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Archive for the ‘Required reading’ Category

Trade Secrets Documentary by Bill Moyers

 

 

Trade Secrets – Transcripts

TRADE SECRETS: A MOYERS REPORT
PROGRAM TRANSCRIPT

TEASE:

NARRATION: They are everywhere in our daily lives – often where we least expect them.

DR. PHILIP LANDRIGAN, CHAIRMAN, PREVENTIVE MEDICINE, MT. SINAI SCHOOL OF MEDICINE: We are conducting a vast toxicologic experiment, and we are using our children as the experimental animals.

NARRATION: Not a single child today is born free of synthetic chemicals.

AL MEYERHOFF, FORMER ATTORNEY FOR THE NATURAL RESOURCES DEFENSE COUNCIL: With chemicals, it’s shoot first and ask questions later.

NARRATION: We think we are protected but, in fact, chemicals are presumed safe – innocent – until proven guilty.

SANDY BUCHANAN, EXECUTIVE DIRECTOR, OHIO CITIZEN ACTION: Years of documents have shown that they knew they were hurting people, much like the tobacco industry.

PROFESSOR GERALD MARKOWITZ Ph.D, JOHN JAY COLLEGE: Historians don’t like to use broad political terms like “cover-up,” but there’s really no other term that you can use for this.

NARRATION: In this special investigation, we will reveal the secrets that a powerful industry has kept hidden for almost fifty years.

TRADE SECRETS: A Moyers Report

PROLOGUE:

NARRATION: There is a three-hundred mile stretch along the coast where Texas and Louisiana meet that boasts the largest collection of petrochemical refineries and factories in the world.

Many who live and work here call it “Cancer Alley.”

RAY REYNOLDS: Many, many nights we were walking through vapor clouds and you could see it. You know how a hot road looks down a long straight? Well, that’s exactly what it looks like – wavy. We would complain about it, and they would pacify us by saying, there’s no long term problem. You might have an immediate reaction like nausea, but that’s only normal. Don’t worry about it.

NARRATION: In the living room of his house a few miles from the chemical plant where he worked for 16 years, Ray Reynolds waits out the last days of his life. He is 43 years old. Toxic neuropathy – poisoning – has spread from his nerve cells to his brain.

MOYERS: What’s the prognosis? How long do they give you?

REYNOLDS: They don’t. There’s too many variables, and there’s too much unknown about it.

NARRATION: Dan Ross had no doubt about what made him sick. Neither does his wife of 25 years, Elaine.

ELAINE ROSS: Went to a dance one night, and he walked in the door, and I had never seen him before, didn’t know what his name was or anything, and he started shooting pool with a bunch of his friends, and the friend that I was with, I told him, I said, “That’s who I’ll spend the rest of my life with.”

MOYERS: Love at first sight?

ROSS: Uh huh.

MOYERS: Did he think that?

ROSS: No.

MOYERS: You had to, had to…

ROSS: I had to persuade him. When we got married, he was still in the Air Force, so he spent eighteen months overseas. When he got back, he had an eighteen-month-old daughter. And so probably the main thing was, he was worried about making a living for everybody, for us.

NARRATION: The plant where Dan Ross made that living produces the raw vinyl chloride that is basic to the manufacture of PVC plastic.

ROSS: Danny worked for them 23 years – and every single day that he worked, he was exposed. Not one day was he not exposed.

As the years went by, you could see it on his face. He started to get this hollow look under his eyes, and he always smelled. I could always smell the chemicals on him. I could even smell it on his breath after a while. But even up until he was diagnosed the first time, he said, “They’ll take care of me. They’re my friends.”

NARRATION: In 1989, Dan Ross was told he had a rare form of brain cancer.

ROSS: He and I never believed in suing anybody. You just don’t sue people. And I was looking for answers. Since I couldn’t find a cure, I wanted to know what caused it.

NARRATION: Looking for an answer, she found something that raised more questions instead.

ROSS: I was just going through some of his papers, and I found this exposure record. It tells you what the amount was that he was exposed to in any given day.

MOYERS: Somebody’s written on here, “Exceeds short-term exposure.” What does that mean?

ROSS: That it was over the acceptable limit that the government allows. So this exceeded what he should have been exposed to that day.

NARRATION: There was also a hand-written instruction.

MOYERS: And then there’s writing that says?

ROSS: “Do not include on wire to Houston.”

MOYERS: Don’t send this to the headquarters?

ROSS: Right.

ROSS: My question was: Why wasn’t it included – why was it held up from going to Houston?

MOYERS: What did you take that to mean?

ROSS: Somebody’s trying to cover something up. Why?

NARRATION: Her discovery led Dan and Elaine Ross to sue.

ROSS: And I promised him that they would never, ever forget who he was, ever.

DOCUMENT WAREHOUSE

NARRATION: And this is the result of that vow.

MOYERS: How long did it take you to gather all this?

WILLIAM BAGGETT, JR, ATTORNEY: Ten years.

NARRATION: Over those ten years, attorney William Baggett, Jr. waged a legal battle for the Rosses that included charges of conspiracy against companies producing vinyl chloride. Dan’s employers – and most of the companies – have now settled. But the long legal discovery led deeper and deeper into the inner chambers of the chemical industry and its Washington trade association. More than a million pages of documents were eventually unearthed.

In these rooms is the legacy of Dan Ross.

We asked to examine the documents buried in these boxes – and discovered a shocking story.

It is a story we were never supposed to know – secrets that go back to the beginning of the chemical revolution.

NARRATION: It was love at first sight. In the decade after World War II, Americans opened their arms to the wonders of chemistry.

Synthetic chemicals were invented to give manufacturers new materials – like plastic.

Pesticides like DDT were advertised as miracle chemicals that would eradicate crop pests – and mosquitoes.

The industry boomed.

Since then, tens of thousands of new chemicals have been created, turned into consumer products or released into the environment. We use them to raise and deliver our food. We clean our carpets and our clothes with them. Plastics carry everything from spring water to cooking oil. They’re in our shower curtains and in our blood bags. They are the material of choice in our children’s toys.

But there are risks that come with the benefits of the chemical revolution.

MT. SINAI SCHOOL OF MEDICINE

MOYERS: In this arm?

NURSE: Preferably, if that’s where your vain is good at.

NARRATION: Specialists in public health at the Mt. Sinai School of Medicine in New York – led by Dr. Michael McCally – are trying to assess how many synthetic chemicals are in our bodies. For the purpose of this broadcast, I volunteered take part in their study. A much larger project is underway at the US Centers for Disease Control.

MOYERS: And you’re looking for chemicals?

DR. MICHAEL McCALLY, VICE-CHAIRMAN, PREVENTIVE MEDICINE, MT. SINAI SCHOOL OF MEDICINE: Not the body’s normal chemicals. We’re looking for industrial chemicals, things that weren’t around 100 years ago, that your grandfather didn’t have in his blood or fat. We’re looking for those chemicals that have been put into the environment, and through environmental exposures – things we eat, things we breathe, water we drink – are now incorporated in our bodies that just weren’t there.

MOYERS: You really think you will find chemicals in my body?

McCALLY: Oh yes…no question. No question.

DOCUMENTS

NARRATION: These secret documents reveal that the risks were known from the beginning. The chemical industry knew much more about its miracle products than it was telling. And one of the most toxic was vinyl chloride – the chemical Dan Ross was working with.

PROFESSOR GERALD MARKOWITZ Ph.D., JOHN JAY COLLEGE: One of the indications they knew they should have been telling the work force and public about this is that they mark all these documents “secret,” “confidential.” They tell each other in these documents – “Keep this within the company, do not tell anybody else about this problem.” So they know this is dynamite.

NARRATION: Gerald Markowitz and David Rosner are historians of public health in New York. They were retained by two law firms to study the Ross archive.

DAVID ROSNER, Ph.D., COLUMBIA UNIVERSITY: They certainly never expected historians to be able to look into the inner workings of their trade association and their vinyl chloride committee meetings and the planning for their attempts to cover up and to basically obscure their role in these workers’ deaths.

NARRATION: The hidden history begins with a document from May, 1959.

To: Director, Department of Industrial Hygiene, The BF Goodrich Company.

“We have been investigating vinyl chloride a bit. … We feel quite confident that 500 parts per million is going to produce rather appreciable injury when inhaled 7 hours a day, five days a week for an extended period.”

NARRATION: It is early correspondence among industry medical officers who were studying the effects of working with vinyl chloride. At the time, workers were regularly exposed to at least 500 parts per million.

November 24, 1959. Inter-company Correspondence, Union Carbide.

“An off-the record phone call from V.K. Rowe gives me incomplete data on their current repeated inhalation study. …Vinyl chloride monomer is more toxic than has been believed.”

NARRATION: BF Goodrich was one of the vinyl chloride producers in on the industry’s private conversations.

BERNARD SKAGGS: I started there in June–it was June the 3rd, 1955.

MOYERS: ’55.

SKAGGS: Uh-huh.

MOYERS: When you began, did you think the work might be dangerous?

SKAGGS: No. They told us it wasn’t. The only thing we had to watch about the vinyl chloride was not getting enough of it pass out.

NARRATION: Fresh out of the Army, Bernard Skaggs went to work at the BF Goodrich plant in Louisville, Kentucky.

There, vinyl chloride gas was turned into a dough-like mixture that was then dried and processed into the raw material for PVC plastic. Bernie Skaggs’ job was to climb into the giant vats that spun and mixed the vinyl chloride – and chip off what was left behind. Workers called it “kettle crud.”

SKAGGS: There was vinyl chloride everywhere. The valve, overhead valves had charging valves over there where the vinyl chloride was pumped into the reactors. All of those leaked and dripped. Most of them dripped on the floor all the time. They said it had to be – I think it was – 1,500 parts per million before you could smell it. Not only could you smell it, you could see it. It would – it would get into a vapor, and through the sunlight it waved, waves, and you see it. It was all the time that way.

My hands began to get sore, and they began to swell some. My fingers got so sore on the ends, I couldn’t button a shirt, couldn’t dial a phone. And I had thick skin like it was burned all over the back of my hand, back of my fingers, all the way up under my arm, almost to my armpit. And after enough time, I got thick places on my face right under my eyes…

MOYERS: Did you think it might be related to your job?

SKAGGS: At the start, no.

NARRATION: BF Goodrich would discover the truth.

From: The BF Goodrich Company To: Union Carbide, Imperial Chemical Industries, and The Monsanto Company.

“Gentlemen: There is no question but that skin lesions, absorption of bone of the terminal joints of the hands, and circulatory changes can occur in workers associated with the polymerization of PVC.”

NARRATION: In other words, they knew vinyl chloride could cause the bones in the hands of their workers to dissolve.

“Of course, the confidentiality of this data is exceedingly important.”

MOYERS: What does this memo tell you? This particular memo?

ROSNER: Oh, it tells me the industry never expected that they would be held accountable to the public about what was happening to the work force. They never even expected their workers to learn of the problems that they were facing and the causes of it.

NARRATION: Bernie Skaggs’ hands were eventually X-rayed.

SKAGGS: I was really shocked.

MOYERS: What did you see?

SKAGGS: Well, on the hands, my fingers were all–you know, showed up–the bones showed up white in the x-ray.

MOYERS: In a normal x-ray.

SKAGGS: Yeah, normal x-ray, yeah. And mine were okay till they got out to this first joint out there. Then from there out, most of it was black. Some of them had a little half moon around the end, and then just a little bit beyond the joint. And I said, “What is that? You’ve really surprised me.” He said, “That–the bone is being destroyed.”

MOYERS: The black showed that there was no bone there.

SKAGGS: Yeah, right. The bone was disappearing, just gone.

MOYERS: Dissolving?

SKAGGS: Yeah.

RICHARD LEMEN Ph.D., FORMER DEPUTY DIRECTOR, NIOSH: It was the slowness of action on the industry’s part that was the most striking issue in reviewing these documents.

NARRATION: Dr. Richard Lemen was deputy director of the National Institute for Occupational Safety and Health until he retired five years ago. The Baggett law firm hired him to analyze the secret documents.

LEMEN: The basic tenet of public health is to prevent, once you have found something, immediately stop exposure.

MOYERS: So they should have told the workers right then.

LEMEN: They absolutely should have told the workers. Even if it was only a suspicion, they should have told the workers what they knew and what they could do to prevent their exposure to what they thought was causing the disease.

NARRATION: That is not what happened. BF Goodrich did not tell the workers, even though its own medical consultants were reporting the truth.

October 6, 1966

“The clinical manifestations are such as to suggest the possibility of a disabling disease as a later development.”

NARRATION: What the company’s advisers feared was that the dissolving hand bones could be a warning of something even more serious.

“May be a systemic disease as opposed to a purely localized disease (fingers). …They (Goodrich) are worried about possible long term effect on body tissue especially if it proves to be systemic.”

MOYERS: “…proves to be systemic.” What’s that saying? Interpret that for a layman.

LEMEN: What that’s saying is that this disease may be much beyond just the fingertips, that it could have effects on other organs in the body or other parts of the body.

MARKOWITZ: If all the doctor is looking for is concerns about tops of the fingers and has not been told in the medical literature that this might be a systemic disease, that this information is kept within the chemical industry, then that worker is going to be misdiagnosed. The worker’s condition is going to get worse, and there is no telling what the effects are going to be for that worker.

MOYERS: He could die not knowing what had killed him.

MARKOWITZ: Absolutely.

NARRATION: Goodrich executives did tell other companies what was happening. But they hoped…

“They hope all will use discretion in making the problem public. …They particularly want to avoid exposes like Silent Spring and Unsafe at Any Speed.”

MARKOWITZ: They understand the implications of what is before them and they are faced with a situation that could explode at any minute, and they are…

MOYERS: Politically.

MARKOWITZ: Politically, culturally, economically – this could affect their whole industry if people feel that this plastic could represent a real hazard to the work force, and if it could present a hazard to the work force, people are going to wonder, consumers are going to wonder what is the impact that it could have for me.

WASHINGTON, D.C.

NARRATION: On April 30, 1969 – ten years after Bernie Skaggs first complained to the company doctor about the pain in his hands – members of the industry’s trade association met at their Washington offices. On the agenda was a report from a group of medical researchers they had hired.

Confidential. Recommendations.

“The association between reactor cleaning and the occurrence of acroosteolysis is sufficiently clear cut. The severity of exposure of reactor cleaner to vinyl chloride should be kept at a minimum…”

NARRATION: The advisers recommended that exposure to vinyl chloride be reduced by ninety per cent – from 500 parts per million to 50 parts per million. But the Occupational Health Committee rejected the recommendation.

“A motion to accept the report as submitted was defeated by a vote of 7 to 3.”

NARRATION: Instead, they changed the report.

“Eliminate the last sentence ‘Sufficient ventilation should be provided to reduce the vinyl chloride concentration below 50 parts per million.'”

MOYERS: What’s stunning to me is that at this meeting were, representing the companies, many people with MDs behind their name, MD the chairman, MD the vice chairman, MD, MD, MD. And they were among those voting against the researchers who had said we’ve got a problem here.

LEMEN: I think that that reflects who the medical doctor’s patient really was. Was their patient the workers in the plant – or were they representing their employer? This is a fundamental problem that we’ve had in public health for a long time – and that is, who is more important? Is it the chemical being produced or is it the human being producing the chemical?

NARRATION: For ten years, the bones in his fingers were disappearing. In that time, the industry never told him what it knew. Bernie Skaggs was kept in the dark – until a few months ago, when we handed him one of the secret documents.

MOYERS: There it is, in black and white. Do you want to read it?

SKAGGS: “There is no question but that skin lesions, absorption of bone of the terminal joints of the hands and circulatory changes can occur in workers associated with polymerization of PVC.”

MOYERS: That was describing the condition you had.

SKAGGS: Right, right.

MOYERS: At the same time they were –

SKAGGS: They were resisting anything –

MOYERS: They didn’t say they knew anything –

SKAGGS: And that bothers me, you know. Well, to think that they’d be this dishonest with me. After all of these years – and I put 37-1/2 years in that place – and that they could be dishonest enough not to even ever admit to me that what they did and what they had was what caused my problem.

MOYERS: Then there’s another. Let me read this. The consultants said “This may be a systemic disease, as opposed to a purely localized disease.”

SKAGGS : This is the first I’ve heard of this. I didn’t know that. The company did a good job of I guess I’d call it brain washing. They actually told us, and they told us this, that this vinyl chloride won’t hurt you.

MOYERS: What do you think when you look at all these documents?

SKAGGS: Makes me more bitter than I was.

NARRATION: By the early 1970s, Dustin Hoffman had been famously advised in the movie, “The Graduate,” that “plastics” was the future. But the vinyl chloride industry was hearing something else.

A scientist at an Italian plant, Dr. P.L. Viola, had exposed laboratory rats to vinyl chloride – and discovered cancer. As he steadily lowered the exposure levels in his tests, the cancer persisted. The discovery cast a pall over the promising future of plastic.

NARRATION: On November 16, 1971, the men from twenty vinyl chloride-producing companies gathered at the Hotel Washington to discuss the bad news.

“Publishing of Dr. Viola’s work in the US could lead to serious problems with regard to the vinyl chloride monomer industry.”

MOYERS: How would you characterize the industry discussion?

ROSNER: Close to panic. There is a whole new ball game out there about who is going to regulate industry, how much influence industry will have over these agencies, and the discovery of cancer, of course, is, you know, potentially not only a public relations disaster, but a regulatory disaster for this industry.

NARRATION: At the meeting, one of the European industry’s own scientists presented an even more disturbing report.

“Doctor LeFevre theorizes that vinyl chloride is absorbed in body fats and carried to the brain.”

NARRATION: Despite the startling prospect that vinyl chloride could affect the brain, the companies took no action – and told no one.

“The present political climate in the US is such that a campaign by Mr. R. Nader and others could force an industrial upheaval via new laws or strict interpretation of pollution and occupational health laws.”

