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RISK ASSESSMENT RESEARCH FOR THE PD PROJECT Thomas A. Miller 1 , David J. Lampe 2 , Ravi Durvasula 3 1 University of California, Riverside, CA 2 Duquesne University, Pittsburgh, PA 3 University of New Mexico, Albuquerque, NM. Regulatory Communication Workshop

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RISK ASSESSMENT RESEARCH FOR THE PD PROJECT

Thomas A. Miller1, David J. Lampe2, Ravi Durvasula3

1University of California, Riverside, CA

2Duquesne University, Pittsburgh, PA

3University of New Mexico, Albuquerque, NM

Regulatory Communication Workshop

7-9 November 2006

UC Washington DC Center

Thomas.miller@ucr.edu


My name is Tom Miller

1. Professor of Entomology.

Teach Insect Physiology and Insect Toxicology.

2. Entomologist in the Agricultural Experiment Station.

Do something about plant pests and disease.

Thomas.miller@ucr.edu


August 25, 2005 Los Angeles Times

Hurricanes in 2004 spread the citrus canker pathogen, Xanthomonasaxonopodis from containment in the 2 southeastern counties of the state where a $500 million program had pushed it.

“The only defense is containment through destruction.”

“We had to destroy the village to save it”

Attributed to many different people, including war correspondent Peter Arnett who supposedly attributed the quote to an unidentified Army officer. Used circa 1968, perhaps during the bloody Tet offensive.

Thomas.miller@ucr.edu


"California is particularly vulnerable to non-indigenous pests and diseases,"

Daniel Sumner, a UC Davis agricultural economist and director of the Agricultural Issues Center.

Thomas.miller@ucr.edu


A new pest comes into California every 60 days. pests and diseases,"

Pierce’s disease first noted in Anaheim in 1884 [“Orange County” disease].

Glassy-winged sharpshooter (GWSS) arrived ≈ 1980s?

Thomas.miller@ucr.edu


T pests and diseases," otal economic impact of more than $170 million a year, the Texas wine industry has more than 85 wineries and is the nation’s fifth-largest wine producing state."

Pierce’s Disease

The most serious threat to wine grapes in Texas, California and other growing areas is Pierce’s disease, which occurs in all areas of Texas that do not have severe winters. Pierce’s disease, which can wipe out a vineyard. Currently, there is no preventative or curative treatment for it.

Efforts to reduce the risk of Pierce’s disease include controlling the glassy-winged sharpshooter. Site selection and chemical control help prevent the pathogen’s spread. Although a large research effort is underway to discover methods for controlling Pierce’s disease, it will probably be a long time, perhaps 10 years or more by some estimates, before a practical, effective solution is available.

Florida grape varieties are resistant to many diseases, principally Pierce's disease (PD), a disease that devastates Vitis vinifera. Soon molecular genetic research will produce further improved varieties and possibly enable traditional wine grape production in our state.

Bryon Biddle Three Oaks Winery, Vernon, FL 20 October 2006

Thomas.miller@ucr.edu


Pierce’s disease control program annual report to the legislature 2005

Thomas.miller@ucr.edu


Grape acreage by County in California 2005 legislature 2005

“back in 1999-2000, people … were saying that the grape growing industry was dead in Temecula and there … will be a 100% loss of vines due to PD.”

-- Nick Toscano

Thomas.miller@ucr.edu


“ … Callaway [vineyards] lost about 100% … close proximity to 120 acres of grapefruit …

“800 out of a total of 2500 acres of vines were removed from Temecula in 2001. Since I initiated and directed the program, 300 new acres have been planted. The number of wineries have increased from 13 to 21 (60% increase).

