Nanotechnology: A Nanotechnology: A Nanotechnology: A Nanotechnology: A Risky Future?Risky Future?yy

George A KimbrellGeorge A KimbrellGeorge A. KimbrellGeorge A. KimbrellThe International Center for Technology The International Center for Technology AssessmentAssessment

Harris Martin’s Cutting Edge Toxic Tort Harris Martin’s Cutting Edge Toxic Tort ConferenceConferenceD b 11 2006D b 11 2006December 11, 2006December 11, 2006Scottsdale, AZScottsdale, AZ

CTA is a Washington, D.C.CTA is a Washington, D.C.--based nonbased non--profit, biprofit, bi--partisan organization committed to providing the public partisan organization committed to providing the public with full assessments and analyses of technologicalwith full assessments and analyses of technologicalwith full assessments and analyses of technological with full assessments and analyses of technological impacts on society. CTA explores the environmental, impacts on society. CTA explores the environmental, human health, economic, ethical, social and political human health, economic, ethical, social and political impacts that can res lt from the applications ofimpacts that can res lt from the applications ofimpacts that can result from the applications of impacts that can result from the applications of technology or technological systems.technology or technological systems.

What Is Nanotechnology?What Is Nanotechnology?What Is Nanotechnology?What Is Nanotechnology?NanotechnologyNanotechnology involves the manipulation of materials involves the manipulation of materials and the creation of structures and systems that exist atand the creation of structures and systems that exist atand the creation of structures and systems that exist at and the creation of structures and systems that exist at the scale of atoms and molecules,the scale of atoms and molecules, nanometer (nm) nanometer (nm) scale.scale.

Engineered/manufactured nanoparticleEngineered/manufactured nanoparticle: A : A particle <100 particle <100 nmnm engineered or manufactured with a specific engineered or manufactured with a specific physicochemical composition and structure to exploit physicochemical composition and structure to exploit p ys coc e ca co pos o a d s uc u e o e p op ys coc e ca co pos o a d s uc u e o e p oproperties and functions associated with its dimensions properties and functions associated with its dimensions and and exhibits new or enhanced sizeexhibits new or enhanced size--dependent properties dependent properties compared with larger particles of the same materialcompared with larger particles of the same material..

A A nanometernanometer (nm) = one billionth of a meter. (nm) = one billionth of a meter. Hair Hair strand=80,000 nm; Red blood cell= 7,000 nm; DNA=2.5 strand=80,000 nm; Red blood cell= 7,000 nm; DNA=2.5 nm.nm.

Measures of Nanotechnology’s Measures of Nanotechnology’s MaturationMaturation

R&D surging: global nanotech R&D= $9 billion, with $1 R&D surging: global nanotech R&D= $9 billion, with $1 trillion estimated for 2015 (Lux Research 2006)trillion estimated for 2015 (Lux Research 2006)

Term “nano” approaches ubiquitous status in U.S. Term “nano” approaches ubiquitous status in U.S. society and media (>18,000 citations in U.S. media in society and media (>18,000 citations in U.S. media in 2005)2005)2005)2005)

The “gold rush” for nanoThe “gold rush” for nano--patents continuespatents continues-- over 4,000 over 4,000 U.S. patents issued to date (Lux Research 2006)U.S. patents issued to date (Lux Research 2006)

Perhaps most importantly nanotechnologyPerhaps most importantly nanotechnologyPerhaps most importantly, nanotechnology Perhaps most importantly, nanotechnology commercialization is moving forward at a rapid rate… commercialization is moving forward at a rapid rate…

Nanomaterials in Consumer Nanomaterials in Consumer Products: The Future is Now Products: The Future is Now

(Photo by David Hawxhurst-Woodrow Wilson International Center for Scholars.)

Nanomaterials in Consumer Nanomaterials in Consumer ProductsProducts

Lux Research’s Lux Research’s 2006 Nanotechnology Report2006 Nanotechnology Report: more : more than $32 billion in nanothan $32 billion in nano--products sold in 2005, 2X the products sold in 2005, 2X the total of 2004. total of 2004.