NARRATION: A year later, another Italian researcher, Dr. Cesare Maltoni, found evidence of a rare liver cancer – angiosarcoma. In studies sponsored by the European industry, cancer appeared in rats exposed to levels of vinyl chloride common on factory floors in the US. The panicked industry came running.

MARKOWITZ: Two or three American representatives of the chemical industry go over to Bologna and the Europeans tell them that there are cancers now not only at the very high levels, at thousands of parts per million, but down to 250 parts per million. And yet they are determined to keep this secret. And they go so far as to even sign a secrecy agreement between the Europeans and the Americans so that each of their researchers will be secret from everybody outside the industry.

MOYERS: They get together, the American representatives and the European representatives, and they say this is top secret, we are not going to make it public…

MARKOWITZ: Exactly. They…

MOYERS: …to anybody? To the workers?

MARKOWITZ: To the workers.

MOYERS: To the doctors?

MARKOWITZ: To the doctors. No one is going to get this information except the companies who have signed the secrecy agreement.

NARRATION: Conoco, BF Goodrich, Dow, Shell, Ethyl, Union Carbide – some of the founding fathers of the chemical revolution – were among those who signed the secrecy agreement, even as they were admitting to themselves the bad news.

February 13, 1973. Union Carbide. Internal Correspondence. Confidential.

“Dow Chemical Company reviewed the work on the European study. They report the results on rats are probably undeniable.”

Ethyl Corporation. Inter-Office. Subject: Vinyl Chloride.

“All agreed the results certainly indicate a positive carcinogenic effect above or at 250 parts per million.”

NARRATION: The companies knew. Working with vinyl chloride – even at low levels of exposure – could cause cancer.

WASHINGTON, DC

NARRATION: By 1973, the federal government was trying to catch up with the chemical revolution.

A new agency – the National Institute for Occupational Safety and Health – NIOSH – published an official request seeking all health and safety information regarding vinyl chloride.

Two months later, a staff member of the industry’s trade association sent a letter to member companies urging that they tell NIOSH about Dr. Maltoni’s findings.

March 26, 1973

“There is the aspect of moral obligation not to withhold from the Government significant information having occupational and environmental relevance… ”

MCA BUILDING

May 21, 1973. Manufacturing Chemists Association. Minutes of meeting.

NARRATION: But meeting in their conference room in Washington, they discussed keeping secret what they knew of the dangers posed by vinyl chloride.

“We should not volunteer reference to the European project, but in response to direct inquiry, we could not deny awareness of the project and knowledge concerning certain preliminary results.”

MARKOWITZ: It is an extraordinary situation where they know they should be telling the Government about this problem. They know that they are wrong not to tell them. And then they admit that their engaging in this kind of activity can be legitimately seen as evidence of an illegal conspiracy.

May 31, 1973. Union Carbide. Internal Correspondence. Confidential.

NARRATION: A Union Carbide executive reported to corporate headquarters that if the March letter admitting knowledge of Maltoni’s work ever became public, it could…

“could be construed as evidence of an illegal conspiracy by industry…if the information were not made public or at least made available to the government.”

ROSNER: You kind of avoid as a historian the idea that there are conspiracies or that there are people planning the world in a certain way. You just try to avoid that because it’s–it seems too–too unreal and too frightening in its implications. Yet, when you look at these documents, you say yes, there are people who understood what was going on, people who thought about the crisis that was engulfing them or about to engulf them and tried in every which way to get out of that crisis and actually to, in some sense, to suppress an issue.

MOYERS: Do you think all of this added up to, to use your word, a conspiracy?

ROSNER: In a moral sense, I think it was a conspiracy.

NARRATION: We have learned from the secret archive that when the industry met with NIOSH, it did not mention Maltoni or angiosarcoma.

Union Carbide. Internal Correspondence. Confidential.

“The presentation was extremely well received and …the chances of precipitous action by NIOSH on vinyl chloride were materially lessened. NIOSH did not appear to want to alienate a cooperative industry.”

MARKOWITZ: Historians don’t like to use broad political terms like “cover-up,” but there is really no other term you can use for this because the industry had the information. They knew the significance of the information they had, and they refused to tell the Government because they were afraid the Government would take action to protect the work force.

MOYERS: And yet, during this time, Dan Ross and others like him, working in vinyl chloride plants, were being told there was nothing to worry about, that there is no danger.

MARKOWITZ: That’s correct. The industry kept assuring the work force that there was not anything that they need to be concerned about and that they were going to protect the work force.

MOYERS: But they didn’t.

MARKOWITZ: No, they certainly did not.

LAKE CHARLES, LOUISIANA

NARRATION: The companies involved were among those producing more than five billion pounds of vinyl chloride every year – and they were expanding. In 1967, one of them – Conoco – was finishing construction of a new complex in Lake Charles, Louisiana. Dan Ross moved his family into a small house less than a quarter of a mile from the new plant’s back door.

ELAINE ROSS: He went to work there, he started as a pumper loader. And he moved up fast in the first year that he was there.

MOYERS: He was eager for hard work or…

ROSS: Or he was smart, he was smart, and a hard worker.

NARRATION: Another early hire at Conoco was Everett Hoffpauir – who took the job shortly after he returned from serving in Vietnam.

EVERETT HOFFPAUIR: We were in the start-up phase, and early operation phase, and they were getting all the bugs out of it, and we had a lotta releases, and we had a lotta problems. Prevailing attitude with management at the time was “Let’s get it back online; downtime is killing us.” So as long as it wasn’t gonna blow sumpin’ up, go on in there and do what you gotta do.

MOYERS: You were breathing it?

HOFFPAUIR: We were breathing it, get higher than a Georgia pine sucking on it, you know. It’s very intoxicating. It’s a lot like propane or any other light end, it’s aromatic and, like I say, it did give you a buzz if you stayed in it long enough.

Their attitude was, if you don’t wanna do the job, there’s four waitin’ at the gate waiting to take your job. Do it – or else.

Vietnam was winding down, had a lot of people that weren’t working or if they were, were working for a lot less money. And plant jobs were very attractive. So if you didn’t want to do the work, just say so – somebody’s waitin’ to take your place.

MOYERS: So you’d worry more about your job than about your health?

HOFFPAUIR: Well, sure you were. I had a wife and three kids at home that I had to feed, you know. Yeah. But nobody told you it was a real health hazard, so you didn’t worry about it.

NARRATION: But the companies were worried.

December 14, 1971. Ad hoc planning group for Vinyl Chloride Research.

NARRATION: To counter the damaging information from the European animal studies, the industry commissioned a confidential study of its own workers that it planned to use in its defense.

“The need to be able to assure the employees of the industry that management was concerned for, and diligent in seeking the information necessary to protect their health. The need to develop data useful in defense of the industry against invalid claims for injury for alleged occupational or community exposure.”

MARKOWITZ: They are telling the scientists this is what we want. They are giving them the money to do the research, and the scientists know that in the end, they have got to come up with something that is approximate to what their funders are interested in.

MOYERS: In other words, they were saying to the epidemiologists, the researchers, the scientists, here is the end we want. Produce the science to get us there.

ROSNER: That’s right.

MARKOWITZ: When research is conducted in that way where you are trying to protect the industry, rather than give the industry the information it needs to protect the work force and the public, the process of science is absolutely corrupted.

LEMEN: Good science is to design a study that will determine whether or not there is an effect from the exposure to the chemical. And you should design that study with the greatest amount of power, the greatest amount of ability to detect whether or not there is an effect. Therefore, you should study those workers that are most directly exposed and eliminate workers that don’t have exposure. That was not done.

MOYERS: Go to the pool of affected workers, not the pool of workers who might be on the margin of the process.

LEMEN: Absolutely. They didn’t do that. They included workers in their study that were probably not ever exposed to vinyl chloride.

MOYERS: So if you bring in secretaries and managers or people out driving trucks, you’re diluting the impact of your study.

LEMEN: Absolutely. Absolutely. And you can’t get a true result when you do something like that.

NARRATION: The researchers were restricted to studying employment records and death certificates. They did not interview the workers themselves.

MARKOWITZ: They were in, from their perspective, a terrible bind. They wanted the information to know if the workers had suffered any injury as a result of exposure to vinyl chloride, but they didn’t want to tell the workers that they might have been exposed to vinyl chloride and that there was a danger in that exposure. So they didn’t want to even alert the workers in any form through these surveys that they might have had a problem that they should investigate themselves, that they should consult with their doctors about, that they should be worried about.

NARRATION: The confidential documents reveal other efforts that affected the outcome.

October 15, 1973. Vinyl Chloride Epidemiological Study. Progress Report.

“Several companies have indicated that they do not wish their terminated employees to be contacted directly.”

LEMEN: If you have workers that have left employment, they may have left because they were sick. They may have left because they had had some reason to leave. And excluding them from the study gives you a very biased result.

NARRATION: The companies also worried that if researchers contacted the families of workers who had died, someone might get suspicious.

“This becomes even more complicated when one seeks information from relatives of past employees who have subsequently died. …In other words, we need the information, but at what risk.”

ROSNER: I think this is how we, as historians, are looking at it. If you could keep that knowledge secret, keep the causes secret, keep the information secret for long enough, workers will die of other things, they’ll vanish from the work force, they’ll go on to other places, they’ll retire and die of diseases that may or may not be directly linked to the experience in the workplace.

MOYERS: How are lay people like me, citizens, supposed to decide what is good and what is bad science?

LEMEN: That’s hard. It’s real hard. Science is easy to manipulate.

NARRATION: In the end, the industry got a report that said what it wanted.

Lake Charles, Louisiana. PPG/Vista.

“Study after study has confirmed there is no evidence that vinyl affects human health – not for workers in the industry, not for people living near vinyl-related manufacturing facilities, not for those who use the hundreds of vinyl consumer and industrial products.”

NARRATION: So workers like Dan Ross were not told why they were getting sick.

ROSS: He came home from work one day, and he was taking off his boots and socks, and I looked at his feet. The whole top of ’em were burned. Now, he had on safety boots, steel-toed, and the whole top of his feet were red where the chemicals had gone through his boots, through his socks, under his feet, and burned them, both feet.

MOYERS: You knew that chemicals had caused it?

ROSS: Oh, yeah. There was no doubt in his mind, because he had been standing in something. I don’t remember what it was. I said, “My God, what was it that goes through leather, steel-toed boots and your socks to do that?” You know, I said, “Don’t get in it again, whatever it was. Don’t get in it again.”

HOFFPAUIR: I got chlorine gas and I went to the hospital, but, you know, it, it was just part a the – it wasn’t an everyday thing that you got chlorine. It was a everyday thing you got vinyl and EDC. Chlorine’s a bad, “bad news doctor” there. It’ll hurt ya. But you weren’t aware. You knew that instantly. You weren’t aware that this insidious little monster was creeping up on you, vinyl chloride was creeping up on you and eating your brain away. And that’s what it all tended out to prove out that it was doing. Just eating your brain up. Who was to know? No one told us. No one made us aware of it.

MOYERS: We can’t live in a risk-free society, can we?

HOFFPAUIR: No, we can’t live in a risk-free society. But we can live in an honest society.

NARRATION: The chemical industry was not being honest with its workers. And it was not being honest with the public.

In beauty parlors across America, hairdressers and their customers were using new aerosol sprays. No one told them they were inhaling toxic gas at exposure levels much higher than on the factory floor.

ROSNER: Vinyl chloride is a gas, and it is used as a propellant in hairsprays, in deodorants at that time, in a whole slew of pesticides and other cans that are propelling chemicals out into the environment. So, if it turns out that this relatively low threshold limit is poisoning workers, what is the potential danger if it ends up poisoning consumers?

NARRATION: Once again, buried in the documents, is the truth the industry kept hidden.

March 24, 1969. BF Goodrich Chemical Company Subject: Some new information.

“Calculations have been made to show the concentration of propellant in a typical small hair dresser’s room. …All of this suggests that beauty operators may be exposed to concentrations of vinyl chloride monomer equal to or greater than the level in our polys.”

NARRATION: The threat of lawsuits gave the industry second thoughts about marketing aerosols.

Union Carbide. Internal Correspondence. Confidential.

“If vinyl chloride proves to be hazardous to health, a producing company’s liability to its employees is limited by various Workmen’s Compensation laws. A company selling vinyl chloride…”

MOYERS: “A company selling vinyl chloride as an aerosol propellant, however, has essentially unlimited liability to the entire U.S. population.” What does that mean?

ROSNER: The problem that they’re identifying is the giant elephant in the corner. It’s the issue of what happens when worker’s comp isn’t there to shield them from suits in court, what happens if people who are not covered by worker’s comp suddenly get exposed to vinyl chloride and begin to sue them for damages to their health.

MOYERS: Unlimited liability.

ROSNER: Unlimited liability. Millions and millions of women, of workers, of people exposed to monomer in all sorts of forms. This is catastrophic. This is potentially catastrophic.

Interoffice Memo. Ethyl Corporation.

“Dow … is questioning the aspect of making sales of vinyl chloride monomer when the known end use is as an aerosol propellant since market is small but potential liability is great.”

ROSNER: They consciously note that this is a very small portion of the vinyl chloride market. So why expose themselves to liability if this minor part of the industry can be excised and the huge liability that goes with it excised?

Allied Chemical Corporation. Memorandum. Subject: Vinyl Chloride Monomer.

“Concerning use of vinyl chloride monomer as aerosol propellant, serious consideration should be given to withdrawal from this market.”

MARKOWITZ: Here you have the industry saying we are going to give up this part of the industry, the aerosol part of the industry, because the liability is so great. But they are not going to inform the work force. They are not going to do anything about protecting the work force because the liability is limited for them. And so it’s a very cynical way of deciding on how you are going to deal with this dangerous product.

They have put people in danger. They have exposed a variety of people to a dangerous product, and, yet, they are not willing to say this is something we did, we didn’t know it, we, you know, had no way of knowing it, whatever excuses they wanted to make up, but they don’t even do that.

NARRATION: Some companies would give up the aerosol business – but quietly. No public warning was issued. Now, 30 years later, those hairdressers and their customers are unaware of the risks to which they were exposed. And it is impossible to know how many women may have been sick or died – without knowing why.

LOUISVILLE, KENTUCKY

NARRATION: 1974. B.F. Goodrich announced that four workers at its Louisville, Kentucky, vinyl chloride plant had died from angiosarcoma – the rare liver cancer uncovered by Dr. Maltoni. A link to their jobs could not be denied.

But neither workers nor the public knew that the companies had kept from them the clear connection between the chemical and the cancer.

WORKER # 1: My test came back bad and I’m only 26 years old, couple of young kids, really scares you.

NARRATION: When news of the four deaths broke, two hundred seventy employees were tested. Blood abnormalities showed up in fifty-five of them.

WORKER # 2: Fifty per cent of the guys I worked with in the late fifties aren’t around now, and that’s a twenty year period. And I’ve been here twenty and a half years.

WORKER #3: It just kindly upsets me and my wife, naturally, and my mother. It’s – I know it’s a problem. It’s, it’s, it’s just – what do you do?

NARRATION: The company provided no answers. But experts like Dr. Irving Selikoff, the country’s leading specialist in occupational disease, rushed to Louisville.

WORKER #4: Have they found anything besides cancer that vinyl chloride might cause? Or have you all looked for anything besides cancer?

DR. IRVING SELIKOFF: The liver can be affected even besides cancer. Scarring can occur in the liver. Fibrosis. The blood vessels can break, the veins can break, and you can get a fatal hemorrhage, even.

WORKER #5: Once you have found that a man has this cancer caused from vinyl chloride, will you be able to cure it?

SELIKOFF: The answer is, no. At this moment, we do not know how to cure angiosarcoma.

BERNARD SKAGGS: My opinion is, if the liver thing had not come to the forefront, I don’t think they would have ever admitted anything.

MOYERS: If those guys hadn’t died.

SKAGGS: If they hadn’t died. I’m thinking about those people that I knew that died needlessly. I’m the fortunate one. I’ve lived through it. I’ve survived it. Some of them were cut off in their youth. I mean, they were young people.

NARRATION: Nine months later – over the objections of industry – the government ordered workplace exposure to vinyl chloride reduced to one part per million.

NARRATION: The aftershocks of the chemical revolution resounded throughout the 1970s. New words began to enter our vocabulary.

In Missouri, oil contaminated with dioxin had been sprayed on the dirt streets of a small working class town. When flood waters spread the poison everywhere, the entire population was evacuated.

In upstate New York, where homes had been built on a long-abandoned chemical dump, children were being born with birth defects. Love Canal was declared a disaster area.

Scientists looking for PCBs found them everywhere – in the mud of lakes and rivers, in birds and fish, and so up into the food chain. They showed up in cow’s milk in Indiana and mother’s milk in New York.

These modern poisons were not only widespread – but long-lasting.

BENZENE

NARRATION: Then came the benzene scare. Although it was known to be toxic, its use in gasoline helped fuel the American economy. But as evidence mounted connecting benzene to leukemia, the Occupational Safety and Health Administration – OSHA – ordered that workplace exposure be lowered to one part per million – a regulation the industry, then producing 11 billion pounds a year, would challenge.

DR. PHILIP LANDRIGAN, CHAIRMAN, PREVENTIVE MEDICINE, MT. SINAI SCHOOL OF MEDICINE: It’s almost inevitable that when a chemical becomes part of the political process that its regulation is going to be delayed. A chemical that has no commercial value is easy to regulate.

NARRATION: To counter the proposed regulation with its own science, the industry created and funded a $500,000 “Benzene Program Panel.”

PETER INFANTE, Ph.D., DIRECTOR OF STANDARDS REVIEW, OSHA: The science at the time was that a) benzene caused leukemia. I think there was no question about that.

MOYERS: There was no doubt in your mind that workers were at risk who were using benzene in those plants?

INFANTE: There was no doubt at all in most scientists that I spoke with. I think the only ones that had a contrary view were some scientists that represented the industry.

NARRATION: Again, the documents reveal that, just as with vinyl chloride, the industry’s own medical officers had known of benzene’s toxicity for a very long time.

