AGENDA

FIFRA SCIENTIFIC ADVISORY PANEL (SAP)

OPEN MEETING

February 25 – 27, 2009

FIFRA SAP WEB SITE http://www.epa.gov/scipoly/sap/

OPP Docket Telephone: (703) 305-5805

Docket Number: EPA-HQ-OPP-2008-0835

U.S. Environmental Protection Agency

Conference Center - Lobby Level

One Potomac Yard (South Bldg.)

2777 S. Crystal Drive, Arlington, VA 22202

Scientific Issues Associated with the Data Required to Register
Plant-Incorporated Protectants.

Please note that all times are approximate (see note at end of Agenda).

Wednesday, February 25, 2009

1:30 P.M.	Opening of Meeting and Administrative Procedures – Joseph
Bailey, Designated Federal Official, Office of Science Coordination and
Policy, EPA

1:40 P.M. 	Introduction and Identification of Panel Members – Steven
Heeringa, Ph.D., FIFRA Scientific Advisory Panel Chair 

1:50 P.M.	Welcome and Opening Remarks – Steven Bradbury, Deputy Office
Director for Programs, Office of Pesticide Programs, EPA

1:55 P.M.	Welcome and Introductions – Janet Andersen, Director,
Biopesticides and Pollution Prevention Division, Office of Pesticide
Programs, EPA 

2:00 P.M.	Introduction of Topics – Chris Wozniak, Ph.D., Biopesticides
and Pollution Prevention Division, Office of Pesticide Programs, EPA

2:05 P.M.	Overview of bioinformatics assessment of novel proteins and
gene/protein nomenclature issues - John Kough, Ph.D., Biopesticides and
Pollution Prevention Division, Office of Pesticide Programs, EPA

2:30 P.M.	Overview of issues associated with synergistic effects of
multiple PIPs in a plant - Annabel Waggoner, Biopesticides and Pollution
Prevention Division, Office of Pesticide Programs, EPA

2:45 P.M.	Overview of issues associated with soil microbial community
effects - Zig Vaituzis, Ph.D., Biopesticides and Pollution Prevention
Division, Office of Pesticide Programs, EPA

3:00 P.M.	Break

3:15 P.M.	Overview of issues associated with environmental assessment of
gene flow - Chris Wozniak, Ph.D., Biopesticides and Pollution Prevention
Division, Office of Pesticide Programs, EPA

3:45 P.M.	Public Comment

5:30 P.M.      ADJOURN

	 



AGENDA

FIFRA SCIENTIFIC ADVISORY PANEL (SAP)

OPEN MEETING

February 25 – 27, 2009

FIFRA SAP WEB SITE http://www.epa.gov/scipoly/sap/

OPP Docket Telephone: (703) 305-5805

Docket Number: EPA-HQ-OPP-2008-0835

U.S. Environmental Protection Agency

Conference Center - Lobby Level

One Potomac Yard (South Bldg.)

2777 S. Crystal Drive, Arlington, VA 22202

Scientific Issues Associated with the Data Required to Register
Plant-Incorporated Protectants.

Please note that all times are approximate (see note at end of Agenda).

Thursday, February 26, 2009

8:30 A.M.	Opening of Meeting and Administrative Procedures – Joseph
Bailey, Designated Federal Official, Office of Science Coordination and
Policy, EPA 

8:35 A.M. 	Introduction and Identification of Panel Members – Steven
Heeringa, Ph.D., FIFRA Scientific Advisory Panel Chair

8:45 A.M.      Charge to Panel

Charge Question A.1 – Please comment on this approach to
identification of proteins found in PIPs to describe the active
ingredient and its function as a pesticide. Please comment on the use of
the gene name or phenotype in PIPs developed using RNAi. Is there
another more systematized naming system that could be employed for
either proteins or RNAi ? Please provide a basis for your answer.

10:00 A.M.	BREAK  	 

10:15 A.M. 	Charge to Panel (continued) 

Charge Question B.1 – Given the negative results of specific serum
screening of novel proteins triggered by identification of six to eight
segment searches for allergenic epitopes to date, please comment on
whether the six to eight amino acid epitope search provides a
statistically significant and biologically meaningful approach for
addressing allergenicity risk in the absence of the 35 percent identity
trigger? Please provide recommendations on criteria for judging
databases for their validity and completeness to address allergen,
toxin, anti-nutrient and other hazardous protein similarities. Please
provide a basis for your answer.

