AGENDA

FIFRA SCIENTIFIC ADVISORY PANEL (SAP)

OPEN CONSULTATION MEETING

November 3 - 6, 2009

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

OPP Docket Telephone: (703) 305-5805

Docket Number: EPA-HQ-OPP-2009-0683

U.S. Environmental Protection Agency

Conference Center - Lobby Level

One Potomac Yard (South Bldg.)

2777 S. Crystal Drive, Arlington, VA 22202

Evaluation of Hazard and Exposure Associated with Nanosilver and Other
Nanometal Pesticide Products

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

Tuesday, November 3, 2009

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

1:35   P.M. 	Introduction and Identification of Panel Members – Carey
Pope, Ph.D., Session Chair, FIFRA Scientific Advisory Panel

1:40   P.M.	Welcome and Opening Remarks – Steven Bradbury, Ph.D.,
Deputy Director, Office of Pesticide Programs, EPA

1:45   P.M.		Evaluation of Hazard and Exposure Associated with
Nanosilver and Other Nanometals –  Office of Pesticide Programs, EPA

	

Introduction - William Jordan, Senior Advisor to the Office Director,
Office of Pesticide Programs, EPA

Regulatory Framework – Mr. Dennis Edwards, Chief, Regulatory 

			Branch I, Antimicrobials Division

Product Chemistry – Najm Shamim, Ph.D., Antimicrobials Divison

Human Toxicity from Silver and Nanosilver – 

		Melba S. Morrow, D.V.M., Antimicrobials Division; 

		Jenny Tao, M.D., Antimicrobials Division; 

		Jessica P. Ryman-Rasmussen, Ph.D., Health Effects Division

Nanosilver Exposure Pathways – Tim Dole, C.I.H., Antimicrobials
Division 

Environmental Fate and Transport– Najm Shamim, Ph.D., Antimicrobials
Division

Ecotoxicity of Nanosilver – Ed Odenkirchen, Ph.D., Ecological Fate and
Effects Division

Summary – William Jordan, Senior Advisor to the Office Director,
Office of Pesticide Programs, EPA

3:30 P.M.	Break

3:45 P.M.	EPA presentation (continued)

5:30 P.M.	Adjourn

	 

AGENDA

FIFRA SCIENTIFIC ADVISORY PANEL (SAP)

OPEN CONSULTATION MEETING

November 3 - 6, 2009

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

OPP Docket Telephone: (703) 305-5805

Docket Number: EPA-HQ-OPP-2009-0683

U.S. Environmental Protection Agency

Conference Center - Lobby Level

One Potomac Yard (South Bldg.)

2777 S. Crystal Drive, Arlington, VA 22202

Evaluation of Hazard and Exposure Associated with Nanosilver and Other
Nanometal Pesticide Products

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

Wednesday, November 4, 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 – Carey
Pope, Ph.D., Session Chair, FIFRA Scientific Advisory Panel

8:45 A.M.	Public Comment 	

10:00 A.M.	Break

10:15 A.M.	Public Comment (continued)

11:00 A.M.	Panel Discussion of Charge 

Charge Question 1.  Potential Risks from Nanosilver Materials Issue: 
Whether pesticide products containing nanosilver as the active
ingredient pose potential hazards and exposures to humans and the
environment that are different from those associated with products
containing conventional silver.   

A.  Available scientific literature indicates that nanosilver products
may exert an antimicrobial effect by releasing silver ions, and that
these ions may pose potential hazards to humans and the environment. 
The Agency is unaware on any information that would suggest exposures to
silver ions released from nanosilver products differ from the hazards of
silver ions released by non-nanosilver (hereafter referred to as silver)
based products and, therefore, might present a different hazard profile.
 Is the Panel aware of any information inconsistent with this
determination?

B.  Available scientific literature also indicates that, in addition to
any hazards resulting from the release of silver ions, nanosilver
particles themselves may present hazards that differ from those of
silver particles. What, if anything, does the existing scientific
literature indicate about the potential for nanosilver materials with
specific particle sizes in the range of 1 to 20 nm, 21 to 50 nm, and 51
to 100 nm to pose different hazards than those of larger-sized particles
of the same material, particularly nanosilver vs. silver?  What does the
existing scientific literature indicate about the potential for
particular physicochemical properties of nanosilver materials (e.g.,
shape, surface characteristics, composition, etc.) to pose hazards that
are different from larger-sized particles of the same material?  Does
existing literature support “bridging” data?  In other words, can
hazard or exposure data developed on 1 to 20 nm silver particles or
silver composites be used to assess the risks for 51 to 100 nm silver
particles or silver composites? 

C.  What, if anything, does the existing scientific literature indicate
about the potential for nanosilver particles in the range of 100 nm –
1000 nm (or “agglomerated” nanosilver or nanometals/nanometal
oxides) to pose hazards that are different from larger-sized particles
of the same material?

D.  If nanosilver particles present different hazards than either silver
or agglomerated nanosilver, the potential risks to human health and the
environment will depend on the extent of exposure.  Several types of
nanosilver pesticide products are described in the attached Background
Paper, and other types seem possible in the near future (e.g.,
sanitizers and disinfectants; and chemicals used in or on industrial,
commercial or residential systems, such as slimicides, preservatives,
antifoulants, metal working fluids, etc.).  What do available data on
the release, fate, transport and transformation of nanosilver particles
suggest regarding potential human or ecological systems exposure to
nanosilver particles (individual or agglomerated) under realistic use
scenarios?

E.  The Agency would like the Panel’s advice as to whether the models
currently used by the Agency would be appropriate to predict potential
environmental exposures to nanosilver and if not, what, if any,
modifications would be necessary.