MOYERS: Here’s an internal memo from 1958, 43 years ago, from Esso Oil’s medical research division. This came out of their own medical center. Quote: “Most authorities agree the only level which can be considered absolutely safe for prolonged exposure is zero.” What does that say to you?

INFANTE: There’s certainly information that the medical department has, and that information, you know, is not being conveyed to the workers, and that information is not being used to modify behavior by the company.

NARRATION: Instead of changing its behavior, the petrochemical industry turned to the courts to stop the regulation. The companies argued that reducing exposure to benzene would be too costly.

October 11, 1977

“We assert that there is no evidence that leukemia has resulted from exposure to benzene at the current concentration limits. The new and lower limitation on exposure would represent an intolerable misallocation of economic resources.”

NARRATION: The Fifth Circuit Court of Appeals in New Orleans – in America’s petrochemical heartland – ruled that the government had not proved the danger to humans to be great enough to justify the cost to industry. The victory propelled an offensive directed by the now re-named Chemical Manufacturers Association.

September, 1979. A Summary of Progress. Presented to the Board of Directors.

“Gentlemen, this is a campaign that has the dimension and detail of a war. This is war – not a battle. The dollars expended on offense are token compared to future costs.

“The rewards are the court decisions we have won, the regulations that have been modified, made more cost effective or just dropped. The future holds more of the same.”

DBCP

NARRATION: The companies had their battle plan in place when trouble erupted over a little-known pesticide – produced by Dow, Occidental and Shell – called DBCP.

WORKER #1: I worked in the DBCP unit itself manufacturing the chemical. And now after telling me that I shouldn’t worry about anything out there because it can’t hurt me, now to find out that I’m sterile from it, their answer was, don’t worry about that because you can always adopt children.

NARRATION: Talking among themselves, workers had figured out that many of them could not have children. Company officials claimed there was no pattern – and no evidence, even though newly-ordered tests proved disturbing.

WORKER #2: They ran a series of four sperm counts on us over a period of, I guess, two or three months. All my sperm counts came up zero. And I’d never been told in the whole time I’d been working out at Shell that this might happen to me.

NARRATION: What the industry also didn’t tell was that its own scientists had known of the dangers for decades.

Dow Chemical Company Biochemical Research Laboratory. July 23, 1958

“Testicular atrophy may result from prolonged repeated exposure. A tentative hygiene standard of 1 part per million is suggested.”

NARRATION: Dow had treated the report as “internal and confidential,” did not reduce exposure to DBCP – and did not tell the truth.

V.K. ROWE, Dow Chemical Company: It is our regular policy wherever to totally inform people about what the material is that they’re working with and what its potential is. So I can’t say precisely what was said in one situation. It’s generally throughout the company that we try our best to inform people about what are the hazards, how to avoid them and what to do if they have an accident – or what.

WORKER #2: The thing that bothers me, I think, more than anything is the fact that the chemical industry had no interest whatsoever in protecting us through telling us the dangers of what we were working with.

NARRATION: The companies were neither protecting their workers – nor their neighbors. An engineer at Occidental had alerted his plant manager.

April 29, 1975. Inter-office memo.

“We are slowly contaminating all wells in our area and two of our own wells are contaminated to the point of being toxic to animals or humans. THIS IS A TIME BOMB THAT WE MUST DE-FUSE.”

AL MEYERHOFF, FORMER ATTORNEY FOR THE NATURAL RESOURCES DEFENSE COUNCIL: DBCP was a reproductive toxicant, a very powerful carcinogen. It was found in drinking water wells throughout the country. It stayed on the market because to ban it, you first had to have an administrative process within a Government agency that was under great political pressure from power people on Capitol Hill. If you put enough hurdles up even the best-intentioned Government regulator is hamstrung.

NARRATION: The companies kept DBCP on the market for eight more years. And it would take a decade for the best-intentioned regulators to finally reduce the exposure level to benzene. By then, the evidence was so overwhelming the industry did not challenge the regulation. For some, it came too late.

LANDRIGAN: We knew how many chemical workers there were, how many rubber workers, how many petroleum workers, how many workers in other industries that were exposed to benzene, and on the basis of knowing how many were exposed and knowing the levels at which they were exposed, we were able to calculate how many unnecessary deaths from leukemia resulted from exposures during that 10-year delay.

MOYERS: How many?

LANDRIGAN: And the number was 492 unnecessary deaths from leukemia. Deaths that almost certainly would have been prevented if the standard had been reduced to 1 part per million back in the 1970’s.

MOYERS: What are the lessons that you would have us draw from this case of delay?

LANDRIGAN: Well, I think the most fundamental lesson is that we have to presume chemicals are guilty until they are proven innocent. What’s needed is an unpolluted political structure that is empowered to set regulations that protect the public health.

NARRATION: That’s not the political structure the industry wanted.

September 8, 1980. Report to the Board.

“The cold fact is that the Congress today has more influence over the agencies than the White House does.

“For even our best friends in Congress, there’s a limit to how long they’ll support us if the public’s against us.”

WITNESS IN HEARING: The industry’s gotten away with murder. That’s why they don’t move forward. Because it’s cost them some money and some effort, and if they’re not pushed, they won’t move.

“We need real muscle, the kind none of your lobbyists are likely to have as individuals. One growing source of political strength outside Washington is the Political Action Committees. PAC contributions improve access to Members.”

NARRATION: Through almost two hundred quickly-formed political action committees, the industry would contribute over six million dollars to the 1980 election campaign.

“When the time comes to play hardball, we’ll try to make good use of the political muscle you’ve been helping us develop.”

REAGAN INAUGURATION

NARRATION: Ronald Reagan was petrochemical’s favorite Presidential candidate. And four of the top five Senate recipients of the industry’s largesse were Republican challengers who defeated incumbents.

The industry was ready to play hardball.

September 28, 1981. Government Relations Committee. Pebble Beach.

“The Committee believes that the new climate in Washington is more reasoned and responsive. …The election of the Reagan Administration appears to have produced changes which bode well for our industry.”

NARRATION: The Reagan team asked business for a wish-list of actions that could be completed within the first 100 days. In less than a third that time, the new President signed an executive order that transformed the battle over the safety of chemicals.

CHANGES FOR THE BETTER

“President Reagan directed EPA to delay proposing or finalizing regulations until it could be determined that they were cost-effective and necessary.”

NARRATION: A prime target was the one law intended to give the Environmental Protection Agency broad authority to regulate toxic chemicals – the Toxic Substances Control Act – TSCA.

JACQUELINE WARREN, FORMER ATTORNEY FOR THE NATURAL RESOURCES DEFENSE COUNCIL: The whole theory of TSCA was that we’re not going to keep waiting until we can count the bodies in the street. We’re going to do some preliminary steps early on, catch the problems in the laboratory, get rid of them, identify the really bad actors, take some steps to reduce exposures, to find substitutes for these. That was the theory. It just in practice has never worked.

NARRATION: Case in point: A class of chemicals known as phthalates. In 1980, the National Cancer Institute had determined that one phthalate – DEHP – caused cancer in animals. By the time the Reagan Administration came to town, the Chemical Manufacturers Association was already spending hundreds of thousands of dollars on efforts to thwart any regulation.

“We must arm ourselves with cost calculations for alternate environmental control strategies; and we must feed that information to EPA as early as possible.”

NARRATION: Industry representatives and attorneys met three times with the number two man at the EPA. No environmental or consumer organizations were invited – or informed. Jacqueline Warren was one of those closed out.

WARREN: And we weren’t really there to say, “We represent another point of view on this that you should hear before you decide to go along with what the industry might be proposing”, since their interest is much narrower. They’re interested in their bottom line, their stockholders, their product, and they’re not as interested at all in what the potential health or safety or environmental effect of exposure to this might be. In fact, they’d rather keep that quiet if they can.

NARRATION: Although phthalates are widely used in common products from shower curtains to children’s toys, the EPA announced it would take no action to either ban or limit the uses.

MEYERHOFF: We refer to it as the Toxic Substances Conversation Act.

MOYERS: Because?

MEYERHOFF: They built in obstacle after obstacle and process after process where it is virtually impossible to get a known high-risk chemical off the market. There have been very few chemicals that have been actually banned because of their health risks. That’s because chemicals get far more due process than people do.

MOYERS: Chemicals have more rights than people?

MEYERHOFF: Far more rights than people.

NARRATION: The public protested that the Environmental Protection Agency had become a captive agency. What the public protested, the industry celebrated.

January 11, 1982. CMA Board of Directors. Grand Ballroom, Arizona Biltmore.

“Just ten days ago, TSCA celebrated its fifth birthday. The first five years of TSCA have seen numerous rules proposed by the Agency. To date, we have seen none of these types of rules finalized.”

WARREN: In terms of what we thought TSCA was going to mean, we haven’t made a big dent in getting tested the very large number of chemicals that are all over the environment and to which people are exposed to all the time, for which there are some data already available to suggest that they may be harmful. We’re still having to wait until the actual harm appears, and then try to do something about it.

MOYERS: Who’s in charge of the process now? LEMEN: The industry.

MOYERS: Regulating itself?

RICHARD LEMEN Ph.D., FORMER DEPUTY DIRECTOR, NIOSH: They’re in charge of doing that. The government is supposed to, but the industry has so much control through the lobbying efforts that they actually indeed do control it themselves.

NARRATION: To this day – almost 25 years after the Toxic Substances Control Act was enacted – only five types of chemicals, out of thousands, have been banned under the law.

INSTITUTE, WEST VIRGINIA

NARRATION: August 11, 1985. The accidental release of a toxic cloud from a Union Carbide plant in Institute, West Virginia sends 134 people to the hospital. It is only eight months after an explosion at a Union Carbide plant in Bhopal, India had killed some 2000 people – and injured 200,000 more.

REPORTER: When they told you it was a leak, what was the first thing that went through your mind?

MAN: India. Because you’re so helpless.

WOMAN: They didn’t know where it came from, they didn’t know what it was till two days later after it happened. You fumble and stumble and cause our lives to be turned upside down over things you misplaced – over 500 gallons of this mixture. Now I can see misplacing one or two gallons of gasoline around your house…

ROBERT KENNEDY, PRESIDENT, UNION CARBIDE: If we don’t make those chemicals, someone will. Someone will make those chemicals, and you know, you can wish the problems on somebody else. I had a dog once who overly aggressive and he bit a mailman once. And he missed a mailman about three times. And I was very upset about it. And I asked a vet finally if she thought that I could find a good home for that dog. And she said, Mr. Kennedy, don’t give your problem to somebody else. And I think I learned something by that. I don’t think we want to quit.

MAN IN AUDIENCE: When will you listen? I don’t want to hear your dog stories. We’re talking about people. And their lives and their homes and their families. You can have my job if you want it. Because by god, I can get another job. I can’t get another life.

NARRATION: Accidents were but one symptom of our co-existence with industrial chemicals.

In the late 1980’s, people began to agitate for the right to know more about the chemicals that they – and their children – were being exposed to.

WOMAN: I don’t think we should be afraid any more about talking about controls on the chemical industry. These are private companies -Carbide, DuPont, FMC, all of them – whose day to day decisions in those corporate board rooms are affecting our lives, our children’s lives, and the future generations.

MAN: What about cleaning up the industry? Stop the leaks, for Christ’ sake. Don’t kill me. Let’s do something.

NARRATION: In California, they did do something. In 1986, citizens themselves rounded up enough signatures to put the Safe Drinking Water and Toxic Enforcement Act – Proposition 65 – on the California ballot.

MEYERHOFF: With Prop 65, if you are a manufacturer of a chemical and you’re exposing my family to a health hazard in a consumer product, in the workplace, in the air and the water, you have to warn me, and that makes a big difference because the public then doesn’t buy the product and it shifts the burden to the company.

MOYERS: You were really turning the system of regulation upside-down.

MEYERHOFF: Yes. It turned the entire system on its head, and that’s why the chemical industry and agriculture and others in California fought the law so hard.

NARRATION: Once again, we have learned from the secret documents how industry planned to fight.

June 4, 1986 California Toxics Initiative.

“A campaign fund of $5 million dollars has been targeted, with a broad coalition of industry and agricultural interests having been formed to finance and manage the campaign.”

MOYERS: “A total of $150,000 is needed by June 25th for fund-raising, research, and advertising, an additional $650,000 payable during July, August, or September.”

MEYERHOFF: Well, I always knew there were resources against us. I actually was unaware of the amount. That actually surprises me that there was quite that high level of dollars, and that was a lot of money then, to oppose Prop 65.

NARRATION: But the industry had been caught short; its money came too late. On election day, California’s right-to-know proposition passed – overwhelmingly.

MEYERHOFF: What the voters were saying is that we don’t trust the Government to protect us any longer from chemicals that cause cancer or birth defects or other harm, give us the information, tell us when we are at risk, we’ll protect ourselves. That was the basic message. And if you fail to do that, then you, a chemical company or grower or others, can be fined up to $5,000 per day, per person that isn’t warned. Prop 65 put the fear of God in the chemical companies, and it had never been there before.

NARRATION: Afraid of aroused public opinion, the companies vowed never to be caught short again.

June 3, 1987 Board of Directors Meeting. Chemical Manufacturers Association. State Toxics Initiatives

“Development of a funding plan which would include an industry-wide ‘pledge’…”

MOYERS: …”pledge” of resources company-by-company, pre-authorization to commit the funds to individual state campaigns.” Does that surprise you?

SANDY BUCHANAN, EXECUTIVE DIRECTOR, OHIO CITIZEN ACTION: Well, it helps me understand why they were able to marshal their forces so quickly in Ohio and from so far across the country, the idea that they were ready for it and committed.

MOYERS: But you didn’t know about this?

BUCHANAN: No. I didn’t know about that until just now.

NARRATION: Sandy Buchanan heads Ohio Citizen Action, the group which took the lead in getting a right-to-know initiative on the Ohio ballot in 1992.

MOYERS: Though you didn’t know it at the time, I assume you were up against a lot of that money?

BUCHANAN: We were up against about at least 4.8 million of it.

MOYERS: 4.8 million.

BUCHANAN: That was the final spending on the actual ballot campaign.

MOYERS: By the industry.

BUCHANAN: By the industry in Ohio. They definitely spent more money than that, though, because at every stage of the process through the legislature and others, they brought us to court and they tried to challenge the legality of our petitions.

MOYERS: So the industry spent 4-point–

BUCHANAN: 4.8 million dollars on the ballot.

MOYERS: And how much did you spend in trying to pass it?

BUCHANAN: Oh, about 150,000.

MOYERS: I would say you were outspent.

BUCHANAN: About 50 to 1 or so, yeah.

NARRATION: For the companies, the dollars spent to defeat the initiative were insurance against the greater loss of being held accountable.

BUCHANAN: If they can’t be held liable, if the tools that citizens or workers can use to try to defend themselves are taken away, then you can protect the bottom line of a corporation.

MOYERS: It would cost them money if people knew.

BUCHANAN: It would absolutely cost them money.

NARRATION: No state right-to-know initiative has passed since 1986. And two years ago, industry persuaded Congress to roll back a major right-to know provision in the Clean Air Act.

TEST RESULTS

NARRATION: Today, an average of twenty new chemicals enter the marketplace every week. We don’t know much about them – and we don’t know what they might be doing to us.

Back at the Mt. Sinai School of Medicine, Dr. Michael McCally was ready to tell me if residues of the chemical revolution had been found in my blood.

MOYERS: So what’s the news?

DR. MICHAEL McCALLY, VICE-CHAIRMAN, PREVENTIVE MEDICINE, MT. SINAI SCHOOL OF MEDICINE: We tested for 150 different industrial chemicals, and you have 84 of those 150.

MOYERS: Wow. Eighty-four.

McCALLY: Eighty-four.

MOYERS: If you had tested me sixty years ago when I was six years old, would you have found those chemicals?

McCALLY: No. No. With one exception.

MOYERS: What’s that?

McCALLY: Lead.

MOYERS: Lead.

McCALLY: Lead. Lead’s been around — we’ve been — we’ve been poisoning ourselves with lead since, you know, practically the cave ages.

MOYERS: So 83 of these 84 chemicals you found in my blood are there because of the chemical revolution –

McCALLY: Yes.

MOYERS: — over the last sixty years.

McCALLY: That’s correct. That’s correct. And we didn’t know this until we looked, but suddenly we find out that the industry has put a bunch of chemicals in our body that, you know, are not good for us, and we didn’t have any say in that. That just happened.

MOYERS: What kind of chemicals?

McCALLY: In the PCB case, you have 31 different PCBs of this whole family of similar chemicals. They are all over the place. And it’s probably a function of where you lived. You lived in some locale where PCBs were in the environment, and you got them into you through the air you breathed. Some of them get down in groundwater. Some of them get coated on food. You didn’t get them sort of in one afternoon because you ate a poisoned apple.

MOYERS: And dioxins?

McCALLY: And dioxins, of all that we measured, you had 13, 13 different dioxins.

MOYERS: You tested for some pesticides.

McCALLY: Yes. The organophosphates — malathion is one we may have heard of because we’re spraying it here in New York because of mosquitoes.

MOYERS: I used to spray malathion on my house in Long — on my yard in Long Island.

McCALLY: We also measured organochlorine pesticides. The best known is DDT. DDT hasn’t been produced in this country for several decades.

MOYERS: Yes. So where would I have gotten that?

McCALLY: Did you ever, you know, watch them spray the trees when you were a little kid?

MOYERS: Young man.

McCALLY: A young man? Yes. Okay.

MOYERS: And I lived around places that had used it.

McCALLY: Well, that’s enough, because again, like PCBs, these are very persistent chemicals. They don’t — the body doesn’t metabolize them, doesn’t break them down into little pieces and get rid of them.

MOYERS: How do the results of my test compare with others around the country?

McCALLY: I wish we had more data. I wish I could give you a clear answer to that. The burdens that you carry are probably biologically less important than if you were, you know, a 21-year-old woman who was in her ninth week of pregnancy. And then the fact that you were circulating some DDT might really be important.

MOYERS: Have these chemicals been tested in terms of what happens when they are combined?

McCALLY: No. No. That is a complexity that we haven’t even looked at.

