P-9.01Pest Control Products ActF-11Financial Administration ActSOR/97-17319974

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PEST CONTROL PRODUCTS ACTFINANCIAL ADMINISTRATION ACTRegulations Prescribing the Fees to be Paid for a Pest Control Product Application Examination Service Provided by or on behalf of Her Majesty in Right of Canada, for a Right or Privilege to Manufacture or Sell a Pest Control Product in Canada and for Establishing a Maximum Residue Limit in Relation to a Pest Control ProductP.C.1997-467 19974

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His Excellency the Governor General in Council, on the recommendation of the Minister of Health and the Treasury Board, pursuant to paragraph 6(1)(d) of the Pest Control Products Act, and paragraph 19(1)(a)a and section 19.1a of the Financial Administration Act, hereby makes the annexed Regulations Prescribing the Fees to be Paid for a Pest Control Product Application Examination Service Provided by or on behalf of Her Majesty in Right of Canada, for a Right or Privilege to Manufacture or Sell a Pest Control Product in Canada and for Establishing a Maximum Residue Limit in relation to a Pest Control Product.aS.C. 1991, c. 24, s. 6INTERPRETATION

1.(1)The definitions in this subsection apply in these Regulations.evaluation means an evaluation by the Minister of the information relevant to the safety, merit or value of a pest control product that begins after the issuance of a notice by the Minister stating that the application in respect of the pest control product has been accepted for evaluation. (évaluation)examination means the services provided in relation to an application in respect of a pest control product. (examen)Minister means the Minister of Health. (ministre)user-requested minor use label expansion means an application made by a user of a pest control product, or a user group, to amend the certificate of registration of the pest control product by adding a new use of that product. (demande d’usage limité par l’utilisateur)(2)All other words and expressions used in these Regulations have the meanings assigned to them by the Pest Control Products Act or the Pest Control Products Regulations.

PART IFEES TO BE PAID FOR AN EXAMINATION OF AN APPLICATION IN RESPECT OF A PEST CONTROL PRODUCTApplication

2.(1)This Part does not apply in respect of an application referred to in section 3 or 4 that was received by the Minister(a)before April 1, 1995; or(b)during the period beginning on April 1, 1995 and ending on April 15, 1997, where, as of April 15, 1997,(i)in the case of an application referred to in section 3, all its components are under evaluation, or(ii)in the case of an application referred to in section 4, the application is under evaluation.(2)This Part does not apply in respect of(a)a user-requested minor use label expansion that meets the criteria set out in subsection (3);(b)a determination of equivalency by the Minister referred to in subparagraph 5(1)(d)(ii) of the Pest Control Products Regulations;(c)a permit referred to in subparagraph 5(1)(d)(iii) of the Pest Control Products Regulations; and(d)except for a component referred to in subitem 1(a), (b) or (c) of Schedule I and any item in Schedule II, an application for a certificate of registration of a pest control product whose active ingredient is(i)an organism,(ii)a substance that is not an agricultural chemical as defined in section B.01.001 of the Food and Drugs Regulations, or(iii)a naturally occurring semiochemical or an identical synthetic substance that affects the behaviour of arthropoda.(3)For the purposes of paragraph (2)(a), the criteria are as follows:(a)some of the information required to accompany the application is generated by the applicant or for the applicant by someone other than the registrant; and(b)the application is accompanied by the registrant’s certification that(i)the registrant agrees to include the new use on the label of the pest control product if the application is approved, and(ii)the registrant’s anticipated revenue from sales of the pest control product in Canada for the new use does not warrant an application for an amendment of the certificate of registration being made by the registrant.

Application for Issuance or Amendment of Certificate of Registration

3.The fee payable for the examination by the Minister of an application for the issuance or amendment of a certificate of registration of a pest control product is(a)if the application includes only one component set out in column I of an item of Schedule I, the fee set out in column II of that item; and(b)if the application includes more than one component set out in column I of an item of Schedule I, a fee that is equal to the sum of the applicable fees for all of the components.

Other Applications

4.The fee payable for the examination by the Minister of an application set out in column I of an item of Schedule II is the fee set out in column II of that item.

Minimum Fee

5.The fee payable for the examination by the Minister of an application for amendment of a certificate of registration that does not include a component set out in Schedule I or is not an application referred to in Schedule II is $150.

Application Received by the Minister on or after April 16, 1997

6.(1)This section applies in respect of an application referred to in section 3 or 4 that is received by the Minister on or after April 16, 1997.(2)Where the fee payable for an application referred to in section 3 is $1,000 or less, the fee is payable at the time the application is made.(3)Where the fee payable for an application referred to in section 3 is more than $1,000, the fee is payable as follows:(a)10 per cent of the fee at the time the application is made;(b)25 per cent on receipt of a notice from the Minister stating that the application has been accepted for a preliminary review for deficiencies; and(c)65 per cent on receipt of a notice from the Minister stating that the application has been accepted for evaluation.(4)The preliminary review for deficiencies referred to in paragraph (3)(b) is a review by the Minister of the information submitted with an application in order to determine that the information is sufficient to enable the Minister to undertake an evaluation of the application.(5)The review referred to in paragraph (3)(b) and the evaluation referred to in paragraph (3)(c) will be undertaken after receipt of the payment referred to therein.(6)The fee payable for an application referred to in section 4 is payable at the time the application is made.

