It's so it's a real pleasure
to have today Speaker with us

Professor Richard bark from
the school public policy.

You've been coming to these for a long
time you know that traditionally we have

you know fairly technical talks but I like
to throw in I wouldn't say non-technical

because I think there's probably going
to be something technical here but but

certainly something a little bit
different to as Monte Python used to say

you know something completely different.

But so so Richard got his bachelor's
degree in physics here at Georgia Tech

before going off to get that master's and
Ph D.

in political science at the University
of Rochester He then spent some time

as a faculty member at the University of
Houston before coming to Georgia Tech in

one thousand nine hundred seven so if you
do the math that's thirty one years ago

where he is currently a professor of
public policy and spend some time

about seven years as an associate
dean of the ivy now in college and

as you'll hear his research interests are
really exploring the intersection between

politics and science which if
unless you're a hermit is a pretty

important topic going on in the world
today so if you go and enough.

I'll begin with a room in this instance
I'm looking at the building at the.

Building.

People always a question I always get is
how in the world did you go from physics

to political science while I was taking
classes in that building I was working

in that building I was working in
a lab doing earthquake research and

I was really interested
in your physics and

I became interested in questions such
as Who is paying for this research and

I remember asking the professor I
was working for other persistently

Why did they pick you how do they know
that you're qualified to do this and

how do you know if you're doing a good
job and he told the rate of question and

then I became curious about
the issue of how the knowledge that

we've been developed in the lab was
going to be used by policymakers so

a number of other accidents would be to go
off and study the policy making process

to try to answer those questions and
it's still pretty much what motivates

my research also a bit more about that as
we go along but I need to start out with

a disclaimer I am not in my nano
scientist I'm not a now a technologist

I'm not even really a physicist
anymore I know just enough

to make me think that I can understand
a lot of what you guys talk about and

just sort of stand in amazement at some of
the things that are going on these days.

So.

So we start out with a problem.

The problem is as you all know can you
see can you guys in the back see this OK

way that they're OK We start with
the problem part of the problem

is the enormous benefits that we're
already seeing from work I'm just

going to use the word nanotechnology
is it sort of a generic blanket term.

The benefits are already seeing
in that are forecast to continue

we're not quite sure what the shape
of that line or the curve is but

it's still going to be substantial at
the same time as E.P.A. and in and

I had a national nanotechnology initiative
and they pointed out there are still a lot

about the risks associated with this
technology that we don't understand and so

one of the questions that comes to
government policymakers is what do we do

about this on the one hand we want to
promote the technology it's Norma's boon

to our economy to the consumer
satisfaction maybe to the military to

health care or whatever you guys
are working on at the same time we need to

balance it against the possibility of
risks the benefits we can establish we can

attach some numbers to those and with
dollar signs in front the risks are a lot

more uncertain and as we'll see there
of course they're more long term so

what is the government's responsibility
what is the government's capability of

dealing with these issues and
to the greed of this is.

The technology is going to be somewhat
shaped by regulations how are they

designed if adopted one of
the issues of course for

emerging technologies not
just nanotechnology but

others that have come along even
starting in the eighteenth thirties with

metallurgy and boilers on steamboats on
the Mississippi River that were bursting

nobody could understand quite well yet the
people were hundreds of people were being

killed with steamboat accidents bursting
boilers but we didn't know much about

metallurgy in the fact of cooling and
heating metal and other daily cycle.

Emerging Technologies a come along since

well I guess since we moved
into into villages and.

They change technology changes far
faster than public policies can and

I'll show you an example of how slow
policies can move in and if you minutes.

Policies in a democracy depend in
large part on public perceptions and

those perceptions depend on education and
on events so what the public

perceives some of it they learn in school
probably not learning nearly enough about

is as much about nanotechnology is you or
I would would like for them to learn.

And then when they pay attention
it's usually because of some event

something that has made it into
the news and it wakes them up and

they say what's this nanotechnology thing
we know that people are risk averse and

we know that visual images matter there's
been a lot of work done trying to

understand risk perception by the way
not just among the public but

even among experts and scientists trying
to understand how people perceive and

process information about risks and
we know that visual images are lasting and

they make a big impact
in contrast to text so

let's look at a couple of previous cases
here is nuclear energy sort of emerging

technology forty's and fifty's then in
the in the one hundred seventy nine this

movie came out if you can't read the well
you have a little bit at the top above

the face is as today only a handful
of people know what it means

soon you will know the China Syndrome who
knows what the China Syndrome referred to.

What was the meltdown right so

a core accident cooling accident the
Clearfield melt through the containment

vessel down through the floor of
the reactor it would just keep going and

would come out and cyanide and of course
everybody that lives in Atlanta knows

that the opposite side of the earth from
Atlanta being at thirty five degrees north

latitude cannot be another country
in the northern hemisphere but

should have called it the Perth Australia
syndrome because that's about the closest

place if you go straight down to come
out of the Indian Ocean near Perth

that would have been as good a title All
right so the movie came out in basically

Jacqueline played the role of a of an
engineer working in a nuclear facility and

he starts to suspect that something may
be wrong and so he checks into it and

he finds out that maybe some
inspection records were fabricated in

the corporate managers of course
being evil people tell him to ignore

all of that because they don't want to
shut down and try to rebuild the place and

he links up with Jane Fonda who's
a trepanned local television reporter and

her soon to be unfortunate camera man.