MOYERS: Have they been tested on vulnerable populations like children?

McCALLY: No. We are just beginning to do that science.

MOYERS: Is it fair to say from all of this that we are, as human beings, being unwittingly exposed to hundreds of toxic chemicals which have been tested enough just to know that they’re toxic, but not tested enough to know the risks?

McCALLY: That’s a fine summary of the current state of affairs. We know enough now to know that it doesn’t make a lot of sense to make chemicals that are carcinogenic and add them to our bodies and then argue about how much we are adding. It just isn’t a good idea. Particularly when there are perfectly acceptable alternatives, and if the industry chose, it could change our exposures dramatically by its own actions.

NARRATION: Three years ago – on the eve of Earth Day – the Chemical Manufacturers Association promised that its member companies would begin to voluntarily test one hundred chemicals a year at an estimated cost of 26 million dollars.

FRED WEBBER, PRESIDENT, CHEMICAL MANUFACTURERS ASSOCIATION: Our vision is that we will be highly valued by society for our leadership, for the benefits of our products and for the responsible and ethical way in which we conduct our business. It’s as simple as that.

NARRATION: Today, we are still waiting for the results of even one of those tests.

During those three years, the industry poured more than 33 million dollars into the election campaigns of friendly politicians.

NARRATION: As the secret documents reveal, the promise to test – voluntarily – was part of a strategy hatched almost a decade ago.

September 15, 1992:

“A general CMA policy on voluntary development of health, safety and environmental information will…potentially avert restrictive regulatory actions and legislative initiatives.”

MEYERHOFF: The idea of a chemical company voluntarily testing its product is not unlike efforts to voluntarily regulate their products. It is an attempt to pre-empt effective government. It is an attempt to try to stop the government from doing its job by doing half-baked measures and then claiming that we’re protecting the public.

DR. PHILIP LANDRIGAN, CHAIRMAN, PREVENTIVE MEDICINE, MT. SINAI SCHOOL OF MEDICINE: There are 80,000 different man-made chemicals that have been registered with the EPA for possible use in commerce. Of those 80,000, there are about 15,000 that are actually produced each year in major quantities, and of those 15,000, only about 43 percent have ever been properly tested to see whether or not they can cause injury to humans.

NARRATION: The industry’s own documents confirm just how little we know.

Meeting of the CMA Board of Directors. Pebble Beach. Report of Health Effects Committee.

“The chemical industry has contended that while a few substances pose a real risk to human health when sufficient exposure occurs, the vast majority of chemicals do not pose any substantial threat to health. However, the problem is, very little data exists to broadly respond to the public’s perception and the charges of our opponents.”

NARRATION: That is worth repeating. “The problem is, very little data exists.”

In other words, the industry itself acknowledged it could not prove the majority of chemicals safe.

LAKE CHARLES, LOUISIANA

NARRATION: Lake Charles, Louisiana. In the spring of 1989, the family of Dan Ross gathered to celebrate their daughter’s graduation from college.

ELAINE ROSS: He was always the kind of man that wore denim. Denim shirts, denim pants. In fact, he got downright indignant if we tried to make him dress up. We thought that was what was wrong with him. He’d complained about having a headache that day, and Robin told him – that’s our daughter. She said, Daddy, you’re not wearing that to my graduation. You’re wearing a suit. We assumed that the look on his face was that he was mad at all of us and was gonna let us remember it forever, you know. And we laughed at him and teased him about it. But afterward, the headache didn’t go away.

NARRATION: Several days later, a CAT scan revealed brain cancer. In the last words he was able to speak, Dan Ross told his wife, “Mama, they killed me.”

ROSS: You start watching him die one piece at a time, you know. It’s like, okay, he’s blind today, but he can still hear, he can still swallow if I put something in his mouth. But he lost the use of one of his arms, and then next day it would be the other arm, the next day it would be one leg. And then he couldn’t hear anymore. The hardest part was when he couldn’t speak anymore.

NARRATION: On October 9, 1990, twenty-three years to the day after he started working at Conoco, Dan Ross died. He was 46 years old.

ROSS: They hurt somebody that meant more to me than my whole life. I would have gladly taken his place to die. Gladly.

NARRATION: Half a century into the chemical revolution, there is a lot we don’t know about the tens of thousands of chemicals all around us.

What we do know is that breast cancer has risen steadily over the last four decades. Forty thousand women will die of it in this year alone.

We do know brain cancer among children is up by 26 per cent. We know testicular cancer among older teenage boys has almost doubled, that infertility among young adults is up, and so are learning disabilities in children.

We don’t know why.

But by the industry’s own admission, very little data exists to prove chemicals safe.

So, we are flying blind. Except the laboratory mice in this vast chemical experiment are the children.

They have no idea what’s happening to them. And neither do we.

PANEL DISCUSSION

MOYERS: Now we want to discuss some of the public policy issues raised by what we’ve seen.

With me are Terry Yosie, Vice-President of the American Chemistry Council; Ted Voorhees, partner in the law firm of Covington & Burling – he represents the Chemical Trade Association in the Ross case; Ken Cook, President of the Environmental Working group — as a matter of disclosure, the foundation I serve made a small grant to Mr. Cook’s organization a few years ago, but I didn’t meet him until three weeks ago — and Dr. Phil Landrigan, a pediatrician and chairman of preventative medicine at Mount Sinai School of Medicine.

Mr. Yosie, thank you very much for coming.

TERRY YOSIE: Thank you.

MOYERS: Given what we’ve just seen, how can the public rely on what the chemical industry says about the safety of synthetic chemicals?

YOSIE: Thank you, Mr. Moyers. If I were a member of the viewing audience tonight, I would be very troubled and anguished if I thought that the information presented during the proceeding 90 minutes represented a complete and accurate account of the story. It does not. For nearly two years, this program has been in preparation. At no time during that two year period have representatives of this program contacted our industry, asked us for information, or provided an opportunity for us to appear on the 90-minute segment.

We believe that it is a sad day in American journalism when two sides of the story can’t be told, when accuracy and balance are not featured in the broadcast. It’s our intention in the limited about of time that we have available this evening to correct some of the errors that we found in the broadcast, but also to present a more complete picture of who this industry does and what it represents and the benefit it delivers for the American people.

How can– turning to your question Mr. Moyers– how can the American people be reassured that the products developed are safe for the intended uses? We test our products and we report that information to the government. There are 9,000 chemical products on the marketplace today. They have been researched, they have been tested, and that information has been disclosed. We do not do this information alone. We work with some of the finest universities in the United States: people at Harvard, the University of California system, the University of Massachusetts– independent researchers with world-class reputations.

We have a major partnership with one of this nation’s leading environmental groups, Environmental Defense, and through that partnership we are disclosing information on those test results no matter what they show. So I believe this commitment to openness and transparency, to working together to identify information needs and to disclose this to the public is to pass the greater confidence in the products we make.

MOYERS: Mr. Cook, do you want to talk about that?

KEN COOK: Well, it’s interesting that you raised the question of testing. As I was struck by so many images in this program, one of the images was that of the x-rays of these vinyl workers who you had in your industry, medical doctors examining without telling them why they were examining them. Their fingers dissolving and this new program you’re describing, the symbol of it is two hands holding a globe. I don’t think I will ever be able to look at the logo for your program without thinking of those vinyl workers and their dissolving finger bones.

As for testing, one of the things that was striking about Bill’s results as I was thinking about it, was just how little is known about the products of your industry showing up in people. Do you, for all your testing you’re saying is being done, do you have any idea how many of the products of your industry, all your companies– it’s a good bit more than 9000– do you know how many show up in people? Have you even tested for that?

YOSIE: Let us respond to some of the issues you’re raising.

MOYERS: You don’t want to answer?

COOK: So you’re testing?

YOSIE: I want to respond to the issues that…

MOYERS: Before you do…

YOSIE: I think the viewers deserve our correction of some statements.

MOYERS: Well we’ll turn to it in just one minute, but how thoroughly are these chemicals tested before they come on to the market?

YOSIE: They are tested using the best scientific methods available, and they are tested not only for their potential hazard, but when we test a product, when we submit that information to the government, we are using standards set by our government, but also international standards. We are applying the best laboratory practices that have been defined by the scientific community.

We don’t do this work in isolation, and when we develop a product, we have margins of safety so that whatever potential effects there may be, we develop those products so that they ensure safety many times below where there could ever be an effect. Subsequent legislation has ratified that approach that we have taken for many years.

COOK: But this is legislation that you have opposed. I mean, your own documents show– whether it’s the clean air act, the clean water act, the safe drinking water act– straight on through, you can read the documents now for the first time that you have never made public before, and it’s quite clear that every time there’s an attempt to tighten regulation on your industry to protect citizens, communities from air pollution, water pollution, your own documents show how you have opposed that.

MOYERS: Let me bring Mr. Voorhees in on this.

TED VOORHEES: Thank you, and let me say that I have met Mrs. Ross, and I have a tremendous amount of sympathy for her situation having lost her husband to brain cancer. At a human level I have sympathy, but no amount of sympathy can justify putting on a program that presents an incomplete, slanted, and essentially misleading characterization of what happened with vinyl chloride.

And to take Ken’s example of the hands, as the first of a couple of examples let me give, the show tells the viewer that this hand problem appeared in the mid 1960’s, and that it was treated as confidential and secret by the industry. What the show doesn’t state is that as soon as that problem was found by B.F. Goodrich company, the doctor who found that problem in 1967, published his findings in the Journal of the American Medical Association, which is probably one of the most widely read professional articles read by doctors, and in that article on the hand problem, Dr. Creech included the very same x-ray images which you showed on your program as if they had been hidden and kept secret from people.

MOYERS: Did that document say that it was linked to the exposure of vinyl chloride?

VOORHEES: It absolutely did, that was the whole subject of the article.

MOYERS: Why didn’t the company tell Bernie Skaggs?

VOORHEES: Bernie Skaggs’ doctor knew about that because he read it in the Journal of the American Medical Association.

MOYERS: But why didn’t the company tell him?

VOORHEES: The company was telling his doctor — the person who would know and who would be able to react to something like that is a professional who would be able to see the relationship.

MOYERS: I believe the documents show that the company did not tell his doctor.

VOORHEES: Well, they published the study of the hand problem in the Journal of the American Medical Association in 1967.

MOYERS: So was the doctor expected to just come across that in random reading? Why didn’t the company tell Bernie Skaggs directly? He worked for the company, Mr. Voorhees. Why didn’t they tell him?

VOORHEES: The Journal of the American Medical Association, JAMA, is not random reading. It’s probably the most widely read professional journal…

MOYERS: Sir, you’re not answering the question. Why didn’t the company tell its employees?

VOORHEES: I don’t know that they didn’t tell Bernie Skaggs.

MOYERS: The documents suggest they didn’t.

VOORHEES: The B.F. Goodrich company had a doctor at the plant. He was the author of this article in JAMA and he would have, as workers came into see him, he would have explained to them what their problem was and I would expect that would happen.

MOYERS: Was Bernie Skaggs lying to me when he said the company didn’t tell him?

VOORHEES: I am certainly not going to accuse him of lying, but what I’m saying is that the doctor at his plant published his findings immediately in the Journal of the American Medical Association and my point is, the program has suggested to your viewer that this was an issue that was kept in secret. Far from keeping it in secret, it was published in the most widely read journal, and the x-rays that were supposedly kept secret were a part of that journal article.

YOSIE: 40 years ago is a very long time. 40 years ago there wasn’t an Environmental Protection Agency. 40 years ago there wasn’t a clean air act. I don’t believe the viewers of this program are interested so much in what happened 40 years ago. I believe they are vitally interested in their own personal health and wellbeing today. They want to know that if the products that we develop and market are safe for their intended uses. They want to know if the products that they’re using in their homes are going to benefit them. and I believe the answer is…

MOYERS: Those are the questions that I sent you a month ago and said, “let’s talk about these policy issues.”

YOSIE: Those are the questions I absolutely want to address.

MOYERS: What about that?

LANDRIGAN: I think that’s really the central question, Bill, Terry.

Today there are many thousands of chemicals on the market. There are a number of chemicals that are registered with the EPA for commercial use is not 9,000; it’s over 80,000. There’s about 3,800 which are called “high production volume chemicals.” A couple of years ago, the Environmental Defense Fund, the same organization with which the chemical manufacturers are partnered, did an analysis of those high production volume chemicals to see what fraction has been tested. Now, to be sure, when the EDF were seeking information on how many were tested, they had to go to the open literature. They obviously didn’t have access to company documents.

In the open literature they found that only 43%, less than half of these chemicals had ever been tested for toxicity to humans. When they looked more deeply, when they asked more sophisticated questions, for example, what fraction of these chemicals has been tested for their effects on children’s health?

What fraction have been tested for the effects on the developing brain, the developing immune system, the developing reproductive organs, the endocrine system of babies? You’re down very close to single digits. Around 8% or 10% of chemicals on the market have ever been tested for these effects.

So I think that it has to be said here today that the toxic substances control act is a well-intentioned piece of legislation, but in its execution, it has mostly been a failure. It is just not doing an adequate job of protecting the American public.

YOSIE: There are not 75,000 products on the market today. There are 9,000.

LANDRIGAN: No, there are not 75,000 chemicals on the market, but there are that many chemicals registered with the EPA for commercial use. And of the 38,000 high production volume chemicals, fewer than half, less than half have been tested for their toxicity.

YOSIE: Mr. Moyers, you’ve had your own body tested and this was shown to the viewers. What was not shown to the viewers, that the products that we make probably saved your life. From what I read in the newspapers, you had a very serious heart operation at about 1994. You had a blockage in an artery leading to your heart. When your doctors discovered this problem and advised you and provided the professional counseling and expertise that made it possible for you to recover to the robust man that you are today, they were using our products. They diagnosed…

MOYERS: Are you sorry about that now? I mean, don’t you wish…?

(laughs)

YOSIE: I am delighted that you’re here. You look very healthy. They diagnosed your problem using technologies that we helped develop. When they operated on you, they used surgical instruments that we helped develop. To ensure that you did not contract a subsequent infection post operation, you were given medicines.

In addition, you were probably given medication afterwards to ensure your continuing return to health. I believe that your state of well-being today was directly dependent on the benefits that our industry provided to you and to every American.

MOYERS: I don’t challenge that, and I didn’t challenge that in our reporting. I do not challenge that.

YOSIE: You do not challenge that but you didn’t report it either.

MOYERS: You just said it. I told you a month ago we wanted you to come on and say what you wanted to say and you just did. But here is the issue that I think that Dr. Landrigan is raising, that my own body burden test is raising, Dr. McCally said to me, I said to him, “Should I be worried?”

He said, “At your age, 66, I don’t think so. But if you were a 21-year-old pregnant woman, it might be a different story.” And he said, “We do not know what this combination of chemicals, what effect it’s having on our health.” This is a new phenomenon. He said, “Your grandfather would not have had this.” This is a new phenomenon. And what I think I was asking in the broadcast, and what I hear Dr. Landrigan asking is, how do we find out what this combination of chemicals is doing in our body? Particularly to children. Are children the most vulnerable?

LANDRIGAN: Children…

YOSIE: Dr. McCally erred in what he told you. He said that 60 years ago the only compound that you would have in your body was lead. 60 years ago, American cities looked like an industrial wasteland. They looked like what Russia or China or Eastern Europe looks like today. 60 years ago, there were no pollution controls on industry or any other major products. 60 years ago, the area that I come from, Western Pennsylvania, people had to wear two shirts to go to work. One to wear outside, one to wear inside.

MOYERS: “Better living through chemistry.” I acknowledge that. We all acknowledge that.

COOK: I think as an environmentalist, I’ll defend your industry. But the thing that surprises me…

YOSIE: Thank you, I’ll take that compliment.

COOK: Let’s go back to the vinyl story. Again, for the first time now it are read tens of thousands of pages of documents that you never made public. If they so strongly defend your position, you never made them public. Now that they are public, one of the striking things about me is how you’re hiding your light under a bushel basket when it comes to inventiveness. Those documents clearly show again and again and again that your industry worried that if vinyl chloride standards were tightened, it would be the end of the industry. Companies would go bankrupt. They say this. They could not continue to operate.

None of them did go bankrupt when it went from 500 parts per million down to one. They all did fine. In fact, they made money. And I think what I respond to you when you make that point is, yes, there are many ways which chemicals make a difference in our lives. But there are also ways in which we can find safer alternatives. And in most cases, the fastest was to those alternatives is to put pressure on the industry beyond what you feel now to move you in that direction. You don’t go rapidly on your own, and that’s been shown time and again.

YOSIE: Three months ago…

VOORHEES: Can I respond to that?

MOYERS: Sure.

VOORHEES: Since he referred to the vinyl chloride story in the litigation, and I would say it would be fair for the viewer to think that the program was about concealment and secrecy. And what the viewer was not shown was that in each of the episodes that you portrayed in the program where you would show a document that says confidential or secret, what you failed to do was to show that shortly after that document was prepared, a study was published. For example, I’ll just give you few examples.

The Viola study in 1970, the first Italian researcher who found some signs of carcinogenity in laboratory animal experiments, and you showed a document that said this could potential be problematic and should be confidential. What you didn’t say is that Viola’s study on that subject was published in 1970, the next year after the confidential document. So the point is, that when we research was being done on these very subjects, research on… initially on laboratory animals, that the research was published and there was not one reference in that whole program to the published articles that followed each of these incidents that are referred to in the program. To me that’s a very misleading presentation.

YOSIE: Three months ago…

MOYERS: Let me just answer Mr. Voorhees. For one thing, it was because that Dr. Viola was going to publish his findings that the chemical association meeting took place to discuss what to do about it. And I was really astonished, Mr. Voorhees, in the materials you sent us before the broadcast which we examined thoroughly. You were very selective in what you gave us. You did not include in there the documents that show how the industry did not want to talk about it, Dr. Maltoni’s research, and made plans not to disclose that to NIOSH, even though NIOSH, the government agency, had asked for those… that information to be volunteered, and your industry did not do that. The documents make it clear that they did not talk about Dr. Maltoni’s argument. But that’s the past.

