Nanotechnology and Nanomaterials in Consumer Products: Regulatory Challenges and Necessary Amendments George A. Kimbrell The International Center for Technology.

Nanotechnology and Nanomaterials in Nanotechnology and Nanomaterials in Consumer Products: Regulatory Consumer Products: Regulatory

Challenges and Necessary Challenges and Necessary AmendmentsAmendments

George A. KimbrellGeorge A. Kimbrell

The International Center for Technology The International Center for Technology AssessmentAssessment

FDA Public Meeting on NanotechnologyFDA Public Meeting on Nanotechnology

October 10, 2006October 10, 2006

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

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).

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

Perhaps 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 ProductsNanomaterials in Consumer Products

Thousands of tons of nanomaterials are already being Thousands of tons of nanomaterials are already being produced each year. produced each year.

>$32 billion in nano-products sold in 2005, 2X the >$32 billion in nano-products sold in 2005, 2X the total of 2004 (Lux Research 2006).total of 2004 (Lux Research 2006).

Wilson Center’s Wilson Center’s Project on Emerging Project on Emerging NanotechnologiesNanotechnologies (2006): 320 self-identified nano- (2006): 320 self-identified nano-products now on U.S. market shelves.products now on U.S. market shelves.

Products include paints, coatings, sporting goods, Products include paints, coatings, sporting goods, sunscreens, cosmetics, personal care products, stain-sunscreens, cosmetics, personal care products, stain-resistant clothing, food and food packaging, and light resistant clothing, food and food packaging, and light emitting diodes used in computers, cell phones, and emitting diodes used in computers, cell phones, and digital cameras.digital cameras.

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

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

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

ProductsProducts Wilson Center’s Wilson Center’s Consumer Consumer

Product DatebaseProduct Datebase::

– largest single category (125 largest single category (125 products) is health and fitness products) is health and fitness (including sunscreens, cosmetics, (including sunscreens, cosmetics, and other personal care products).and other personal care products).

Friends of the Earth Friends of the Earth Nanomaterials, Sunscreens and Nanomaterials, Sunscreens and CosmeticsCosmetics Report Report

– At least 116 cosmetics, sunscreens, At least 116 cosmetics, sunscreens, and personal care products and personal care products containing nanomaterials containing nanomaterials commercially available.commercially available.

Nanomaterials in Consumer Products: The Nanomaterials in Consumer Products: The Personal Care Industry Leading the WayPersonal Care Industry Leading the Way

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

Case Study: Nano-Silver Consumer ProductsCase Study: Nano-Silver Consumer Products

brooms, food storage, brooms, food storage, refrigerators, air filters, refrigerators, air filters, drywall, paint, medical drywall, paint, medical coatings, sports coatings, sports clothes, washing clothes, washing machinemachine

Ex’s- Samsung’s Ex’s- Samsung’s Silvercare WasherSilvercare Washer; ; Shaper Image’s Shaper Image’s Fresher Fresher Longer Miracle Food Longer Miracle Food storagestorage

What Does All This What Does All This

Commercialization Mean?Commercialization Mean?

FDA is charged with overseeing the FDA is charged with overseeing the safety and efficacy of many of safety and efficacy of many of these products, the first wave of these products, the first wave of nano-products. Thus, FDA’s First nano-products. Thus, FDA’s First Public Meeting is a necessary Public Meeting is a necessary development, but is development, but is dangerously dangerously overdueoverdue; ditto FDA’s recently ; ditto FDA’s recently created Nanotechnology Task Forcecreated Nanotechnology Task Force

The time for action is nowThe time for action is now

FDA should immediately prioritize FDA should immediately prioritize human health and environmental human health and environmental concernsconcerns– A framework that adequately accounts A framework that adequately accounts

for the fundamental differences of for the fundamental differences of nanomaterials and protects human nanomaterials and protects human health and the environmenthealth and the environment

– Much more robust EHS research (EHS Much more robust EHS research (EHS currently only 4% of NNI’s annual $1 currently only 4% of NNI’s annual $1 billion budget)billion budget)

At the Nano-scale, Size Matters: ‘Nano’ is At the Nano-scale, Size Matters: ‘Nano’ is best understood to mean best understood to mean fundamentally fundamentally

differentdifferent Materials engineered or Materials engineered or

manufactured to the nano-scale manufactured to the nano-scale exhibit different fundamental exhibit different fundamental physical, biological, and chemical physical, biological, and chemical propertiesproperties

– Quantum physics effectsQuantum physics effects– Exponentially increased surface areaExponentially increased surface area

These new properties (“nano-ness”) These new properties (“nano-ness”) create unique and unpredictable create unique and unpredictable human health and environmental human health and environmental risksrisks

