Green Nanotechnology Challenges and Opportunities

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Green Nanotechnology Challenges And Opportunities

June 2

A white paper addressing the critical challenges to advancing greener nanotechnology issby the ACS Green Chemistry Institute® in partnership with the Oregon Nanoscience a

Microtechnologies Instit

www.acs.org/greenchem


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IntroductIon

Nanotechnology is an emerging eld. It is an interdisciplinary science whose potential hasbeen widely touted or well over a decade. Despite signicant private and public investment,

progress moving nanomaterials rom the laboratory to industrial production has been slow and

dicult. Two challenges that have slowed development have been the poor understanding

o the new hazards introduced by nanotechnology and lack o appropriate policies to manage

any new risks. Scientists, engineers and entrepreneurs, however, continue to move orward,

grappling with challenges that range rom the technical to the regulatory and everywhere

in between. Just as the concepts o nanoscale invention have required new insights rom

scientists, they are also demanding new approaches to managing, producing, unding and

deploying novel technologies into the larger chemical sector. In this case, there is an unusual

opportunity to use science, engineering and policy knowledge to design novel products that are

benign as possible to human and environment health. Recognition o this opportunity has led to

the development o the “green nanoscience” concept 1,2.

EXEcutIVE SuMMArY

Kira JM Matus, James E Hutchison, Robert Peoples, Skip Rung, Robert L Tanguay



Green nanotechnology has drawn on the eld o green chemistry, and the ramework o the 12

Principles o Green Chemistry [3] eatures signicantly in work to design new nanotechnologies

or joint economic, social, and health/environmental benet [4]. These eorts have been aided by

awareness throughout the nanotech community that they need to address the potential negative

impacts o nano rom the outset.1 That has not meant, however, that green nanotechnology

has gained widespread and popular acceptance in the scientic and business communities.Awareness is still limited in many sectors, and green nanoscience, along with nanoscience more

broadly, still aces signicant challenges in transitioning rom concept to reality.

thE SuMMIt

As part o its mission to advance the implementation o green chemistry throughout the

chemical enterprise, the American Chemical Society Green Chemistry Institute® (ACS GCI) has

begun a process to engage in yearly “summits” on major issues in the elds o green chemistry

and green engineering. In 2010, the rst pilot summit was held in conjunction with the Saer

Nanomaterials and Nanomanuacturing’s (SNNI) Fith Annual Conerence in Portland, Oregon.2

ACS GCI engaged a small group o experts,3 and its own project team4 to participate in the

conerence sessions, in order to develop answers to key questions on our aspects o greener

nanoscience:

1. What are the most important technical challenges?

2. What are the challenges to understanding nanotoxicology and the associated

inormatics challenges?3. What new policies are necessary to advance greener approaches to nanotechnology?

and

4. What the most pressing industrial deployment challenges?

The team was also tasked with identiying important opportunities or green nanotechnology,

and to ormulate an action plan or ACS GCI’s uture involvement in advancing the eld o

green nanoscience.

1 Examples include: Rice University’s “International Council on Nanotechnology,” http://icon.rice.edu/; The NNI EHS

strategy process http://strategy.nano.gov/blog/generic/page/drat-nni-ehs-strategy and the NIEHS NanoHealth

Enterprise

2 GN10: Reducing principles to practice, 16-18 June 2010, Portland, OR. This conerence was sponsored by Air Force

Research Laboratory under agreement number FA8650-05-1-5041. The views and conclusions contained herein are

those o the authors and should not be interpreted as necessarily representing the oicial policies or endorsements,

either expressed or implied, o Air Force Research Laboratory or the U.S. Government.

3 Dr. Jim Hutchison (U. Oregon), Mr. Skip Rung (ONAMI), Dr. Robert Tanguay (OSU)

4 Dr. Robert Peoples (Director, ACS-GCI) and Dr. Kira Matus (LSE)



The summit itsel drew approximately 120 participants rom academia, industry, NGO’s and

government agencies around the United States. There were three main sessions, each o which

began with two keynote speakers. The keynotes were ollowed by our to ve short “rapid re”

talks. Each session ended with a prolonged group panel discussion session. In this manner, the

summit presented a wide range o material to participants, and also encouraged debate and

discussion o some key issues in the eld. The sessions aligned with the broad areas that theproject team and experts had decided were most important or GCI to investigate. The three

sessions were:

1. Meeting Characterization Challenges to Support Greener Nanomaterials and

Nanomanuacturing,

2. Nanotechnology Innovation and Governance: Moving rom “Natural Enemies” to

“Partners or Nature”, and

3. Advancing Greener Nanomanuacturing: Additive processes and Greener

Nanomaterial Production.

At the conclusion o the conerence, SNNI’s expert group and GCI’s project team came

together to identiy the key issues and challenges acing green nanotechnology, along

with strategies and opportunities or uture GCI involvement in order to help move greener

nanotechnologies orward, as part o its broader commitment to supporting the development

and implementation o green chemistry throughout the chemical enterprise.

The Central Challenge: The challenge o simultaneously developing useul products or themarket, advancing the underlying science, and instituting a green nanoscience development and

deployment paradigm.

One o the most undamental challenges particular to green nanotechnology is that the

science, the testing, the regulatory strategy, and even the processes needed or commercial

production are all being developed and deployed at the same time. From this central challenge

fow many early stage challenges that were discussed during the course o the workshop. Six

key barriers were identied (see Box 1).



Box 1- Barriers to the Development and Commercialization o Green Nanotechnology

1. There are no clear design guidelines or researchers in initial discovery phases o green

nanoscience;

2. Many green nanomaterials require new commercial production techniques, which

increases the need or basic research, engineering research, and coordination o the twobetween the industrial and research communities;

3. The lack o a “deep bench” o scientists and engineers with experience developing green

nanotechnology;

4. Toxicology and analysis protocols need to be developed and constantly updated to

refect advances in the science;

5. Regulatory uncertainty persists, and green nanotechnologies oten ace higher regulatory

barriers than existing or conventional chemicals;

6. The end-market demand is unclear, especially since there are only a limited number o

commercial grade products that can be compared to conventional materials in terms o

perormance.

thE ActIon AgEndA

Green nanotechnology has been making great orward progress, but the challenges presented

above point to an agenda o actions where involvement by the scientic research community,

industry and government could bring about changes that would be crucial to supporting a

more rapid and eective commercialization o green nanotechnology. Such changes have the

potential to reestablish competitive leadership in the eld, with positive economic implicationsor the manuacturing and associated job creation.