I would love to come back to this issue. Look, the people out there watching this thing, you know, we know our lives are better because of chemistry. But we also know that pediatricians and physicians like Dr. Landrigan are saying, we don’t know what this new combination is doing to us. So what is the question? What are the issues?

LANDRIGAN: I that’s the… excuse me, Terry. I think the issue, Bill, is that this is not something of the past. Many of the chemicals, for example, that were tested last week in that CDC report that was released to the nation on the 21st of March, are chemicals that reside…

MOYERS: That was the center for disease control, right?

LANDRIGAN: The center for disease control in Atlanta, that’s right.

Many of the chemicals which they tested, for example the pesticide products, are relatively short-lived chemicals. Those are chemicals, when they get into the body of a child, only stay there for a matter of weeks or at most a month or two, and then they’re gone.

So the chemicals that were measured by CDC in Americans are chemicals where the exposures are taking place today. And in response to your question, it’s absolutely true that children are the most vulnerable among us to those chemicals, and kids are vulnerable for two reasons. First of all, they take more chemicals into their body. They breathe more air. They drink more water. They eat more food pound for pound. So they take more chemicals into their body that are present in the air, on their food, in their water. And of course, kids play on the floor. They drop a lollipop on the rug. If there’s pesticide on that rug, they pick up the lollipop, they put the lollipop into their mouths and the pesticide gets in.

Then on top of that, besides being more heavily exposed, kids are biologically more vulnerable. I mean, anybody who has seen a little child– I’ve got a grandson who is just a bit over a year old– anybody who’s got a little child knows how precious and how vulnerable they are. Their brains are growing and developing. If a chemical like lead, like a pesticide, like PCB’s, like organic mercury gets into the brain of a baby during those early months of development, the consequences can be life-long.

YOSIE: Three months ago, the Department of Health and Human Services… Please, Bill, please, be fair.

LANDRIGAN: What really troubles me here is we don’t know… we simply do not know the long-term consequences of exposures in early life. As a pediatrician, as a parent, as a grandparent…

MOYERS: But what’s the public’s policy you’d like to see come out of this, and I would like to hear Terry Yosie say why the industry wouldn’t support that public policy?

LANDRIGAN: I think we need four things, four things only.

Number one, we need thorough independent testing of chemicals, including testing that looks at pediatric effects.

YOSIE: That’s underway.

LANDRIGAN: Number two, and it needs to be independent of the industry.

YOSIE: Colleagues… Mr. Cook’s colleagues in the environmental community are working directly with us. We just participated in a process with environmental groups and others to test compounds for their impact on children.

LANDRIGAN: Well, that’s… it just leaves…

YOSIE: There is an agreement in place to do just that.

LANDRIGAN: I’m glad. I noticed in the show itself that of promises were made, the results haven’t yet appeared. But the second thing that needs to be done is that we need to continue the nationwide testing of chemicals in the bloodstream of Americans that CDC has started. CDC, I understand…

YOSIE: We support that objective.

LANDRIGAN: And that’s good, that’s good.

YOSIE: We think the CDC report, which by the way, used technology that we helped develop. Those analytical methods that were used in your body and used on the recent CDC report are an outgrowth of our commitment to science to improve better analytical detection techniques. And so we support CDC’s continued efforts to learn more about the health status of the American people.

LANDRIGAN: Excellent. Number three, I think we need to work together. And this might actually be an area where the chemical industry and the environmental community and the academic community can work together. This is to support a national right-to-know initiative. For this nation, we ought to have the national equivalent of the Proposition 65 law that they have in California. Everybody in this country ought to be able to get good, accurate, unbiased information on every product they buy in the stores.

And fourthly, on the final need that I think we have to have in this country, is we need to have a more efficient, more effective process than we do today to get toxic chemicals off the market and to replace them with safer chemicals.

That’s what America’s kids need.

YOSIE: Two comments: One is, Mr. Landrigan, Dr. Landrigan, does raise the issue of what is the health status of children. Three months ago the Department of Health and Human Services, which includes the Center for Disease Control, issued a report. Let me read you a sentence in the very first paragraph of that report: “We’ve made life better for our children.” The Department of Health and Human Services, like the CDC, looks at the broad spectrum of issues that could potentially effect children’s health. And there is some very good news to report.

There are record child immunization rates. There’s a decline in youth drug use and smoking. There is a decline in teenaged mothers giving birth. There’s a decline in infant mortality. But even beyond children, cancer rates are down.

LANDRIGAN: Cancer death rates are down, cancer incidence rates are up, Terry.

YOSIE: But that’s an artifact of better reporting.

LANDRIGAN: No, it’s not.

YOSIE: Life expectancy rates in this country. We are living better and healthier, not only but because of the products we make but because people are being more sensible in terms of how they live and how they behave.

LANDRIGAN: The facts don’t support… some of what you’re saying is true, but it’s very selective.

YOSIE: I’m quoting to the CDC, Phil.

LANDRIGAN: You’re quoting part of a 30-page CDC report. Cancer death rates are down, but the number of new cases of cancer in children is up. I don’t know why they’re up, but since 1972, which is when we began to keep national records in this country, we have experienced a 42%… 41% increase in the incidents of brain cancer, the number of cases of brain cancer per thousand children. That is not a reporting artifact. We weren’t missing 40% of brain cancers 30 years ago when I started my pediatric career. We just weren’t. In young men 15-30, there has been a 68% increase in the incidents of testicular cancer.

Now, you’re quite right, American children today live longer. They live longer because we have conquered most of the infectious diseases in this country. But the rates of asthma have doubled.

YOSIE: What are the principal health risks that children today. To some extent they do come from environmental factors, but domestic violence…

LANDRIGAN: Oh, the principal cause of hospitalization of American children is…

YOSIE: …lack of access to healthcare, a number of other factors…

MOYERS: Are those not involuntary, but chemicals in our food and chemicals in our toys are not something that people ask for, they just happen, as you said I think, or McCally said in the interview, suddenly we’ve got all these chemicals in our body.

VOORHEES: These are products that have been very carefully scrutinized by the scientific community, by government agencies, and as a result…

YOSIE: Let me make one point if I may, one point, if I may.

LANDRIGAN: Why is there…

YOSIE: Phil made the point that we need to take the compounds off the market. That has been tried in many countries and disaster has resulted. The nation of Peru stopped chlorinating its water supply. Chlorine is one of our major products. What happened after that event? A cholera epidemic broke out and over 10,000 people in Peru and Latin America lost their life.

LANDRIGAN: And in this country we took tetraethyl lead out of gasoline American’s blood levels have declined 99%.

YOSIE: And proponents of removing chlorine are saying that ought to be done in this country. There are ten to 25 million people perishing because of a lack of a drinking water supply.

LANDRIGAN: In this country, over the vigorous objection of the Ethyl Corporation, we removed tetraethyl lead from gasoline. The average blood lead level in American children has declined by 90%, and the average IQ of American babies has increased by three points.

YOSIE: You and I were on the same side of that debate when I served as the official of the environmental protection agency.

LANDRIGAN: When you were at EPA.

YOSIE: When I was at EPA.

COOK: Yeah, but the companies you represent…

YOSIE: You and I were on the same side of that debate, and we still are.

MOYERS: What was that, Ken?

COOK: The companies you represent weren’t, and that’s the point. If you look at these documents which we now have– and let me just put in a plug, ewg.org, you can read 40,000 pages of them going back to 1945 now.

YOSIE: And we will correct those in abouttradesecrets.org.

MOYERS: What’s your web site?

YOSIE: Everybody’s got a web site. Ours is abouttradesecrets– that’s one word– abouttradesecrets.org.

MOYERS: And yours is…

LANDRIGAN: Childenvironment.org.

MOYERS: Covington & Burling?

VOORHEES: Well, we have a law firm web site, but I’m not sure people…

MOYERS: (laughs) Ours is pbs.org.

It’s only fair that you get a chance to answer this question, because as I’ve said to you, investigative journalism is not a collaboration between the journalist and the subject, and I did lay out there, Sherry Jones and I laid out, the record of the industry and opposing right to no initiative.

Why has, in every case that I can find, why has your industry opposed citizens effort to use the right to know initiative and every right to know efforts?

YOSIE: I think you have your facts wrong.

MOYERS: Tennessee, Hawaii, California, Ohio, Illinois, Massachusetts.

YOSIE: We supported the amendment, the Superfund statute, in 1986, creating the Toxic Release Inventory. We supported in 1990, the amendment of the Clean Air Act so that information would be made available to communities about chemicals that were being used in their neighborhoods. We supported, with Environmental Defense, the complete and total disclosure of any testing results going on with our current agreement with them. We had been a strong supporter of right to know, and here’s why.

We have had over the last dozen years, a program that has instituted over 300 community advisory panels wherever this industry is located in this country. We have learned a great deal from listening to communities where we play a major part. One of the greatest testimonials that you hear about this industry is from people who live near it, because they have seen the very direct health and environmental progress and the emissions reductions that result from our industry. When they have a question about plant safety or noise levels or environmental emissions, they have direct access to the plant manager. They have access to go inside the plant gates and see what’s going on.

COOK: I’ve talked to an awful lot of people…

YOSIE: That is why we have 60% decline in emissions over the last decade, the best of any American industry.

COOK: Well, you almost make it sound as if you volunteered to do that, and you did not.

YOSIE: We supported those measures.

COOK: Listen, what you selectively may have supported, everyone can now read what decisions you made and how you made them to take a stand on clean air and clean water and drinking water, and it’s… I respectfully disagree, it is not as you describe it. No, what these communities are often left with is just asking a plant manager, “Can you tell us?” No authority, no power under law to actually compel that information to come forward. And to get back to the testing point, I just want to, because there would be some confusion…

MOYERS: We have about 45 seconds.

COOK: There will be some confusion out there. If these chemicals are so well tested, then how come you had to come forward with a program just two years ago to voluntarily test the most widely used ones if they were tested? Some of them have been used for decades.

YOSIE: Because we’re a responsible industry. Because we’re always seeking answers to question. We’re a science-based…

COOK: About 40 years late.

YOSIE: We’re a science-based industry, and by nature we are asking these questions. There are a million men and women who work in this industry who apply chemistry to make a variety of products and services. I’m very proud to represent them here tonight, and as we close this broadcast, I want to thank them for the contribution they’ve made to society. They’ve made America a better, healthier and safer society. And to the viewing audience, I want to say that we are committed to continuing to improve our environmental health and safety performance. I think you all know that what happened 40 years ago is no reflection of the kind of industry that we represent today.

MOYERS: We’re going to let you have the last word.

YOSIE: Thank you.

MOYERS: Thank you very much, Terry Yosie, thank you, Mr. Voorhees, thank you Dr. Landrigan, thank you Ken Cook.

I’m Bill Moyers. Thanks for watching. Good night.

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New battlefront for petrochemical industry: benzene and childhood leukemia by Kristen Lombardi for The Center For Public Integrity

ATHENS, Georgia — It was December 29, 1998, six years after Jill McElheney and her family had moved next to a cluster of 12 petroleum storage tanks. Jill was escorting her son Jarrett, then 4, to the doctor again. He had spent the day slumped in a stroller, looking so pale and fatigued that a stranger stopped her to ask if he was all right.

It was an encounter Jill couldn’t shake. For the previous three months, she had noticed her once-energetic preschooler deteriorating. He complained of pain in his knee, which grew excruciating. It migrated to his shoulder and then his leg. His shins swelled, as did his temples. At night, Jarrett awoke drenched in sweat, screaming from spasms. Jill took him to a pediatrician and an infectious-disease specialist. A rheumatologist diagnosed him with anemia.

Now, as Jarrett lay listless, Jill found herself back at the pediatrician’s office. Tests confirmed a blood count so low that she was instructed to get him to an emergency room immediately. Within hours she was at a hospital in Atlanta, some 65 miles from her home in Athens, watching nurses rush in and out of Jarrett’s room. Doctors identified a common form of childhood leukemia. “I heard the words,” Jill recalled, “and I only knew the bald heads and the sadness.”

In the waiting room, family members heard more unsettling news: A neighbor’s child also had developed leukemia.

Days later, Jarrett’s doctor penned a letter to federal environmental regulators about the two cancer patients, highlighting their “close proximity” to Southeast Terminals, a group of 10,000-gallon tanks containing gasoline, diesel and fuel oil.

“Could you please investigate,” the doctor wrote, “whether high levels of chemicals could have contaminated the water, possibly contributing … to the development of leukemia?”

Only then did the McElheneys consider the possibility that living beside one of the nation’s 1,500 bulk-oil terminals — known sources of cancer-causing benzene — had triggered their son’s leukemia.

“It was one of those light-bulb moments for us,” said Jeff McElheney, Jarrett’s father. “You never get over it.”

New battlefront for industry

Jarrett McElheney does not represent the standard benzene plaintiff. He’s not among the hundreds of thousands of people who toil in American oil refineries or other workplaces contaminated with the chemical and run the risk of developing leukemia. In the rancorous world of toxic-tort litigation, he stands virtually alone. A lawsuit filed by his parents in 2011 against Southeast Terminals owners BP and TransMontaigne is among a relatively few alleging leukemia caused by environmental benzene exposure. Among these, the McElheney case is rarer still: Most have hinged on adult leukemia.

Yet the case may signal an emerging quandary for the petrochemical industry, according to tens of thousands of pages of previously secret documents that have come to light in lawsuits filed against benzene manufacturers and suppliers on behalf of those who suffered from leukemia and other blood diseases, including Jarrett McElheney.

Internal memorandums, emails, letters and meeting minutes obtained by the Center for Public Integrity over the past year suggest that BP and four other major petrochemical companies, coordinated by their trade association, the American Petroleum Institute, spent at least $36 million on research “designed to protect member company interests,” as one 2000 API summary put it. Many of the documents chronicle a systematic attempt by the petrochemical industry to influence the science linking benzene to cancer. Others attest to the industry’s longstanding interest in topics such as childhood leukemia.

“A number of publications in the last few years have attempted to link increased risks of childhood leukemia with proximity to both petroleum facilities and local traffic density,” another 2000 API memo warns. “Although these publications have had little impact to date, the emphasis on ‘Children’s Health’ may cause these concerns to resurface.”

“This is indeed a battlefront for the oil industry,” said Peter Infante, a former director of the office that reviews health standards at the Occupational Safety and Health Administration, who has studied benzene for 40 years and now testifies for plaintiffs in benzene litigation. He has worked on a handful of cases involving children sickened by leukemia.

“It’s in the industry’s economic interests to refuse to acknowledge the relationship between benzene and childhood leukemia,” Infante said.

In May, in a sign of the chemical’s continuing threat, the U.S. Environmental Protection Agency estimated that 5 million Americans — excluding workers — face heightened cancer risks from benzene and 68 other carcinogens spewed into the air by the nation’s 149 oil refineries. The EPA has proposed a rule that would require refinery operators to monitor for benzene, in particular, along their fence lines.

Aimed at curbing “fugitive” emissions from equipment leaks and similar releases, the proposal would set a fence line limit for benzene of 3 parts per billion — a fraction of the 10 ppb the agency recommends as the maximum chronic exposure level for the chemical.

Industry groups are pushing back. In written comments, the API’s Matthew Todd called the proposal “a major and significant Agency action [that] will dramatically increase the paperwork and recordkeeping burden on refineries. It includes several precedent-setting proposals, will cost our industry hundreds of millions of dollars per year, increase safety risk [and] may impact fuels production and cost …. Production outages will likely occur.”

The EPA also heard from the people the rule is designed to protect. “We live near a refinery, and as a result my son can’t breathe,” a woman from Fontana, California, wrote in Spanish. “My cousin had respiratory problems while living near a refinery for more than 10 years,” a woman from Houston wrote, also in Spanish. “Unfortunately, he died 2 years ago from bone cancer. We believe this was a result of the ambient air where he lived.”

In June, California officials lowered the long-term exposure level for benzene from 20 ppb to 1 ppb — among the lowest in the country — setting the stage for further emissions cuts at refineries and bulk-oil terminals in that state. Officials say such regulatory actions aim to protect children, who are more susceptible to benzene’s toxic effects than adults because their cells aren’t as developed. California is considering classifying benzene not just as a human carcinogen, but as a “toxic air contaminant which may disproportionately impact children.”

“The fact that benzene impacts the blood-forming organs when you’re a developing child is a big deal,” said Melanie Marty of the state’s Office of Environmental Health Hazard Assessment.

Hidden menace

ill McElheney agrees. A warm, garrulous mother of five who has schooled herself in the health effects of pollution, she has spent the past 16 years seeking the cause of her son’s leukemia. She has filed open-records requests and contacted state and federal agencies, piecing together a history of gasoline spills and diesel-fuel leaks at Southeast Terminals. She can cite endless details about lingering benzene contamination on terminal property — extensively catalogued in state enforcement files — located “a stone’s throw away” from the trailer park where her family lived for seven years.

Jeff, Jarrett and Jill McElheney stand in the former site of the Oakwood Mobile Home Park, where the family was living when Jarrett was diagnosed with a form of childhood leukemia. Phil Skinner for the Center for Public Integrity
Now vacant and overgrown with brush, the former site of the Oakwood Mobile Home Park lies across a residential street from Southeast Terminals, its tanks rising above a thicket of pines and oaks. All day, every day, trucks drive in and out of the facility’s gates, filling tankers with gasoline and other products.

What can’t be seen is the plume of benzene that has worked its way into the groundwater beneath the tanks. “It’s not like Cancer Alley, with smokestacks belching crap in your face,” Jill said. “It’s hidden — literally.”

When she and Jeff moved to Oakwood in 1992, they saw the 14-trailer community as something of an oasis — quiet, tight-knit. Nestled under shady trees, near churches and schools, it seemed like the perfect location. Even the park’s water supply, drawn from an unpermitted well dating back decades, appeared idyllic: Its pump house served as a beacon on park property, visible for all to see — including, court depositions later confirmed, terminal employees.

