Today I want to continue
talking about tobacco. Because tobacco law is a
paradigm for many other problems that we’ve discussed,
but also demonstrates difficulties of managing the
relationship between freedom of choice and freedom of speech,
as well as managing certain kinds of hazards in the
environment. And I wanted to refresh your
memory about this idea that this industry evolved with the clear
recognition that the product that they were selling was not
aesthetically appealing on its own.
So the idea that you would have
to create a cultural preference for the product is really
intriguing. Think about if you were a
corporate leader and you were trying to figure out how to
invest your finances to increase your sales,
increase your profitability. Well, you’d wonder about what
forms of advertising you could use.
You’d think carefully about the
way that you would characterize hazards as opposed to product
benefits. And you probably would think
very heavily, very carefully about the way
that you would conduct your own research.
And I wanted to reemphasize a
couple of points here. And one is the way that
advertising had been targeted particularly to those that were
most vulnerable to adopting cigarette products,
tobacco products in the early teens,
really between the ages of twelve and fifteen years of age.
And I also want to bring to
your attention one target of advertising that I didn’t
discuss the other day, which is interesting.
There is an overlap obviously
between the intensity of physical activity among the
young, so that the youngest are most physically active.
And those that participate in
sports became figures that promoted tobacco use in a
variety of different media. There was a concentration,
not just to target women and ethnic groups,
but also exceptional athletes in a variety of different
sports. So claims that “They don’t
get your wind,” as an example,
appeared in Popular Mechanics more than half a
century ago. I also did not talk about other
kinds of tobacco products, and it was curious,
because I had a class several years ago with perhaps four or
five baseball team players. And I got to understand that
chewing tobacco is not uncommon at all among baseball players.
And there’s very little
understanding about the chemical content or the relative risk of
tobacco products, cigarettes as opposed to
smoking tobacco. So just to provide a quick
background set of statistics, the National Cancer Institute
has a site that reviews the presence of twenty-eight
different carcinogens in smokeless tobacco.
And one dose of smokeless
tobacco, depending upon the size that you pull out of the can,
has three to four times the nicotine level.
So that those that are chewing
tobacco absorb far more nicotine and it can be measured at higher
concentrations in the blood than if you have a cigarette.
And it’s now used by almost
eight million people in the United States.
It’s also recognized to
increase risk of oral cancer that can cause bone degeneration
and different other illnesses of the nasopharyngeal cavity.
I also did not talk much about
specific advertising targeted to young kids.
But the idea that Big League
Chew chewing gum, for example,
would allow a kid to think that they were behaving like a Major
Leaguer by chewing bubble gum the way that the Major Leaguers
chew tobacco. And also, the sale of
cigarettes in candy form to children.
These are still marketed in the
United States today. One other fact that I didn’t
discuss is the idea of freedom of choice relative to children
growing up in families that smoked.
I grew up in a family that
smoked, and just have vivid memories of being in the
backseat of a car filled with smoke or sitting around the
kitchen table where parents smoked and perhaps some of you
have had that same experience. The estimate today is about
twenty-five percent of kids between the ages of three and
eleven grew up with one smoker in the household.
So thinking about the freedom
of choice argument on the part of the industry relative to this
population poses some particular problems.
And I left you the other day
talking about the efforts on the part of the industry to
understand nicotine and the human response to nicotine.
And I want you to think about
this a little bit more carefully.
So this general counsel to
Brown and Williamson back in 1963,
so almost fifty years ago, claimed,
“Well, we are then in the business of selling nicotine,
an addictive drug.” Beyond nicotine,
by the way, there are many other hazardous chemicals in
tobacco smoke, and I’m not going to spend any
more time on this than to let you know that dozens of
compounds are really very well recognized and they are the
targets of a variety of different types of environmental
laws. So these chemicals are tightly
restricted under the Safe Drinking Water Act,
the Clean Air Act, the hazardous pollutant
regulations. So that the idea that they
would escape regulatory attention in a tobacco product
where the dose would be so much higher than you would get if you
were exposed to outdoor air to low levels in drinking water is
really a very interesting thought.
