Minor Use Update, Provincial Perspectives

Crop Life CSRC meeting

January 19, 2011

J. ChaputProvincial Minor Use Coordinator

** Presentation Outline **

• 2010 Review– URMULEs– Emergency uses (ON)– Active projects, IR-4 projects

• Stakeholder roles, process and successes• Joint reviews, NAFTA, 914, Global trends• Issues

– MRLs– Technology gap– Occupational exposure data requirements– Application of different safety factors– Invasive pests– Workload, Provincial resources

• Questions/Discussion

2010 Review• Approximately 54 URMULE registrations were

granted in 2010 to date on a range of individual crops and crop groups. Ontario was the sponsor or key proponent of 60% of these registrations.

• Notable registrations include:– Previcur on GH and outdoor ornamentals– Mertect on mushrooms– Upbeet on red (garden) beets– Command on field cucurbits– Rimon on beans, peppers, stone fruit, Brassicas,

strawberries– Nova on pears– Matador on carrots– Smartfresh on pears

• Apiculture added to URMULE-eligible commodities

2010 Review

EMERGENCY USES THAT ONTARIO WAS INVOLVED IN:

• In 2010, 18 emergency use requests were received, reviewed, processed and submitted to PMRA.

• All submissions have been approved. • In 11 of the 18 submissions, other provinces also

collaborated with OMAFRA. • All of the emergency uses supported by Ontario have a

full URMULE project or registrant submission underway to address the longer term issue.

• This saved Ontario over $ 500 M in potential crop losses.

2010 Review – Emergency uses

• Treeazin (ash trees) – emerald ash borer• Switch (GH cucumbers) – powdery mildew• Manzate (GH cucumbers) – downy mildew • Revus (GH cucumbers) – downy mildew • Intercept (Brassica GH transplants) – swede midge• Apivar (beehives) – Varroa mites• Confine (potatoes, grapes) – late blight, silver scurf, downy

mildew• Petro Canada Spray oil 13E (stone fruit) – reduction of damage

from PPV• Carzol (dry bulb onions) – thrips• Maestro (ginseng) – Phytophthora• Lorsban (outdoor ornamentals) – Japanese beetle• Scholar (carrots post-harvest) – white mold• Dibrom (GH peppers) – pepper weevil• Actara (GH peppers) – pepper weevil• Permanone (beehives) – small hive beetle• Previcur (GH cucumbers) – downy mildew

Active Minor Use Projects

• Approximately 500 active URMULE projects underway currently

• Approximately 23% of these are joint projects with the US IR-4 program

• Approximately 14% are minor uses for field crops

• Approximately 42% are minor uses for field vegetables

• Approximately 10% are minor uses for greenhouse vegetables

• Approximately 22% are minor uses for fruit crops

• Approximately 10% are minor uses for ornamentals and turf

Provincial Ministries of Agriculture (i.e. OMAFRA, MAPAQ, BCMA, Sask. Ag., etc.)

• Facilitate a grower-driven process to identify and prioritize minor use needs on all crops

• Submit provincial priorities to AAFC-PMC to be part of Canadian national minor use needs list

• Collaborate with one another to identify common needs• Submit minor use projects for regional issues and for

priorities not addressed at the national level• Respond to emergency use situations• Host annual PMRA summer tour to visit specialty crop

producers• Provincial minor use coordinator acts as liaison between

province and federal government, US IR-4, registrants, grower/processor organizations, Australian and UK minor use programs

U.S. IR-4 Program & AAFC-PMC Program

• Coordinates and hosts USA’s and Canada’s annual, national, minor use priority-setting workshops

• For the top selected projects, IR-4 and PMC conducts data-mining, residue trials, prepares reports and makes minor use submissions to EPA and PMRA

• Collaborates with minor use programs in other countries (i. e. Australia, Brazil) to conduct joint minor use projects for common crop / pest problems

Registrants (Crop Protection Product Companies)

• Help to identify solutions to minor use crop/pest priorities

• Contribute data from global sources in support of minor use submissions

• Introduce new crop protection products to Canada• Encouraged to introduce new products as joint

reviews to NAFTA, OECD and beyond• Encouraged to introduce new products with as

many specialty crops included on the first label• Continue to work with regulatory agencies on

harmonization of data requirements• Support for emergency use registrations

The Minor Use Process

• Minor use submissions to PMRA can come from only 3 sources:– AAFC-PMC “A” priorities– Provincial sponsor via the Provincial Minor Use

Coordinator– Registrant submissions

• Projects selected as ‘A’ priorities in year 200X are conducted in year 200X + 1

• Typically for minor uses that require efficacy and/or residue data, the timeframe is 3 years (same as IR-4)

• Some minor uses can be achieved in 1 year• Priorities chosen are a grower-driven process• Registrant support is critical to success

Collaboration!!• Minor use program would not succeed without

it!• All stakeholders must actively participate

– Growers and producers of food and ornamental crops

– Processors, seed companies– Provincial crop/discipline specialists, minor

use coordinators– Registrants– Researchers (gov’t and private)– PMRA, AAFC-PMC

Minor Use Program – Successes 2000 - 2010

• Over 475 minor use label expansions approved in the past decade on a wide range of minor and specialty food and non-food crops

• Ontario has been the sponsor and/or key proponent of 56% of these projects.

• New EPA/PMRA crop groups have added over 100 new specialty crops to the list of eligible minor use crops

• We have moved from less than 30% Canadian access to reduced risk active ingredients to 65% access

• Over 70% of the new actives introduced in North America are joint reviews with the U.S.