“We saw Oakwood as an opportunity,” recalled Jeff, a mustachioed, genial man who operates a roofing company and managed the park for his father, its previous owner.

Jarrett McElheney, center, with 3 of his 4 siblings. Courtesy of the McElheney family
Jarrett arrived two years later and, by his fourth birthday, had grown into an adventurous boy with an abiding love of water. His parents remember him splashing in the tub for hours. Often, he swam in an inflatable pool in their yard, dressed in what he called his “little blue [wet] suit.” He slurped on Kool Aid and popsicles made from well water whose purity his parents never questioned — until his 1998 diagnosis of acute lymphocytic leukemia, or ALL, a form of the blood cancer found overwhelmingly in children.

Within days of hearing the news, Jarrett’s parents tested their water. Samples from the Oakwood well revealed a brew of such chemicals as carbon tetrachloride and 1,2-dichloroethane, sparking a state investigation. The Georgia Environmental Protection Division (EPD) found benzene in the water of Oakwood’s well at levels up to 13 ppb — 26 times higher than the federal safety standard. In response, the agency shuttered the well and connected residents to public water.

Over the next year, state geologists worked to identify the contamination’s source. They dug monitoring wells and collected soil samples. Their initial investigation linked at least one pollutant in the park well — not benzene — to nearby abandoned grain silos. Geologists eventually eyed Southeast Terminals as a likely source of the benzene contamination, records show.

“The terminals are certainly suspects for the benzene detected in the [Oakwood] well,” one posited in a 2000 email. “The probable path is deep ground water.”

Another noted the presence of “a possible plume (with benzene) moving by Oakwood … and within a few hundred feet of the [park]’s former well, [thus] too close for comfort for a public-water supply well.”

Two years later, EPD investigators were still documenting high levels of benzene, ranging from 8,000 to 12,000 ppb, on terminal property — as well as the likelihood that, one 2002 EPD memorandum states, “the benzene contamination found in the trailer park well came from the Southeast Terminals.”

Ultimately, though, the state’s two-year, nearly $200,000 investigation yielded few answers. By 2008, groundwater monitoring results revealed only trace amounts of benzene at Oakwood. Today, EPD officials say they lack definitive proof tying the well’s benzene pollution to any source.

For Jill McElheney, the outcome of the inquiry was anything but satisfying. “It just seems to me that when you’ve got benzene in a well and a major source of it next door, you’d make the connection,” she said.

In fact, Jill already had been seeking answers elsewhere. In 2000, she turned to the federal Agency for Toxic Substances and Disease Registry, or ATSDR, petitioning it for a public health assessment. Instead, the agency launched a less-thorough public health consultation, meant to ascertain the risk to human health posed by the contaminated well water at Oakwood.

The results brought little clarity. In a 2001 report, the ATSDR determined that “the groundwater contaminant plume” initially sampled in the Oakwood well “is a public health hazard.” At the same time, it singled out a pollutant other than benzene as the threat. For benzene, the agency found that “the likelihood someone would get cancer as a result of their exposure is very low.”

In a 2000 draft filed with the state, however, the ATSDR concluded that the highest concentrations of benzene in the water were of concern. “This risk DOES exceed an acceptable risk level,” the draft states, “and may result in an elevated risk of cancer for exposed individuals.”

An ASTDR spokeswoman did not respond to requests for comment.

Mounting evidence on benzene and leukemia

The science linking benzene to cancer — particularly leukemia, in all its forms — has preoccupied the petrochemical industry for more than half a century. As far back as 1948, the API’s toxicological profile of the chemical discussed “reasonably well documented instances of the development of leukemia as a result of chronic benzene exposure,” cautioning that “the only absolutely safe concentration … is zero.”

Later, as scientific evidence of benzene’s hazards accumulated and regulatory limits on workplace and environmental levels tightened, the industry took a different stance. By 1990, the API and member companies such as BP, Chevron, Mobil and Shell had launched a research program meant to keep further restrictions at bay — or, minutes from an API meeting in 1992 state, research “that will be most useful in improving risk assessment and influencing regulation.”

Within months, the API task force overseeing the program was enumerating “developing issues.” Topping its list, according to minutes from a meeting in 1993, was this notation: “link to childhood leukemia?”

That possible link appeared on the industry’s radar again in 2000, documents show. At the time, API representatives were drumming up financial support for an unparalleled study of workers exposed to benzene in Shanghai, China, delivering what amounted to a sales pitch for the project. They touted what one 2000 API overview described as its “tremendous economic benefit to the petroleum industry” — helping to combat “onerous regulations” and “litigation costs due to perceptions about the risks of even very low exposures to benzene.” Childhood leukemia was mentioned explicitly.

Five years later, industry representatives grew concerned enough to bankroll their own research. Documents show the API task force approved funding for what minutes of one meeting in 2005 dubbed a “benzene regulatory response,” comprising a “childhood leukemia review” and “child-to-adult sensitivity to benzene” analysis, for a total of $30,000.

By then, the scientific evidence on benzene and leukemia in adults was well-established. Throughout the 1960s and early 1970s, studies of Italian shoe and leather workers indicated a relationship between the chemical and the cancer. Then, in 1977, the National Institute for Occupational Safety and Health, part of the Centers for Disease Control and Prevention, launched a seminal study of two Goodyear plants in Ohio that made Pliofilm, a thin rubber wrap. The research quantified for the first time the leukemia risk for workers exposed to benzene, prompting OSHA to work on a stricter standard that took effect in 1987.

In years since, the science has solidified. Recent research has shown lower and lower levels of the chemical — less than the OSHA limit of 1 part per million — can cause leukemia as well as other blood and bone marrow disorders.

By contrast, experts say, the research on benzene and childhood leukemia isn’t as conclusive. Multiple studies have indicated that children whose mothers were exposed to benzene-containing solvents during pregnancy experience elevated risks of developing the disease. Others have shown that children living near gas stations or highways — breathing in benzene in the air — face heightened risks. One 2008 study reported a significant spike in the rate of the disease in Houston neighborhoods with the highest benzene emissions.

Taken together, the nearly four dozen publications on the topic strongly suggest the carcinogen can cause leukemia as much in children as adults, experts say.

“Children aren’t another species,” said Infante, the former OSHA official who has reviewed the scientific literature for medical associations and governmental agencies. “If benzene causes leukemia in adults, why wouldn’t it cause leukemia in children?”

The scientist behind the API-commissioned analysis would likely disagree. In 2009, David Pyatt, a Colorado toxicologist with long-standing ties to the petrochemical industry, published a journal article about his review, in which he reported examining 236 studies on the relationship between benzene and childhood leukemia. Many of the studies suggesting a link “suffer from the same limitations,” he concluded, such as poorly quantified exposure estimates.

“At this point,” Pyatt wrote, “there is insufficient epidemiologic support for an association or causal connection between environmental benzene exposure … and the development of childhood [leukemia].”

Some say the review reflects a common industry tactic: Compile studies on a subject, and then shed doubt on each one by claiming the data aren’t good enough.

Pyatt did not respond to repeated emails and phone calls from the Center seeking comment; nor did the API.

In depositions, Pyatt acknowledged that he has never testified for a plaintiff in a benzene exposure case. He has worked as a consultant and defense expert for such petrochemical giants as BP, ConocoPhillips, ExxonMobil and Shell, he has said; the API has financed additional work of his on benzene, as has the American Chemistry Council, the chemical industry’s main lobby.

In a deposition taken last year, Pyatt said he wouldn’t discount benzene’s link to childhood leukemia — at least, not to acute myeloid leukemia, or AML, a type rarely found in children.

“There is no reason to think that [children] are going to be protected,” he testified. “So I would certainly think that a child can develop AML if they are exposed to enough benzene.”

In other depositions, Pyatt has conceded no link between benzene and ALL, the type that attacked Jarrett McElheney.

‘They have to stop this practice’

For the McElheneys, the extent of the benzene contamination from Southeast Terminals only came to light years after Jarrett’s chemotherapy regimen had beaten back his leukemia. Yet state and federal enforcement records pinpoint on-site releases of the chemical in 1991, a year before the family moved to the area. At the time, managers of the terminal — jointly owned and operated by BP and Unocal Corp. — discovered a leak of diesel fuel seeping through soil where an underground pipeline was buried.

Terminal employees removed 40 cubic yards of “petroleum contaminated soils,” according to a report filed by BP with the state, and recorded benzene on site at levels as high as 81 ppb. Groundwater samples showed even higher concentrations: 12,000 ppb.

State regulators found such pollution “exceeds our ‘trigger’ levels,” a 1991 letter to the company states, and requested further action.

Under Georgia law, the company was required to develop what the EPD calls a “corrective action plan,” which, among other things, would have delineated the terminal’s benzene plume, as well as identified nearby public water wells.

In a 1991 reply, BP promised the EPD it would file its plan in four months.

Nine years later — after the McElheneys had tested their well water and the EPD had issued a 2000 citation against BP for failing to submit a “timely” corrective action plan — the company finally carried out that requirement, records show.

BP, in charge of the terminal’s daily operations, declined to comment for this article. At different times, Unocal, Louis Dreyfus Energy and TransMontaigne have been BP’s partners at the site. TransMontaigne, its current partner, did not respond to repeated emails and phone calls. TransMontaigne purchased Louis Dreyfus Energy in 1998. Chevron, which merged with Unocal in 2005, declined to comment.

Today, state regulators attribute their own delay in cracking down on the diesel leak to an internal debate over which EPD division had authority over the terminal’s benzene contamination — its underground storage tank program, which has purview over the pipeline; or, its hazardous waste branch. For years, compliance officers in that branch, along with their counterparts at the EPA, had been monitoring the facility’s practice of dumping benzene-laced wastewater on site — a practice later confirmed by terminal employees in court depositions.

In 1990, the EPA issued new rules classifying benzene as hazardous waste and requiring bulk-oil terminals to have permits for discharging the “bottoms water” in petroleum tanks. This wastewater can become tainted by the chemical when mixed with gasoline. Rather than treat the water, Southeast Terminals funneled it through an “oil/water separator” to skim off fuel, and then dumped it into a ditch on the ground.

Company records at the time show that terminal supervisors admitted they drained the wastewater “direct into streams” or “a dike area which eventually drains offsite into a stream.”

“I remember thinking, ‘They have to stop this practice,’” said John Williams, an EPD environmental specialist who inspected the terminal in 1993 and documented the dumping.

Three months later, the EPD issued a notice of violation against Southeast Terminals, forcing supervisors to test the bottoms water. Regulators found benzene at levels four times greater than the legal limit of 0.5 ppb, prompting the EPA to take action.

“We saw an issue there,” said Darryl Hines, of the EPA’s regional office in Atlanta, explaining why officials initiated a 1997 civil enforcement action against the facility.

In its complaint, the EPA accused BP and then-partner Louis Dreyfus Energy of violating federal hazardous-waste law — disposing waste without a permit, and failing to categorize it as hazardous. The agency ordered the companies to shut down the oil/water separator, and implement a plan addressing “any groundwater contamination.”

By the time Jarrett developed leukemia a year later, the EPA had negotiated a settlement with the companies and laid out a series of requirements for cleaning up the benzene. Without admitting fault, BP and Louis Dreyfus agreed to spend at least $100,000 to remove leaking underground pipelines and install above-ground infrastructure. They also paid a penalty of $15,000.

When BP finally filed its long-delayed action plan, it revealed the presence of what EPD project officer Calvin Jones described as a “dissolved hydrocarbon” plume containing benzene — “a bigger problem than we had thought.” The chemical, concentrated at 500 ppb and counting, had spread beyond the immediate spill areas. Of greater concern to regulators, the plan identified “free product” in groundwater.

“There was actually gasoline floating on the water,” explained Jones, of the EPD’s underground storage tank program, who oversaw the facility’s protracted cleanup. Referring to gasoline’s ability to dissolve in water, he said, “You can’t get higher concentrations of benzene … than free product.”

Despite a decade-long cleanup — 35.2 million gallons of contaminated groundwater and 1,009 pounds of benzene were collected — the chemical still saturates much of the nearly 19-acre Southeast Terminals site, records show. Last year, the EPD issued a letter declaring “no further action required,” which released the companies from remediation. At the time, the state-sanctioned benzene count remained at 1,440 ppb.

Over the years, enforcement records show, company consultants and regulators alike have tried to trace the path of the wastewater at the terminal. One company analysis details a trail beginning at the property line and then spilling into adjacent woods before hitting a tributary. Another document, produced by the EPA, depicts the discharge as moving offsite through woods and into a resident’s backyard.

“It’s where the drainage flows,” said Jeffrey Pallas, deputy director of the agency’s hazardous waste division in Atlanta, who oversaw the case against BP and Louis Dreyfus, explaining that the document, complete with photographs, was only intended to verify the hazardous-waste law violations.

“We cannot substantiate from the documentation we have that the benzene left the site,” he said.

Seeking accountability

The McElheneys have seen the evidence they need to connect Southeast Terminals to the benzene in the Oakwood well — and Jarrett’s suffering. They believe all the state and federal enforcement actions have yielded few consequences for the facility’s owners. If Jarrett hadn’t gotten sick, they say, they might never have known about the benzene hazard. “The companies would have paid off their small fines,” Jill said, “and nobody would have been the wiser.”

Seeking some accountability, the family filed a lawsuit three years ago against BP, TransMontaigne and seven other previous owners, alleging that the “illegal discharge and release of toxic chemicals” at Southeast Terminals contaminated the surrounding environment and caused Jarrett to develop leukemia.

In court filings, the companies denied the allegations and dismissed any link between benzene and childhood leukemia. Last year, defense lawyers invoked a familiar tactic: They cited the Pyatt review to support their claims that the chemical couldn’t have caused Jarrett’s illness. The family recently has agreed on a settlement in principle and is working toward resolving the litigation.

“I thought, ‘This is par for the course,’” said Jill, who has read some of the industry documents uncovered by the lawsuit. “The oil industry has fought regulations and lawsuits for workers and adults. Now they’re going to do it with children.”

Jarrett is now a slight, reserved 20-year-old in remission. He remembers his bout with leukemia through a child’s eyes — the “really cool” ambulance rides, the nurses with coloring books, swinging golf clubs in hospital hallways. “I remember being stuck over and over again by needles” while getting a bone-marrow aspiration or a chest catheter or countless blood draws, he said. “But it wasn’t until much later I realized what happened to me didn’t happen to other kids.”

Today, he has had to grapple with cancer’s lasting effects — the feebleness, and the fatigue — as well as its lingering fears. As a leukemia survivor, he is at risk for developing osteoporosis, cataracts, or even another cancer. Sitting in an Olive Garden in Athens, sandwiched between his parents, Jarrett came across as exceedingly shy, uncomfortable in the limelight. Often, his parents did the speaking for him.

Moments earlier, Jill had explained how leukemia had changed her son, taken an emotional toll.

“He had a really loud voice as a toddler but that voice has mellowed,” she said. “I’ll take that voice over anything.”

Maryam Jameel contributed to this story.

Click on the link below to access the original article at the Center for Public Integrity

http://www.publicintegrity.org/2014/12/08/16356/new-battlefront-petrochemical-industry-benzene-and-childhood-leukemia

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A dozen dirty documents
Twelve documents that stand out from the Center’s new oil and chemical industry archive

By Kristen Lombardi for The Center for Public Integrity

The Center for Public Integrity, along with researchers from Columbia University and the City University of New York, on Thursday posted some 20,000 pages of internal oil and chemical industry documents on the carcinogen benzene.

This archive, which will grow substantially in 2015 and beyond, offers users a chance to see what corporate officials were saying behind the scenes about poisons in the workplace and the environment.

Here are 12 examples of what the petrochemical industry knew about benzene; the impetus behind industry-sponsored science; and the corporate spin that often occurs when damning evidence against a chemical threatens companies’ bottom lines.

What the industry knew:

The industry knew the dangers of benzene exposure at both high and low concentrations, as illustrated by this 1943 report for Shell Development Company by a University of California researcher.

“Inasmuch as the body develops no tolerance to benzene, and as there is a wide variation in individual susceptibility, it is generally considered that the only absolutely safe concentration for benzene is zero.” That was a conclusion reached in a 1948 toxicological review of benzene prepared for the American Petroleum Institute, a trade association.

Benzene’s dangers known in 1943 (pg 2)
This 1943 report, prepared for Shell, is among the earliest to suggest that any prolonged exposure to benzene may be harmful.

No safe exposure level (pg 4) This 1948 review, prepared for the oil industry’s main trade group, the American Petroleum Institute, continues to torment the industry in litigation alleging benzene can cause various types of leukemia and other diseases of the blood-forming organs. In essence, it says the chemical is so potent that there is no safe exposure level.

A 1950 consultant’s memo to Shell lists benzene as having “established carcinogenic qualities.”

Benzene recognized as a well-known carcinogen (pg 1)

This 1950 memorandum from a consultant for Shell Development Company notes that benzol — an obsolete name for benzene — is a well-known carcinogen. As the author states, the memo was prompted by “an increased concern about the incidence of cancer” among Shell workers.

Motivations for industry involvement in research:

In 1995, a benzene study by the National Cancer Institute caught the attention of Exxon scientists, who closely monitored it.

Industry interest in cancer research (pg 1)
An Exxon scientist, B.F. Friedlander, explains that he and industry colleagues are “monitoring” a series of studies by the National Cancer Institute because of their focus on “health risks at low benzene exposures.” The memo shows the petrochemical industry’s early interest in the work of the NCI, which has examined the effects on Chinese workers exposed to benzene at levels below the legal occupational limit in the United States.

While attempting to gain support for a proposed study of benzene toxicity in Shanghai, China, the American Petroleum Institute cites “a tremendous economic benefit” to companies, which could gain data to combat “onerous regulations.” A project overview explains that publications linking benzene to childhood leukemia may cause concerns about the chemical to “resurface.”

‘Tremendous economic benefit’ from the industry study (pg 1)
The six-page overview touts the proposed Shanghai research as a way for the petrochemical industry to gain an “accurate understanding” of benzene’s health effects, which, in turn, would bring “tremendous economic benefit.”