Now, David Kessler,
who wrote Question of Intent,
when he spoke in this lecture, knew of my interest and the
research I was then doing on pesticides.
And he pointed me to an expert
in Switzerland, who had pulled together
information on pesticides used to produce tobacco.
So nobody had ever looked at
the number of chemicals that were allowed for use or what
happened to them when the tobacco itself burned.
So it turned out that there are
about 101 different pesticides used on tobacco.
And when they are burned,
some concentrations make their way into indoor air,
but others transform. So that the mixture of known
carcinogens that are not pesticides with these pesticide
metabolites or combustion by-products is really quite a
remarkable mixture of substances.
Now another idea that Kessler
had that I’ve taken up in a variety of different research
projects has been to explore patents as a way of
understanding what a corporation knew about a product and when
they knew it and how their advertising matched up with
their background knowledge of benefit as opposed to risk.
So if you look at some of these
patent examples that the Food and Drug Administration was able
to conduct research on, you find that back as early as
the 1960s and through the ’70s, ’80s, and 1990s,
the companies were conducting intensive research on nicotine
content. So if you take a look at the
first patent description. And increased nicotine content
in the tobacco smoke by use of a nicotine-ion exchange placed in
the filter. What?
Placed in the filter?
I thought filters were supposed
to take out particles or dangerous chemicals.
So they were thinking that they
might even add the nicotine to the filter.
The second, increase nicotine
content in the smoke of a tobacco product by adding
nicotine to carbon black in the filter.
The next, add tobacco extract
containing nicotine to the filter of cigarettes.
The next one,
create a device to deliver increased nicotine by applying
nicotine solution to the filter. And finally,
on this sheet, method of producing a wrapper
for a smoking rod, a cigarette,
which has a screen printed on it,
among other things, a physiologically active agent
such as nicotine. So thinking about adding ink to
the paper, thinking about adding liquids
and vapors to the filters, as well as the example that I
described the other day, increasing the ammonia content
in the tobacco that would free up more nicotine.
So all with an idea to
manipulate the dose that the individual would get per
cigarette. The list goes on.
And the idea of putting other
additives in that would make high nicotine content less
harsh, because nicotine can be very
irritating to the throat and the nose.
And also lowering the ratio of
particulate matter of nicotine and smoke using internal heat
sinks and special nicotine-containing absorbents.
So the cigarette product
itself, many have the idea that it’s simply tobacco.
It’s not at all.
It’s a very interesting
combination of different technologies,
all designed to manipulate the chemical mixture that the smoker
receives. And as this research was going
on, the slide that I showed you the other day kind of reinforces
that this knowledge was being incorporated in a manner that
allowed them to figure out how to increase the nicotine content
in cigarettes during the same period.
There was an interesting
article that was published in 1998 by a researcher in the
Tobacco Control Journal. And it references a memo
that was quoted in that journal. “We are searching
explicitly for a socially acceptable addictive product
involving a pattern of repeated consumption,
a product which is likely to involve repeated handling,
the essential constituent is most likely to be nicotine or a
direct substitute for it.” So this is all just to say that
as these debates were going on inside Congress over whether or
not nicotine is an addictive drug,
there is a video that I’ll put up on the website for you that
shows all of the tobacco executives,
the major corporate executives, appearing before Congress.
And one Congressman asked them,
Henry Waxman from California, “Gentlemen,
is tobacco or is nicotine addictive?”
And each one of them went down
the row, “No, it is not addictive.”
And this was well after this
research had been published and well after this memorandum was
written. So that a central debate in the
management of the technology has been over the management of
nicotine. Now, by the late 1990s,
major medical organizations around the world had concluded
that nicotine is addictive, including the U.S.
the World Health Organization, et cetera.
So that this eventually
prompted Kessler, once he had all of this
information derived from patents,
but also derived from National Institute of Health
independently-conducted research and recognizing that there was
much research that had gone on in these companies that was
disclosed to the Food and Drug Administration.
They developed their proposal.
And this proposal is pretty
well laid out in the question of intent.
And it included a ban on
cartoon graphics, particularly with an eye to the
Joe Camel ad that I showed you a few days ago.
