food program udtupdate fuw - 2010 - ir-4 projectir4.rutgers.edu/fooduse/fuworkshop/industry...
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Food Program U d tUpdate
FUW - 2010Jerry Baron
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O iOverview1 Food Crops Program1. Food Crops Program
• Minor use tolerances & registrations• Research Activities • Crop grouping• Crop grouping• International MRL’s/activities• Biotechnology Success
2. Infrastructure Changes2. Infrastructure Changes3. Challenges
• External• InternalInternal• Timelines
4. Thanks to our Supporters
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D li bl /F d CDeliverables w/Food CropsClearances Chemical Approvals
1014 9911110
999 956 50
60
1000
1200pp
567
793647
34 3541
32
40800
281
567 564 53825
31 32
20
30
400
600
212281
9 814 12 14 13
0
10
0
200
001998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009
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R h A ti itiResearch Activities
2010 New Studies/Field Trials: 107 Studies & 609 field trials including 51 in Canada2009 Studies/Field Trials: 109/ 5532009 Submissions to EPA: 126 petitions submitted involving 36 active ingredients.Projects in Regulatory Queue for future EPAProjects in Regulatory Queue for future EPA Submission
2010 – 119 (many already submitted)2011 - 1592012 – 110
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NAFTA C G St tNAFTA Crop Group Status
Approved: Bulb Vegetable group Small BerriesApproved: Bulb Vegetable group, Small Berries and Fruit, Edible Fungi – approvedCodified Soon: Oilseed, Citrus Fruits, Fruiting Vegetables, Pome FruitPreliminary Approved: Stone Fruit, Tree NutsSubmission Pending: Tropical Fruit groupSubmission Pending: Tropical Fruit groupUnder Review: Herb and Spice group
Codex – Significant progress, will review Fruit groups in 2012
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International Activities
• Data 29 reports submitted to JMPR/Reg• Data-29 reports submitted to JMPR/Reg. Authorities
• Leadership-OECD, Codex CCPR,p , ,• Capacity Building w/FAS in Africa (24 countries, 40
delegates reviewed crop grouping, working group for specialty crops, pilot programs)
• Global Residue Study• Global Minor Use Summit 2• Global Minor Use Summit 2
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GLOBAL RESIDUE STUDY
22 Countries- 27 Trials20 sample sets in US20 sample sets in US6 to be completed 1 lost
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R i t ti SRegistration Successes
HoneySweet Plum- Transgenic resistance to Plum Pox Virus
Ralph Scorza –USDA-ARS Kearnysville
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People and Infrastructure
NY & USDA MD L b Sh td
People and Infrastructure
• NY & USDA-MD Lab Shutdowns• New Lead Chemists in MI and FL• HQ
– Food &International Programs-D. Kunkel g– Registrations Manager-D. Carpenter, – Public Health Pesticides-K.Malamud-Roam,Public Health Pesticides K.Malamud Roam, – Ornamental Horticulture-K. Hester
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R l & Li i i Ch ll
Clean Water Act Discharge Permits
Regulatory & Litigation Challenges
• Clean Water Act Discharge Permits• Endangered Species Act assessments
E d i di ti i• Endocrine disruption screening• Additional safety factors for non-food & farm
hildchildren • Crop damage liabilityTo help, EPA provided classified chemicals
(red/yellow/green) This relates to PRIA Public Interest Findings
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Internal Challenges
Fi ld Sit f di-- Field Site funding-- Personnel-- Laboratory backlog-- Laboratory equipmentLaboratory equipment-- Required info from MFG
PROJECT TIMELINES (P t l P titi )-- PROJECT TIMELINES (Protocol Petition)
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IR 4 R h Ti li
C t l i 30 th
IR-4 Research Timelines
• Current goal is 30 months– Varying degree of success– Some packages complete in < 12 months– Many others > 3 years– Industry standard now12-18 months
• Improvement of IR-4 timelines is pcritically important– Limited opportunities for submissionpp
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Pinch Points
• Delays in finalizing the protocols
Pinch Points
• Delays in finalizing the protocols• Missing the time window for crops
N d t t fi ld t i l• Need to repeat field trials• Delay completing Field Data Book• Delay in starting method work up• Problems with method• Delay in completing Analytical Summary
Reportp
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Pinch Points (continued)
G l l b t b kl
Pinch Points (continued)
• General laboratory backlog• Too many different chemicals• QA rechecking previous audits• Addressing QA comments that are non-Addressing QA comments that are non
GLP• Continuing work on dead projects• Continuing work on dead projects
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Pinch Points (continued)
D l i i idi i d
Pinch Points (continued)
• Delay in companies providing required registration documentation
• Bundling issues; one lab has completed chemical, waiting on others to submit reports for same chemical
• Loss of staff and other personnel presource issues
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What is being doneWhat is being done
• PMC supporting comprehensive review of research process – Look at ways to reduce timelines
• Everything is on the table – HOWEVERIR-4 must continue to provide scientifically relevant data to meet EPA regulations and guidelines
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Process• FRD RFC LRD QA SD will each
Process• FRD, RFC, LRD, QA, SD will each
develop list of problems areas & potential improvementspotential improvements– Submit report by October 8
PMC ill i t t O t ti• PMC will review reports at Oct. meeting• Empower small task group to look at
reports and develop recommendations by March 2011.
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F d U W k h S tFood Use Workshop Supporters
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Wh P f IR 4?Who Pays for IR-4?
Direct ContributionsDirect ContributionsOver $18 million
USDA-NIFA $12,180,000USDA-ARS $ 4,000,000USDA-ARS/DoD $ 250,000USDA-FAS $ 500,000USDA FAS $ 500,000USDA-APHIS $ 172,000State Ag. Exp. Stations $ 481,182Grants from Ind str $ 1 100 000Grants from Industry $ 1,100,000
Indirect ContributionsIndirect ContributionsAt least $18 million