Specically, we are proposing that action be taken according the agenda in Box 2 below. In

this case, the order o the agenda is important. The rst, and most pressing need is or more

and better analysis and characterization tools. These are a key input which are required to

support the rest o the agenda. They are needed or scientists who wish to understand the

mechanisms o the reactions that produce nanomaterials in order to develop better synthesis

methods. And they will allow or improved and more complete toxicological studies o green

nanomaterials, which are required or better and smarter regulation. Similarly, the second

item o the agenda, improved mechanistic understanding, is a key part o the oundation or

developing green nanomaterial design guidelines. Finally, new regulations, as well as outreach

to regulators must be based on the analysis, understanding, and design concepts that are the

result o the rst three items.



Box 2- The Action Agenda

1. Discover, uncover and provide key analysis and characterization tools

ACTORS ACTIONS

Federal unding

agencies (NIST, NSF,

NIH), university

researchers, nationaland government

laboratories, industrial

nanomaterials

practitioners and

companies that

develop and sell

analysis tools

o Discover and develop new analytical methods that

enable more comprehensive and reliable nanomaterial

characterization

o Increase eciency and reproducibility o analytical methods.Accelerate throughput by streamlining sample preparation,

data collection and analysis. Reduce costs or analysis.

o Develop approaches or real-time monitoring o

nanomaterials to support mechanistic investigations and

process analytical needs.

o Extend the use o existing methods and develop

new methods and tools to detect, monitor and track

nanomaterials in complex media (eg environmental and

biological systems)

2. Develop, characterize and test precision-engineered nanoparticles or biological and

toxicological studies needed to guide greener design

NIST and universities,

but access to materials

and knowledge in rms

also required

o Develop reerence libraries o precision engineered

nanomaterials that represent materials or basic mechanistic

investigations and that are projected or commercial use

Academic institutions in

partnerships with small

start-ups that could

provide the materials as

a service to users.

o Provide the above reerence materials to groups that need

them or testing. Support the use o those materials with

analytical data or each batch and supporting documentation

describing best practices or storing and handling the

materials

Universities o D evelop protocols and use these to test the biological and

toxicological impacts o materials. Develop hypotheses thathelp guide redesign o materials that are greener.

3. Investigate and understand reaction mechanisms to support more ecient and precise

synthesis and production techniques.

Universities o Develop new synthetic methods and conduct research

on reaction mechanisms or nanoparticle ormation. Use

mechanistic knowledge to produce precision-engineered

materials and enhance reaction eciency

o Study barriers to reliable and scalable production and

develop novel approaches to maintain product integrity as

the reaction scale is increased.

Universities in

partnership with

companies

o Develop design guidelines or commercially producible green

nanomaterials.

o Aggregate and make available data generated rom

mechanistic studies, analytical studies and testing, and other

sources or use by research community.

o Share critical and undamental knowledge on barriers and

engineering hurdles discovered during the scale-up and

commercialization process.



4. Develop design guidelines or green nanomaterials

Universities o Produce design guidelines or early stage researchers and

materials developers to support greener nanomaterial

development and production.

5. Denition o green criteria or new nanomaterials or ast-track approval by the US EPA.

US EPA o Implement a ast-track approval route or new nanomaterialinnovations that can:

· demonstrate benets over existing materials on the market

· provide basic testing data to demonstrate a reasonable

expectation that the material in question poses

no additional hazard due to its classication as a

nanomaterial1.

6. Education and outreach to regulators to ensure regulatory structures or green

nanotechnology refect accurate knowledge o their intended uses and potential impacts.

Regulatory Agencies:

Economic, Scienticand Environmental

(Department o

Commerce, EPA, FDA,

DOE, NIH, etc…)

o Agencies need to work together and coordinate so that

each can ulll their mission regarding the development o nanotechnology as an industry.

o Agencies need to reach out to experts in science and

business to better understand what is needed, and what

policies would be eective.

Universities,

Companies, Regulators

o Bring regulators most recent inormation to help determine

rules or the circumstances where nanomaterials may require

specialized regulatory approaches instead o being treated

like any other new chemical substances.

o Provide education on green nano concepts to uture

generations o scientists, business people and policy makers.

The amount o data required should be tiered according to the level o production o the material.

Nanotechnology presents an opportunity to develop a revitalized, sustainable U.S.

chemical and materials manuacturing base. We are at a unique point where we have more

understanding o how to go about this than at any time in the past. This new emerging

science and associated technologies do not have to ollow the typical path o many past

innovations in the chemical industry that, despite providing signicant benets, also turned

out to have unanticipated costs to human and environment health. The development and

commercialization o viable green nanotechnologies is dicult, and the barriers mentioned

will require eort rom the scientic, research and government communities. But as the

presentations at GN10 indicated, there is a pathway orward, and concrete actions that could

construct a solid oundation or a protable and environmentally sustainable uture or

nanotechnology.



IntroductIon

Nanotechnology is an emerging eld. It is an interdisciplinary science whose potential hasbeen widely touted or well over a decade. Despite signicant private and public investment,

progress moving nanomaterials rom the laboratory to industrial production has been slow and

dicult. Two challenges that have slowed development have been the poor understanding

o the new hazards introduced by nanotechnology and lack o appropriate policies to manage

any new risks. Scientists, engineers and entrepreneurs, however, continue to move orward,

grappling with challenges that range rom the technical to the regulatory and everywhere

in between. Just as the concepts o nanoscale invention have required new insights rom

scientists, they are also demanding new approaches to managing, producing, unding and

deploying novel technologies into the larger chemical sector.

Nanotechnology, as an emerging technology, presents an important opportunity or the

scientic and business community. Nanotech is unlike some other sectors o the chemical

industry, where signicant capital is already invested in the orm o large plants and established

supply chains in which production techniques are technologically and culturally embedded.

In act, the need to develop both new nanoproducts, and their equally novel production

techniques presents an important opportunity or innovators. In this case, there is an unusual

opportunity to use science, engineering and policy knowledge to design novel products thatare benign as possible to human and environment health.

SuMMIt rEport

Kira JM Matus, James E Hutchison, Robert Peoples, Skip Rung, Robert L Tanguay



Recognition o this opportunity has led to the development o the “green nanoscience”

Concept [1,2]. Green nanotechnology has drawn on the eld o green chemistry, and the

ramework o the 12 Principles o Green Chemistry [3] eatures signicantly in work to design

new nanotechnologies or joint economic, social, and health/environmental benet [4]. These

eorts have been aided by awareness throughout the nanotech community that they need to

address the potential negative impacts o nano rom the outset.