Text only is allowed in the
advertising, banning brand names on hats,
t-shirts, and other products,
they targeted event sponsorship,
requiring corporate names but not product names,
eliminating vending machines, free samples,
and mail order, and eliminating self-service in
stores, and suspending licenses to sell
to those who did not restrict sales to minors.
So the history of this FDA rule
is I think very interesting and will lead to what I think of as
one of the more important success stories in the late
twentieth century that swirl around these environmental
health cases. The FDA rule proposed in August
of 1996 by President Clinton at Kessler’s urging was announced
by the Food and Drug Administration.
The tobacco industry,
within a matter of a couple of months,
filed a lawsuit against the FDA rule arguing that the Food and
Drug Administration had no authority over tobacco products
under the Food, Drug, and Cosmetic Act,
basically that tobacco products were not a drug,
that the cigarettes or the cigars were not a drug delivery
device. And they also argued that FDA’s
rules on marketing restrictions violated the First Amendment.
So we had the right to make
claims about our product and to sell it.
The major plaintiffs in the
case included these corporations.
And as a sideshow,
which is a bit interesting, back in 1997,
John McCain introduced the Universal Tobacco Settlement
Act. And the Senate passed a revised
version of the McCain bill that included many elements of the
FDA rule. So rather than the government
agency, the Food and Drug
Administration just adopting these regulations without going
specifically to Congress, the McCain strategy was,
well let’s try to push this through Congress and see how far
we can get. But it was defeated in the
Senate just about a year later. The U.S.
Court of Appeals ruled in a
two-to-one vote that FDA had no authority to regulate tobacco
products in 1999. Because it ruled that FDA had
no authority, the Fourth Circuit did not rule
on whether or not FDA’s rules or marketing restrictions violated
the First Amendment. And just as a background,
because we haven’t spent much time on the overall structure of
the judicial system, there are ninety-four federal
district courts in the U.S., there are ten regional
appellate courts. And then obviously one Supreme
Court with one justice and eight associates.
Now in part because of
recognition of the medical costs associated with treating people
that had tobacco-related illnesses,
attorneys general from more than forty states got together
and launched a lawsuit. And this eventually was settled.
It was called the Master
Settlement Agreement with the Tobacco Industry.
And as you may or may not know,
most lawsuits don’t make their way to a trial or to a jury.
Most are settled.
And in this case,
in 1998, the attorneys general from forty-six states signed
this agreement with four of the biggest companies,
tobacco companies, in the nation.
And it prohibited tobacco
advertising that targeted kids younger than eighteen years of
age. So, once again,
this is kind of an interesting story that kids play an
important role in the history of the product regulation.
So what were key elements of
this settlement? Well, first that tobacco
companies could not use cartoon characters, that tobacco
companies could not target youth in advertising or promotion.
Tobacco companies could not
sponsor concerts or other events with significant youth
audiences. And tobacco brand names cannot
be advertised at stadiums and arenas.
So here you see three different
institutional arenas basically considering the same issues.
You see the Food and Drug
Administration attempting to regulate by adopting
regulations. And you find the attorneys
general using litigation as a way of forcing settlement so
that you get the companies themselves to agree that they’re
not going to do these things. That’s a very different
approach than having FDA tell them that they can’t do those
things. And then you have the McCain
initiative in Congress. So the curious thing about this
is that you can think about a variety of different
institutional targets for legal reform.
Should you target the federal
government? Should you target a federal
regulatory agency trying to get them to adopt new regulations?
Or should you use the judicial
system. So that in this case,
all three institutional venues were being exercised.
I also wanted to pose another
problem to you. And that is that like other
types of environmental problems, there are certain groups in
society that are at special risk.
And in this case the Americans
with Disabilities Act was used to eliminate or limit
environmental tobacco smoke in the workplace.
And it requires that an
employer make a reasonable accommodation to the known
disabilities of an employee who requests the accommodation.
So that workers used the
Americans with Disabilities Act effectively to clear up the air
within workplaces. Another settlement proved
interesting, an occupational question as well.
The airline flight attendants
were concerned about their intense exposure to tobacco
smoke. And you’re probably too young
to remember flying when cigarette smoking was allowed on
aircraft. But the distinction between the
smoking and the no smoking zone was simply a row number.
