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Keller and Heckman LLP Serving Business through Law and Science ® ® Nanotechnology and Pesticide Apparel February 5, 2004 Hilton Crystal City John B. Dubeck, Esq. Keller and Heckman LLP (202) 434-4125 [email protected]

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Page 1: Nanotechnology and Pesticide Apparel · Nanotechnology and regulation lExample: Apparel that is made and then treated with a pesticide ØCan damage fibers, alter material vs. lApparel

Keller and Heckman LLPServing Business through Law and Science ®

®

Nanotechnology and Pesticide Apparel

February 5, 2004Hilton Crystal City

John B. Dubeck, Esq.Keller and Heckman LLP

(202) [email protected]

Page 2: Nanotechnology and Pesticide Apparel · Nanotechnology and regulation lExample: Apparel that is made and then treated with a pesticide ØCan damage fibers, alter material vs. lApparel

What is nanotechnology?

l Depends on who you askl National Nanotechnology Initiative

Definition:ØLength scale of 1-100 nanometersØNovel properties/functions related to

sizeØAbility to control/manipulate on atomic

scale

Page 3: Nanotechnology and Pesticide Apparel · Nanotechnology and regulation lExample: Apparel that is made and then treated with a pesticide ØCan damage fibers, alter material vs. lApparel

How big is a nanometer?

DNA~2-1/2 nm diameter

Things NaturalThings Natural Things ManmadeThings Manmade

Fly ash~ 10-20 µm

Atoms of siliconspacing ~tenths of nm

Head of a pin1-2 mm

Quantum corral of 48 iron atoms on copper surfacepositioned one at a time with an STM tip

Corral diameter 14 nm

Human hair~ 60-120 µm wide

Red blood cellswith white cell

~ 2 -5 µm

Ant~ 5 mm

Dust mite

200 µm

ATP synthase

~10 nm diameterNanotube electrode

Carbon nanotube~1.3 nm diameter

The Challenge

Fabricate and combine nanoscale building blocks to make useful devices, e.g., a photosynthetic reaction center with integral semiconductor storage.

Mic

row

orl

d

0.1 nm

1 nanometer (nm)

0.01 µm10 nm

0.1 µm100 nm

1 micrometer ( µm )

0.01 mm10 µm

0.1 mm100 µm

1 millimeter (mm)

1 cm10 mm

10 -2 m

10 -3 m

10 -4 m

10 -5 m

10 -6 m

10 -7 m

10 -8 m

10 -9 m

10 -10 m

Visi

ble

Nan

ow

orl

d

1,000 nanometers =

Infra

red

Ultra

viol

etM

icro

wav

eSo

ft x-

ray

1,000,000 nanometers =

Zone plate x -ray “lens”Outer ring spacing ~35 nm

Office of Basic Energy SciencesOffice of Science, U.S. DOE

Version 10- 07- 03, pmd

The Scale of Things The Scale of Things –– Nanometers and MoreNanometers and More

MicroElectroMechanical(MEMS) devices10 -100 µm wide

Red blood cellsPollen grain

Carbon buckyball

~1 nm diameter

Self -assembled,Nature -inspired structureMany 10s of nm

Page 4: Nanotechnology and Pesticide Apparel · Nanotechnology and regulation lExample: Apparel that is made and then treated with a pesticide ØCan damage fibers, alter material vs. lApparel

How big is a nanometer?

A hockey puck is 3 inches (or 76,200,000 nanometers) wide

It has an area of 4,560,000 square nanometers

Page 5: Nanotechnology and Pesticide Apparel · Nanotechnology and regulation lExample: Apparel that is made and then treated with a pesticide ØCan damage fibers, alter material vs. lApparel

What is nanotechnology used for?

l Water purification systemsl Catalystsl Drug delivery systemsl Clothing coating systemsl Nanocoatings on air conditioning

valves to reduce frictionl Many more applications in

development

Page 6: Nanotechnology and Pesticide Apparel · Nanotechnology and regulation lExample: Apparel that is made and then treated with a pesticide ØCan damage fibers, alter material vs. lApparel

What technology is on the horizon?

l Drug delivery systems

l Cooling chips

l Medical diagnostics

l Sensors for airborne pollutants

Page 7: Nanotechnology and Pesticide Apparel · Nanotechnology and regulation lExample: Apparel that is made and then treated with a pesticide ØCan damage fibers, alter material vs. lApparel

Concerns with small particle size

l Much promise, more uncertaintyl Toxicity? Reactivity?

l Studies with carbon nanotubes

Page 8: Nanotechnology and Pesticide Apparel · Nanotechnology and regulation lExample: Apparel that is made and then treated with a pesticide ØCan damage fibers, alter material vs. lApparel

Small particles: Steel

Page 9: Nanotechnology and Pesticide Apparel · Nanotechnology and regulation lExample: Apparel that is made and then treated with a pesticide ØCan damage fibers, alter material vs. lApparel