5

That has not meant, however,that green nanotechnology has gained widespread and popular acceptance in the scientic

and business communities. Awareness is still limited in many sectors, and green nanoscience,

along with nanoscience more broadly, still aces signicant challenges in transitioning rom

concept to reality.

What then, are the main challenges that those practicing greener nanoscience must overcome?

How do these dier, i at all, rom those being addressed in the wider nano community? Or the

chemical industry more generally? And what actions can be taken to drive greener nanoscience

orward? Considering nanoscience is an area o rapid development, bold innovation, and

signicant investment, ensuring that nanotechnologies are designed and deployed to

minimize potential harms is o interest to stakeholders throughout academia, industry,

government and civil society.

5 Examples include: Rice University’s “International Council on Nanotechnology,” icon.rice.edu/; The NNI EHS strategy

process strategy.nano.gov/blog/generic/page/drat-nni-ehs-strategy and the NIEHS NanoHealth Enterprise



thE SuMMIt

As part o its mission to advance the implementation o green chemistry throughout the

chemical enterprise, the American Chemical Society Green Chemistry Institute® (ACS GCI) has

begun a process to engage in yearly “summits” on major issues in the elds o green chemistry

and green engineering. In 2010, the rst pilot summit was held in conjunction with the Saer

Nanomaterials and Nanomanuacturing’s (SNNI) Fith Annual Conerence in Portland, Oregon.6

ACS GCI engaged a small group o experts,7 and its own project team8 to participate in the

conerence sessions, in order to develop answers to key questions on our aspects o greener

nanoscience:


2. What are the challenges to understanding nanotoxicology and the associated

inormatics challenges?

3. What new policies are necessary to advance greener approaches to nanotechnology?

And

4. What the most pressing industrial deployment challenges?

The team was also tasked with identiying important opportunities or green nanotechnology,

and to ormulate an action plan or ACS GCI’s uture involvement in the eld o green nanoscience.

The summit itsel drew approximately 120 participants rom academia, industry, NGO’s and

government agencies around the United States. There were three main sessions, each o which

began with two keynote speakers. The keynotes were ollowed by our to ve short “rapid re”talks. Each session ended with a prolonged group panel discussion session. In this manner, the

summit presented a wide range o material to participants, and also encouraged debate and

discussion o some key issues in the eld. The sessions aligned with the broad areas that the

project team and experts had decided were most important or GCI to investigate. The three

sessions were:

1. Meeting Characterization Challenges to Support Greener Nanomaterials and

Nanomanuacturing,

2. Nanotechnology Innovation and Governance: Moving rom “Natural Enemies” to

“Partners or Nature”, and

3. Advancing Greener Nanomanuacturing: Additive processes and Greener

Nanomaterial Production.

6 GN10: Reducing principles to practice, 16-18 June 2010, Portland, OR

7 Dr. Jim Hutchison (U. Oregon), Mr. Skip Rung (ONAMI), Dr. Robert Tanguay (OSU)

8 Dr. Robert Peoples (Director, ACS-GCI) and Dr. Kira Matus (LSE)



At the conclusion o the conerence, the SNNI expert group and GCI’s project team came

together to identiy the key issues and challenges acing green nanotechnology, along

with strategies and opportunities or uture GCI involvement in order to help move greener

nanotechnologies orward, as part o its broader commitment to supporting the development

and implementation o green chemistry throughout the chemical enterprise. This report will

discuss the challenges or greener nanotechnology that were identied in our key areas:technical, toxicology/analytics, regulations and policy, and industrial implementation. The

report will also outline avenues or GCI involvement in shepherding green nanoscience into the

mainstream paradigms o the scientic and industrial communities.

Box 3- Key Questions about Green Nanotechnology


2. What are the challenges to understanding nanotoxicology and the associated inormatics

challenges?

3. What new policies are necessary to advance greener approaches to nanotechnology?

4. What are the most pressing industrial deployment challenges?

currEnt StAtE

Presentations at the summit underscored two important points. The rst is that there are still many

actors that contribute to the diculties in commercializing greener nanotechnology. But the

presentations were also demonstrations o how ar green nanoscience has progressed over the pastdecade. There are solid oundations in place, and an important step in moving orward is recognizing

the current state o the science, both in terms o nanomaterials and toxicology and analysis.

Nanomaterial design, production and analysis

During the rst decade o nanoscience and nanotechnology development, the science was

dominated by the discovery o new materials and properties that uelled continued interest

in the eld. Reported research described new properties and novel devices, but or the time

being, skipped over some o the key issues related to implementation or commercialization

o the technology. New materials were discovered largely by Edisonian (trial and error)

approaches, reproducibility o new procedures was oten a problem, and characterization

was typically unctional rather then structural. Materials were oten prepared by any

means necessary and in quantities just large enough or the studies at hand. What was

missing were the structural characterization and reproducible methods needed to reliably

relate nanomaterial structure to unction. In addition, in the discovery phase, hazards and

ineciencies can be ignored and, or the most part, they were.



Within the last ve years, greater emphasis has been placed on structural characterization,

synthetic methods development (including mechanistic studies), reliable purication methods

and the development o greener production methods. It has been recognized that an

appropriate level o characterization, whether or toxicology studies or physical investigation,

requires multiple, complementary characterization techniques [3]. A variety o new synthetic

approaches and mechanistic studies have been reported. Novel purication approaches havebeen developed that, in combination with new characterization approaches provide greater

condence in the structures and purities o materials that are being studied[4]. Finally, a

variety o greener production methods have been developed, including micro-scale and/or

continuous fow reaction systems that provide potentially aster and easier paths or scaling

and commercialization o nanomaterial production.

Although signicant progress has been made, the results rom the last decade have also

revealed newchallenges. New characterization strategies are needed that are rapid enough to

keep pace with (or accelerate) materials development eorts. Analytical methods that identiy

and provide structural inormation about nanomaterials embedded within complex matrices

(environmental compartments or biological systems) are needed to derive mechanistic insights

about nanomaterial/biological system interactions. New synthetic techniques and production

methods are needed that allow reproducible production o precision-engineered materials at

any scale. Finally, versatile purication methods are needed that make it possible to produce

materials o dened purity quickly, economically, and rom a range o reaction media.