And he tries to alert the public to
the possibility that this nuclear

power plant might have had a design
problem and of course see it in them

at the end of the movie he resolves
the way all good engineers resolve their

conscience problems but
exercising his second amendment rights.

So I was it was a gripping movie
a really good story good actors and

as you see the release date was March
sixteenth one thousand nine hundred

seventy nine March sixteenth twelve days
later this happened three mile island

right and do you coupling of a big

fairly successful movie with a big
not very successful accident.

The public perception of nuclear
energy and nuclear technology for

a very long time probably still
including today people that were born

in one thousand seventy nine are probably
still impacted by this by this perception.

Here's another example Jeannette if
genetically modified organisms great

potential also maybe some risks Well
we began this era in one nine hundred

seventy five with a conference center in
the coast of California called a Solem R.

and about one hundred eighty sorry hundred
forty biologists etc got together and

said in effect this technology that we're
developing the science and technology that

we're developing we know that it's going
to carry along with a certain risks and

the government is going to do something
about it if we don't do it ourselves so

they had a conference and they put
together a set of guidelines to so

that the become a D.N.A. research
community could become a self-governing

community establish
reasonable guidelines and

then preempt government regulations
it was a an amazing group

the furry guy on the top right on the
right is David Baltimore who when and when

a Nobel Prize I think same year and the
next picture down on the far right that's

Paul Bergen also also Nobel Prize winner
so the heavy hitters in the field and

came together and
said we're going to regulate and

try to control the science and technology
ourselves well of course that couldn't

last because pretty soon it was a lot more
than one hundred forty people involved and

a lot more than just the United States
involved and so forth and so

of course the the next
big step in understanding

genetically modified organisms was.

Was Mr Rex here.

If you remember the movie Jurassic Park
there was actually a very good little

animated film at one point in the movie
explaining the technology and

it was that wasn't bad at all but it ended
up with this monster eating almost eating

some children and happily enough
eating a lawyer and the lawyer said.

Yeah OK so one more self driving cars
a current technology you know there's

a bunch of Google cars and here is a woman
ironically enough reading a paper book or

magazine while her car is driving itself
you think it should be looking at

a Kindle or an i Pad or
something if she's using paper.

The way that we get we're hearing
the stories about the promise of this

technology and then March nineteenth
a little more than a week ago self driving

over car kills pedestrian in
Arizona where robots roam.

Roaming robots in Arizona so.

We have to assume that the way the public
is exposed to technologies and

their cost and benefits are going to be
not next necessarily what scientists and

engineers would say so

now we kind of nanotechnology how many
of you have read Michael Crichton's book

OK it's basically Jurassic Park with
little tiny dinosaurs right it's

the same story and it's kind of amazing
that a movie hasn't really been made.

Based on because it was written
pretty much like a screenplay.

It was popular for a while.

So where do we stand now of public
perception we've got creepy little

nanobots about the color somebody is
eyeball to top right there was a movie

a couple of years ago where Johnny Depp
was a computer scientist and

uploaded his personality his
consciousness into a super computer and

then used an old technology to.

Hopefully do good things but it turns
out maybe not such good things and

the animation is from a website for
an anti nanotechnology the interest

group that is showing military planes
spring nanobots all over the world.

That's what the black stuff is not great
goo black goo so yeah it's in it's kind of

hard to find a visual image that portrays
nanotechnology in a positive way so

this is part of the challenge for
policymakers is how do people

perceive the benefits and
the risks All right so the basic problem

as I see it is that first of all
there is a problem the magnitude.

Of the magnitudes of the benefits and
the benefits of the potential risks and

there are a variety most imagine all of
you know these better than I do such as

direct exposure to workers
lab workers consumers and so

forth environmental effects
malfunctions of new machines so forth

possibility of it being used as offensive
military weapons and then malevolence

things like terrorist weapons based on
a technology that a lot of scenarios.

And other problems unfamiliarity
nobody can see a nanotechnology and

of course the rules say that
you know allowed to call it.

Nano technology unless there is behavior
different at the nano scale than there is

at the micro scale so almost by definition
it's something that we can't perceive and

it relate to personally it's almost you
know it's like trying to understand.

How electron spin velocity the speed and

direction of change we think we know it
but it always varies and surprises this

variability nanotechnology to use that
the rubric is not a single thing but

it's often talked about it as if it is in

the location of the problem whatever the
problem is it ranges from the local and

state level all the way up to multi
national and global scales so

the challenge then is first I said is how
do we balance the benefits of the risks.

Some parts of the challenge differing
timescales the benefits are likely

to accrue more quickly some of the risks
that people talk about are longer term.

There's a lot of you know people drawn
analogies between inhalation of carbon

nanotubes and as best as fiber is even
though they're very different scales.

And as best as manifests itself in ten
twenty even forty years after exposure so

the time scale for the risks is very
different than the time scale for the X.

some of the expected benefits and
those timescales will be different for

different actors in the process.

The spatial scales the possibility
of local use of this technology but.