– increased surface area creates increased surface area creates increased reactivity and enhanced increased reactivity and enhanced intrinsic toxicity intrinsic toxicity

– Size creates unprecedented mobility to Size creates unprecedented mobility to human body and environmenthuman body and environment

Human Health RisksHuman Health Risks

Enhanced toxicityEnhanced toxicity: some nanoparticles shown : some nanoparticles shown to cause DNA mutation, structural damage to to cause DNA mutation, structural damage to mitochondria and even cell death in laboratory mitochondria and even cell death in laboratory studies.studies.– Nanoparticles of titanium dioxide and zinc oxide Nanoparticles of titanium dioxide and zinc oxide

(cosmetics and sunscreens) photoactive in studies, (cosmetics and sunscreens) photoactive in studies, producing free radicals and causing DNA damageproducing free radicals and causing DNA damage

– Carbon fullerenes (Carbon fullerenes (CarbonCarbon6060): Adverse impacts on ): Adverse impacts on aquatic species and low levels have been found to aquatic species and low levels have been found to cause damage to human liver cellscause damage to human liver cells

Human Health RisksHuman Health Risks Unprecedented mobilityUnprecedented mobility::

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

– Once in the blood stream, nanomaterials can be Once in the blood stream, nanomaterials can be transported 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, organs and tissues including the brain, heart, liver, kidneys, spleen, bone marrow and nervous system.kidneys, spleen, bone marrow and nervous system.

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

A new class of manufactured non-A new class of manufactured non-biodegradable pollutantsbiodegradable pollutants

Pathways:Pathways: during manufacturing, transport, use, or disposal during manufacturing, transport, use, or disposal (e.g., nano-cosmetics or other nano-personal care products: (e.g., nano-cosmetics or other nano-personal care products: washed off in the shower and join water waste streams.)washed off in the shower and join water waste streams.)

Environmental Impacts:Environmental Impacts:– MobilityMobility--ability to persist; reach places larger particles cannot; ability to persist; reach places larger particles cannot;

move with great speed through aquifers and soils; settle slower.move with great speed through aquifers and soils; settle slower.

– TransportationTransportation--large and active surface for absorbing smaller large and active surface for absorbing smaller contaminants that could “hitch a ride” over long distancescontaminants that could “hitch a ride” over long distances

– ReactivityReactivity--interactions with substances present in the soil interactions with substances present in the soil could lead to toxic compoundscould lead to toxic compounds

– Durability and BioaccumulationDurability and Bioaccumulation-- nano-aluminum and nano-aluminum and stunted plant growth; nano-silver and microorganismsstunted plant growth; nano-silver and microorganisms

A new class of manufactured non-A new class of manufactured non-biodegradable pollutantsbiodegradable pollutants

Management Challenges: Detection and Management Challenges: Detection and Removal??Removal??– New protocols and cost-effective technologies New protocols and cost-effective technologies

for measuring, monitoring, and controlling for measuring, monitoring, and controlling nanomaterials are requirednanomaterials are required

FDA is charged with regulating the safety and FDA is charged with regulating the safety and effectiveness of most food, drugs, and cosmetics, as effectiveness of most food, drugs, and cosmetics, as well as other substances such as medical devices, well as other substances such as medical devices, animal feed, and combination products (21 U.S.C. animal feed, and combination products (21 U.S.C. Ch. 9 Ch. 9 et seq.et seq.))

– Many currently available nano-products fall under FDA’s Many currently available nano-products fall under FDA’s broad regulatory schemebroad regulatory scheme

– Cosmetics (21 U.S.C. § 361 Cosmetics (21 U.S.C. § 361 et seqet seq) )

– Sunscreens (21 U.S.C. § 321(g)) (classified as human drugsSunscreens (21 U.S.C. § 321(g)) (classified as human drugs) )

FDA is aware of “several FDA regulated products FDA is aware of “several FDA regulated products [that] employ nanotechnology,” including “cosmetic [that] employ nanotechnology,” including “cosmetic products claim[ing] to contain nanoparticles to products claim[ing] to contain nanoparticles to increase the stability or modify the release of increase the stability or modify the release of ingredients” and “nanotechnology-related claims ingredients” and “nanotechnology-related claims made for certain sunscreens.”made for certain sunscreens.”

FDA treats nanomaterial product FDA treats nanomaterial product ingredients no differently than bulk material ingredients no differently than bulk material ingredients or products. FDA’s current ingredients or products. FDA’s current stance is to regulate (or decline to regulate) stance is to regulate (or decline to regulate) based on safety assessment of the same based on safety assessment of the same material in bulk form (e.g., nano- material in bulk form (e.g., nano- sunscreens)sunscreens)

FDA “believes that the existing battery of FDA “believes that the existing battery of pharmacotoxicity tests is pharmacotoxicity tests is probably adequateprobably adequate for most nanotechnology products that we for most nanotechnology products that we regulate. Particle size is not the issue.”regulate. Particle size is not the issue.”