So row number twenty-three and
forward might allow smoking and row number twenty-four and back
would not. So you could very easily be
sitting next to somebody smoking.
And the air inside the cabin is
controlled by the pilot who decides on what the refresh rate
will be. It’s called bleed air that
comes off of the engines and circulates back through the
aircraft. So that at high altitudes,
the temperature is really low so that it means that they have
to expend more fuel the more they recycle or refresh the
quality of the air from the outside to heat it back up to a
comfortable cabin temperature. So there’s a tendency not to
refresh that air. There was an interesting case
just a couple of months ago about an airliner that had a
fuel leak that had seeped into that bleed air and passengers
claimed that they were quite ill once they landed,
including many of the flight attendants.
So let’s take a look at the
Food and Drug Administration case versus Brown &
Williamson and the Supreme Court ruling on March of 2000
that was issued in a five-to-four decision.
This was interesting,
because it basically concluded that existing law does not
provide FDA with authority over tobacco or tobacco marketing.
They claimed that FDA
consistently stated before 1995 that it lacked jurisdiction over
tobacco. So the shift in the
administrator of the Food and Drug Administration,
they were arguing, was the only reason that they
were taking this issue on. And the Congress had enacted
several tobacco-specific statutes that fully demonstrated
that they had not intended that these regulations proposed by
the Food and Drug Administration be adopted.
So Congress considered and
rejected many bills that would have given the agency that
authority. So the argument that the
Supreme Court bought was that this was a matter that should
have been dealt with in Congress specifically,
but Congress chose not to deal with it.
So what if you look more
carefully at it? Well what if you ask the
question, well, should it be considered to be a
drug under the Food, Drug and Cosmetic Act?
And you might read the
statement by an RJ Reynolds executive.
“In a sense,
the tobacco industry may be thought of as being a
specialized, highly ritualized and stylized
segment of the pharmaceutical industry.
Tobacco products uniquely
contain and delivery nicotine, a potent drug with a variety of
physiological effects,” and say case closed.
You know, the evidence is clear.
They even believe themselves
that tobacco products should be classified or are a type of
drug. Well, the decision,
as the Supreme Court interpreted it,
and don’t forget that this was a five-to-four decision,
which is interesting, because the dissenting opinions
are something that you probably have not read.
But I commend to you the
opinion of Steven Breyer, which I think is perhaps the
most cogent. So that the definition of a
drug turned out to be dependent in turn about whether or not
there was an identifiable benefit.
So, and I’m going to quote:
“Various provisions in the Act require the agency to
determine that at least for some consumers,
the product’s therapeutic benefits outweigh the risks of
illness or serious injury…This the FDA cannot do,
because tobacco products are unsafe for obtaining any
therapeutic benefit. The inescapable conclusion is
that there is no room for tobacco products within the
FDCA’s, Food, Drug, and Cosmetic Act’s,
regulatory scheme. If they cannot be used safely
for any therapeutic purpose and yet they cannot be banned,
they simply do not fit” the legal scheme that Congress
had intended. And Sandra Day O’Connor wrote
this opinion: “The agency has amply
demonstrated that tobacco use, particularly among children and
adolescents, poses perhaps the single most
significant threat to public health in the United
States.” Yet, “we believe that
Congress has clearly precluded FDA from asserting jurisdiction
to regulate tobacco products.”
Now many people heard about
this decision and they assumed that the Supreme Court was off
their rocker, that they really were
concluding something that was not morally defensible.
But their job is not to
conclude what is morally appropriate or morally
defensible. Their job is to determine
whether or not an agency action in this case complied with the
intent and letter of the law. So that it’s important to
recognize that these are debates about the nature and the
language, the very specific language and
definitions contained in the statutes that provide the
authorizing language to the administrative agency,
such as the Food and Drug Administration.
So that continuing with this
opinion: “Congress has foreclosed a ban on such
products, choosing instead to create a
distinct regulatory scheme focusing on the labeling and
advertising of cigarettes and smokeless tobacco.”