Eventually having a global impact so there
again the benefits could be localized

the risks could be global according
to some scenarios incommensurability

simply you know you can put dollar signs
in front of the lot of the benefits you

can't put dollar signs in front of a lot
of the risks so how do you compare these

as a problem for a lot of areas of policy
not just this one and the distribution

question Who gains who pays so it may be
that if you companies or as we all know

you guys are all going to get filthy rich
at least that's what the world believes as

scientists and engineers get
really rich from their research.

And.

But other people will pay whatever
costs there are to come from the risks.

Then there's the question of
authority who's going to decide

who makes the decisions
about how whether to and

how to regulate this technology should it
be autonomous scientists and engineers

like in asylum are with recombinant D.N.A.
I think it's way past that

should it be the marketplace should it be
law basically relying on liability and.

Tort problems or intellectual
property law to govern the devout

development of the technology and
what would be the role of government or

governments at the state local national or
international level so

as we try to deal with this messy problem
I'll just point out that my focus is.

The work I do focuses on that
national regulatory policy and

I'm doing research now looking
specifically at time scales.

Doing a project with one of our former
students recently at graduate recent

graduate from Harvard Law School and
we're doing a project looking at how in

the regulatory around how both
the cognitive aspects of subjective time.

Perception and the time skills of
organizations like regulatory agencies

how they come together to try to shape our
policies in a nutshell people don't think

of time we don't perceive time as puts
on a clock or a pages on the calendar we

have very subjective sort of a log or is
made compression of time into the present.

And yet we don't take those things into
account when we talk about issues such as

this the future is long and
diffuse the present is very salient and

and compressed and that's pretty
much what we pay full attention to

cognitive scientists have been
doing some fascinating work on this

it looks like our brains were not
evolved to think about the future.

Right for most of human history it
didn't matter what was going to happen

twenty years from now you were concerned
about the next two weeks at most or

maybe the next year.

Our brains don't function very well
when we try to think about long terms

in the case so

why would we regulate risk first of
all there information asymmetries.

Some people know a lot some
people don't know anything

there's a lack of shared information
about the cost of benefits and

cost and benefits of nanotechnology there
was a consumer in products inventory

just a couple of years ago and found that
forty nine percent of those products did

not disclose the composition of the Nano
material used if they did disclose it it's

not clear how useful that would have been
to consumers I don't know about you but

I look at the side of the box when I'm
eating my breakfast and I'm sure not

I don't I'm not sure what Niacin is that
good or bad and how much do I need so

just giving people information isn't
necessarily the key this is something

that Adam Smith was wrestling with in the
more than two hundred years ago which is

how do we get proper information to
people so they can make wise decisions.

You can either do it with the government
providing the information or

the government requiring manufacturers
to provide the information and

this is going to be the case that we're
going to come back to in just a couple

of minutes there's also the problem
of what are called negative

externalities the marketplace is
supposed to work with buyers and

sellers making voluntary exchanges well
informed about what's being bought and

sold and so forth but in some cases buyers
and sellers are producers and users.

Benefit by X.

by exploiting some of the cost of
production to third parties a classic

example is pollution right you can keep
the cost of fuel production down if you

dump all of your pollution in the river
and somebody else gets to pay for

it it's not the producer or the buyer of
the steel it's somebody downstream so

what the government typically does is it
tries to internalize re internalize those

costs using fines and penalties which is
a lot more difficult than it sounds trying

to figure out what are the correct
levels of those and

how much they should change or you can
limit the production of bad things bad so

you can use command and control
regulations whether for example E.P.A.

simply tells a company this is what you
must do or this is what you cannot do and

there's no flexibility there or you can
use performance standards where you tell

a company you're allowed in effect you're
allowed to do this much bad stuff but

you've got to bring down your level of
bands to this level how you achieve that

level of bads is up to you you can do it
the most efficiently way possible but

we're not going to tell you exactly how to
do it so there are variety of tools and

I'm barely scratching the surface terms of
the regulatory tools that are available

but this is these are some of the reasons
why these are some of the things

that shape regulatory policy and as we get
into more detail on that you'll see this.

There's another set of
design principles for

policymaking and it doesn't fit well
into the market or economic model but

it's certainly something that
drives a lot of the motivations for

regulation which is this notion of
equal treatment in and basic rights.

Those are still operating principles for
the government.

The notion that people
are entitled to certain.

Equal protections and certain
fundamental protections life liberty

property of pursuit of happiness and
so forth.

Another key design principle is that there
should be no unchecked power in society

this is a principle that goes back to
the early seventy's hundreds in Scotland.

The notion that it doesn't matter whether
it's in the public sector or private

sector scientific fact or engineering
sector or medical sector it doesn't matter

that it is ultimately harmful you know
you may say differently ultimately it is

very risky to have some power in society
which is not checked by another power.

OK And I'll just leave the proof to
the reader on this one government put

it pursues these objections through laws
Congress passes laws it delegates a lot of

decisions to agencies and those agencies
develop experience expertise they

divide the labor and develop really
good skills we hope in the finer

details of what these controls
should be on risks to

society these decisions are shaped by
standard administrative procedures.

Basically a law that was passed
in one thousand nine hundred

six called the Administrative Procedure
Act which is pretty much still in fact it

was largely still in effect that basically
tells agencies here is the right way and

the wrong way to make regulations and
setting the stage for

a case that we're going to look at in the
minute those decisions agencies make must

be reasonable fair transparent and
accessible.