Wilson Center’s Wilson Center’s Project on Emerging Project on Emerging NanotechnologiesNanotechnologies 2006 Consumer Product Database: 2006 Consumer Product Database:

h 300 lfh 300 lf id ifi did ifi d ddmore than 300 selfmore than 300 self--identified nanoidentified nano--products now on products now on U.S. market shelves.U.S. market shelves.

P d t i l d i t ti ti dP d t i l d i t ti ti dProducts include paints, coatings, sporting goods, Products include paints, coatings, sporting goods, sunscreens, cosmetics, personal care products, stainsunscreens, cosmetics, personal care products, stain--resistant clothing, cleaning products, and light emitting resistant clothing, cleaning products, and light emitting di d d i t ll h d di it ldi d d i t ll h d di it ldiodes used in computers, cell phones, and digital diodes used in computers, cell phones, and digital cameras.cameras.

US Leads in Nanotechnology US Leads in Nanotechnology US Leads in Nanotechnology US Leads in Nanotechnology CompaniesCompanies

No Where Are Nanomaterials Reaching No Where Are Nanomaterials Reaching the Consumer Faster than in Personal the Consumer Faster than in Personal the Consumer Faster than in Personal the Consumer Faster than in Personal Care ProductsCare Products

Wil C ’ P d D bWil C ’ P d D bWilson Center’s Product Datebase Wilson Center’s Product Datebase largest single category (125 largest single category (125 products)products)

Friends of the Earth Report: 116 Friends of the Earth Report: 116 cosmetics, sunscreens, and cosmetics, sunscreens, and personal care products containing personal care products containing nanomaterials commerciallynanomaterials commerciallynanomaterials commercially nanomaterials commercially availableavailable

“free” nanoparticles, not fixed in “free” nanoparticles, not fixed in d t t i d d il dd t t i d d il d

Photo by David Hawxhurst Woodrowproduct matrix; used daily and product matrix; used daily and

directly on the skin; they may be directly on the skin; they may be inhaled and are often ingested. inhaled and are often ingested.

Hawxhurst-Woodrow Wilson International Center for Scholars.)

Report Findings: Companies Using Report Findings: Companies Using Nanomaterial IngredientsNanomaterial Ingredients

AlmayAlmayBarneyBarney’’s NYs NYCh lCh lChanelChanelCliniqueCliniqueEstee LauderEstee LauderEstee LauderEstee LauderJohnson & JohnsonJohnson & JohnsonLL’’OrealOrealLancôme Lancôme RevlonRevlonAnd many othersAnd many others

Size MattersSize Matters

Materials engineered or Materials engineered or manufactured to the nanomanufactured to the nano scale canscale canmanufactured to the nanomanufactured to the nano--scale can scale can exhibit different fundamental exhibit different fundamental physical, biological, and chemical physical, biological, and chemical p y gp y gpropertiesproperties

Quantum physics effectsQuantum physics effectsp yp yExponentially increased surface areaExponentially increased surface area

These new properties (“nanoThese new properties (“nano--ness”)ness”)These new properties ( nanoThese new properties ( nano ness ) ness ) can create unique and unpredictable can create unique and unpredictable human health and environmental human health and environmental i ki krisksrisks

Human Health RisksHuman Health Risks

Unprecedented mobilityUnprecedented mobility::

Entry through inhalation or ingestion; the jury still out on Entry through inhalation or ingestion; the jury still out on ease of skin penetration.ease of skin penetration.

Due to size, nanoparticles more easily taken up by the Due to size, nanoparticles more easily taken up by the human body and can cross biological membranes, cells, human body and can cross biological membranes, cells, tissues and organs more efficiently than larger particlestissues and organs more efficiently than larger particlestissues and organs more efficiently than larger particles.tissues and organs more efficiently than larger particles.