Application Received by the Minister before April 16, 1997

7.(1)This section applies in respect of an application referred to in section 3 or 4 that is received by the Minister during the period beginning on April 1, 1995 and ending on April 15, 1997 where, as of April 15, 1997,(a)the application has not been accepted for evaluation; or(b)the application has been accepted for evaluation, but the application or one or more of its components are not yet under evaluation.(2)Notwithstanding sections 3 and 4, an application referred to in paragraph (1)(a) is subject to the payment of(a)65 per cent of all applicable fees provided for in this Part on receipt of a notice from the Minister stating that the application has been accepted for evaluation; and(b)25 per cent of all applicable fees provided for in this Part on receipt of a notice from the Minister stating that the evaluation of the application has been completed.(3)Notwithstanding sections 3 and 4, an application referred to in paragraph (1)(b) is subject to the payment of(a)65 per cent of all applicable fees provided for in this Part with respect to any evaluation commenced on or after April 16, 1997, payable on receipt of a notice from the Minister indicating the status of the evaluation; and(b)25 per cent of all applicable fees provided for in this Part on receipt of a notice from the Minister stating that the evaluation of the application has been completed.

Reduction of Fees

8.(1)In this section, sales verification period, in respect of a pest control product for which an application for a reduction of the fee is made under this section, means the period beginning on the date that the pest control product is first sold in Canada as, or in, a registered pest control product and ending on the earliest of the date(a)that is three years after that date,(b)on which the pest control product ceases to be registered or the registration is cancelled or suspended pursuant to section 20 of the Pest Control Products Regulations, and(c)on which the sale of the pest control product is discontinued in accordance with section 16 of the Pest Control Products Regulations.(2)A person who makes an application for the issuance of a certificate of registration of a pest control product referred to in section 3 may apply to the Minister for a reduction in the fee payable(a)in the case of an application referred to in subsection 6(1), at the time the application is made; and(b)in the case of an application referred to in subsection 7(1), at the time the fee is payable.(3)The Minister shall approve an application made pursuant to subsection (2) where the Minister has reasonable grounds to believe that, during the sales verification period, the registrant’s revenue from sales in Canada of the pest control product to which the application relates will be less than 10 times the fee calculated in accordance with section 3 or, where applicable, subsection 7(2) or (3).(4)The registrant’s revenue from sales referred to in subsection (3) and (5) shall include, in respect of an application for the issuance of a certificate of registration,(a)in the case of a new active ingredient, the revenue from sales of all the pest control products registered during the sales verification period that contain the active ingredient; and(b)in any other case, the revenue from sales of all the registrant’s pest control products containing the same active ingredient for which products applications were submitted at the same time and included for evaluation a common component set out in Schedule I.(5)Notwithstanding sections 3 and 7, where the Minister approves an application made pursuant to subsection (2), the fee payable in respect of the application is the lesser of(a)the fee calculated in accordance with section 3 or, where applicable, subsection 7(2) or (3), and(b)an amount equal to not less than 10 per cent of the fee calculated in accordance with section 3 or, where applicable, subsection 7(2) or (3), that is the greater of(i)10 per cent of the registrant’s anticipated revenue from sales of the pest control product in Canada during the sales verification period, and(ii)10 per cent of the registrant’s revenue from sales of the pest control product in Canada during the sales verification period, as verified by the sales records for the pest control product certified on behalf of the registrant by a person designated for that purpose and submitted to the Minister.(6)Where the fee payable pursuant to paragraph (5)(b) is(a)10 per cent of the fee calculated in accordance with section 3, the fee shall be paid as prescribed in subsection 6(2) or (3);(b)10 per cent of the fee calculated in accordance with section 7, the fee shall be paid as prescribed in subsection 7(2) or (3); or(c)an amount calculated in accordance with subparagraph (5)(b)(i) or (ii), the fee shall be paid as follows:(i)an amount equal to 10 per cent of the registrant’s anticipated revenue from sales of the pest control product in Canada during the sales verification period shall be paid(A)in the case of an application referred to in subsection 6(1), in accordance with subsection 6(2) or (3), and(B)in the case of an application referred to in subsection 7(1), in accordance with subsection 7(2) or (3), and(ii)the balance, if any, shall be paid within 60 days after the expiration of the sales verification period.(7)Where the Minister determines that, on the basis of any information available to the Minister, the certified sales records referred to in subparagraph (5)(b)(ii) may not be adequate for the purpose of determining the fee payable, the Minister may require that a registrant submit sales records in respect of a pest control product that have been audited by a qualified independent auditor.(8)Where the audited sales records submitted pursuant to subsection (7) are inconsistent with the certified sales records referred to in subparagraph (5)(b)(ii), the fee payable is determined on the basis of the records indicating the higher amount of sales.(9)Where, at the expiration of a sales verification period, a registrant has not submitted to the Minister the sales records certified pursuant to subparagraph (5)(b)(ii) or audited pursuant to subsection (7) in respect of a pest control product, the fee payable is the fee determined in accordance with section 3 less any fee paid pursuant to paragraph (5)(b).