12:00 P.M.	Lunch

1:15 P.M.	Panel Discussion of Charge Question 1 (continued)

2:00 P.M.	Panel Discussion of Charge 

Charge Question 2.   Data Requirements Issue:  If the panel believes
that nanosilver is different in terms of hazard/exposure what type of
data (studies) would EPA need to adequately assess the potential risks
associated with the use of an antimicrobial pesticide containing
nanosilver particles, when the product is intended for use as an
additive to various substrates (e.g., textiles, plastics, ceramics) to
impart antimicrobial properties to the treated substrate?  In liquid,
spray form?                                                             
                                                                        
                                                                        
                     

A.  What types of data on the nanoscale material would be sufficient to
adequately evaluate whether the hazard and exposure properties of the
nanoscale material were comparable to that of a macroscale/bulk form of
the same material?  Could EPA rely on toxicity data for the bulk
material to assess the risk of the nanoscale material?  

B.  What types of data would be sufficient to:

1)  Evaluate whether the nanoscale material, once it has been applied to
or incorporated within a substrate, remains associated with the
substrate through the whole-life cycle of that substrate to such an
extent that there would be essentially no human or environmental
exposure to the nanoscale material or nanosized composite, and 

2) Measure and characterize exposures to nanomaterials that may leach
from treated materials?  

C.  Assuming appropriate studies could adequately show that nanosilver,
which is applied to a substrate, would bind with that substrate to such
an extent that there is essentially no exposure to the nanosilver, does
the Panel think that other types of data (such as toxicity studies on
the nanosilver particles or composite) would be needed?  Similarly, if
only silver ions are released from substrate containing nanosilver,
would consideration of the potential risks associated with the silver
ions be sufficient or would additional data be needed to assess hazards
and exposure to human health and the environment from nanosilver?

3:30 P.M.	Break 

3:45 P.M.	Panel Discussion of Charge 

Charge Question 3. Other Risk Assessment Issues.  

A.  Products developed using nanotechnology may contain a distribution
of particle sizes.  Please comment on how information concerning the
percentage of the particles in a product falling within the nanoscale
range (e.g., 1 - ~100 nm) could affect the risks of a product.  Are
particles at the lower end of the range (e.g., 1 nm) likely to behave
like particles at the upper end of the range (e.g., 100 nm)?

B.  Please comment on the extent to which the scientific literature
indicates that data on one form of a nanosilver particle or other
nanometal/nanometal oxide particle can be used to assess the potential
hazards and exposures of another form of nanosilver that has different
physicochemical properties (e.g., is a different size or shape or has
different surface properties).  For example, if nanosilver is reacted
with a non-metal material to form a nanosilver complex or composite, to
what extent could data developed for the nanosilver be used to predict
the toxicity of the complex or composite?

C.  Please comment on the extent to which the scientific literature
indicates that nanosilver physicochemical properties change under
different environmental or physiological conditions, what those
conditions are, and how this variation could be best addressed.

5:00 P.M.      ADJOURN

AGENDA

FIFRA SCIENTIFIC ADVISORY PANEL (SAP)

OPEN CONSULTATION MEETING

November 3 - 6, 2009

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

OPP Docket Telephone: (703) 305-5805

Docket Number: EPA-HQ-OPP-2009-0683

U.S. Environmental Protection Agency

Conference Center - Lobby Level

One Potomac Yard (South Bldg.)

2777 S. Crystal Drive, Arlington, VA 22202

Evaluation of Hazard and Exposure Associated with Nanosilver and Other
Nanometal Pesticide Products

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

Thursday, November 5, 2009

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

8:40 A.M. 	Introduction and Identification of Panel Members – Kenneth
Portier, Ph.D., Session Chair, FIFRA Scientific Advisory Panel

8:50 A.M.	Panel Discussion of Charge 

Charge Question 4.  Research Needs. 

 

A. In the next year, what types of new information on individual
products would be most useful to EPA for assessing potential risks of
antimicrobial pesticides containing nanosilver or nanosilver composites,
such as toxicity studies, exposure studies, etc.

B. What types of long term research would be most helpful for improving
the assessment of the potential risks of antimicrobial pesticide
products containing nanosilver or nanosilver composites? 

10:00 A.M.	Break

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

12:00 P.M.	Lunch

1:15 P.M.	Panel Discussion of Charge (continued as needed)

2:45 P.M.	Break 

3:00 P.M.	Panel Discussion of Charge (continued as needed)

5:00 P.M.      ADJOURN

AGENDA

FIFRA SCIENTIFIC ADVISORY PANEL (SAP)

OPEN CONSULTATION MEETING

November 3 - 6, 2009

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

OPP Docket Telephone: (703) 305-5805

Docket Number: EPA-HQ-OPP-2009-0683

U.S. Environmental Protection Agency

Conference Center - Lobby Level

One Potomac Yard (South Bldg.)

2777 S. Crystal Drive, Arlington, VA 22202

Evaluation of Hazard and Exposure Associated with Nanosilver and Other
Nanometal Pesticide Products

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

Friday, November 6, 2009

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

8:40 A.M. 	Introduction and Identification of Panel Members – Kenneth
Portier, Ph.D., Session Chair, FIFRA Scientific Advisory Panel

8:50 A.M.	Panel Discussion of Charge (continued as needed)

10:00 A.M.	Break

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

12:00 P.M.	Lunch

1:15 P.M.	Panel Discussion of Charge (continued as needed)

2:45 P.M.	Break 

3:00 P.M.	Panel Discussion of Charge (continued as needed)

5:00 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) 564-2045; fax:
(202) 564-8382; or email: bailey.joseph@epa.gov

 PAGE   

 PAGE   3 