-- Nick Toscano 12 October 2006

Nick Toscano

Specialist &Extension Entomologistemail: nick.toscano@ucr.edu(951)827-5826(951)827-3725

FISCAL YEAR 2003/04 2004/05 2005/06

REVENUE

State (Budget Act) 6,408,000 4,408,000 4,341,000

Federal (USDA) 9,885,525 14,903,606 15,300,000

Board Assessment 968,000 305,000 343,400

Total Resources 17,261,525 19,616,606 19,984,400

EXPENDITURES

Personal Services 3,053,409 3,456,754 3,658,520

Operating Expenses 2,206,328 3,040,503 2,852,186

County Payments 12,001,788 13,119,349 13,473,694

Total Expenditures 17,261,525 19,616,606 19,984,400

Thomas.miller@ucr.edu


Symbiotic control of PD proximity to 120 acres of grapefruit …

2. Design toxins against Xylella.

2004 (+)

1. Find a symbiont (blue) cycling with the pathogen (orange).

3. Disease cycle testing.

2001

Axd

2001

Dave Lampe Duquesne University, Pittsburgh PA

DsRed Alcaligenes (RAxd)

S1 RAxd

Endophyte Candidate:

Alcaligenes xylosoxidans

Tim Yolo and Arinder Arora, UC Riverside

Carol Lauzon CSUEB Hayward CA

2001-2005

2003: Field testing of RAxd?

Thomas.miller@ucr.edu


  • Where is risk assessment done? proximity to 120 acres of grapefruit …

  • In the laboratory at BL-1.

  • In the field.

  • Laboratory data poorly predict field results.

  • GWSS die in 3 weeks in the lab.

  • Grapevines do poorly in greenhouses.

  • It may be impossible to simulate citrus next to vineyards.


Field testing for Risk Assessment proximity to 120 acres of grapefruit …

We want to test behavior of RAxd in grapevines (2003).

Okay, but you have to burn the grapevines at the end of the season.- EPA

Then how will we know if the disease is cured or not?

We don’t make the laws.

(National Environmental Protection Act 1969;

FQPA 1996; PPA 1990;

TSCA 1976; FIFRA 1972).

The UCR Biosafety Committee approved of working with RAxdat BL-1 level. Why are we burning grapevines?

“… appropriate for working with microorganisms that are not known to cause disease in healthy human … municipal water-testing laboratories, in high schools, and in some community colleges teaching introductory microbiology classes …”

Thomas.miller@ucr.edu


"The Biosafety level is chosen to be commensurate with the potential risk.  Rather than ensure absolute containment of every experiment, which would be onerous for researchers, containment safeguards are allowed to be more relaxed when the risk is small.  It is recognized that BL1 may not ensure containment all of the time, but that is acceptable since (for example) damage caused by release is considered insignificant and the likelihood of the organism to survive outside the lab is also considered low."

-- Howard Judelson

Professor of Plant Pathology

UC Riverside

23 October 2006

BioSafety ruling incompatible with regulation?

Thomas.miller@ucr.edu


Needle inoculation of grapevines, Napa, CA summer 2003. potential risk.  Rather than ensure absolute containment of every experiment, which would be onerous for researchers, containment safeguards are allowed to be more relaxed when the risk is small.  It is recognized that

Bagged grapevines, Temecula, CA 2004

Thomas.miller@ucr.edu


Movement of alcaligenes in host plants
Movement of potential risk.  Rather than ensure absolute containment of every experiment, which would be onerous for researchers, containment safeguards are allowed to be more relaxed when the risk is small.  It is recognized that Alcaligenes in HostPlants

Plant typeDetected/tested: amount* found

Lemon 25/25: 3,591,427 cells/2cm

Orange 25/25: 943,305 cells/2cm

Crepe Myrtle 8/25: 884,770 cells/2cm

Periwinkle 10/25: 304,820 cells/2cm

Grapevine 24/25: 18,225 cells/2cm

* Cells in 2 cm of plant stem

Movement three inches away in two weeks; Lemon preferred

Thomas.miller@ucr.edu


The GloFish potential risk.  Rather than ensure absolute containment of every experiment, which would be onerous for researchers, containment safeguards are allowed to be more relaxed when the risk is small.  It is recognized that

Normal Zebra fish

Los Angeles Times, front page, 22 November 2003

Thomas.miller@ucr.edu


Regulatory wars potential risk.  Rather than ensure absolute containment of every experiment, which would be onerous for researchers, containment safeguards are allowed to be more relaxed when the risk is small.  It is recognized that

Can we sell DsRed zebra fish as pets?