Toxicology and analysisAs the excitement o nanotechnology began to grow, the initial approach to address the

potential toxicity o engineered nanomaterials was to assume that these novel materials

will behave like their bulk counterparts. A strong dismissive tone regarding potential hazard

reigned supreme. It was apparent that material scientists were guiding saety assessment in the

early stages o this eld. Inevitably, biologist and toxicologist became involved and took a new

leadership role in the saety evaluations o nanomaterials. Unortunately, out o the gate there

were missteps. Although the toxicology discipline utilizes rigorous well developed methods,

the unique properties o nanomaterials were not immediately recognized by this eld.

Early there was insucient appreciation or the essential need or material characterization

and purity. There were great challenges in dening dosemetrics or nanomaterials. Many

o the initial toxicological studies utilized commercially available materials with little or no

characterization. Toxicological responses varied by vendor and by batch, and it became clear

that at least some o the reported toxicity was actually due to contaminants rather than the

nanomaterials themselves [7]. As the unding base or nanotoxicology increased, it became

clear that new methodological characterization methods were needed. It also became



evident that in order to move this eld orward material scientists and toxicologist needed

to work together to utilize solid science based approaches to guide saer nanotechnology

development.

The eld now agrees that basic nanomaterial characterization must be in place in order to

produce interpretable biological response data. Given the many variables in characterization o nanomaterials, including purity and stability as well as their behaviours in biological systems,

we currently do not ully understand the nanomaterial characteristics that are important

in driving biological activity. Predictive toxicity models that incorporate nanomaterial

properties are the current ocus. The challenge that we continue to ace is the path to

ollow or nanomaterial hazard identication. The National Academy o Sciences report or

T oxicity Testing in the 21st Century is highly relevant to greener nanoscience [8]. The Academy

recommends that we take bold moves to develop testing strategies that move us toward

predictive toxicity models, and away rom standard rodent models. It is apparent that it is

not advisable to evaluate the toxicity o each new nanomaterial in expensive rodent testing

protocols. This “one at a time” approach has ailed or small molecules, and will unquestionably

ail or nanoscience. The nearly unlimited variations in the elemental composition, core size,

surace unctionalization, purity, and synthesis methods indicate that the independent testing

o every variation is not easible. The material needs or this strategy alone is cost prohibitive.

Examples of Success

One example success is the utilization o the embryonic zebrash model as a sensitive,

dynamic biological testing platorm. It is well-established that the undamental developmentalprocesses are highly conserved across species as are the underlying molecular signalling

pathways [9], thereore, the results obtained using zebrash are highly relevant to humans

. The sensitivity o the developmental-stage assay results rom the observation that the ull

repertoire o gene expression is operational. To be clear, in order or a nanomaterial to produce

an adverse response, it absolutely must infuence the activity or expression o critical biological

targets. Developmental lie stages thus oer unprecedented access and opportunities to probe

the ull complement o potential nanomaterial targets. Since perturbation o molecular targets

is the only conceivable way in which a nanomaterial can produce toxicological responses; this

is an ideal platorm to explore the nano/bio interace. There are technical advantages that

make zebrash particularly well-suited or high-throughput screening. Embryos are small, they

develop externally, are optical transparent, and they develop is small volumes which greatly

reduces the material needs or assessments. To date, this assay has evaluated the biological

activity o a ew hundred precisely engineered nanomaterials, and most did not produce

adverse responses.



Box 4- The Twelve Principles o Green Chemistry [3]

1. Prevention

It is better to prevent waste than to

treat or clean up waste ater it has

been created.

2. Atom Economy

Synthetic methods should

be designed to maximize theincorporation o all materials used in

the process into the nal product.

3. Less Hazardous Chemical Syntheses

Wherever practicable, synthetic

methods should be designed to use

and generate substances that possess

little or no toxicity to human health

and the environment.

4. Designing Saer Chemicals

Chemical products should be

designed to eect their desired

unction while minimizing their

toxicity.

5. Saer Solvents and Auxiliaries

The use o auxiliary substances

(e.g., solvents, separation agents,

etc.) should be made unnecessary

wherever possible and innocuous

when used.

6. Design or Energy Eciency

Energy requirements o chemical

processes should be recognized or

their environmental and economicimpacts and should be minimized. I

possible, synthetic methods should be

conducted at ambient temperature

and pressure

7. Use o Renewable Feedstocks

A raw material or eedstock should

be renewable rather than depleting

whenever technically and economically

practicable.

8. Reduce Derivatives

Unnecessary derivatization (useo blocking groups, protection/

deprotection, temporary modication

o physical/chemical processes) should

be minimized or avoided i possible,

because such steps require additional

reagents and can generate waste.

9. Catalysis

Catalytic reagents (as selective as

possible) are superior to stoichiometric

reagents.

10. Design or Degradation

Chemical products should be designed

so that at the end o their unction they

break down into innocuous degradation

products and do not persist in the

environment.

11. Real-time analysis or Pollution

Prevention

Analytical methodologies need to be

urther developed to allow or real-

time, in-process monitoring and control

prior to the ormation o hazardous

substances.

12. Inherently Saer Chemistry or

Accident Prevention

Substances and the orm o a substance

used in a chemical process should be

chosen to minimize the potential or

chemical accidents, including releases,

explosions, and res.

To move the eld orward it is now possible to systematically investigate the relative infuence

o core size, surace chemistry, charge, and sample purity on nanomaterial toxicity using

precisely engineered gold nanoparticles (AuNPs). Libraries o precisely engineered materials

are produced where individual parameters are altered. When zebrash embryos are exposed

to each unique AuNPs, the biological eects were dependent on these parameters. Specically

the surace unctionality played the largest role in the driving dierential biological responses.



The oundation is in place to move greener nanotechnology orward as numerous

multidisciplinary teams have been built. There is increased evidence that material scientists are

working side-by-side with toxicologists, environmental scientists, and educational experts to

help identiy nanomaterial hazards. There is now a signicant amount o data on nanomaterial-

biological interactions; however, there is no consensus on the most appropriate test methods

or assessing nanomaterial hazard. It is recommended that specic nanomaterial eaturesbe identied that infuence biological interactions and activity. This will ultimately lead to a

ramework o structure-activity relationships. It is becoming clear that a much more systematic

approach is necessary where the individual nanomaterial eatures can be isolated to provide

inormed rules or saer nanoparticle design and synthesis. This approach requires precision

engineering and robust, sensitive, rapid-throughput biological testing platorms.