Once in the blood stream, nanomaterials can be Once in the blood stream, nanomaterials can be transported aro nd the bod and can be taken p btransported aro nd the bod and can be taken p btransported around the body and can be taken up by transported around the body and can be taken up by organs and tissues including the brain, heart, liver, kidneys, organs and tissues including the brain, heart, liver, kidneys, spleen, bone marrow and nervous system.spleen, bone marrow and nervous system.

Human Health RisksHuman Health RisksIncreased reactivity: Increased reactivity: Increased surface area creates increased Increased surface area creates increased reactivity and enhanced intrinsic toxicity. Some nanoparticles reactivity and enhanced intrinsic toxicity. Some nanoparticles shown to cause DNA mutation, structural damage to shown to cause DNA mutation, structural damage to mitochondria and cell death.mitochondria and cell death.

Conventional risk assessments and toxicity tests are Conventional risk assessments and toxicity tests are insufficientinsufficient

Nanotoxicology: new paradigms of toxicity testingNanotoxicology: new paradigms of toxicity testing ---- up to 16up to 16Nanotoxicology: new paradigms of toxicity testing Nanotoxicology: new paradigms of toxicity testing up to 16 up to 16 physiochemical parameters should be evaluated physiochemical parameters should be evaluated –– a far cry from the 2 a far cry from the 2 or 3 usually measured (Oberdorster or 3 usually measured (Oberdorster et al.,et al., Part Fiber ToxicolPart Fiber Toxicol, 2005), 2005)

Industry commenter: “Some scientists believe that under Industry commenter: “Some scientists believe that under current conditions determining the true safety of such products current conditions determining the true safety of such products is ais a lottery for consumerslottery for consumers ””is a is a lottery for consumerslottery for consumers..

Simon Pittman, CosmeticsDesign.com (10/27/06)Simon Pittman, CosmeticsDesign.com (10/27/06)

Environmental Impacts: A new class of Environmental Impacts: A new class of

manufactured nonmanufactured non--biodegradable pollutants.biodegradable pollutants.manufactured nonmanufactured non biodegradable pollutants.biodegradable pollutants.

Pathways to the environment:Pathways to the environment: during manufacturing, during manufacturing, transport use or disposaltransport use or disposaltransport, use, or disposaltransport, use, or disposal

RisksRisksRisksRisksMobilityMobilityTransportationTransportationR ti itR ti itReactivityReactivityDurabilityDurabilityBioaccumulationBioaccumulation

Management Challenges: Testing Detection andManagement Challenges: Testing Detection andManagement Challenges: Testing, Detection and Management Challenges: Testing, Detection and Removal??Removal??

Case study: carbon fullerenesCase study: carbon fullerenes

Fullerenes (CarbonFullerenes (Carbon6060) known as ) known as buckyballs used in some face and antibuckyballs used in some face and anti--buckyballs, used in some face and antibuckyballs, used in some face and antiaging creamsaging creams

E i t l i tE i t l i tEnvironmental impactsEnvironmental impactsAdverse impacts on aquatic Adverse impacts on aquatic species: cause brain damage in fishspecies: cause brain damage in fishspecies: cause brain damage in fish, species: cause brain damage in fish, kill water fleas, and have kill water fleas, and have bactericidal properties.bactericidal properties.

Human Health impactsHuman Health impactslow levels have been found to be low levels have been found to be toxic to human liver cells.toxic to human liver cells.

Case study: nanoCase study: nano--sunscreenssunscreens

Engineered nanoparticles make them Engineered nanoparticles make them “ i ll l ”“ i ll l ”transparent or “cosmetically clear,” transparent or “cosmetically clear,”

rather than white.rather than white.

legally patented for their novelty.legally patented for their novelty.legally patented for their novelty.legally patented for their novelty.

WidelyWidely--available and used, “free” available and used, “free” particles; placed directly on skin.particles; placed directly on skin.

Nanoparticles of titanium dioxide and Nanoparticles of titanium dioxide and zinc oxide shown to be photoactive in zinc oxide shown to be photoactive in some studies, producing free radicals some studies, producing free radicals ggand causing DNA damage to human and causing DNA damage to human skin cells when exposed to UV light.skin cells when exposed to UV light.