-- 2003

Let’s see, okay go ahead, we can’t stop you, there is no law against that.

— USDA, FDA, EPA, CDC, NIH

Hey, that’s the same transgene as in RAxd. Why don’t you make them burn the fish tanks?

We don’t make the laws.

Thomas.miller@ucr.edu


November 2003 potential risk.  Rather than ensure absolute containment of every experiment, which would be onerous for researchers, containment safeguards are allowed to be more relaxed when the risk is small.  It is recognized that

Thomas.miller@ucr.edu


http://ucbiotech.org/ potential risk.  Rather than ensure absolute containment of every experiment, which would be onerous for researchers, containment safeguards are allowed to be more relaxed when the risk is small.  It is recognized that

Regulatory agencies don’t need to worry about the “values” question; others are already doing that.

Thomas.miller@ucr.edu


Study what researchers think is important. potential risk.  Rather than ensure absolute containment of every experiment, which would be onerous for researchers, containment safeguards are allowed to be more relaxed when the risk is small.  It is recognized that

  • Environmental Impact of Transgenic Alcaligenes Used to Control Pierce’s Disease.

  • Miller, UCR; Durvasula, Yale; Lampe, Duquesne

  • September 2004.

  • Identification of hazards.

  • Fitness alteration

  • Transfer to non-target organisms:

  • Transgene instability

  • Assessment of community ecology impacts.

  • 1.Creating transgenic Axd strains.

  • 1a. Attenuated strains.

  • 1b.Cysteine auxotrophic strains

  • 2. Measuring the rate of horizontal gene transfer

  • 3. Monitoring for HGT in natural environments by RT PCR.

  • Reducing the likelihood of HGT; genetic toxin-antidote.

  • Testing of ecological impact of transgenic Axd.

  • 5.1. Bacterial census of grapevine.

  • 5.2. Changes in bacterial census (grapevine).

  • 5.3. Bacterial census of grape rhizosphere.

  • 5.4. Changes in bacterial census (rhizosphere).

  • 6. Modeling transgenic Axd in the environment.

Amount requested: $200,000/yr

Amount funded: $100,000/yr

Term: 2 years.

Thomas.miller@ucr.edu


4 events in 2004 potential risk.  Rather than ensure absolute containment of every experiment, which would be onerous for researchers, containment safeguards are allowed to be more relaxed when the risk is small.  It is recognized that

Pew Foundation 22 Jan 2004

Business Week 3 May 2004

NAS Dec 2004

NAS Dec 2004

“… science knows too little about how the novel organisms will behave in the real world.”

“ … likelihood of success [of symbiotic control] is limited …”

Regulation of transgenic insects is unprepared.

Regulatory and public discourse centers around the “unnaturalness” of genetic transformation.

Thomas.miller@ucr.edu


Pages 109-110: potential risk.  Rather than ensure absolute containment of every experiment, which would be onerous for researchers, containment safeguards are allowed to be more relaxed when the risk is small.  It is recognized that

“Using paratransgenesis to manage PD clearly would be along-term strategy, and one in which the likelihood of success is limited. Although some progress toward transformation of GWSS endosymbionts has been made (Lampe and Miller, 2002), the committee views this as Category 4 research, in addition to its scientific uncertainty, there are ecological and regulatory barriers to success that are at least as significant as any technical barriers.”