A 2000 summary of the API’s research strategy, drafted by the group’s Benzene Task Force, explains that the research program “is designed to protect member company interests.” The anticipated results could “significantly ameliorate further regulatory initiatives” to curb benzene emissions.

Protecting industry interests (pg 2)

The summary describes the intent of the API’s research program as being “designed to protect member company interests.”

An email exchange explains how “HSE [health, safety and environment] issues surrounding benzene as well as the litigation claims” against the industry compel companies to participate in the industry-sponsored study.

Motivations for research (pg 2)
An email from one Shell executive argues that the “litigation claims we continue to see” are prime reasons for the company to spend millions of dollars on the proposed Shanghai research.

A PowerPoint presentation from 2001 lists “significant issues of concern” to encourage financial support for the API’s research on benzene-exposed workers in China. Among them is “litigation alleging induction of various forms of leukemias and other hematopoietic diseases.” The study, according to the presentation, could provide “strong scientific support for the lack of a risk of leukemia or other hematological diseases at current ambient benzene concentrations to the general population.”

Significant issues of concern (pg 3)
This PowerPoint slide suggests “significant issues of concern” that the proposed Shanghai research might help combat, which would save the petrochemical industry “millions of dollars in expenses.” The issues include more stringent regulations and litigation from benzene exposure.

“Litigation support” and “risk communication” are listed as goals in this 2007 memorandum describing an API risk management program. Further objectives are to establish current regulations as “protective” and avoid additional action.

Oil lobby’s risk management program (pg 1)
The memorandum details the oil lobby’s benzene “risk management” program, intended to “develop scientific data” for it and its member companies to use for “science advocacy” and “litigation support.”

Corporate spin

An undated litigation defense guide written by a senior Shell attorney acknowledges the 1948 report on leukemia and offers a “comprehensive strategy” on how to respond to litigation, including releasing benzene-related documents only on court order.

Acknowledgement of the science showing no safe levels of benzene (pg 4)

Here the author, Richard O. Faulk of Shell Oil’s legal department, references a 1948 Toxicological Review prepared for the American Petroleum Institute. The review found that “the only absolutely safe concentration for benzene is zero.”

After a draft of an API recruitment brief reminds potential study sponsors of “personal injury claims,” an email exchange among members of the Benzene Health Research Consortium urges deletion of “the reference to legal liabilities.”

Don’t mention the legal liabilities (pg 3)

This email from a Shell executive responds to an attached draft of a 2002 recruitment brief that reminds prospective donors about benzene liability costs. In the email, the executive urges colleagues to delete “the reference to legal liabilities” and emphasizes that “the only reason we are doing this is in support of protecting workers.”

A 2001 email from the consortium’s communications committee explains that the perception of the study “needs to be that this is not being done to protect against litigation”

Controlling the message on benzene (pg 1)

The email shows the companies behind the Benzene Health Research Consortium working hard to control their message. It lays out the “scope of public affairs” for the consortium’s communications committee, which includes countering any “perception” that the Shanghai study was “done to protect against litigation.”

Click on the link below to access original article and archival documents.

http://www.publicintegrity.org/2014/12/05/16361/dozen-dirty-documents

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Internal documents reveal industry ‘pattern of behavior’ on toxic chemicals by David Heath for The Center for Public Integrity

Sixty-six years ago, a professor at the Harvard School of Public Health wrote a report linking leukemia to benzene, a common solvent and an ingredient in gasoline. “It is generally considered,” he wrote, “that the only absolutely safe concentration for benzene is zero.”

The report is remarkable not only because of its age and candor, but also because it was prepared for and published by the oil industry’s main lobby group, the American Petroleum Institute.

This document and others like it bedevil oil and chemical industry executives and their lawyers, who to this day maintain that benzene causes only rare types of cancer and only at high doses.

Decades after its release, a lawyer for Shell Oil Company flagged the 1948 report as being potentially damaging in lawsuits and gave out instructions to “avoid unnecessary disclosure of sensitive documents or information” and “disclose sensitive benzene documents only on court order.”

Plaintiff’s lawyers like Herschel Hobson, of Beaumont, Texas, wield such documents in worker exposure cases to demonstrate early industry knowledge of benzene’s carcinogenic properties.

“It shows a pattern of behavior,” Hobson said. “It shows how industry didn’t want to share bad news with their employees. None of this information was made available to the average worker … Most of this stuff kind of gets lost in the weeds.”

No more. Today, the Center for Public Integrity; Columbia University’s Mailman School of Public Health and its Center for the History and Ethics of Public Health; and The Graduate Center at the City University of New York are making public some 20,000 pages of benzene documents — the inaugural collection in Exposed, a searchable online archive of previously secret oil and chemical industry memoranda, emails, letters, PowerPoints and meeting minutes that will grow over time.

The aim is to make such materials — most of which were produced during discovery in toxic tort litigation and have been locked away in file cabinets and hard drives — accessible to workers, journalists, academic researchers and others.

Some are decades old, composed on manual typewriters; others are contemporary. Combined with journalism from the Center — such as today’s story on a $36 million benzene research program undertaken by the petrochemical industry — and articles and papers from Columbia and CUNY faculty and students, the archives will shed light on toxic substances that continue to threaten public health.

Exposed: Decades of denial on poisons

The benzene documents are just the start. In coming months, we’ll be posting hundreds of thousands of pages of discovery material from lawsuits involving lead, asbestos, silica, hexavalent chromium and PCBs, among other dangerous substances. And we’ll be on the lookout for other documents.

The inspiration for the project came when we realized that in CPI’s reporting on environmental and workplace issues, we routinely obtained reams of court documents. Often, these documents hold secrets found nowhere else.

Last year we reached out to William Baggett Jr., a lawyer in Lake Charles, Louisiana, who had acquired more than 400,000 pages of documents from a decade-long case against manufacturers of vinyl chloride, a cancer-causing chemical used in plastics. Baggett agreed to give us all of them.

At the same time, public health historians Merlin Chowkwanyun, David Rosner and Gerald Markowitz were collecting court documents to create a public database and had approached Baggett. We decided to collaborate. Chowkwanyun is currently a Robert Wood Johnson Foundation Health & Society Scholar at the University of Wisconsin-Madison, and will be an assistant professor of sociomedical sciences at Columbia next year. Rosner is Ronald Lauterstein Professor of Sociomedical Sciences and History at Columbia. Markowitz is a professor of history at the City University of New York. Both Rosner and Markowitz have served as expert witnesses in a number of major cases related to these documents and have written Deceit and Denial: The Deadly Politics of Industrial Pollution and other books and articles based on them.

This is not the first database of its ilk. The University of California, San Francisco, maintains a massive collection of documents from tobacco-related lawsuits called the Legacy Tobacco Documents Library, which exceeds 80 million pages.

How to search the documents

Our database allows you to search for a word, combination of words or an exact phrase in any of the documents. You can also:

Do a search that excludes a word by putting a ‘-‘ sign in front of the word.
Do a fuzzy search that includes variations of a word by putting a tilde ‘~’ at the end of a word with the numbers of characters that don’t have to match exactly. For example, ‘planit~2’ will match ‘planet.’
Do a search that optionally contains a word by putting a ‘|’ between the words.
Do a search with a phrase by putting double quotes around the phrase.
Each document will include the court case from which it came, including the case title, case number, court as well as date filed and date terminated. The original complaint for each lawsuit is also part of the database.

Soon, we will make available a robust set of text-mining tools that will allow researchers to construct chronologies of documents; generate lists of common words, phrases and names; and sort documents in a number of ways. Qualified researchers will also have access to an even larger set of documents that will eventually contain millions of pages.

Robert Proctor, a professor of the history of science at Stanford, has used the UCSF tobacco archive extensively to do research for several books. He called it “an unparalleled treasure” that gives researchers the ability “to look through the keyhole of the mansion of this hidden world and see [corporate officials’] private thoughts, their intent, their ruminations, their jokes, their plans, how they treat their workers, how they treat the public…”

Proctor said he sees value in a similar archive on toxic chemicals. “The internal records of the chemical industry are known only to a tiny group of lawyers and journalists,” he said. “This is going to create a new kind of democracy of knowledge. It also will set the stage for whistleblowers to come forward with documents.”

That’s our hope. The search interface includes options to send us documents or contact us. The ultimate goal, to borrow Proctor’s phrasing, will be to give users “a strong magnet to pull rhetorical needles out of archival haystacks.”

Click on the link below to access the original article at The Center for Public Integrity

http://www.publicintegrity.org/2014/12/04/16330/internal-documents-reveal-industry-pattern-behavior-toxic-chemicals

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Are Any Plastics Safe? Industry Tries to Hide Scary New Evidence on BPA-Free Bottles, Containers

http://www.democracynow.org/2014/3/4/are_any_plastics_safe_industry_tries


AMY GOODMAN: “Are any plastics safe?” That’s the title—that’s the question of a new exposé by Mother Jones that may shock anyone who drinks out of plastic bottles, gives their children plastic sippy cups or eats out of plastic containers. For years, public campaigns have been waged against plastic containing BPA, Bisphenol-A, a controversial plastic additive. But a new investigation by Mother Jones magazine has revealed that chemicals used to replace BPA may be just as, if not more, dangerous to your health than their cousin compound.

BPA is still widely used in everything from the lining of soup cans to printed receipts, even though studies show it mimics the behavior of estrogen in the human body, and have linked it to breast cancer, diabetes, obesity and heart disease. Just last week, a study estimated the use of BPA in food and beverage containers is responsible for some $3 billion a year in healthcare costs. But because BPA can hamper brain and organ development in young children, it’s been banned in bottles and sippy cups since 2012. Now new studies show the plastic products being advertised as BPA-free, and sold by companies such as Evenflo and Nalgene, Tupperware, are still releasing synthetic estrogen.

The Mother Jones report goes on to look at how the plastics industry has used a Big Tobacco-style campaign to bury the disturbing evidence about the products you use every day.

We’re joined in Washington, D.C., now by Mariah Blake, staff reporter with Mother Jones magazine.

Mariah, welcome to Democracy Now! Just lay out what you have found.

MARIAH BLAKE: Well, essentially, there is relatively new research showing that the vast majority of plastics, at least commercially available plastics that are used for food packaging, contain BPA-like chemicals, so chemicals that are what they call estrogenic. And the—

AMY GOODMAN: And explain what BPA is.

MARIAH BLAKE: So BPA is a chemical that mimics the hormone estrogen. And estrogen plays—we all have estrogen in our bodies. It plays an essential role in various bodily functions and is also very important in human development, so the development of our brain, the development of our organs. However, too much or too little of this hormone, basically, especially during early childhood or prenatally, can set you up for disease later on in life. So, exposure—what the research shows is that exposure in the womb can then lead to breast cancer, diabetes, increased aggression, really sort of a staggering list of health problems later on in life.

AMY GOODMAN: And so, talk about what has happened since BPA has been banned.

MARIAH BLAKE: So, yes, and many people will recall that in 2008 the dangers of BPA became very widely known. There was a scare. Major retailers pulled BPA from their shelves. Customers began demanding BPA-free products, especially for children. And many manufacturers began introducing products that were BPA-free. And all of us who have children have these BPA-free products in our home, most likely. One of the—so—and in many cases, it turns out that the chemicals that were used to replace BPA, or the plastics contained chemicals that were, you know, similar to BPA—at any rate, many of these chemicals had not been tested to see whether they had similar properties to BPA, whether they mimicked estrogen, in essence. And it turns out that many of them do. So, the implication is that they could have similar effects on human health.

AMY GOODMAN: You begin your piece by telling us the story of Michael Green and his daughter.

MARIAH BLAKE: Yes.

AMY GOODMAN: Talk about that experience.

MARIAH BLAKE: So, Michael Green is—he had a two-year-old daughter. He’s somebody who works in the environmental health field. And he had heard—he had seen research suggesting that BPA-free plastics may have posed some of the same problems to human health. And—but he told me this very moving story about himself and his two-year-old daughter. Somebody else in the family had given his two-year-old daughter this pink plastic sippy cup with a picture of a princess on it, which she just loved. And every night at dinner time, they would have this battle of the wills over this pink plastic sippy cup: He wanted to give her the stainless steel sippy cup; she wanted the pink plastic sippy cup. And in the interest of maintaining peace in the household, occasionally he gave in and gave her this pink plastic sippy cup. But the decision really weighed on him. And I think that those of us who have children—I have a three-year-old son—can relate to this situation, where sometimes you do the expedient thing in the interest of peace, but you wonder if it’s the best thing for your child. And in this case, he decided that he would try to answer that question. And he runs this environment health organization, and he collected sippy cups from Wal-Mart and Toys”R”Us—Babies”R”Us, I’m sorry—and he sent them to an independent lab in Texas to be tested. And he found out that in fact roughly a third of them did contain estrogen-like chemicals.

AMY GOODMAN: And that pink sippy cup?

MARIAH BLAKE: His daughter’s sippy cup was leaching estrogenic chemicals. So his fears were founded.

AMY GOODMAN: And what can that do to her?

MARIAH BLAKE: This is the big question. We know a lot about BPA. BPA is one of the most studied chemicals on the planet. And we know that these chemicals generally are associated with a range of negative health effects. But the specific effect of any given chemical varies slightly from chemical to chemical, and we actually don’t know what chemical is leaching out of that sippy cup. So it’s impossible to know. I mean, there’s a very high correlation with breast cancer, for example, with all of these estrogenic chemicals, and with certain developmental problems. But other specific diseases vary from chemical to chemical. So, Michael Green, the way he describes it is an unplanned science experiment that we’re doing on our families all of the time.

AMY GOODMAN: We’re going to break and then come back to this discussion and talk about Big Tobacco, what Big Plastic has learned from Big Tobacco. We are talking to Mariah Blake, a staff reporter with Mother Jones. Her story is in the new issue of the magazine. It’s called “The Scary New Evidence on BPA-Free Plastics: And the Big Tobacco-Style Campaign to Bury It.” Stay with us.

[break]

AMY GOODMAN: This is Democracy Now!, democracynow.org, The War and Peace Report. I’m Amy Goodman. We are with Mariah Blake, staff reporter for Mother Jones magazine. “The Scary New Evidence on BPA-Free Plastics: And the Big Tobacco-Style Campaign to Bury It” is her new piece. What is the campaign to bury the information, Mariah Blake?

MARIAH BLAKE: Well, there are multiple facets to the campaign, but the primary—the primary objective is to cast doubt on the scientific evidence linking these chemicals to human health problems. So—and there are various ways this is done. In the case of BPA, for example, the industry funded studies, which were biased studies that found that this—that the chemical was not harmful to health. And there’s a sort of network there. They published them in certain journals that, in many cases, had links to the tobacco industry. They relied on scientists that, in many cases, had helped to discredit the science linking smoking and secondhand smoke to disease. So, in many ways, this is—they didn’t only borrow strategies and tactics from Big Tobacco; they are actually relying on the same cadre of experts that Big Tobacco relied on to bury—to bury the truth about smoking.

AMY GOODMAN: I want to turn to a video made by the plastics industry featuring the vice president of Eastman’s specialty plastics division, Lucian Boldea, speaking in the video made by the company. A pregnant woman is one of the people shown buying plastic products as Boldea speaks.

LUCIAN BOLDEA: We understand that there are concerns about plastic materials that are used in consumer products that consumers use every day. Those products include water bottles, baby bottles and food storage containers. We can see how available information about plastic materials can be confusing and how it can be difficult for consumers to tell what is really safe. We want you, the consumer, to know the facts behind our clear, tough material named Tritan. Consumers can feel confident that the material used in the product is free of estrogenic activity.

Consumers should have high expectations of the products that they use, and no one is tougher on our products than the researchers and engineers at Eastman Chemical. Most importantly, we have used reputable, independent, third-party laboratories that have used well-recognized scientific methods to prove that Tritan is free of estrogenic activity. Numerous regulatory agencies around the world have independently reviewed our data and have approved the product for use in food contact applications. Some of the world’s most recognized brands trust Tritan as their ingredient.

AMY GOODMAN: That was Lucian Boldea, who is president of Eastman Chemical’s specialty plastics division. Can you respond to this, Mariah Blake?

MARIAH BLAKE: Well, the Eastman product, called Tritan, which is the product that Boldea is speaking about in this video, is actually one of the primary focuses of my investigation. A number of independent scientists have tested this product and found that it is actually more estrogenic than polycarbonate, which is the plastic that contains BPA. And Eastman Chemical, according to internal documents which were released as part of a lawsuit, has taken pains to suppress the evidence showing that its products—or that this product, in particular, is in fact estrogenic.

AMY GOODMAN: So how is it the EPA isn’t regulating this?

MARIAH BLAKE: Well, and this is one of the most surprising things to me when I read this—when I was reporting the story. So, there are about 80,000 chemicals in circulation in the United States. Virtually none of those chemicals has been tested for safety, or a very, very small fraction of those chemicals has been tested for safety. In general, chemicals are presumed safe until proven otherwise under the U.S. regulatory system. So, when a chemical like BPA is removed from a production line, the industry will substitute another chemical that is untested, and we really, in many cases, just don’t know the health effects of that chemical. So, it’s largely an unregulated realm.

AMY GOODMAN: Tell us about George Bittner.

MARIAH BLAKE: OK. George Bittner is a neuroscientist at the University of Texas, and he has launched an independent lab called CertiChem—it also has a sister company called PlastiPure—and it tests products for estrogenic activity. And he—working with a prominent Georgetown professor, he and his staff tested, I think it was, 455 commercially available plastics that are on the market and published a paper in Environmental Health Perspectives, which is the premier NIH journal, which found that virtually all commercially available plastics have estrogenic activity. And among the plastics he tested were Tritan products, several Tritan products. And this publication, this finding, prompted a pretty big backlash from the industry. So he ended up being targeted by the industry as a result and, in fact, was sued by Eastman, which is—many of the documents that formed the basis of my story were released as a result of that lawsuit.