LESSonS LEArnEd About thE bArrIErS to grEEn chEMIStrY

While steady progress has been made in the development o green nanomaterials and the

accompanying toxicology and analysis, large-scale commercialization has yet to occur. In some

respects, this is not surprising. Almost all new technologies ace signicant barriers in moving

rom the laboratory and into the market. This issue has been documented by scholars and

business people alike or decades [10]. Furthermore, green chemistry, the principles o which

are a core part o green nanotechnology, has also been documented to have its own, distinct

challenges in terms o commercialization [11,12]. However, there are some unique aspects

to green nanotechnology, as it is an emerging science that must deal with the compounded

challenges present in a new area o science, while at the same time breaking new ground onincorporating environmental and health considerations into research and development at the

earliest stages.

Generally speaking, innovations ace barriers that arise in six dierent areas: organizational,

economic and nancial, cultural, regulatory, market, and limitations rom previous decisions

about investment, development and use o existing technologies (also reerred to as “path

dependence” [10,13-23]. Research on green chemistry in particular has ound that these

barriers do appear, but that in dierent countries and subsectors, their role and importance

vary [11]. For example, in China, path dependence is currently not an element o the major

barriers to innovation or green chemistry technologies, largely due to the signicant amount

o capital investment that is currently taking place, which has so ar prevented legacy capital

and technology rom becoming overly limiting. On the other hand, Chinese green chemistry

technologies ace special burdens that stem rom the particulars o the primacy placed on

economic growth over environmental protection, even when the government issues explicitly

pro-green technology policies [11].



Box 5- Barriers to Green Chemistry Innovation9

United States China

Economic and Financial Economic and Financial

Regulatory Competing Government Agendas

Technical Training

Organizational Bureaucratic Disincentives

Cultural Funding Structure or Scientic R&D

Denition and Metrics Engineering Capacity

In the United States, or green chemistry, path-dependency and technology lock-in (when

technologies already in use limit the ability to make changes or implement innovations) has

been more o a problem, since the chemical industry has a great deal o legacy inrastructure

that would be highly costly to replace or radically alter. Within the United States context,

many o the challenges refect the strength o the US in discovery, and the declining

ocus on domestic manuacture. As a result, cultural barriers that make it dicult to train

interdisciplinary science, organizations that are unsure o, or unable to assign the value o

green chemistry to their businesses, and the lack o a consensus on how to operationalize the

12 Principles o Green Chemistry into more concrete denitions and metrics are considered to

be major roadblocks [11].

9 Adapted rom Matus 2009



Box 6- Dune Sciences: A Case Example o the Challenges Facing Green Nanotechnology

In 2006, Dune Sciences (www.dunesciences.com) was ounded with the aim o bringing

nanotechnology inventions rom the University o Oregon to the market. The technologies

that Dune Sciences licensed dealt largely with chemical linkers that permitted strong,

irreversible binding between a nanoparticle and substrate. Dune Sciences took advantage

o this technology to link nanosilver (nanoAg) to suraces to produce the rst nanosilver-

based antimicrobial suraces that permanently bound the particles to the surace,

eectively preventing loss o the particles into the environment. The bound particles actas reservoirs o silver and slowly release silver ions that are responsible or the antimicrobial

activity. The primary market or these materials is athletic apparel where the antimicrobial

activity prevents the development o “persistent odor” in polyester garments. The

development o persistent odor shortens the liespan o these garments. An anti-odor

solution could extend the use o these garments signicantly and, as a result, reduce

material, energy and water use as well as reducing the use o detergents. Dune estimates

that the use o 2.4 kilograms o silver could double the liespan o a million athletic shirts,

preventing the use o the embedded raw materials, energy, water and transportation costs.

By way o comparison, over 700,000 kg o silver are currently used each year in industry.

In designing this new technology, Dune Sciences applied the principles o green chemistry

to product design and process development. The product prevents particle release rom the

garments and minimizes silver ion release into the environment by using strong linker binding

and the minimum silver loading needed or product perormance, respectively. The source o

nanosilver is a waste stream rom another process and the conversion o that wastestream to

the active ingredient is an all aqueous process that produces almost no waste.

Unortunately, despite the technical success and exciting social potentialo the product,

regulatory barriers prevented the commercialization o the product and uncertainties

surrounding possible regulations made it more dicult to attract investors needed to

urther the development o the technology, and the company had to reduce employment.

Because antimicrobial materials are considered pesticides in the U.S. registration o the

product with EPA was required. Throughout much o 2009 and 2010 was no path orwardto register new products. The argument was made to the EPA OPP and to their Scientic

Advisory Panel that i particles are not released rom the garment that the potential impacts

o these products would be the same as or products that incorporate micro- or macro-scale

silver, articles that are already approved. In addition, it was pointed out that articles that the

EPA had previously registered have nanosilver within them. Neither o these approaches

was successul.

As a consequence o these impasses to registration o the product and securing unding

needed to continue optimizing the technology, Dune Sciences put this product on hold

until a more avourable path to commercialization could be identied.

The problems that Dune Sciences aced in getting a commercially viable, ecacious andgreener product to the market are a good example o some o the key challenges acing

greener nanomaterials, especially in the regulatory arena.



How does green nanotechnology t into this broader landscape o innovation? Given its

oundation in the concepts o green chemistry, there should be some areas o overlap.

However, there are specic aspects o green nanotechnology that would also be expected

to present a unique set o challenges. For example, because it is so new, and requires novel

commercialization techniques, technological lock-in and path dependency should not yet be

a problem. On the fip side, uncertainty surrounding the costs o bringing these products tomarket, which would include the need to develop these new commercialization technologies

and analysis protocols, could increase the nancial uncertainty, making them riskier and

less attractive investments. From the discussions at GN10, many o the details o the actual

barriers that have been aced by entrepreneurs became clear, both in their similarities to, and

dierences rom, other green chemistry innovations, and innovations more broadly.

Like all innovations, the process through which green nanotechnology moves rom the

laboratory and into the market involves a series o steps, and the involvement o a number o

institutions (Figure 1). For green nanotechnology, this process usually involves universities,

smaller start-up companies, and nally large companies. In most cases, there are also other

groups that become directly or indirectly involved, including government agencies (FDA, EPA,

etc…), nancial backers, consumers, and even NGO and civil society groups.