Compared to pesticides,
where they created a scheme that now stands that the agency,
in that case the Environmental Protection Agency,
has to make a formal finding of reasonable certainty of no harm.
Not in this case.
Not in this case at all.
So that the focus on labeling
and advertising, rather than on risk assessment
or risk minimization, is a very different approach to
managing a product or a technology in the marketplace.
So its express policy is to
protect commerce and the national economy while informing
consumers about any adverse health effects.
Now, one might argue as well,
well, how did the tobacco industry get away with this
legal regime? How were they so successful in
escaping regulation? It’s almost the ideal situation.
So that they have the sense of
being regulated because of the advertising controls,
but they have virtual freedom to manipulate the chemical
composition of their products. So that if I were a tobacco
executive, I would think that legal regime
is pretty good and I would definitely defend against any
change in the legal regime that would increase the authority of
the Food and Drug Administration on the part of Congress.
So Justice Breyer’s dissent on
FDA’s authority is interesting. So: “According to the FDA,
only 2.5 percent of smokers successfully stop smoking each
year, even though seventy percent say
they want to quit and thirty-four percent actually
make an attempt to do so…The fact that only a handful of
those who try to quit smoking actually succeed illustrates a
certain reality. The reality that the nicotine
in cigarettes creates a powerful physiological addiction flowing
from chemically-induced changes in the brain…The FDA found
that the makers of cigarettes intend these physical effects,
hence nicotine is a drug, the cigarette that delivers the
nicotine to the body is a device,
and the FDCA’s language, read in light of its basic
purpose, permits the Food and Drug
Administration to assert the disease-preventing jurisdiction
that the agency now claims.”
So the issue seemed like it was
over until the Obama administration came into power
and all of these provisions that had been in the proposed
regulations on the part of the Food and Drug Administration
made their way into bills that were introduced to the House and
the Senate that eventually became the Family Smoking
Prevention and Tobacco Control Act in June of 2009.
So this bill adopted by
Congress amends the Food, Drug, and Cosmetic Act to grant
the Food and Drug Administration authority to regulate the
advertising, marketing, and manufacturing of
tobacco products. What does it do?
Well, it restricts tobacco
marketing and sales to youth. It bans all outdoor advertising
within 1,000 feet of schools. It bans free giveaways of any
non-tobacco items with the purchase of a tobacco product.
It bans the sponsorship of
sporting events and entertainment events.
It limits to black and white
text only advertising in publications with significant
teen readership and restricts vending machines and
self-service displays to adult-only facilities.
And it continues to require
retailers to verify age for all over-the-counter sales.
By the way, I didn’t mention a
point that I meant to earlier. You know, we had talked about
preemption before. And under the different
statutes that we’ve looked at when would the federal
government preempt or prevent states from adopting different
kinds of regulations? Well preemption turns out to be
an important component in this case as well with respect to the
tobacco settlement. Now the tobacco settlement was
not law that was formed by statute.
It was not formed by
regulation, it was formed by agreement between attorneys
general of the states and the tobacco companies.
But the states started to
enforce the provisions of that settlement that brought the
questions into court. And some states,
such as Massachusetts and California, proposed advertising
that was distinctive and more restrictive.
Outdoor advertising bans so
that no billboards could be located within 1,000 feet of a
school in the state of Massachusetts.
Similar kinds of legislation in
a variety of different states. So that the Supreme Court
considered this in the 2000 decision and it basically
reinforced the preemption provision that was part of a
variety of different statutes. So that the court found that
preemption would prevent Massachusetts,
California, and other states from adopting more rigorous
advertising restrictions. It’s just kind of an
interesting point, how the attorneys general could
draw the settlement issue back into court and then it would
capture the Supreme Court’s attention.
So that basically,
you see the language being moved from the Food and Drug
Administration’s proposed regulations into statutory
language, and this was blessed by
Congress. It provides FDA with authority
to develop regulations that restrict advertising and
promotion to the full extent permitted by amendment to the
Constitution and it requires a detailed disclosure of tobacco
product ingredients for the first time.
So the tobacco companies have
to disclose not just chemicals used for the growing of tobacco,
but the chemicals in the tobacco plants themselves,
whether or not they’re genetically modified,
and what kinds of additives they placed,
not just in the tobacco but in the filter as well as the paper.