The Views of the Scientific Community: New Nano-The Views of the Scientific Community: New Nano-specific Toxicity Testing Paradigms are Requiredspecific Toxicity Testing Paradigms are Required

The European Commission’s Scientific Committee The European Commission’s Scientific Committee on Emerging and Newly Identified Health Risks on Emerging and Newly Identified Health Risks (SCENIHR): (SCENIHR):

– ““Experts are of the Experts are of the unanimousunanimous opinion that the adverse opinion that the adverse effects of nanoparticles cannot be predicted (or derived) effects of nanoparticles cannot be predicted (or derived) from the known toxicity of material of macroscopic size, from the known toxicity of material of macroscopic size, which obey the laws of classical physics.” which obey the laws of classical physics.”

The U.K. Royal Society and Royal Academy of The U.K. Royal Society and Royal Academy of Engineering:Engineering:– ““Substances made using nanotechnology should be Substances made using nanotechnology should be

considered considered new chemicalsnew chemicals and undergo extra safety and undergo extra safety checks before they hit the market to ensure they do not checks before they hit the market to ensure they do not pose a threat to human health.”pose a threat to human health.”

New paradigms of toxicology testing have been New paradigms of toxicology testing have been proposed (Nel proposed (Nel et al.et al., , ScienceScience (2006); Oberdorster (2006); Oberdorster et al.et al., , Particle and Fibre ToxicologyParticle and Fibre Toxicology (2005)). (2005)).

First-ever Legal Action On First-ever Legal Action On Risks Of NanotechnologyRisks Of Nanotechnology

May 2006: CTA and coalition of consumer, health, May 2006: CTA and coalition of consumer, health, and environmental groups file legal petition and environmental groups file legal petition challenging FDA’s failure to regulate human health challenging FDA’s failure to regulate human health and environmental threats from nanomaterials.and environmental threats from nanomaterials.

– The petition calls for:The petition calls for:

Comprehensive nanomaterial-specific regulationsComprehensive nanomaterial-specific regulations

New paradigms of nano-specific toxicity testingNew paradigms of nano-specific toxicity testing

Classification of nanomaterials as new substancesClassification of nanomaterials as new substances

Mandatory nanomaterial product and ingredient Mandatory nanomaterial product and ingredient labelinglabeling

Compliance with the National Environmental Policy Compliance with the National Environmental Policy Act (NEPA)Act (NEPA)

Petition Focus: Nano-sunscreensPetition Focus: Nano-sunscreens

Sunscreens are classified by FDA as human Sunscreens are classified by FDA as human drugs and should be subject to rigorous pre-drugs and should be subject to rigorous pre-market regulation.market regulation.

Red flags regarding free radical creation and Red flags regarding free radical creation and DNA damage; unanswered questions about DNA damage; unanswered questions about skin penetration.skin penetration.

Despite their unique dangers and patented Despite their unique dangers and patented differences, FDA currently considers nano-differences, FDA currently considers nano-sunscreens equivalent to bulk material sunscreens equivalent to bulk material sunscreens.sunscreens.

Petition calls for nano-sunscreen recall until Petition calls for nano-sunscreen recall until manufacturers submit and FDA reviews pre-manufacturers submit and FDA reviews pre-marketing testing data proving the drugs’ marketing testing data proving the drugs’ safety and efficacy.safety and efficacy.

ConclusionsConclusions Learn from the pastLearn from the past: FDA must act quickly if it : FDA must act quickly if it

hopes to avoid repeating the mistakes of past hopes to avoid repeating the mistakes of past federal agency regulatory failures of “wonder” federal agency regulatory failures of “wonder” materials or technologies (e.g., asbestos, CFCs, materials or technologies (e.g., asbestos, CFCs, DDT, PCBs)DDT, PCBs)

Adequate RegulationAdequate Regulation: A regulatory framework is : A regulatory framework is needed that protects workers, the general public needed that protects workers, the general public and the environment from the impacts of and the environment from the impacts of nanomaterials throughout their lifecyclenanomaterials throughout their lifecycle

Much more robust EHS StudyMuch more robust EHS Study: Adequate, publicly : Adequate, publicly available, independent, peer-reviewed safety available, independent, peer-reviewed safety studies studies on the environmental and health impacts on the environmental and health impacts of nanomaterialsof nanomaterials

For More InformationFor More Information

George A. KimbrellGeorge A. KimbrellInternational Center for Technology International Center for Technology

AssessmentAssessment(202) 202-547-9359(202) 202-547-9359

[email protected]@icta.org,, www.icta.orgwww.icta.org