Food Program U d tUpdate

FUW - 2010Jerry Baron

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

D li bl /F d CDeliverables w/Food CropsClearances Chemical Approvals

1014 9911110

999 956 50

60

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1200pp

567

793647

34 3541

32

40800

281

567 564 53825

31 32

20

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400

600

212281

9 814 12 14 13

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001998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009

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

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

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

GLOBAL RESIDUE STUDY

22 Countries- 27 Trials20 sample sets in US20 sample sets in US6 to be completed 1 lost

R i t ti SRegistration Successes

HoneySweet Plum- Transgenic resistance to Plum Pox Virus

Ralph Scorza –USDA-ARS Kearnysville

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

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

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)

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

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

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

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

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

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.

F d U W k h S tFood Use Workshop Supporters

Th kThank You!

Jerry BaronJerry Baronjbaron@aesop.rutgers.edu

732.932.9575 x4605

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