It also requires the FDA to
require changes to tobacco that would protect public health.
So public health now is a
decision-making standard that has to be viewed and treated
with every decision that FDA makes.
Oh, and one critical aspect of
this new statute is that FDA is now allowed,
granted the authority to reduce nicotine content or to ban
ingredients that it believes are hazardous,
but it’s not allowed to require the reduction of nicotine to
zero or to ban any particular class of products,
say cigars or chewing tobacco as an example.
It also controlled,
gives, FDA the authority to control reduced-harm products so
that the descriptors such as “light”
or “mild” or “low”
on labels or in advertising will now become subject to the
review of the agency. You’ll remember that the light
products that I showed you last Tuesday had higher nicotine
content in them than the normal products.
And it requires larger and more
specific health warnings to cover the top fifty percent of
the front and rear panels of the package.
And it directs the FDA to issue
a rule requiring graphic warnings on labels within a year
from now. So recall the Canadian
government’s tobacco labeling requirements as an example.
Curiously, they also transfer
the costs of all regulation back to the companies so that all
tobacco-related Food and Drug Administration costs now have to
be allocated among the manufacturers of cigarette
tobacco and smokeless tobacco products sold in the U.S.
based upon their different
shares of the marketplace. So in this interim time between
when the Food and Drug Administration was found by the
Supreme Court not to have authority to move forward on
tobacco and when in 2009 the Congress adopted the new
statute, what was happening?
Well, states became very active
in their own tobacco control programs.
And these programs turned out
to be really remarkable social experiments.
They turned out to be quite
effective. In California,
adult smoking dropped from twenty-six percent to eighteen
percent in about an eight-year period following a variety of
educational campaigns, public service announcements,
school programs. So that Massachusetts similarly
found a thirty-one percent decline between 1992 and 1999.
In Oregon, tobacco use fell
eleven percent. In Florida in one year,
teen smoking had gone down the fastest that it had since 1980.
The key elements have been mass
media campaigns, smoking bans and restrictions,
particularly in public places, in buildings as well as
restaurants. Price increases,
they found that tobacco adoption rates were extremely
sensitive to tax levels. So in the states that had the
most elevated taxes, you had the lowest adoption
rates. In states that had the highest
intensity of bans on place-based restrictions,
restrictions in buildings, they had the highest rates of
quitting. So that price sensitivity
turned out to be a really important component of the
strategy. And they also found that
different types of physician interventions–
nicotine patches–were much more effective when they were
combined with these other educational programs than they
had earlier believed. So basically another lesson
here is that mass media works. And remember the 1967 Fairness
Doctrine campaign that itself resulted in a significant
decline in smoking. In California,
the media campaign reduced sales of cigarettes by 232
million packs in only a two-year period.
And when media spending dropped
from sixteen million to six million, the program became less
effective. So that education is really
important and it works. Well, I want to step back from
this case and I want you to think about how this history
should be conceived. Should you be thinking about
this as a success story? Should you be thinking about
this as offering other lessons for other kinds of environmental
problems? And I’ve got a number of
students that went to Copenhagen in December and came back
throwing their hands up in the air not knowing really what
happened and feeling rather disillusioned with the inability
of nations to decide to agree on what level of carbon in the
atmosphere should be allowed or what the rate of use of
alternative forms of energy should be.
And this history,
as well as the other histories that I’ve showed you that you’ve
read about through the term I think should give you some sense
that legal reform is a long road.
It demands education,
it demands a shift in values and it demands willingness on
the part of those that are the culprits,
so to speak, the people that are behaving in
a way that adversely effects the environment.
It requires them to internalize
the values that are imbedded in the law, otherwise it’s not
going to work. So I view this as one of the
greatest examples we’ve got about how science had moved out
of the tobacco industry into the public sector funded by the
government. A very different view evolved
of what was risky and what was not.
A different quality of
knowledge developed about the nature of the health risks.
And it eventually led the
public to realize that this was a technology,
this was a product that demanded greater public
attention. And you can think of the
parallels between nuclear weapons testing,
think of the parallels between pesticides.
