Pesticide Market and Product Registration in Canada

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1 Shuyou Han Correspondent (China), Agrow WeChat: hanshuyoucan CAC Conference, Feb. 28 Mar. 3, 2017, Shanghai China

2 Content General Info on Canadian Agriculture Main Agricultural Provinces Major Crops Top 10 Products for Major Crops Pesticide Registration in PMRA The Needed Data Data Compensations Pesticide Sales Channels in Canada Bigger Distributors Smaller Distributors 2

3 Total Farm Map of Canada 3

4 Alberta Saskatchewan Manitoba Ontario Quebec

160 Major Crop Area in Canada (million mu, 2016) 140 140.68 120 121.52 100 80 60 40 20 38.76 35.45 33.17 25.94 20.21 17.

5 160 Major Crop Area in Canada (million mu, 2016) Wheat Canola Barley Lentils Soybeans Dry field peas 中国 ( 百万亩, 2015) Corn for grain Oats 5

6 Soybean Production (Metric Tonnes),

7 Corn Production (Metric Tonnes),

8 Canola Production (Metric Tonnes),

9 Wheat Production (Metric Tonnes),

10 Top 30 Pesticide Markets ($m) in the World, 2015 Data Source: Phillips McDougall 10

11 Pesticide Market Analysis Global Value: m$ 51,210 (2015) NAFTA Value: m$ 9,356 (2015) Canada Value by Class : m$ 1,505 (2015) Canada Value by Crop : m$ 1,505 (2015) Data Source: Phillips McDougall 11

12 Top Ten Products on Wheat 唑啉草酯啶磺草胺草甘膦溴苯腈炔草酸二甲四氯氟唑磺隆氯氟吡氧乙酸恶唑禾草灵磺酰草吡唑? 丙硫菌唑戊唑醇苯醚甲环唑甲霜灵叶菌唑吡唑醚菌酯丙环唑氟唑环酰胺灭菌唑嘧菌酯噻虫嗪毒死蜱吡虫啉三氟氯氰菊酯氯虫苯甲酰胺溴氰菊酯马拉硫磷乐果氯菊酯 12

13 Top Ten Products on Canola 草铵膦草甘膦烯草酮甲氧咪草烟喹禾灵唑草酮二氯吡啶酸??? 溴草腈杀草强丙硫菌唑啶酰菌胺吡唑醚菌酯戊苯吡菌胺异菌脲啶氧菌酯咯菌腈苯醚甲环唑氟唑菌酰胺甲霜灵噻虫胺噻虫嗪三氟氯氰菊脂溴氰菊酯溴氰虫酰胺毒死蜱甲萘威马拉硫磷氯虫苯甲酰胺氯菊酯 13

14 PRODUCT SUBMISSION CATEGORIES 14

15 NUMBER OF SUBMISSIONS COMPLETED BY PMRA FROM APRIL 1, 2012 TO MARCH 31,

16 NUMBER OF NEW ACTIVE INGREDIENTS REGISTERED BY PMRA FROM APRIL 1, 2012 TO MARCH 31,

17 Pre-Sub Assembling an efile Loading an efile Screening Data Evaluation Decision Making E-index Cover letter stating the purpose of the application Application form (form 6005) Statement of product specification form (from 6003) Fee form (form 6011) Proposed product label (English and French) Application fee calculated based upon the data part submitted Data to support this application as outlined Letter of authorization (LOA) 17

18 Pre-Sub Assembling an efile Loading an efile Screening Data Evaluation Decision Making eindex: a type of fiel which can be created, modified and finalized through the eindex Builder. The dile is created in XML format and can be viewed through the eindex Builder. All non-finalized eindex files will be saved with a.xml extension. PRZ file: When an eindex is finalized, a PRZ file including a package of the e-index fiel along with all of the referenced e-files is created. This PRZ file is the file which should be sumitted to the PMRA. 18

19 Pre-Sub Assembling an efile Loading an efile Screening Data Evaluation Decision Making Automation through secure web portal Double check required forms are included Follow up with PMRA if the confirmation is not received within 7 days Naming your PRA for a response data including application number 19

