
Coming into Force
These Regulations, except section 6, come into force on the day on which they are registered or on April 1, 2017, whichever is later.
Section 6 comes into force on April 1 of the year after the year in which these Regulations are registered.
Fees for Applications to Register, or to Amend the Registration of, a Pest Control Product Other Than a Semiochemical or Microbial Agent Column 1 Column 2 Item Component of Application Fee ($) 1 Product chemistry — active ingredient 4,873 2 Product chemistry — end-use product or manufacturing concentrate 2,713 3 75,807 15,830 2,954 4 17,498 5,758 5,214 5 Metabolism data 28,943 6 Residue data 15,838 7 42,685 23,637 11,546 8 37,277 23,690 2,465 9 Value and effectiveness data for a pest control product 906 10 Identification of compensable data 2,162
Fees for Applications in Respect of a Pest Control Product that is a Semiochemical or Microbial Agent Column 1 Column 2 Item Type of Application Fee ($) Semiochemicals, other than straight-chain lepidopteran pheromones, and microbial agents 1 Registration of a new active ingredient — food use 7,236 2 Registration of a new active ingredient — non-food use 4,341 3 Amendment of registration — new risk assessment necessary — environmental fate data, environmental toxicity data or exposure data 2,894 4 Amendment of registration — data required, label changes 1,447 5 Amendment of registration — data required, other 1,158 6 Amendment of registration — no data required 290 Straight-chain lepidopteran pheromones 7 Registration of new active ingredient 579 8 Amendment of registration 290
Fees for Other Applications in Respect of a Pest Control Product Column 1 Column 2 Item Type of Application Fee ($) 1 5,080 5,080 1,217 1,217 2 Research notification 247 3 7,827 1,133 4 125,461 15,838