So once again, I’m not Dr.
Doom and Gloom,
I’m showing you examples in history that I think are really
remarkable success stories, such as the Limited Test Ban
Treaty, the Food Quality Protection
Act, and in this case, the statute that was just
passed. Now when you discuss this in
your sections this week, you probably will think about
different strategies that might be applied to control tobacco
and how the freedom to choose should best be limited.
So I’m going to do my own
little survey here. How many people here think that
the control of advertising is an appropriate way to control
tobacco products and associated risks?
How many people feel that
individuals ought to have the right to choose whether or not
they use tobacco products? How many people feel that
tobacco products should be banned?
Well, I’d say maybe eight to
ten percent of you think that tobacco products should be
banned. There’s remarkable consistency
year to year. I’ve asked this question for
the past decade in this class. And the number of people that
believe that, for example,
DDT or other hazardous air pollutants or pesticides should
be banned is normally far higher than it is for tobacco.
So explaining why that is is
really quite interesting. And I think that the
advertising schemes that I displayed to you over the past
couple of lectures play some role in having shaped cultural
attitudes and acceptance of this technology in ways that really
is quite remarkable. Now, I want you to think about
the nature of the politics too, in the last few minutes of the
lecture. What do you know,
what could you say about the forms of argument that we’ve
seen across the different cases that we’ve looked at?
How are they consistent and how
are they different? Well first, I’d like you to
take a look at some of the key industry arguments that we’ve
seen, where the promoter of the
product, the promoter of the service,
the promoter of the technology, the promoter of national
security in the case of the weapons testing or the War Games
testing in Vieques. They emphasize the benefit of
the product or technology or the social demand for it as the
logic for why it should be allowed to continue.
They argue that evidence is
insufficient to justify regulation.
They play the good scientist.
They develop the science
in-house and then present their interpretations of it to the
regulatory body. The industry or proponent would
trivialize claims of hazards and compare the hazards always to
natural hazards. Like, we experience risks from
flying across the country from radiation.
So the radionuclides in our
milk are relatively insignificant.
So figure out ways of
trivializing risk by using comparative metrics.
You find consistently across
these cases that exposure is often averaged among different
populations. It’s averaged over time,
it’s averaged over space, it’s averaged demographically.
And this act of averaging,
when you have a really– the image is really one of
pockets of risk, the averaging is going to
compress peoples’ perception of and the magnitude of the risk.
So paying attention to the
distribution of risk has been very important to legal reform
in all of these cases. Age restrictions also.
The role of kids,
the concern of society for the very young,
for the fetus, for the kids,
for future generations, this is an appeal on the part
of consumers that is often quite effective and leads industry to
still fight a ban, like to fight prohibition,
but to accept age restrictions, to accept labeling,
to accept training requirements or licensing requirements.
So the strategy,
if you are the corporate executive, is to well,
fight those, but to accept them instead of
taking a product prohibition. Registration is a property
right. They will always fight that if
you take away the right to do what they did in the past that
you have to compensate for them under the Fifth Amendment of the
Constitution. So treat your registration,
treat your past freedom to sell, your freedom to choose,
as a property right and demand compensation.
And courts have traditionally
responded favorably to these arguments.
push for the longest patent life that you can.
And you basically want to fight
regulation until the end of your patent life,
which at that time, the product becomes generic,
it can be picked up by other corporations.
You find this with pesticides,
you find this with drugs. So that the industry will fight
to keep the product in the marketplace until the end of
that patent life, which is now a twenty-year
period. And you often find litigation
effective in delaying prohibitions for fifteen to
twenty years. So it’s a very effective
strategy. And often–if you’ve invested
say a hundred million dollars, there was one pesticide that I
worked on where a hundred million dollars was invested in
this chemical to bring it to the marketplace and to study it–
if you’ve invested that amount of money,
it often takes you to seventy-five percent of the
patent life to start to get a return on that investment.
So the profitability for new
drug, the profitability for a new
expensive technology, expensive to bring to the
marketplace, it often doesn’t pay off until
that last five-year period. So that’s a guarantee that
you’re going to have a legal fight.