Figure 1- The Commercialization Process

PRODUCT DEVELOPMENT EXECUTION

GLOBAL MARKET INTELLIGENCE

ORGANIZATIONAL ROLES/NEEDS IN GREEN NANO COMMERCIALIZATION:

Universities: scientic discovery, undamental invention, talent development, shared useracilities. NEED: public and philanthropic unding, enabling regulatory/legal environment

Startup companies: pioneering technology and market development o small but disruptive

–rst opportunities. NEED: equity/royalty licenses, large company customers/partners, high-risk

(early stage) capital, minimal regulatory/legal burdens

Large companies: Manuacturing scale-up and global business development. NEED: large and

protable “mainstream” markets, low-risk technology options



Figure 1 is a simplied version o a process that involves these many players, and lots o

eedbacks between them. However, it is a good way to understand where in the chain, and

how, dierent barriers emerge between the initial discovery phase, and the eventual entry and

use o a marketable product.

The Central Challenge:Simultaneously developing useul products or the market, developing the underlying science, and

operationalizing a green nanoscience development and deployment paradigm.

One o the most undamental challenges particular to green nanotechnology is that the

science, the testing, the regulatory strategy, and even the processes needed or commercial

production are all being developed and deployed at the same time. From this central

challenge fow many early stage challenges that were discussed during the course o the

workshop, including

Box 7- Barriers to Development and Commercialization o Green Nanotechnology

1. There are no clear design guidelines or researchers in initial discovery phases o

green nanoscience;


increases the need or basic research, engineering research, and coordination o

the two between the industrial and research communities;

3. The lack o a “deep bench” o scientists and engineers with experience developing

green nanotechnology;

4. Toxicology and analysis protocols need to be developed and constantly updated

to refect advances in the science;

5. Regulatory uncertainty persists, and green nanotechnologies oten ace higher

regulatory barriers than existing or conventional chemicals;

6. The end-market demand is unclear, especially since there are only a limited

number o commercial grade products that can be compared to conventional

materials in terms o perormance.

These green nanotechnology-specic barriers can be cross correlated with the general ones

rom the innovation literature, in terms o whether they contain some aspects o these. It

would appear that many o the challenges are the result o organizational problems, as well

as some diculties with the cultural aspect o incorporating concepts like interdisciplinary

collaboration and sustainability into stove-piped scientic organizations. More interestingly,

the traditional barriers to innovation do not capture some key elements o the challenges

described by green nanotechnology innovators. This includes many o the technical and

scientic challenges, and the core issue o just how much deeply undamental research is still

required in support o the development and commercialization.



Table 1-Correlation o Green Nanotechnology Challenges and General Barriers to

Innovation

General Barriers to Innovation

S p e c i f c C h a l l e n g e s o r G r e e n N a n o t e c h n o l o g y

Or g a ni z a t i on a l

E c

on omi c /

F i n a n c i a l

C u

l t ur a l

R e

g ul a t or y

M

a r k e t

P a

t h -

D e p en d en c e

Lack o Design

GuidelinesX

Coordination and

development o

new production

techniques

X X X X X

Experience with

development and

commercialization

X X X

Toxicology and

analysis protocolsX X

Regulatory

uncertaintyX X X

Market uncertainty X X X X X

The presentations and discussions during the GN10 workshop provided both greater depth

o understanding about how and why these exist, and also about the kinds o policies, actions

and approaches that are required to move green nanotechnology orward. These are discussed

in more detail below, and together they orm a research agenda or the uture o green

nanoscience and nanotechnology.

1. Lack o Design Guidelines or Discovery-phase Researchers

The problem: The choices made by academic researchers as they synthesize new green

nanomaterials can have implications throughout the development and commercialization

process- but most researchers are unaware o these impacts. There is a need or guidance

on what kinds o materials, and processes, will be both commercially viable, and will help to

minimize environmental and health impacts.



Location in the Innovation Chain: This problem is primarily in the research and early

development phase, although its impacts reverberate down the chain.

Actors Involved: Although the users are mainly academic researchers (especially in chemistry

and materials science), they require input rom toxicologists, engineers, and others urther

down the supply chain in order to align their needs and disseminate their knowledge back upthe discovery pipeline.


increases the need or basic research, engineering research, and coordination o the

two between the industrial and research communities.

The problem: Unlike other chemistry innovations, which can rely largely on proven industrial

processes, production o green nanomaterials on a commercial scale requires entirely new

methods. This makes it initially more expensive, and more dicult/uncertain to move

new technologies out o the laboratory phase and into production. Solving this problem

requires involvement rom industry, but also by academics in elds like chemical and process

engineering and materials science, in order to develop useul new techniques. Because the

challenges are not apparent until rms begin to produce in larger quantities, this also requires

communication between the industrial and academic communities.

Location in the Innovation Chain: This is a problem that is aced by small companies and start-ups, but is also a challenge or larger rms. Solutions will rely at least partially on work done by

the research community.

Actors Involved: The development o new production processes alls naturally to

small and large manuacturers, who need urther support rom the community o academic

researchers pioneering greener methods.



3. There is not yet a “deep bench” o scientists and engineers with experience developing

green nanotechnology;

The problem: Green nanotechnology, and nanotechnology more broadly, is a new eld with

relatively ew commercialized products. Due to the novelty o production methods, there are

very ew chemists and engineers in any given organization who have a depth o experiencedealing with the particular technical challenges o commercializing green nanotechnologies.

In some cases, interns or new employees coming rom academia are the most experienced

individuals on a project, despite having little or no experience in an industrial setting. There are

ew, i any, collaborations between industry and academia that could help train experienced

industrial chemists and engineers in the new technologies and processes or green

nanomaterials.

Location in the Innovation Chain: The impacts o this problem are elt most acutely by small and

large industrial rms.

Actors Involved: This is a problem that is dealt with by small and large industrial rms.

4. Toxicology and analysis protocols need to be developed and constantly updated to

refect advance in the science

The problem: Green nanoscience requires new analytical techniques and toxicological protocolsin order to ully understand the impacts on people and the environment. These elds need

to balance the task o being able to nd ways to eectively analyze new technologies as they

emerge, and also to develop undamental understanding o how dierent properties link to

impacts, in order to provide guidance to the discovery community so that they design the

most benign products possible rom the start. There is also a need to develop in-line process

analytical and control techniques or ull-scale manuacturing operations.

Location in the Innovation Chain: This is a problem that occurs as products come to the market,

and need to be tested or potentially harmul impacts. There are also impacts rom research

that is done earlier in the innovation process, when materials and processes are developed and

analyzed or easibility.



Actors Involved: This problem involves academic researchers, especially rom the toxicology

community, but also rom nanoscience and engineering. There has also been involvement

rom national research laboratories that work on impact analysis, standards, and testing

protocols, and also rom regulators who set rules or what kinds o data and testing will be

required or products to enter the market.