Those words pretty much speak for
themselves except the first one

reasonable in this context doesn't
mean yeah it's reasonable or

you have that fits of common sense
reasonable in this context means based on

explicit reasoning you have to
be able to provide an explicit

defensible reason why you're making
the decision you're making OK so

you can't just toss things out and say
well we all know that it's this is bad or

we all know this is good you have to
be able to provide justifiable reasons.

One of the things that really grates
on that teach a course on regulatory

policy and I get a lot of students from
science and engineering to come over and

take it bless their hearts and one of
things that drives them crazy is that

this is an inherently designed
to be an adversarial process

the notion of why can't they just
figure out what the truth is and

make decisions based on the best available
evidence and just don't just get it done.

The problem is that our system
is set up to be adversarial so

that there are basically it's almost
a version of one of Newton's laws for

every interest there's an equal and
opposite and or opposing interest.

And it's one of the ways that we check
power is to make sure that whatever

is being suggested there's
somebody out there to to put it

to the task to test the assertions to test
the data to bring in alternative evidence

alternative arguments to give
voice to opposing interests and

so forth so when people say
you look at the process and

say you have to do all just
always fighting with each other.

The process was designed for them to fight
with each other up to a point I mean

it can be taken way too far sometimes as I
think we're seeing sometimes these days.

But it's basically it's a fairly sensible
way to design a system that involves

allocation of power to make sure that
everybody has a chance to weigh in and

try to influence decisions again
this is setting the stage for

a specific example I'm going to look
at in a minute all right so that I

guess that minute is arrived so regulating
nanotechnology risk how do we do it.

We start out with law.

Most of the fundamental source
of authority for this or

any other type of regulatory action
is Congress our elected officials and

so they pass laws and they study in fact
we're going to have clean water E.P.A.

go make clean water or

we're going to have clean air or
how many of you know what fifth is.

It's of course it's the federal
insecticide fungicide and rodents aside.

Yeah there's a logic for
that circle is also better known as

Superfund dealing with
hazardous waste sites and

wrecker a resource conservation Recovery
Act is also dealing with hazardous waste.

Most of these laws go back to
the one nine hundred seventy S.

when we were just trying to figure
out how to control what looked like

runaway environmental pollution you know
you've seen pictures of all Los Angeles or

Pittsburgh look like in
the one nine hundred forty S.

or they didn't look like because
you couldn't see them for

all the smog burning rivers the coyote
River in Ohio on fire a couple of times.

Love Canal and
wayside outside of Buffalo that turned out

people had been sold houses on
top of a hazardous waste dump so

there were a number of events
very visible of the visual events

that led to the passage of a number
of these laws the bottom one here

I'm singling out because we're going to
come back to this is it's called Tasca.

Does it refer to Italian operates
the Toxic Substances and Control Act.

And that's what an awful lot of
the nanotechnology regulation at least

under E.P.A. now comes under the Food and

Drug Administration also has
a role in this regulate but

it tends to regulate products not
technologies or categories of technologies

but generally looks at things on a case by
case basis deals much more with drugs and

with things like dietary supplements or
more food a lot of food regulation is done

by the Department of Agriculture not
by the Food and Drug Administration.

And you can imagine the political reasons
why that would occur and then OSHA and

there's the Institute for

Occupational Safety Health dealing with
workplace safety and health issues.

Some of which I'm sure apply to
things that go on in this building so

there are a number of.

I could have listed the laws that
allow F.D.A. or require F.D.A.

and OSHA to do what they do as well but
it's a large

number of agencies as we'll see in
a large number of laws that that set up.

And here's an example to read
the whole thing this is an excerpt

from the nine hundred seventy six
Toxic Substances Control Act And

there are some words here
that are highlighted.

An act of Congress a law generally
starts out with findings and

a purpose here is what we're trying to do
so it starts off by saying Congress finds

that human beings in the environment are
being exposed each year to a large number

of chemical substances and makes yours
among these are some which may present

an unreasonable risk of injury to the to
health or the environment notice that word

unreasonable reasonable risk not all
risks are bad just unreasonable risks or

bad who's going to decide
what's an unreasonable risk.

Coming back to that it is a policy that I
say is that adequate information should

be developed in the development
that information should be.

Should be can really see here the
responsibility of those who manufacture so

not only do we need information but
those who produce the stuff.

Have the responsibility of
providing this information.

Adequate authority to regulate
chemical substances and mixtures

which present this unreasonable risk of
injury to health of the environment and.

Third that any authority over all of
this any regulations should be done so

as not to impede unduly or
create unnecessary economic

barriers to technological innovation
as long as we make sure that we

avoid unreasonable risks of injury or to
the health of the environment now notice

the number of words in here that are kind
of challenging so we'll just take.

Take last three here such
a manner as to impede unduly or

create unnecessary barriers to innovation.

Avoiding an unreasonable risk so
there are a lot of flexible words in here

and why does Congress do that why do
they pass laws with this kind of sort of

squishy language well in part it's because
Congress knows that it doesn't know enough

to be specific in many cases
Congress knows that the scientists

engineers don't know enough yet
to be specific and so

they put they put this language in laws
basically telling in this case the E.P.A..