As with nanoAs with nano--cosmetics jury is still outcosmetics jury is still outAs with nanoAs with nano cosmetics, jury is still out cosmetics, jury is still out on ease of skin penetrationon ease of skin penetration

Case study: nanoCase study: nano--silver productssilver products

A universe of products A universe of products containing (or purporting to containing (or purporting to contain) silver nanoparticles: contain) silver nanoparticles: food storage washingfood storage washingfood storage, washing food storage, washing machine, refrigerator lining, machine, refrigerator lining, shoe lining, air filters and shoe lining, air filters and fresheners, drywall, paint, fresheners, drywall, paint, y py pmedical coatings, and wide medical coatings, and wide range of other productsrange of other products

Inserted for their nano antiInserted for their nano anti--Inserted for their nano antiInserted for their nano anti--microbial properties; but the microbial properties; but the same enhanced properties same enhanced properties are harmful to are harmful to microorganisms and microorganisms and ecosystems (NACWA letters)ecosystems (NACWA letters)

NanoNano--silversilverNanoNano silver silver products=pesticides? (see products=pesticides? (see infrainfra))

Case study: nanotubesCase study: nanotubes-- the new the new asbestos?asbestos?

Familiar needleFamiliar needle--like shape of nanotubes, nanowires, and like shape of nanotubes, nanowires, and nanofibers. nanofibers. 2003 NASA Study: effects of nanotubes on the lungs of rats 2003 NASA Study: effects of nanotubes on the lungs of rats produced more toxic response than quartz dust. produced more toxic response than quartz dust.

"The message is clear. People should take precautions. Nanotubes "The message is clear. People should take precautions. Nanotubes can be highly toxic.” can be highly toxic.” g yg y

-- Dr. Robert Hunter (NASA researcher)Dr. Robert Hunter (NASA researcher)

“Fiber“Fiber--shaped nanomaterials possibly represent a unique inhalation shaped nanomaterials possibly represent a unique inhalation hazard, and their pulmonary toxicity should be evaluated as a matter hazard, and their pulmonary toxicity should be evaluated as a matter , p y y, p y yof urgency.” of urgency.”

--Maynard Maynard et al.,et al., Nature,Nature, 2006)2006)

Regulatory Action (or Inaction)Regulatory Action (or Inaction)FDA: CTA PetitionFDA: CTA Petition-- FirstFirst--ever Legalever LegalFDA: CTA PetitionFDA: CTA Petition-- FirstFirst--ever Legal ever Legal Action On Risks Of NanotechnologyAction On Risks Of Nanotechnology

On nanomaterial consumer productsOn nanomaterial consumer productsComprehensive nanomaterialComprehensive nanomaterial--specific regsspecific regsNew paradigms of nanoNew paradigms of nano specific toxicity testingspecific toxicity testingNew paradigms of nanoNew paradigms of nano--specific toxicity testingspecific toxicity testingClassification of nanomaterials as newClassification of nanomaterials as newsubstancessubstancesL b liL b liLabelingLabelingNEPA complianceNEPA complianceRecall nanoRecall nano--sunscreens until reviewed as new drug sunscreens until reviewed as new drug ggproductsproducts

FDA held firstFDA held first--ever public meeting (Oct 2006) but not ever public meeting (Oct 2006) but not e d se d s e e pub c ee g (Oc 006) bu oe e pub c ee g (Oc 006) bu oyet responded otherwiseyet responded otherwise

Regulatory Action (or Inaction) ContinuedRegulatory Action (or Inaction) ContinuedRegulatory Action (or Inaction) ContinuedRegulatory Action (or Inaction) Continued

EPAEPAEPAEPA

FIFRA/NanoFIFRA/Nano--SilverSilver (Nov 2006) (Nov 2006) “first federal restriction to focus largely on nanotechnology”; “test “first federal restriction to focus largely on nanotechnology”; “test case”case” ((Wash PostWash Post 11/23/06) (proposed rule forthcoming)11/23/06) (proposed rule forthcoming)