5. Regulatory uncertainty persists, and green nanotechnologies oten ace higher

regulatory barriers than existing or conventional chemicals.

The problem: Green nanotechnology products ace the same regulatory hurdles as other

new nanomaterials, but have no advantages over similar, but less green materials already on

the market. Depending on their uses, they could all under the purview o several dierent

agencies, including the FDA and the EPA. The regulation o nanotechnology more broadly is

still contested. At this point, it is still not known, with any clarity, whether nano materials are

undamentally more hazardous that conventional chemicals. Given this, there are indications

that the EPA, or at least some materials (such as carbon nanotubes and nanoAg) is adapting a

stricter stance than they generally have towards new chemical substances. And even or those

green nano materials that do not come under specic rules, they still ace the pre-manuacture

notice (PMN) process under TSCA, which is itsel being discussed or major reorm in the US

Congress. Even under the most lenient o the current regulatory rameworks, producers o

green nano materials are at a disadvantage rom chemicals already on the market beore 1976,

which do not have to incur the costs o PMN, or the sometimes more restrictive signicant newuse rules (SNUR’s) and consent decrees that the EPA has used to address concerns about certain

new materials, or novel uses o those currently on the market (SNUR’s are the current method

or regulating carbon nanotubes). All o these actors add up to uncertainties or rms who

ace an unknown set o potential uture rules, higher regulatory hurdles, or, more positively,

potential ast-tracking or lowered costs or greener products i certain elements o the TSCA

reorm bill are passed.

This regulatory uncertainty negatively impacts the availability o investment in green

nanotechnologies, both rom internal sources in corporations, as well as rom early and growth-

state sources such as angel investors and venture capital rms.

Location in the Innovation Chain: This problem is one aced by small and large industrial rms as

they attempt to move green nano technologies into the market place.



Actors Involved: The main actors involved are small and large manuacturers and the regulatory

community- including both government agencies and lawmakers at the ederal and state levels.

6. End-market demand is unclear, especially since there are only a limited number o

commercial grade products that can be compared to conventional materials in terms o perormance and market success, and the applications are oten just as innovative as

the materials themselves.

The problem: Relatively ew nanomaterials have been produced at a commercial scale. The

discussion is still largely about the promise o green nanotechnology, as opposed to its results.

Given many o the other barriers that have been identied, lack o clear market signals, or

a detailed understanding o the applications or which green nanotechnology would be

particularly advantageous make it dicult or rms to make a strong business case. Smaller

start-up rms need to convince investors that they oer attractive ROI despite long payback

time rames and high initial costs. Large rms ace a similar challenge surmounting internal

investment hurdles, and i anything have much lower risk tolerance. All o this sharply limits

investment possibilities (e.g. compared to ostensibly more capital-ecient opportunities in

social networking and e-tail), which in turn limits the number o products able to make it onto

the market.

Location in the Innovation Chain: This problem is one that occurs at the point where

promising innovations rom the laboratory are picked up by industry- either small rms orlarger ones, that then have to come up with the unding to get through development and

commercialization, and end up with a protable, marketable product.

Actors Involved: The main actors here are the small and large rms, along with their unding

inrastructure- incubators, angel investors, venture capitalists, banks, other investors and

internal investment mechanisms. There is also some involvement rom government programs

that und innovative start-up ventures (i.e. SBIR granting agencies).



Box 8- Barriers to Green Nano Commercialization

BarrierLocation in the Innovation

ChainStakeholders

1. There are no clear design

guidelines or researchers in

initial discovery phases o

green nanoscience;

Discovery phase; link

between academic research

and industry

Universities

2. Green nanomaterials

require new commercial

production techniques,

which increases the need or

basic research, engineering

research, and coordination

o the two between the

industrial and research

communities;

Development and

Production phase; Research

phase; link between

academic research and

industry

Universities; Small and large

industry

3. There is a lack o “deep

bench” o scientists and

engineers with experience

developing green

nanotechnology;

Development and

Production phase

Small and large industry

4. Toxicology and analysis

protocols need to be

developed and constantly

updated to refect advance in

the science;

Research phase; link

between academic research

and industry

Universities, National

Laboratories, Regulatory

Agencies, Small and large

Industry

5. Regulatory uncertainty

persists, and green

nanotechnologies oten ace

higher regulatory barriers

than existing or conventional

chemicals;

Commercialization phase Regulatory Agencies,

Small and large Industry,

Consumers

6. The end-market demand is

unclear, especially since there

are only a limited number o

commercial grade products

that can be compared to

conventional materials in

terms o perormance

Commercialization phase Small and large industry,

consumers, nancing

mechanisms



concLuSIonS: thE ActIon AgEndA

Green nanotechnology has been making great orward progress, but the challenges presented

above point to an agenda o actions where involvement by the scientic research community,

industry and government could bring about changes that would be crucial to supporting a

more rapid and eective commercialization o green nanotechnology.

O the challenges that have been previously described, one important common eature is

that many o them are the result o issues that occur well in advance o commercialization, i.e.

during the design and production process development phases. Improvements in specic

characterization and data analysis tools would have an impact on these issues. Further, there

is an ongoing need or research into the underlying reaction mechanisms at work in greener

nanomaterial synthesis routes. Finally, integrating inormation rom analytical and mechanistic

studies is needed to develop design guidelines or greener nanomaterials.

Specically, we are proposing that action be taken in the ollowing areas:

Box 9- Action Areas

1. Discover, Uncover and Provide key analysis and characterization tools,

2. Investigate and Understand reaction mechanisms or support o better synthesis and

production techniques,

3. Develop design guidelines or commercially producible green nanomaterials,

4. Denition o Green Criteria or new nanomaterials or ast-track approval by the US EPA,



The order o this agenda matters. The rst, and most pressing need is or better analysis and

characterization tools and protocols. These are a critical enabler or the rest o the agenda.

They are required by scientists and engineers who need to understand the mechanisms o

the reactions that produce nanomaterials in order to develop better synthesis methods. And

they will allow or improved and more complete toxicological studies o green nanomaterials,

which are required or better and smarter regulation. Similarly, the second item o the agenda,

improved mechanistic understanding, is oundational or developing green nanomaterial

design guidelines. Finally, new regulations, as well as outreach to regulators must be based on

the analysis, understanding, and design concepts that are the result o the rst three items.



For each area o action, specic recommendations are described below, along with the actors

required or each.