Small particles: TiO2

Page 10: Nanotechnology and Pesticide Apparel · Nanotechnology and regulation lExample: Apparel that is made and then treated with a pesticide ØCan damage fibers, alter material vs. lApparel

U.S. Government Initiative

Page 11: Nanotechnology and Pesticide Apparel · Nanotechnology and regulation lExample: Apparel that is made and then treated with a pesticide ØCan damage fibers, alter material vs. lApparel

Reaction to nanotech

“Given the concerns raised over nanoparticle contamination in living organisms, governments should declare an immediate moratorium on commercial production of new nanomaterials and launch a transparent global process for evaluating the socio-economic, health, and environmental implications of the technology.”

Page 12: Nanotechnology and Pesticide Apparel · Nanotechnology and regulation lExample: Apparel that is made and then treated with a pesticide ØCan damage fibers, alter material vs. lApparel

Reaction to nanotech

“Why not hold a citizens’ jury to determine scientific priorities on nanotechnology?”

Page 13: Nanotechnology and Pesticide Apparel · Nanotechnology and regulation lExample: Apparel that is made and then treated with a pesticide ØCan damage fibers, alter material vs. lApparel

Nanotechnology and pesticides

l Antimicrobial-treated clothing/fibers

l Microemulsions of pesticides

l Nanolayers of antimicrobials

Page 14: Nanotechnology and Pesticide Apparel · Nanotechnology and regulation lExample: Apparel that is made and then treated with a pesticide ØCan damage fibers, alter material vs. lApparel

Nanotechnology and regulatory schemes

l Emerging area—is EPA ready?

l Are current regulatory schemes adequate to address challenges posed by this technology?

Page 15: Nanotechnology and Pesticide Apparel · Nanotechnology and regulation lExample: Apparel that is made and then treated with a pesticide ØCan damage fibers, alter material vs. lApparel

Nanotechnology and regulation

l Example: Apparel that is made and then treated with a pesticideØCan damage fibers, alter material

vs.

l Apparel that is made from individual fibers that have a coating of pesticides

Page 16: Nanotechnology and Pesticide Apparel · Nanotechnology and regulation lExample: Apparel that is made and then treated with a pesticide ØCan damage fibers, alter material vs. lApparel

Regulatory issues, cont’d

l EPA’s regulatory system is set up on an agricultural model—very toxic pesticides over large area

l Nanotechnology is different

Page 17: Nanotechnology and Pesticide Apparel · Nanotechnology and regulation lExample: Apparel that is made and then treated with a pesticide ØCan damage fibers, alter material vs. lApparel

Other Nanotech Pesticide Examples

l Microemulsion with highly fabricated nanostructure

l Coated pesticide with unreactedingredients

Page 18: Nanotechnology and Pesticide Apparel · Nanotechnology and regulation lExample: Apparel that is made and then treated with a pesticide ØCan damage fibers, alter material vs. lApparel

More Regulatory Issues

l Issue: What kind of toxicity data would EPA require?

Exposure is considered.

Exposure is not considered. Why?

Page 19: Nanotechnology and Pesticide Apparel · Nanotechnology and regulation lExample: Apparel that is made and then treated with a pesticide ØCan damage fibers, alter material vs. lApparel

Regulatory issues, cont’d

l Is this the clash that will cause a restructuring of FIFRA?

l FQPA inserted special provisions in FIFRA for antimicrobials, allowing for different framework than other pesticides

Page 20: Nanotechnology and Pesticide Apparel · Nanotechnology and regulation lExample: Apparel that is made and then treated with a pesticide ØCan damage fibers, alter material vs. lApparel

Regulatory issues, cont’d

l How do you evaluate the toxicology of nanoparticles?

l Applications may be totally benign, and are difficult to accommodate in today’s regulatory structure

Page 21: Nanotechnology and Pesticide Apparel · Nanotechnology and regulation lExample: Apparel that is made and then treated with a pesticide ØCan damage fibers, alter material vs. lApparel

Regulatory challenges

l EPA must ensure public confidence in its decisions

l EPA must overcome public mistrust of government assurances of safety

Page 22: Nanotechnology and Pesticide Apparel · Nanotechnology and regulation lExample: Apparel that is made and then treated with a pesticide ØCan damage fibers, alter material vs. lApparel

Regulatory Questions

l Does EPA need a separate, specific pesticide nanotech rulemaking?

l Can EPA effectively deal with this technology under its current regulatory scheme?

l Occupational exposures?

Page 23: Nanotechnology and Pesticide Apparel · Nanotechnology and regulation lExample: Apparel that is made and then treated with a pesticide ØCan damage fibers, alter material vs. lApparel

Conclusion

l Emerging field

l Opportunities for industry and regulatory innovation and caution

l How will the government respond?

l How will the public respond?