As you do your work trying to implement
this law you're going to have to

figure out what unduly impede or
unnecessary or

barrier unnecessary barrier
is means in practice.

Now there not just handing over
that authority to the agency and

saying You go figure it out
well they kind of are but

they're also doing it with a club hidden
behind their back which is that from time

to time we're going to invite the E.P.A.
administrator up to Capitol Hill and

we will have heard from constituents
including people who are doing it now and

then sorry no manufacturing or
other sorts of things

we're going to be hearing about how
the E.P.A. is being unreasonable unfair.

Unduly restrictive.

And impeding technological innovation so
you're going to come up occasionally and

give us the reasons there is that
Were you going to give us the reasons

why you're doing what you're doing you're
going to defend what you're doing so

they delegate a lot of
the authority to the agency but

they do it in such a way that the Congress
would ultimately have the authority

I mentioned in the previous slide
the one nine hundred seventy six

resource conservation
Recovery Act Congress told B.P.

to go deal with hazardous waste it turns
out there's a lot of it out there and

we need for you to clean it up so E.P.A.
started doing that they started

doing an inventory of hazardous waste
sites around the country within two years

they had found out that the magnitude of
the hazardous waste dump dumping problem

landfills and so forth was at least ten
times as large as Congress had thought

it was just two years earlier when
Congress passed the law and so

we started implementing the law we didn't
know how bad the problem actually was and

then the E.P.A. said my gosh we've got
this huge problem how do we prioritize

Congress has given us X.

number of dollars to clean stuff up it
turns out there's ten times as much stuff

out there as we thought we don't have
nearly enough money to clean it all up so

we need to prioritize it
would we clean up first

do we clean up places where there is
a small community facing immediate risk

what about a large community
where the risk is five or ten or

twenty years away how do we prioritize
Congress didn't tell us how to do that so

they basically they froze they waited
until somebody took them to court and said

Why aren't you cleaning up my neighborhood
and this force Congress to go back and

act again eight years after they passed
this first law Congress passed another law

that was amazingly specific and
what it stipulated in terms of you know

plastic liners and Clay liners
underneath hazardous waste landfills and

it's incineration techniques and huge
amount of been learned in only eight years

so sometimes it happens all right so
here's another example so we pass Tasca

that previous law that was nine hundred
seventy six this is an act of Congress.

June ninth twenty fifteen this is
the Senate version the bill finally passed

the full Congress about a year later this
is the Senate version of the bill to amend

the Toxic Substances Control Act the one
we were just looking at to reauthorize and

modernize that act and for other purposes
this is the Senate version it's got sixty

co-sponsors this is only a couple
of years ago you know the era of

rampant partisanship and so forth so
you've got sixty Republicans and

Democrats together sponsoring this
bill in the Senate so sometimes

the stuff that doesn't make the news
sometimes Congress actually does its job

pretty well it's just not very exciting
and so they don't cover it on the news.

But what they did was they said look it's
been a long time since we passed Tosca

there are a lot of new products out there
including the stuff you guys work with.

And it's not clear that the current
that the old law applies as well

today as it used to and the old law had
some flaws in it as well so this is one

of the major It's been a few other
revisions of Tasca In the meantime but

this is the most recent one so
this is Congress

now saying we're going to go back and try
to address some of these these problems.

This is part of that law and

again a lot of detail here but basically
what's relevant for the nano folks is.

A section this is a person meaning person
or company that who manufactures or

processes or proposes to manufacture or
process a chemical substance etc

shall provide records in reporting
with respect to the following

the name chemical identity and molecular
structure of each chemical substance.

The total amount of each substance and
mixture that's going to be produced

reasonable estimates of them out that
will be manufactured or processed and

reasonable estimate as to minutes for
each of the categories of use or

proposed categories of use a description
of the by products resulting

from the manufacturing etc all existing
information regarding environmental health

effects of such substance or mixture
the number of individuals exposed and

reasonable estimates of
the number who will be exposed.

And the manner or

method of the disposal of this stuff
as part of the production process.

Right.

They did in fact I mean that it's a great
question I'm going to come back to that

so.

Yeah this is this is the this is.

Actually this is this is the law Congress
did not define that they left it to E.P.A.

to define that yet and
we'll see that in just a minute.

Because Congress really didn't know
enough especially looking at stuff.

Some of the part of this explicitly
included nano scale materials and

Congress basically if you go back and look
at the record they said we don't know how

much of this stuff is around we don't know
whether it's being produced by little tiny

companies big companies you're going
to have to figure this out OK so

other skip down here to section
the health and safety studies.

E.P.A. shall require any person
who manufactures process or

distributes etc any of this stuff
to provide the lists of health and

safety studies that they know about.

And also down here is stationary anybody
who obtains information which recently

reasonably supports the conclusion that
such substance or makes your presents this

presents a substantial risk
shall immediately inform E.P.A.

OK reasonably supports the conclusion that
it presents a substantial risk right so

basically this is a way of requiring
people that manufacture chemicals

including nano scale
stuff to report to E.P.A.

what it is they're doing how much of
it they're doing what they know about

the possible health and environmental
risks and to continue to report as they

learn more about what they're doing so
this is this is what the law told E.P.A.

to do OK They passed a law
nothing happens until E.P.A.

decides to they need to act on
what Congress told them to do so

now Congress E.P.A.
has to act here are the questions.