PART IIFEES TO BE PAID FOR A RIGHT OR PRIVILEGE TO MANUFACTURE OR SELL A PEST CONTROL PRODUCT IN CANADA

9.(1)A registrant shall pay, in respect of each pest control product that on April 16, 1997 and on April 1 in any year thereafter is registered in the name of the registrant, an annual fee that is the lesser of(a)$2,690, and(b)an amount that is equal to 3 per cent of the annual sales of the pest control product in Canada during the registrant’s preceding fiscal year, but not less than $75.(2)The registrant shall pay the fee referred to in subsection (1) as follows:(a)on receipt of a notice from the Minister requesting payment; or(b)in four equal quarterly payments with the first payment due on receipt of a notice from the Minister requesting payment.(3)Where the payment is made under paragraph (1)(b), the registrant shall, at the time of making the payment referred to in paragraph (2)(a) or the first quarterly payment referred to in paragraph (2)(b), submit to the Minister the sales records that have been certified on behalf of the registrant by a person designated for that purpose and for the year referred to in paragraph (1)(b).(4)Where the Minister determines that, on the basis of any information available to the Minister, the certified sales records referred to in subsection (3) may not be adequate for the purpose of determining the fee payable, the Minister may require that a registrant submit sales records in respect of a pest control product that have been audited by a qualified independent auditor.(5)Where the audited sales records submitted pursuant to subsection (4) are inconsistent with the certified sales records referred to in subsection (3), the fee payable is determined on the basis of the records indicating the higher amount of sales.

10.Where a fee is payable under this Part in respect of a pest control product by a registrant who has paid a fee pursuant to subsection 3(2) or 4(2) of the Authority to Sell Drugs Fees Regulations in respect of the same pest control product for the period beginning on October 1, 1996 and ending on September 30, 1997 and the fee paid is less than the fee payable under this Part, the registrant shall pay an amount that is equal to the difference between the fee payable under this Part and the fee paid pursuant to the Authority to Sell Drugs Fees Regulations.

COMING INTO FORCE

11.These Regulations come into force on April 16, 1997.

SCHEDULE I(Sections 2 and 3 and subsection 8(4))APPLICATION FOR ISSUANCE OR AMENDMENT OF A CERTIFICATE OF REGISTRATION OF A PEST CONTROL PRODUCTColumn IColumn IIItemComponentFee ($)1.(a) Label accompanying an application for the registration of a pest control product consisting of or containing a new active ingredient262(b) Label accompanying an application in respect of a pest control product representing a new use262(c) Label — other1542.Product chemistry — active ingredient1,1723.Product chemistry — end-use product or manufacturing concentrate1,1724.(a) Toxicology data accompanying an application for the registration of a pest control product consisting of or containing a new active ingredient98,248(b) Toxicology data accompanying an application in respect of a pest control product representing a new use35,456(c) Toxicology data — acute studies only4,2745.(a) Exposure data accompanying an application for the registration of a pest control product consisting of or containing a new active ingredient24,384(b) Exposure data accompanying an application for a major new use of a registered pest control product24,384(c) Exposure data — other9,7426.Metabolism data6,0347.Residue data8,4488.(a) Environmental fate data accompanying an application for the registration of a pest control product consisting of or containing a new active ingredient26,953(b) Environmental fate data accompanying an application for a major new use of a registered pest control product26,953(c) Environmental fate data — other6,7389.(a) Environmental toxicology data accompanying an application for the registration of a pest control product consisting of or containing a new active ingredient14,882(b) Environmental toxicology data accompanying an application for a major new use of a registered pest control product14,882(c) Environmental toxicology data — other3,72010.Value and effectiveness data for a pest control product906SCHEDULE II(Sections 2 and 4)OTHER APPLICATIONS IN RELATION TO A PEST CONTROL PRODUCTColumn IColumn IIItemApplicationFee ($)1.Renewal of certificate of registration1542.Research permit (administration fee)1503.(a) Import for manufacture and export registration4,601(b) Amendment to import for manufacture and export registration1544.Establishment of maximum residue limit for an unregistered pest control product or for an unregistered use of a pest control product8,448