Box 10- The Action Agenda

1. Discover, uncover and provide key analysis and characterization tools

ACTORS ACTIONS

Federal unding agencies (NIST, NSF,

NIH), university researchers, national

and government laboratories, industrial

nanomaterials practitioners and companies

that develop and sell analysis tools

o Discover and develop new

analytical methods that enable

more comprehensive and reliable

nanomaterial characterization

o Increase eciency and reproducibility

o analytical methods. Accelerate

throughput by streamlining sample

preparation, data collection and

analysis. Reduce costs or analysis.

o Develop approaches or real-time

monitoring o nanomaterials tosupport mechanistic investigations and

process analytical needs.

o Extend the use o existing methods

and develop new methods and

tools to detect, monitor and track

nanomaterials in complex media (eg

environmental and biological systems)

2. Develop, characterize and test precision-engineered nanoparticles or biological and

toxicological studies needed to guide greener design

NIST and universities, but access to materials

and knowledge in rms also required

o Develop reerence libraries o

precision engineered nanomaterialsthat represent materials or basic

mechanistic investigations and that are

projected or commercial use

Academic institutions in partnerships with

small start-ups that could provide the

materials as a service to users.

o Provide the above reerence materials

to groups that need them or testing.

Support the use o those materials

with analytical data or each batch and

supporting documentation describing

best practices or storing and handling

the materials

Universities o Develop protocols and use these totest the biological and toxicological

impacts o materials. Develop

hypotheses that help guide redesign o

materials that are greener.



3. Investigate and understand reaction mechanisms to support more ecient and precise

synthesis and production techniques.

Universities o Develop new synthetic methods

and conduct research on reaction

mechanisms or nanoparticle

ormation. Use mechanistic knowledge

to produce precision-engineeredmaterials and enhance reaction

eciency

o Study barriers to reliable and scalable

production and develop novel

approaches to maintain product

integrity as the reaction scale is

increased.

Universities in partnership with companies o Develop design guidelines or

commercially producible green

nanomaterials.

o Aggregate and make available data

generated rom mechanistic studies,analytical studies and testing, and

other sources or use by research

community.

o Share critical and undamental

knowledge on barriers and engineering

hurdles discovered during the scale-up

and commercialization process.

4. Develop design guidelines or green nanomaterials

Universities o Produce design guidelines or early

stage researchers and materials

developers to support greenernanomaterial development and

production.

5. Denition o green criteria or new nanomaterials or ast-track approval by the US EPA.

US EPA o Implement a ast-track approval route

or new nanomaterial innovations that

can:

· demonstrate benets over existing

materials on the market

· provide basic testing data to

demonstrate a reasonable

expectation that the material

in question poses no additional

hazard due to its classication as a

nanomaterial2.





Regulatory Agencies: Economic, Scientic and

Environmental (Department o Commerce,

EPA, FDA, DOE, NIH, etc…)

o Agencies need to work together and

coordinate so that each can ulll their

mission regarding the development o

nanotechnology as an industry.

o Agencies need to reach out to expertsin science and business to better

understand what is needed, and what

policies would be eective.

Universities, Companies, Regulators o Bring regulators most recent

inormation to help determine

rules or the circumstances where

nanomaterials may require specialized

regulatory approaches instead o being

treated like any other new chemical

substances.

o Provide education on green nano

concepts to uture generations o scientists, business people and policy

makers.

Nanotechnology presents an opportunity to develop a new technology, and a new industry

in a sustainable way rom the outset. We are at a unique point where we have more

understanding o how to go about this than at any time in the past. This new emerging

science and associated technologies do not have to ollow the path that has been typical o

many past innovations in the chemical industry that, despite providing signicant benets,

also turned out to have signicant, unanticipated costs to human health and the environment. The development and commercialization o viable green nanotechnologies is dicult, and

the barriers mentioned will require eort rom the scientic, research and government

communities. But as the presentations at GN10 indicated, there is a pathway orward, and

concrete actions that could construct a solid oundation or an economically protable and

environmentally sustainable uture or nanotechnology.



grEEnEr nAno 2011 SuppLEMEntAL obSErVAtIonS

In an eort to be comprehensive, this short supplement has been added to ensure the most

up to date inormation has been incorporated into this white paper. It is based on the Greener

Nano 2011 meeting held in Cupertino, CA May 1-3, 2011. Presentations or Greener Nano 2011

may be ound at http://www.greennano.org/GN11_presentations

• Once again in 2011 there was a major theme around the issue o characterization. I anything

the urgency in this area was reinorced as a need or both understanding what is being

tested rom a toxicology perspective, but also or the ability to implement a consistent and

reproducible manuacturing operation.

• It seems micro reactors may oer an especially attractive approach or process control o nano

scale materials. On microreactors or nanoparticle/object production, it might be pointed out

that both batch (like Lawrence Berkeley National Laboratory’s WANDA) and continuous fow

techniques have been reported. It may require a combination o learnings rom these two

approaches to satisy industrial cost/eciency needs in at least some cases [24].

• The question o how “purication” o a nano material infuences and in act changes

properties was also raised as a major challenge. In particular methods used to prepare

samples or analytical or toxicological testing have the potential to change states o

aggregation which may result in signicant changes in physico/chemical properties and the

resulting interaction with biological systems [25].

• The issues o surace area, particle size and especially surace charge continue to receive

considerable attention. Sonication is a commonly employed tool or dispersing nano

particles, but evidence shows a signicant change in states o aggregation and properties

may result. This year the element o shape was discussed and how these various

characteristics actor into infammation response and the initiation o apoptosis. The use o

coatings may also have a proound impact on the state o aggregation.

• New insight served as a major development in the act that nano particles have been in our

environment or much longer than we appreciate. The example used was nano silver, and

the revelation that silver nanoparticles are readily generated in a humid environment. This

raises questions in the context o exposure and toxicity since it appears we have all been

exposed through the routine wearing o jewelry, etc. This was discussed in a paper recently

submitted to Science.



• The eld o computational toxicology is advancing rapidly and the goal is to move to a

predictive capability or use in new risk assessment approaches. The EPA recently held a

meeting on their Advancing the Next Generation o Risk Assessment (NexGen) program in

Washington, DC to enable movement in this direction [26].

•

On the regulatory ront, there is growing recognition that neither ‘penalty’ nor ‘data call’approaches by regulators are succeeding at the dual goal o advancing innovation and

ensuring saety. While there is no consensus on timely alternatives to resolving uncertainty,

there may be some openness to consider ‘incentive’ or ast-track approaches to getting

greener nanomaterials with probable net environmental benet to market aster. Since

many o these innovations come rom resource-constrained small companies, this remains an

urgent agenda item.



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