TSCATSCA::Voluntary NanoVoluntary Nano--chemicals Pilot Program (expected 2007)chemicals Pilot Program (expected 2007)

NIOSHNIOSH

In the Federal vacuumIn the Federal vacuum-- local regulationlocal regulation –– Berkeley, CA Berkeley, CA proposed city ordinance/disclosure reqsproposed city ordinance/disclosure reqsp p y qp p y q

Putting Nano in Toxic Tort Terms Putting Nano in Toxic Tort Terms

Some possible issues:Potential plaintiffs and defendants?Potential plaintiffs and defendants? Exposure to harmful substances or products?Causation/uncertainty questions?Latency between exposure to the substance and manifestation of adverse impacts?St i t li bilit d i d f t f il t ?Strict liability: design defect or failure to warn?

Some possible indications from potential p pdefendants:

A lack of transparency/CBI on safety evidence?Internal/public statement inconsistencies?Responsive to agency and public?

ConclusionsConclusionsMuch More EHS Research (and EHS Funding)Much More EHS Research (and EHS Funding)::Much More EHS Research (and EHS Funding)Much More EHS Research (and EHS Funding): :

Existing studies raise red flags, underscoring the urgent Existing studies raise red flags, underscoring the urgent d f f h dd f f h d Ad bli l il blAd bli l il blneed for further study.need for further study. Adequate, publicly available, Adequate, publicly available,

independent, peerindependent, peer--reviewed safety studies reviewed safety studies on the on the environmental and health impacts of nanomaterials. environmental and health impacts of nanomaterials. pp

seminal seminal NatureNature article: 14 experts urged nanoarticle: 14 experts urged nano--safety "grand safety "grand challenges" that must be tackled in the near future, includingchallenges" that must be tackled in the near future, includingchallenges that must be tackled in the near future, includingchallenges that must be tackled in the near future, including

develop air and water detection/tracking, develop air and water detection/tracking, develop methods to evaluate nanodevelop methods to evaluate nano--toxicity, and toxicity, and d l t f l ti d d l f di ti h lth dd l t f l ti d d l f di ti h lth ddevelop systems for evaluating and models for predicting health and develop systems for evaluating and models for predicting health and environmental impacts over product lifecycle. environmental impacts over product lifecycle.

(Maynard (Maynard et al., Nature, et al., Nature, 11/16/06)11/16/06)

FY06 NNI Budget: FY06 NNI Budget: only 4%only 4% of $1 Billion goes to of $1 Billion goes to Environmental Health and Safety (EHS) researchEnvironmental Health and Safety (EHS) research

ConclusionsConclusionsLearning from the pastLearning from the past: regulators must act : regulators must act quickly if they hope to avoid repeating the quickly if they hope to avoid repeating the

i t k f t l t f il (i t k f t l t f il (mistakes of past regulatory failures (e.g., mistakes of past regulatory failures (e.g., asbestos, DDT, PCBs)asbestos, DDT, PCBs)

Only the first or “passive” phaseOnly the first or “passive” phase: increased : increased nanonano--engineering capabilities are expected to engineering capabilities are expected to lead to more sophisticated and heterogeneouslead to more sophisticated and heterogeneouslead to more sophisticated and heterogeneous lead to more sophisticated and heterogeneous materials and devices (active nanostructures)materials and devices (active nanostructures)

(M. Roco, 2004)(M. Roco, 2004)

Adequate OversightAdequate Oversight: A regulatory framework is : A regulatory framework is needed that protects workers, the general needed that protects workers, the general p , gp , gpublic and the environment from the impacts of public and the environment from the impacts of nanomaterialsnanomaterials

For More For More I f tiI f tiInformationInformation

George A. Kimbrell George A. Kimbrell International Center for Technology AssessmentInternational Center for Technology Assessment

gkimbrell@icta.orggkimbrell@icta.org,, www.icta.orgwww.icta.org3 Nanotechnology L. & Bus. 329 (Fall 2006) 3 Nanotechnology L. & Bus. 329 (Fall 2006)