NAS Dec 2004

COMMITTEE ON CALIFORNIA AGRICULTURAL RESEARCH

PRIORITIES: PIERCE’S DISEASE

___________________________________________________________

JAN E. LEACH, Chair, Kansas State University, Manhattan

PEDRO BARBOSA, University of Maryland, College Park

MICHAEL J. DAVIS, University of Florida, Homestead

DAVID G. HOEL, Medical University of South Carolina, Charleston

L. JOE MOFFITT, University of Massachusetts, Amherst

ALISON G. POWER, Cornell University, Ithaca

TERRY L. ROOT, Stanford University, Stanford

JACK SCHULTZ, The Pennsylvania State University, University Park

WILLIAM F. SPLINTER, University of Nebraska, Lincoln

BRIAN J. STASKAWICZ, University of California, Berkeley

MARIE-ANNE VAN SLUYS, University of São Paolo, Brazil

T. ULF WESTBLOM, Central Texas Veterans Health Care System,

Texas A&M University, Temple

Staff

KIM WADDELL, Study Director (through March 2004)

ROBIN SCHOEN, Senior Program Officer

MICHAEL KISIELEWSKI, ResearchAssociate

DONNA WILKINSON, Research Intern

PETER ROGERS, Research Intern

CINDY LOCHHEAD, ProjectAssistant

JULIE COFFIN, Project Assistant

This is exactly what “they” said about transgenic pink bollworm.

Thomas.miller@ucr.edu


Frances Oldham Kelsey potential risk.  Rather than ensure absolute containment of every experiment, which would be onerous for researchers, containment safeguards are allowed to be more relaxed when the risk is small.  It is recognized that , Ph.D., M.D., (b. 24 June1914) is a naturalizedAmericanpharmacologist, most famous as the reviewer for the U.S. Food and Drug Administration (FDA) who refused to authorize thalidomide for market because she had concerns about the drug's safety. Her concerns proved to be justified when it was proven that thalidomide caused birth defects. Kelsey's career intersected with the passage of laws strengthening the FDA's oversight of pharmaceuticals.

Frances Kathleen Oldham Kelsey receiving the President's Award for Distinguished Federal Civilian Service from President John F. Kennedy, in 1962

Thomas.miller@ucr.edu


1 potential risk.  Rather than ensure absolute containment of every experiment, which would be onerous for researchers, containment safeguards are allowed to be more relaxed when the risk is small.  It is recognized that 3. Regulatory Issues with Biotechnology (Thomas A. Miller)

1) Margaret McFall-Ngai, Univ. Wisconsin, Symbiosis as an emerging field [invited, no reply]

2) Angela Douglas Univ.York, UK, Symbiosis as an emerging field [accepted in another session]

3) David Brooks, Oxitec, UK Transgenic insects [invited]

4) FDA and tooth decay, Jeffrey Hillman, Oragenics, FL, USA [accepted, health allowing]

5) Shrimp aquaculture, Ravi Durvasula, Univ. of New Mexico [accepted]

6) Chagas disease, Ravi Durvasula, Univ. of New Mexico. [accepted]

7) India Regulatory process, lead by K. P. Gopinathan, Bangalore, India [invited]

8) China Regulatory process, lead by Yongping Huang [accepted]

9) Thailand and Laos Regulatory process, Yupa Hanboonsong [accepted]

10) USA Regulatory process, Janet L. Andersen, EPA-BPPD [invitation pending]

11) USA Regulatory process, Robyn Rose, APHIS-BRS [invitation pending]

12) British Regulatory process, Angela Douglas [accepted]

13) Canadian Regulatory process, Brian Belliveau, Health Canada [recruiting someone else]

14) Greek Regulatory process, Hanneke Drosopoulos [accepted]

15) Korean Regulatory process, Ministry of Environment [accepted – being organized]

16) French Regulatory process, [asked Rene Feyereisen to suggest someone]

17) Morocco Regulatory process, Malika Bounfour [invitation pending]

18) Slovenia Regulatory process, Prof. Dr. Maja Ravnikar [accepted]


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