The E.P.A. has to deal with first of all
what does the language actually mean what

is what does the law require only pointed
to some of these somewhat ambiguous words.

And as I said sometimes Congress puts
these words in because they don't want to

decide because if Congress is too specific
the stakeholders that are going to lose

under their definitions are going to raise
all kinds of commotion and if they are and

so forth a lot of times they just kick
the can down the road to the agency but

most of the time it makes sense for
Congress not to be that specific.

How quickly must action be taken.

What do we have to do in the first year
I do it is Congress saying we have to

issue all of these guidelines and

start collecting this information in
the next month the next six months

the next three years most of time congress
lot of times Congress doesn't say that.

Who is being affected so who should
we consult doesn't exist in a vacuum

they need to be in there in contact with
industry with environmental groups and so

forth but who should be involved in the
discussion about how to actually implement

what Congress told them to do what
are the costs what are the benefits.

I'm sure you recognize
how difficult that is

my school public policy we teach an entire
semester course cost benefit analysis and

next year will offer a second course
called Advanced cost benefit analysis as I

tell difficult it is and
we want people to know how to do it well.

How will actions be
portrayed in the media.

That agencies generally don't admit that
this is a major concern of theirs but

of course it has to be.

Back in the seventy's there was a great
deal of concern about radon gas in

people's houses basically daughter from.

Trace amounts of.

Radium in things like granite to if you
got if you got concrete block in your

basement you've got radon in your basement
and it's colorless odorless tasteless and

all of that but over the long term it's
a substantial health risk and E.P.A.

was trying to regulate it because the
epidemiological study showed that this was

actually a significant health risk even
though most people don't know it so

they tried regulating it and
all kinds of fury broke loose because

people said you're going to make me do
what to clean up the air in my basement

there's no problem there my basement
I don't smell anything what

about the my water tastes funny so why
isn't he a worry about my water and E.P.A.

said Well we've tested your water and
it may taste a little bit funny but

it's perfectly safe it's your
basement it's dangerous and

it went all the way up to Congress and
coal Congress basically said the E.P.A.

You need to respond to
the public's concerns.

It's not about the role science it's
about what the public perceives So

this matters what do the experts say.

Who are the experts
are you guys the experts

yes you are to most of the world
you guys are sort of we're

the experts as soon as you say you're
a Georgia Tech people think that you're

kind of a weird expert but this becomes a
interesting question only politically but

legally because who is who is qualified
to provide information as an expert.

The courts have had to worry about this
in a variety of guises you know how

does a judge admit testimony from somebody
that says I'm a scientific expert and

I'm what I'm presenting
in the courtroom or

the case of an agency is what
science knows about nanotechnology

Well who says science knows that
what does that mean what if.

I mean I just wonder how many disciplines
are represented in this room physics

chemistry chemical engineering biomedical
engineering logical engineering what else

time is anybody material science Yeah so

there's material scientists qualified
to act as an expert on something that

involves biological effects
of exposure to particular

nanoscale phenomena Well
you might have a Ph D.

in material science or chemistry does
that make you an expert on biology.

This is a profound question that
agencies have to deal with and

we did a big study for the part of energy
number of years ago looking at how

scientists with Ph D.'s in science or
engineering.

Currently working in research capacity
is how they perceive risks and

it turns out that there is an enormous
variance in how scientists and

engineers from different fields working
in different sectors of the economy even

to some degree by gender
how they perceive risks so

it matters which expert you ask sometimes
I'm sure that doesn't surprise you

what will Congress say what will the court
say what will the president say if he

says we're going to do this who's going
to challenge them or question and.

Ultimately they also confront this
question it's something again that

agencies don't like to talk about where
they have to acknowledge this thing about

what is the right thing to do there are
always questions at some point where you

say well the law is unclear we
don't have clear guidance what

is the right thing to do so ultimately
that appears so real quickly and

it's going to go through a couple of
things this was the rule that E.P.A.

issued as a result of this new law and

I know you can't see it from back
from probably even the front row but

basically this is the Federal Register
something that comes out every single day

it's worth all the agencies say here's
what we're doing so everybody can see

today agency the CIA doesn't do
it not every agency but basically

all the regulatory agencies are required
to do this and so couple of years ago.

In twenty fifteen they started they issued
what was called a proposed rule and

they said here's what we're thinking about
doing now two years later they're saying

a proposed rule and what happens in
that period is I'm going to do that very

quickly but this is basically basically
saying here's what this rule is about

E.P.A. is requiring persons
that manufacture or process or

intend to manufacture blah blah blah and
it mentions that

include certain nanoscale materials and
how this stuff has to be reported.

Here's how to get involved here's how
you guys can know what's going on

they provide the information here is
the you can go online and look at all

the information E.P.A. has been using here
is the office the room number there is

the phone number for more information
here is Jemma all wood at A.P.A. he's

the guy who's in charge of doing all this
stuff here is his phone number his e-mail

address if you have any questions concerns
or objections he's your guy there's

no secret you know every person in this
room could leave here and five minutes

later be on the phone trying to talk to
Mr All that maybe he'll return your call.