11:15 A.M.	Charge to Panel (continued)  

Charge Question C.1 – EPA has developed a draft test guideline [See
OPPTS Guideline 890.3800- Synergistic Activity Test] for determining the
potential for synergism for combination PIP products, specifically for
registration applications that intend on citing existing toxicological
data from previously registered PIP event lines. Please comment on the
methodology to support the analysis for synergistic effects for
combination PIP products and any additional comments on this approach-
including identifying instances where the Agency would be justified to
require additional testing with a combination test substance containing
a mixture of two or more active ingredients for data development on
human health and non-target organism effects.

12:00 P.M.	LUNCH

1:15 P.M.	Charge to Panel (continued)

Charge Question C.2 – EPA has developed soil microbial community
toxicity tests for plants that are modified to inhibit microbial growth
(e.g., a gene is inserted into a plant that exhibits a microbiocidal
mode of action against a plant pathogen) [See OPPTS Guideline 890.3850
Soil Microbial Community Toxicity Test ]. Considering the natural
fluctuation of microbial populations in the soil ecosystem and the
inherent variability in extracting representative soil samples, please
comment on limiting testing to examining effects on activity of
beneficial soil microbes, specifically carbon and nitrogen cycling at
the soil microbial community level (soil is analyzed for NH3 and NO3
content to establish ammonification and nitrification values,
respectively, and for CO2 efflux, in the presence and absence of the
stressor). Please provide a basis for your answer.

2:15 P.M.	Charge to Panel (continued)

Charge Question D.1 – Gene flow has been distributing various
naturally occurring genes between sexually compatible species for
millions of years and some of these genes encode traits for plant
disease and insect resistance mechanisms. Various methods have been used
to study the impacts of natural gene flow. Assuming a case wherein
hybridization and introgression of a transgene expressing a pesticidal
substance occurs between crop and wild species:

 a.) The EPA asks the Panel to discuss whether it is possible to
evaluate, in part, impacts of a gene flow event by gathering data on
target (pest) species which are associated with the wild species
(transgene recipient).

b.) The EPA asks the Panel to discuss whether the gathered data will
allow estimating the degree to which resistance to these target species
may influence the population dynamics or invasiveness of the wild
relative. 

c.) The EPA asks the Panel to discuss whether empirical data regarding
the target species (e.g., fungi, insects, etc) and non-target species
(e.g., pollinators, detritivores) associated with the sexually
compatible wild relative have the potential to inform about risks to the
SCWR population and the associated community. d.) The EPA asks the Panel
to discuss whether an understanding of the potential effect(s) of
introgressed transgenes on basic plant habit, phenology and physiology
provide a basis for a assessing potential impacts following a gene flow
event.

d.) The EPA asks the Panel to discuss whether an understanding of the
potential effect(s) of introgressed transgenes on basic plant habit,
phenology and physiology provide a basis for a assessing potential
impacts following a gene flow event.

	

3:15 P.M.	Break

3:30 P.M.	Charge to Panel (continued)

5:00 P.M.	Adjourn

AGENDA 

FIFRA SCIENTIFIC ADVISORY PANEL (SAP)

OPEN MEETING

February 25 – 27, 2009

FIFRA SAP WEB SITE http://www.epa.gov/scipoly/sap/

OPP Docket Telephone: (703) 305-5805

Docket Number: EPA-HQ-OPP-2008-0835

U.S. Environmental Protection Agency

Conference Center - Lobby Level

One Potomac Yard (South Bldg.)

2777 S. Crystal Drive, Arlington, VA 22202

Scientific Issues Associated with the Data Required to Register
Plant-Incorporated Protectants.

Please note that all times are approximate (see note at end of Agenda).

Friday, February 27, 2009

8:30 A.M.	Opening of Meeting and Administrative Procedures – Joseph
Bailey, Designated Federal Official, Office of Science Coordination and
Policy, EPA 

8:35 A.M. 	Introduction and Identification of Panel Members – Steven
Heeringa, Ph.D., Scientific Advisory Panel Chair

8:45 A.M. 	Charge to Panel (continued as needed)

10:00 A.M.	Break

10:15 A.M.	Charge to Panel (continued as needed)

12:00 P.M.	Adjourn

Please be advised that agenda times are approximate; when the discussion
for one topic is completed, discussions for the next topic will begin.
For further information, please contact the Designated Federal Official
for this meeting, Joseph Bailey, via telephone: (202) 564-0130; fax:
(202) 564-8382; or email: bailey.joseph@epa.gov.	

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