Strategically regulate rather
than ban. Argue that well,
can I use the product in this way but not that way?
Can I continue to sell the
tobacco in cigarettes if not cigars?
Could I continue to use a
pesticide outdoors if you ban it indoors?
So try to maintain market share
anyway that you can, and if you can’t,
if they decide no it’s going to be banned, then let us export
it. Please let us export it to
other nations. Substitutes,
don’t compare us among competitors.
Make sure that you focus
exclusively on our product because we don’t want the risk,
the threat, the environmental damage from our product to be
thought of an in an additive way with competitors’ products.
Another logic is comparative
risk. Well, the risk associated with
our product or our behavior or our technology is really minimal
compared to the risk of not using the latest safety
technology in a car, trying to launch a suicide
prevention program, a drug control program,
etcetera. Finally, self-study,
self-monitoring and self-reporting.
Let us do the studies and then
provide you with the data. Don’t set up an independent
organization to do that. So let us report not only on
the nature of the danger but also on its distribution and
what its cost to society might be.
Now how about the environmental
and consumer groups’ arguments? How would they respond?
Well, their response has been
pretty consistent. Let’s shift the burden of proof
back to the private sector to demonstrate safety.
Why should the public have the
burden to demonstrate danger in all of these cases?
It takes too long and you often
can’t demonstrate danger. So let’s have the expense,
the time and the burden to rest on the private sector.
Second, they’ll argue that
evidence is insufficient to justify finding safety.
So they will delay for the same
reasons that industry would delay, saying that the evidence
is insufficient to justify increased regulation.
But if this burden of proof is
switched, it’s basically providing a mirror image to the
former regulatory regime. Susceptibility.
Think about how susceptibility
varies in the population. Again, all the cases that we’ve
looked at in the course so far have involved those that are
especially vulnerable, those that are especially
exposed. So look at exposure patterns
and how they vary by age class. Look at variability by
ethnicity. Look at differences in use
patterns or behavior among different ethnic groups,
perhaps in different seasons, perhaps in different parts of
the country, so that looking at variability
and how that plays out in how goods and bads are distributed
is really important to all the cases.
Think about mixtures.
Don’t just regulate single
products or single compounds, but think about regulating the
entire mixture. We’ve seen that with respect to
diesel exhaust. Tobacco smoke is another good
example. It’s the mixture that’s being
regulated, not the individual component, with the exception of
nicotine. Aggregated exposure.
So think about where you might
get exposed to the same kind of threat from a variety of
different sources, from air, from water from
foods. Think about the pace of review.
Make sure that if you give an
agency a burden to transform an industrial sector from being
risky to being safe, what’s the pace of review that
you’re going to demand? How long are you going to give
them? And remember the idea of a new
technology that would change vehicle emissions under the
Clean Air Act? That requires a four-year
period that the industry has to retool,
to think about how they’re going to redesign their engines
to meet that new standard. So restricted use and label
changes and ecological restrictions are often critical
arguments of environmental and consumer use,
consumer protection groups. And environmental testing,
make certain that the environmental testing is
independently conducted. Finally are the most exposed,
also the most susceptible? Try to figure out how to adjust
the legal regime if you can to protect those that are exposed
and those that are most at risk. And can you do that in a way
that would allow continued use of the technology?
So can you protect kids from
tobacco in a way that would provide sufficient respect for
the value that we assign to the freedom to choose?
oppose federal preemption of state and local controls.
So environmental groups will
commonly oppose preemption because they want 1,000
regulations to bloom. They want California to have
the opportunity to adopt more rigorous regulations,
because California’s population and consumer market share is so
extraordinarily high as a percentage of the U.S.,
what happens in California is going to happen in the United
States. And what happens in the United
States is going to happen abroad.
So if you restrict the ability
of a lower level of government to adopt these regulations,
then you are not going to have the innovation in legal reform
that you otherwise might. So I’ll leave you with these
ideas to think about how you might conduct these comparisons,
and also how you might take some of these strategies to the
problems that you care about. So I’m going to break here and
I think that we are all set to give the exams back,
so if you could perhaps spread yourselves out across the front
so not everybody comes to the same place,
that would be terrific.