But the process is amazingly open
most people don't realize is in some

ways the regulatory process is the most
democratic small of the democratic process

we have in the United States because it is
this open and permeable a bit more on that

here's some guidelines they
provide on how to comment OK So

the E.P.A. issues a proposed rule and
they say anybody if you don't like this or

if you've got contrary evidence you
can comment here's how to comment

they even give you guidelines to me
reminding you things like please read and

understand the document that you're
commenting on that would be good

explain your views clearly
avoiding the use of profanity or

personal threats suggest alternatives and
substitute language for

your requested changes base your comments
on sound reasoning scientific evidence and

so forth describe any assumptions
you're making if you're

if you're estimating cost and benefits
please explain how you arrived at this

estimate in sufficient detail to allow for
it to be reproduced or checked and so

forth so every one of you can comment.

They just goes on to talk about
the actions that it's taking.

This will all be in the slide deck
which I guess will be available to you.

Here's the point I wanted to make up for
this proposed rule there were eighty six

comments that were filed and
here's a partial list of them and

you can't see those even on the front
row but some of them are for example.

The titanium dioxide
Stewardship Council the Alliance of

Automobile Manufacturers the Nano
Manufacturing Association the U.S.

tire manufacturers Association executive
director of the nanotechnology again

coalition somebody from that part of
the ecology the state of Washington

the enzyme technical Association
Semiconductor Industry Association and so

forth there is one thing in here
called Anonymous public comment.

I didn't look at the numbers for this
one but its recent study of the F.D.A.

found that about eighty five
percent of comments that are filed

are filed by industry or
industry groups it's not.

Environmental groups or
consumer groups or individuals.

Most of the comments are filed by by
industry and these are people that can say

there is this detail here in what you're
proposing that just doesn't make sense.

And they know that they know how to
communicate effectively with these

agencies so here's an example this is
what my screen up your disappeared.

Comment five what E.P.A.

does what agencies do is they
grouped together the comments and

they say there were a whole bunch of
comments that dealt with this question.

Many commenters stated the proposal
gives too much discretion to interpret

compliance obligations I suggested
clarifying the definition of unique and

novel properties and so forth response
based on these comments E.P.A.

agrees that what is a reportable chemical
substance should be better defined in

clarified E.P.A. is finally in this rule
with further explanation of what you mean

by this and you can go through all of the
the docket and you can see times where.

You come it makes sense we we could
have done a better job here we've

adjusted things try intervening
with your member of Congress

to get a piece of legislation
adjusted based on your input or

the input from your company or
or trade association so

the process can work pretty darn
well it's also pretty darn slow.

I'll try to finish up quickly
how fast does this go.

Two thousand eight.

Hundred the sayings that was under
the Bush administration then

Obama came in September two thousand and

nine he said yeah we're going
to review that approach and

see whether we can include nanomaterials
in the same thing that the Bush

administration was saying that we're
not really going to pay attention to.

Twenty fifteen E.P.A. said it was formally
developing a rule twenty fourteen they

said they're developing a new
proposal twenty fifteen E.P.A.

issues the proposed rule twenty
sixteen Congress passes this new law

twenty seventeen Congress E.P.A.
in January E.P.A. issues this final rule

the one I was just showing you and
June of twenty seventeen E.P.A.

announced how it's going to try to
implement some of these things.

And last month the E.P.A. in its fiscal
year twenty nine thousand budget announced

that it's going to be conducting research
on a number of topics and basically no

one knows how the current administration
is going to in the current U.P.A.

is going to be dealing with what the Obama
come up with I mean they're going to be

constrained to some degree by all but how
how quickly they go in implementing things

and how they're going to implement it is
still to be still to be seen all right so

I'm just going to mention this one very
quickly there are a lot of agencies

are involved I've mentioned E.P.A. and
if V.A. but these are all of the federal

departments and agencies that participate
in the national nanotechnology initiative.

OK Everybody got that list memorized good.

And there are some of them here that have
asterisks which you can't see very well

and those are the ones that actually
have a budget dedicated and

the technology research and development
this is these are the dollar amounts

again this will be on the slide
deck that if you can get these.

With all of those agencies
working in this area there's got

to be some kind of coordination and
this is the denationalize

this is the Nanoscale Science Engineering
and Technology subcommittee.

Who's up here at say we've got Office
of Science and Technology Policy Office

of Management Budget Consumer Product
Safety Commission Department of

Commerce just going on the left and that
could the Patent and Trademark Office and

so forth apartment Defense Department
Education Energy Health and

Human Services Homeland Security Interior
and

so forth basically the entire federal
government is involved in some way in

the here are the names of the people I
don't know Danial JONES But Jim Kim and

Emily mock at O.M.B. those are the people
that work on that nano stuff for O.M.B.

which is part of the executive
office of the president.

One of them has a Ph D.

from Johns Hopkins in

something technical like a member also
has a master's in bioethics from Penn.

That's James Kim Emily Marquez a second

heard the graduate degrees were
in something in science and

engineering She has a law degree from
Oxford these are not amateurs these

are very serious people with you know
they're both in their early thirty's but

still these are these are these are people
so you know don't think about faceless

bureaucrats they don't know anything or
trying to influence these policies.

