Environmental Politics and Law

EVST 255 - Lecture 16 - Evolution of Tobacco Law

Chapter 1. Efforts on the Part of the Industry to Understand Nicotine [00:00:00]

Professor John Wargo: Okay, let’s start in. I want to make a couple of announcements about readings for next week, just so that you all know where they are. They’re electronic, they’re up on the Classes server under Week Ten from March 30 to April 1. And there are four different readings, five different readings. Only two of these are required for section next week. The Rosenbaum public lands overview, as well as the Girard piece on carbon sequestration strategies. And the others are for your own edification. We’ll be talking, we’ll be moving into a discussion about the ecological basis of land use planning and regulation as of next Tuesday, so a basic understanding of the way that ecosystems are distributed around the world is kind of important background literacy for anybody thinking about the way to manage public lands or private land use. So I encourage you to browse those other readings that are on the site. But the Girard and Rosenbaum readings are the ones that are required.

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 [cigarettes] 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.

Chapter 2. Tobacco Industry Challenges FDA; Various Settlements [00:11:07]

Now, by the late 1990s, major medical organizations around the world had concluded that nicotine is addictive, including the U.S. Surgeon General, 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.

Chapter 3. If It’s a Drug, Where’s the Benefit? [00:20:24]

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.”

Chapter 4. Family Smoking Prevention and Tobacco Control Act [00:25:25]

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.

Chapter 5. Control Programs; Mass Media; Science and Industry [00:31:12]

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.

Chapter 6. Industry Arguments; Environmental and Consumer Group Arguments [00:37:09]

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. Exposure. 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.

Patent life, 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?

And finally, 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.

[end of transcript]

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