• We have moved from 5% of our projects being joint with the U.S. IR-4 program to over 20% being joint projects

• We have seen the 1st ever global joint reviews and registrations• The concept of global residue zones is now actually being

considered• New tank mix and value guidelines are being implemented

NEW crop groups adopted by EPA and PMRA

• Crop group 8-10: Fruiting vegetables– Expanded from 6 to 21 commodities– Subgroups 8-10A, 8-10B, 8-10C

• Crop group 11-10: Pome Fruit– Expanded from 7 to 12 commodities

• Crop group 20: Oilseeds– Subgroups 20A, 20B, 20C

NAFTA, Global Joint Reviews, Program 914

• In the past 5 years, approximately 15 joint reviews and 3 work-shares have been submitted, reviewed and registered

• These have addressed some key priorities of Canada’s minor and specialty crop producers

• 4 active ingredients registered under program ‘914’• 1 active ingredient currently under review in program

‘914’• 1 active ingredient candidate under review• 4 potential active ingredient candidates at pre-sub stage• New potential candidates as identified in the “Grower

Priority Database” being contacted by PMRA• Program ‘914’ needs to become the technology gap

program and needs to truly meet this mandate

Global Trends

• Canada remains a very small market for pest control products

• Canada is a micro market for many crops and products• However, we have one of the most organized and

active minor use programs in the world• Resistance management concerns have become a key

priority-setting criteria• Biopesticides are an increasingly important market;

expected $2.8 billion by 2015• The effect of pest control products on pollinators may

also impact priorities• Potential for utilization of global residue zones• OECD and 2012 Global Minor Use Summit II

MRL Issues• Impact upon trade and priority-setting• When the U.S. loses a product, they may revoke the

tolerance before Canada creating an immediate trade problem

• ‘Harmonized’ process is still not a harmonized decision• We continue to see non-harmonized decisions amongst

regulatory agencies• Different default MRLs between countries

– Japan, EU 0.01, Canada 0.1, etc.• Database inconsistencies

– Homologa, NAFTA Grower Priority Database, U.S. EPA, PMRA, APVMA, Codex, Japan MRLs, European Union, etc.

– Information does not match between sites – Search functionality is time-consuming

Examples of MRL Issues

• Countries like Japan and the EU use their lower default as a non-tariff trade barrier

• Products granted U.S. exemption from the requirement for residue or that are naturally found in the environment (i.e. K salts of phosphorous acid) fall under the Canadian default of 0.1 ppm but are permitted at over 50 ppm elsewhere

• Revocation of 0.1 default MRL garnered much U.S. producer, processor and regulatory interest and triggered the formation of a more robust NAFTA Grower Priority Database

• The evaluation of individual risks cannot realistically be harmonised. Risk assessment and management remain the sovereign right of individual countries. (Crop Life Int’l)

Examples of MRL Issues

Active Crop(s) CDN ppm

US ppm EU ppm JPN ppm

Other

acetamiprid

Blueberries

0.6 1.6 0.01 5.0

azoxystrobin

Sorghum 0.03 11.0 0.05 ---

Legumes subgroup 6A

0.02 3.0 3.0 3.0 3.0 Codex

boscalid Blueberries

3.5 13.0 10.0 3.5 10.0 Codex

bentazon

Dry beans

0.5 0.05 0.1 0.2 0.05 Codex

captan Grapes 5.0 50.0 0.02 5.0 10.0 AUS

chlorothalonil

Onions 5.0 0.5 0.5 0.5 0.5 Codex

desmedipham/ phenmedipham

Sugarbeets

0.05 0.1 0.1 0.05

glyphosate

Wheat 5.0 30.0 10.0 5.0 5.0 AUS

propiconazole

Soybeans

0.2 2.0 0.1 0.05 0.07 Codex

Sorghum 0.05 3.5 0.05 --- 0.05 AUS

spinetoram

Bushberries

0.5 0.25 0.05 ---

Technology Gap: Registered Reduced Risk Uses2001 comparison to 2010

2001 2010• 37 active ingredients• > 1500 crop or crop group uses

• 56 active ingredients• > 2800 crop or crop group uses

• 13 active ingredients• < 500 crop or crop group uses

• 38 active ingredients• < 1400 crop or crop group uses

Technology Gap: Registered Biopesticides

> 200 active ingredients

< 50 active ingredients

Other Issues Impacting the MU Program

• Occupational exposure data requirements are not harmonized and create serious difficulties for our greenhouse food and non-food crop industries

• The requirement for DFR studies and the non-acceptance of many European greenhouse data costs the Canadian MU program far more than necessary

• Application of different safety factors in determining risk creates a different outcome with the same submitted data

• Use site category – strongly encourage that all critical USCs be captured on the 1st product submission

• Invasive and quarantine pests (SWD, BMSB, JB, Kudzu, Goatgrass, etc.)

• Does Crop Life have any interaction with CFIA on these issues?• Cosmetic bans and their impact on agriculture – esp. turf and

ornamental sectors; pest outbreaks in urban areas• Re-evaluation of soil fumigants and impact of mitigation measures• Inconsistent level of support from registrants for minor use projects• Provincial fiscal resources and personnel workload management

How can you contribute to our continued success?

• Participate in the minor use priority setting process with suggested solutions and data

• Encourage your colleagues (growers, processors, crop consultants, researchers, seed companies, etc.) to participate

• Ensure you are represented at the national minor use meetings

• Respond to PMRA D.3.2 decision letters in a timely fashion

• Provide timely and accurate responses to emergency use situations, data requests and product use information requests

• Continue to emphasize the need for a more harmonized crop protection product regulatory system

THANK YOU

Discussion…Questions…