Congress.

With fine print up there on the top ride

a sample of the number of
congressional committees and

subcommittees that held hearings on and
on technology over a number of years and

there are more than that one of them
is the subcommittee on European affairs

Well it's because there is this question
about trying to harmonize whatever we do

in the United States within the regulatory
well with what the Europeans are doing on

regulating and the Europeans are a little
bit ahead of us in some ways there was in

their congressional nanotechnology caucus
this was a big enough issue that a number

of members of Congress Republicans and
Democrats House and Senate.

Got together occasionally and said This
is a big an issue for our state or for

our district and we're going to work
together to try to make good policy.

That this caucus disappeared
in two thousand and

eleven is kind of curious about
why I couldn't find a reason and

I think this might be
the reason this is funding for

nanotechnology by fiscal year and you can
see around twenty ten in two thousand and

eleven there's a peak and
then the funding starts to drop off when

funding starts to drop off so
does congressional interest so.

That might be why this
caucus disappeared but

from time to time Congress actually
gets pretty energized and and involved.

In the legal realm.

Not very much has happened yet
as the beginning of next year or

last year but there's been no
reported American case where.

Damages have been awarded to a person
claiming to be injured by nanoparticles

but that that still leaves the door
open for a number of things this will be

interesting to follow over the years final
of question is how do we get it right.

This is what a lot of you maybe want to
get this is all really complicated a lot

of legal political stuff how do we just
get it right first of all trying to figure

out what the problem is that we're trying
to solve how are these uncertainties that

we've talked about how are they going to
be resolved which institutions are going

to be involved and so forth what's the
time horizon for the problems the thing

I've been working on and ultimately what's
the objective when we want to have as

much good stuff from nanotechnology as
possible while minimizing the risk.

Seems seems reasonable.

That's a pretty broad objective So what is
it that we actually expect to happen well.

Sorry here's what I would expect to
happen first of all there's going to be

continuing an incremental regulatory
change sort of what we've been saying.

There was we should see some greater
coordination between agencies and

between agencies and industry and
things have gotten fairly comfortable so

people think we've got too comfortable
some kind of better regulation what

the European Union did was they set out
a code of conduct which basically set up

here this thirty thousand foot level we're
going to set up a some general principles

and then industry and agencies across the
E.U. can try to comply with those general

principles so it's regulations such
as voluntary data reporting so

forth public dialogue I've been seeing
a lot of stuff that says that the areas of

synthetic biology bioengineering medicine
and cosmetics are going to get more

attention over the next few years then
things like their machines environmental

issues and military uses So
if you doing stuff with the bio realm.

You'll be watched and

maybe there will be a prototype of that
some kind of a release some kind of

accident somebody claiming that something
happened to them so here are two visions

of the future on the left we've got how
nanotechnology could reengineer us.

And there are all sorts of examples
here this is out there in the public

with all kinds of examples of ways
that she's being fixed her bones or

tissues organs or
we all kinds of things by nanotechnology

the right is a fairly unfortunate
looking I think it's a guy.

And these are the diseases associated
with nanotech nanoparticle exposure and

all kinds of horrific things.

So we've got two visions of the world
here two visions of the future and

what's going to happen I'll just leave
it this way you're a Georgia Tech arse

current slogan is creating the next
I can't think of a better group of

people to put the challenge to
OK you're a Georgia Tech and

you're in the business of creating
the next so it's largely up to you OK

if you have any questions I don't
think we have some time for that.

I said that there are a number of people
in my school that have a strong interest

and some of us been doing work with folks
at their new technology center in Arizona

state summit Santa Barbara Moore Arizona
state so if any of you want

to pursue any of these questions further
with people outside the science and

engineering realm there are a number of
us you can contact me and I'll put you if

it's not me up and talk to somebody who's
an appropriate person to work with yes.

The language

it's often used is that the Europeans
are more open about adopting what's called

the precautionary principle in the
precautionary principle it's controversial

in this country and other places but
basically the question is

Where does the burden of proof lie does it
lie with the producers of the technology

to prove that something safe or does it
lie with say environmental groups and

government regulators to show
that something is dangerous so

the Europeans have proclaimed if they
do even the Conservative government

the United Kingdom a few years ago said
to of course we adopt the precautionary

principle which seems a lot
more restrictive you but to

put the burden of proof on the producers
of the technology the manufacturers to

say you got to show to us this
stuff is safe before you can do it.

So that's a lot of people
would say that for

that reason the Europeans are ahead but
they've also been.

Slow reluctant.

To get very specific about what is and
what isn't allowed.

The regulatory history of the ice States
is filled with examples of regulatory

agencies slowing things down because
the technology is changing so quickly

that whatever you say in June somebody
at Georgia Tech is going to come up with

something in October that's going to make
that standard obsolete so you have to sort

of let the technology ripen and mature
before you can set specific standards and

that's kind of what the Europeans have
been doing to their pronouncements have

been a bit broader and more ambitious but
I'm not sure that they're.

The details or are that different and
harmonization is a really

big issue because no one way that a lot of
companies have a really strong stake in

making sure that whatever the Germans the
French and the British say that the same

rules would apply to research and
production in the United States so

there were sort of it's a it's
a delicate dance between those realms.

When you think you're sure.