20 Pre-Sub Assembling an efile Loading an efile Screening Data Evaluation Decision Making Deficiencies may be identified at any level of the registration process May be communicated by clarification request ( or fax) or deficiency letter Clarification Request 10 day response timeline No change to the application timeline Includes clarifications regarding incomplete forms Deficiency Letter 45 day response timeline Application clock stopped until a complete response received Application screen restarted when responses received including missing data, incomplete formulant information 20

21 Pre-Sub Assembling an efile Loading an efile Screening Data Evaluation Decision Making 21

22 Pre-Sub Assembling an efile Loading an efile Screening Data Evaluation Decision Making 22

23 GENERIC REGISTRATIONS Regulatory provisions for the protection of test data are intended to encourage the introduction of new pesticides by protecting the innovator's substantial investment in a supporting database. At the same time, established limits on the data protection period allow for timely introduction of equivalent products by generic manufacturers, thus enhancing market competition to the benefit of users, including growers. PMRA published and implemented changes to the generic application review process in The intent of these changes are to make the process more transparent and predictable, to streamline the application process, to decrease the time to complete these assessments, to resolve operational challenges in processing these applications, and to improve the tracking and reporting on performance. In , 34 generic products were registered, including 22 technical or manufacturing products and 12 end-use products. Some examples of generic active ingredients registered for agricultural use include, chlormequat chloride, chlorpropham, diquat, mancozeb, and quinclorac. 23

24 USEPA & PMRA PMRA tends to be more strict on impurities in technicals, such as content of dioxin etc. PMRA asks the analytical method (GLP) for formulations. Data compensation must be resolved before issuing the registration certificate. Patents might be the potential hurdles to product registrations. For generic product registrations, five-batches analysis reports, and physicalchemical reports are needed both in EPA and PMRA. 24

25 Big Fishes (distributors/dealers in Canada) 25

26 Small Fishes (distributors/dealers in Canada) Aceto Agricultural Corp. Adjuvants Unlimited AgMarket Results AkzoNobel Surface Chemistry LLC Albaugh Inc. Ashland, Inc Birdsong Peanuts Brandt Consolidated Chemorse Cimarron Label Clariant Corporation Compliance Services Int. Council of Producers & Distributors of Agrotechnology Croda Inc. CST-Lamberti Group ENSAFE Ethox Evonik Goldschmidt Corp. Exacto Inc. ExcelAg Corp. USA Exponent ExxonMobil Chemical Fine Americas Garrco Products Helena Chemical Co. Huntsman Corporation Italpollina USA, Inc. Keller & Heckman Kincannon & Reed KRS, Inc. Landis International Lee Container Corporation Lonza Agro Ingredients Marketing Arm International Oxiteno USA, LLC Precision Laboratories Rosen's Royal Chemical Sipcam Advan USA Inc. Solvay, Inc. Spring Trading Company Stepan Company Stillmeadow, Inc. Technology Sciences Group Tide International USA, Inc. United Suppliers Vive Crop Protection Wilbur-Ellis Company Winfield Solutions, LLC 26

27 Western Canada AgResource (Cargill) Univar: provide segments of the crop protection industry with storage and logistics services through the Fort Storage business units ProVMWeb by Univar United Suppliers Independent retailers have about 35% of CP business in Western Canada 27

28 Corporate Chains The manufactures sell direct to following chains Cargill CPS (Crop Production Services) Federated Co-op (Federated Co-operatives Limited, FCL) Richardson Pioneer: Canada's largest privately owned agri-business United Farmers of Canada 28

29 Top 10 Distributors in Canada CPS (Crop Production Service) mainly in Alberta, Saskatchewan, and Manitoba. Richardson largest private company in Canada Federated coop --- federated co-operatives limited, active in BC, SK, AB, MB. La Coop fédérée Cargill Univar Paterson grain Interag (the distribute Bayer products only) Mccains Cavendish Agri Service East Canada (maritime) Synagri (BASF), Quebec 29

30 Thanks for your time 30

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