AMY GOODMAN: I want to read from a memo that Eastman’s senior chemist, Emmett O’Brien, wrote after customers began asking about George Bittner’s tests that showed that Tritan may still be estrogenic. O’Brien describes a meeting with Whole Foods executives who were considering replacing their polycarbonate bulk food bins with ones made from Tritan. He wrote, quote, “We called Bittner a mad scientist. They didn’t know his name actually. They asked twice, by two independent people, what we thought of them. I hemmed and hawed (ducked and dodged) saying I prefer not to comment, but we joked and pushed and flat out said the guy was ‘shady’ — with this non-stereotypical crowd it was a good term.” O’Brien added, “They asked if they could do their own tests — I mentioned the cost is very high and they were quick to chime in that the tests take very long.” Can you respond to that, Mariah Blake?

MARIAH BLAKE: I think you chose the most telling possible quote. So this was effective—this was the strategy they used. Firstly, they worked to discredit Bittner, and they did this through a campaign of personal character assassination and by calling his business practices into question. And secondly, they worked to discredit the science. So, one of the things that Eastman did was they claimed that the test that Bittner is using, which relies on a specialized line of breast cancer cells, had been rejected by the EPA, when in fact it hadn’t. The EPA is considering using this very line of breast cancer cells for its own screening program for what they call endocrine-disrupting chemicals. BPA is one of those.

So, the other thing they did was they commissioned their own research, so they paid labs to perform research which found that Tritan was not estrogenic. And—but if you look at—if you look at the research closely, you’ll see that it is—the studies are essentially designed in a way that guarantee that estrogenic activity will not be found. So, for instance, they use a type of rat; it’s called a Charles River Sprague Dawley rat. This rat is known to be insensitive to estrogen, so it can withstand doses, according to one Japanese study, a hundred times higher than a human female can withstand, with—and show absolutely no effect. They also used doses that are below what is known as the no-observable-effect level, so the doses that are known not to cause an effect. And they then published their own study in a scientific journal, which is—has numerous tobacco industry ties, finding that Tritan was in fact not estrogenic. So, that is essentially how they responded to the finding that their product contained these chemicals that are potentially harmful to human health: They attempted to cover it up.

AMY GOODMAN: Your report cites some leaked minutes from a 2009 meeting of the BPA Joint Trade Association, whose members include the American Chemical—the American Chemistry Council, Coca-Cola, Del Monte. During the meeting, they explored messaging strategies that included using what they called, quote, “fear tactics.” For example, “Do you want to have access to baby food anymore?” The attendees agreed that the “holy grail” spokesperson was a, quote, “pregnant young mother who would be willing to speak around the country about the benefits of BPA.” Mariah?

MARIAH BLAKE: Yes, and this is one of the most disturbing things I discovered during the course of reporting this, is that in their efforts to portray plastics as safe, they oftentimes target the groups who are most vulnerable to the effects of these chemicals. So, prenatal exposure and exposure during early childhood is potentially the most harmful, and oftentimes the marketing of these products targets pregnant women, targets families with children. And also, Eastman, for example, in their efforts to portray their products as safe, also targeted these specific groups.

AMY GOODMAN: Can you talk about Nalgene bottles, Evenflo—is it Evenflo?—Tupperware, Rubbermaid, CamelBack?

MARIAH BLAKE: Yes, all of these companies produce at least some products that are made with Tritan, so—and they’re not alone. There are hundreds, probably, of companies that use this. This is the only plastic on the market that markets itself as being free of all estrogenic activity, so many companies that cater to consumers who are concerned about their health and many of the high-end consumer brands have started using this plastic. I think the thing to keep in mind is that Eastman misrepresented their product to their customers, as well. So these brands are not necessarily to blame for this. They have been told by Eastman that Eastman produced—performed independent, third-party testing and found no evidence of estrogenic activity. And so, in many cases, it appears that these companies are trying to do the best thing for their customers, but they were not given—they were not given accurate information about the plastic that they use in their products.

AMY GOODMAN: Last week, NPR did a report, “Maybe That BPA In Your Canned Food Isn’t So Bad After All.” Can you talk about that?

MARIAH BLAKE: Yes. So, this is based on a recent study that was performed by FDA scientists. This is a $30 million taxpayer-funded study. And the FDA used many of the same tactics that the industry uses. For instance, they used the Charles River Sprague Dawley rat. The other thing about this study is that the lab appears to have been contaminated. So the control group of rats—these are the rats that are supposed to not be exposed to BPA, so that you can—you have some sort of a baseline to measure the animals that have been exposed to this chemical—they were somehow accidentally exposed to BPA. I have been talking to scientists about this and am planning to write about this later this week. And the academic scientists I have been speaking to say that this essentially—this raises very serious questions about the validity of the findings, and it’s unclear whether any conclusions can be drawn based on this study.

AMY GOODMAN: What most shocked you in all your research, Mariah?

MARIAH BLAKE: Boy, that’s a good question, because there were a lot of—a lot of shocking things I discovered. I would say there’s a couple things. One, the fact that so few of the chemicals that are in the products we use every day have been tested for safety. So, as I said, there are 80,000 chemicals that are in commercial use in the United States; only a tiny fraction of those have been tested for safety.

Two, how easy it is for the industry to bias that safety testing in their favor. I had—obviously, many of us know about Big Tobacco and the way they were able to essentially buy science saying their products were safe. But I was not aware that that was happening on such a grand scale today. And it really is. You know, plastics—as I worked on the story, it became evident to me that plastics—that this is not the only industry—the plastics and chemical industry are not the—is not the only one that is using these tactics. These tactics are fairly widespread.

And I guess, on a micro level, one of the things that surprised me most, in Bittner’s testing, he looked at various types of commercially available plastics, and one of the types of plastic that was most frequently estrogenic was the corn-based plastic, so the plastic that is biodegradable, that you often find in restaurants—health food restaurants, health food stores, that this is potentially one of the most harmful types of plastic.

AMY GOODMAN: Explain that again.

MARIAH BLAKE: So, Bittner looked at various kinds of plastic, Bittner and his colleagues, when they tested plastics. There’s a variety of different kinds of plastic—polyurethane, PET-P, polycarbonate—all these different kinds of plastic. So he broke it down by types of plastic. He tested a number of samples of each one. And he—in the final paper, they showed which ones—what percentage of each type of plastic tested positive in their tests. And there is a type of plastic that is—frequently you’ll find it in Whole Foods, you’ll find it in health food stores. It is corn-based, and it is marketed as biodegradable. Oftentimes there are forks made out of this, for example, in health food restaurants. I believe the statistic was 95 percent of samples made out of this kind of plastic tested positive for estrogenic activity.

AMY GOODMAN: So what are you going to do with your three-year-old? What have you decided to use?

MARIAH BLAKE: Well, what I’ve already done is removed all plastic from my home. So, I have switched to natural materials. We use glass or stainless steel for our Tupperware, for our sippy cups, for everything that we possibly can. Plastic is unavoidable, so we still buy food packaged in plastic, because there is no alternative. But we try to minimize it.

AMY GOODMAN: Saran Wrap?

MARIAH BLAKE: Saran Wrap, actually, in Bittner’s tests, I believe it was somewhere around 99 to 100 percent of plastic wraps tested positive for estrogenic activity.

AMY GOODMAN: And where does the EPA come down when you question them about when they’re going to be regulating some of this, in the way that they regulated BPA?

MARIAH BLAKE: Well, the EPA still does not regulate BPA. The FDA—the FDA banned BPA in sippy cups and bottles at the request of the industry. So—and they still—the agency still insists that BPA is safe. So the industry asked the FDA to ban it, because they wanted to reassure parents that their products are safe. There has been no meaningful regulation of any of these chemicals, with the exception of phthalates. And in the case of the EPA, they have a program which was supposed to screen these 80,000 chemicals for what’s called endocrine disruption. So, endocrine-disrupting chemicals are chemicals that mimic hormones, like BPA. And they—this was supposed to be at least partially done by 2000. They still haven’t fully vetted a single chemical. So the industry has managed to throw stumbling blocks in their path. And delay is the name of the game, essentially, sowing doubt and delay. So—

AMY GOODMAN: And how much does the plastic in water bottles and juices leach into the water and the juices?

MARIAH BLAKE: PET or PETE, which is most commonly used for water bottles, is—I believe 75 percent of samples in Bittner’s study leached estrogenic activity. There is another study performed by a scientist in Germany which also found that this particular type of product was estrogenic. So, it seems, based on the available evidence, that many or most of these bottles leach estrogen.

AMY GOODMAN: And the longer the bottle of water you buy sits, is the water becoming increasingly contaminated?

MARIAH BLAKE: Well, there are certain factors that increase the risk of these chemicals being released. So, exposure to UV rays, heat, if they’re put in a dishwasher, these are the things that are known to increase—increase the risks that these chemicals leach out of plastics. So, with reusable plastics, in particular, this is a concern. If you boil them, if you put them in your dishwasher, if you leave them in your car, that causes plastics to break down, and it’s more likely that estrogenic chemicals will leak into whatever those containers contain.

AMY GOODMAN: Well, Mariah Blake, we want to thank you for your research, staff reporter with Mother Jones magazine. Her story is just out in the new issue; it’s called “The Scary New Evidence on BPA-Free Plastics: And the Big Tobacco-Style Campaign to Bury It.” We’ll link to it at democracynow.org. You can also follow her on Twitter. Later today, she’ll be doing a Twitter chat with readers.

http://www.motherjones.com/environment/2014/03/tritan-certichem-eastman-bpa-free-plastic-safe

The Scary New Evidence on BPA-Free Plastics

And the Big Tobacco-style campaign to bury it.

—By Mariah Blake | March/April 2014 Issue – MotherJones


Chasing Molecules by Elizabeth Grossman

An excerpt from the chapter, “The Polycarbonate Problem.”

BPA, Benzene, Phenols, & Carbonyl Chloride (also known as Phosgene)

Although it’s only in the past few years that news of bisphenol A’s health impacts began to reach a nonscientific general public–news that has since spread rapidly–it was first recognized as a synthetic estrogen in the 1930s. Papers published in the journal of Nature in 1933 and 1936 describe its estrogenic effects on lab rats. These papers also commented on the possible carcinogenic activity of materials with similar or comparable composition to bisphenol A–specifically materials synthesized from petroleum (from which bisphenol A is ultimately derived) and coal tar.

Some two decades later, bisphenol A was launched into everyday life with the development of commercially produced polycarbonates. Major production of these plastics began in the United States in the late 1950s after a General Electric engineer named Daniel W. Fox formulated a material based on BPA that GE called Lexan. The invention was not so much deliberately planned as it was the result of what Fox called his ability to take “a few clues and jump to conclusions that frequently panned out.”

While experimenting with different materials that might ultimately make a good moldable polymer, Fox decided to work with bisphenols, compounds derived from petroleum processing that were then being used to make various epoxy resins. As molecules, bisphenols have a structural feature that makes them useful as potential chemical building blocks. Attached to their hydrocarbon ring is what’s called a hydroxyl group, an oxygen and hydrogen that together form a site to which other molecules can bond. This structure is common to both synthetic and naturally occurring compounds, a coincidence that will later turn out to be important to how bisphenol A behaves.

Fox’s interest in the hydroxyl group was as a polymer building site, not for its biological activity. But when attached to a hydrocarbon ring as it is in bisphenol A, the entire chemical grouping becomes a molecule known as a phenol–an aromatic hydrocarbon, a ring made up of six carbon atoms and five hydrogen atoms plus a hydroxyl group. Phenols are commonly made by oxidizing benzene, which essentially means adding oxygen to benzene. Phenols are toxic, but they are also known for their antiseptic properties and so were used to kill germs in the nineteenth century surgical procedures.

This molecular group consisting of six carbon-five hydrogen rings with a hydroxyl group attached, however, is also part of the structure of substances produced naturally by the human body, compounds that include estrogen and thyroid hormones. Introducing a manufactured chemical that includes the phenol group into a cellular environment may therefore pose a problem because the synthetic material may compete biochemically with the similarly structured naturally occurring chemical. Thinking in green chemistry terms, the presence of a phenol group on a synthetic, therefore, should be a sign to investigate that substance’s potential as an endocrine disruptor.

The potential cellular toxicity of phenols has actually been known for decades. Research done in the 1950s, written about by Rachel Carson in Silent Spring, discussed the mechanisms by which pesticides constructed with phenols had the ability to prompt oxidation processes that upset cellular metabolism. These reactive chemical groups can disrupt formation of enzymes vital to energy production, which in turn may interfere with how an organism produces and differentiates cellular material. These processes of cellular reproduction are involved in virtually every bodily system, from how an individual processes sugars and calcium to how its reproductive system functions. Carson described the introduction of xeniobiotic phenols as thrusting “a crowbar into the spokes of a wheel. Had Fox been a green chemist, our current synthetic landscape might look very different.

But because Fox and his colleagues were focused on functional performance and on working with readily available chemical ingredients, bisphenols seemed a good choice. As an additional building block that might combine with the bisphenol molecules’ hydrocarbons to yield a useful polymer, Fox chose a chlorine compound called carbonyl chloride. Carbonyl chloride was then–and is currently–a common ingredient in the synthetics known as isocyanates that are used to make any number of products, including polyurethanes that go into varnishes, paints, and plastic foams. By the 1950s it was known that chlorinated hydrocarbons made useful synthetics so this was a logical route for Fox to follow–but no one had yet made the kind of moldable, shatter-resistant plastic that Lexan turned out to be.

If you’re building a polymer, a linked chemical chain in effect, you need lots of the same repeating pieces; ideally you’ll work with shapes that are easy to find and lend themselves to chemical bonding. It’s here that a Tinkertoy or Lego analogy comes to mind. To add pieces to a chemical structure, you need sites where new sticks and building blocks can be attached. So it was with the choice of bisphenols and carbonyl chloride, which lend themselves to such bonding and were both readily available industrial chemicals. Had Fox been practicing green chemistry, however, he would never–even with what was known in the 1950s–have launched a product that required copious quantities of carbonyl chloride.

Carbonyl chloride is also known as phosgene and is so toxic that it was used as a chemical weapon during World War I. The isocyanates it’s used to make are also highly toxic. One such compound, methyl isocyanate, was the gas involved in the deadly 1984 disaster at the Union Carbide plant in Bhopal, India. Lest anyone wonder if nerve gas is lurking in your bike helmet or CD cases, however, let me quickly explain that no phosgene or even any chlorine ends up in the final bisphenol A polymer; the chlorine compound is simply a reagent, an ingredient that enables the desired chemical bonding to take place.

Yet speaking to an interviewer in 1983, Fox acknowledged that using large quantities of a chemical such as phosgene was indeed hazardous. But, Fox continued, it “was not a totally frightening undertaking because we had good advice. I would say that we have been tightening up our whole phosgene handling ever since, investing in an awful lot of money in trying to make the stuff doubly safe and then triply safe and quadruply safe.” Still, the interviewer pressed, “Has there ever been a problem?” To which Fox responded, “We have had one or two small discharges. To my knowledge, I don’t think GE advertised it, but I think we probably had a ‘casualty’ from phosgene.” Did this give anyone second thoughts about going into business? “I don’t think it did,” Fox replied.

At the time Fox was working, new material inventions like carbonates were just that–inventions that came first, with applications and markets found later. “When we invented polycarbonates in the early 1950s we had a polymer with an interesting set of properties and no readily apparent applications,” Fox said in 1983. But what was known about polycarbonates’ behavior early on that might have hinted at what’s since been discovered about their physical and biological behavior” Could this information have been used to prevent what are clearly problems of chemical contamination? Endocrine-disruption science is relatively new, but some of what was known early on about bisphenol A and polycarbonates would seem to indicate a material perhaps not ideally suited for use, say, with food, heat, and dishwashing detergents.

That polycarbonates built from bisphenol A were vulnerable to certain detergents, solvents, and alkali solutions (household ammonia would qualify) has been known since at least the 1970s. Ammonium hydroxide (essentially a solution of ammonia in water) was discussed as a possible way to break polycarbonates down to its chemical constituents–for materials recovery and reuse and as a way to remove unwanted polycarbonate from another surface. It was also known that various additives used to modify polycarbonate mixtures could leach from the finished plastics when they came into contact with certain liquids. Documents filed with the Federal Register in 1977 list chloroform, methylene chloride, and chlorobenzene among these additives. (The U.S. Department of Health and Human Services considers chloroform and methylene chloride suspected carcinogens, while chlorobenzene is known to cause liver, kidney, and nervous system damage and produce a precancerous condition in lab rats.) Correspondence between GE Plastics Division personnel in the 1970s and 1980s also voiced concern over the presence of chlorobenzene in water stored in polycarbonate bottles (but not bottles made by GE as it happened) and about how the stability of these polymers might affect their ability to be used with food.

A memo circulated within the Lexan division of GE in 1978 also noted that “through reaction with water,” polycarbonate resin can degrade. “The two largest applications of Lexan resin for which hydrolytic stability is critically important are baby bottles and water bottles,” ran the 1978 memo.

In each application the finished parts are subjected to conditions which will cause, after prolonged treatment, molecular weight reduction. However, in each application, actual product failure is usually observed before significant molecular weight reduction is detectable by the usual techniques…..Baby bottles are subjected to autoclaving at 250 degrees F in saturated steam and fail under these conditions by becoming opaque, and sometimes by shrinking and deforming. Milk and water bottles are washed in aqueous solutions of alkaline or caustic cleaning agents and fail by stress cracking. The relationship between practical failure modes and the fundamental physical and chemical processes involved is not fully understood.

That polycarbonates might degrade when heated, washed, or exposed to sunlight was also discussed in company memos in the late 1970s and early 1980s. Three decades later, the plastics industry assures consumers that such wear and tear of polycarbonate baby bottles poses no health concerns for infant users.

Pages 58 – 62

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“The Toxins That Affected Your Great-Grandparents Could Be In Your Genes”

Biologist Michael Skinner has enraged the chemical community and shocked his peers with his breakthrough research

By Jeneen Interlandi for Smithsonian magazine, December 2013

Michael Skinner’s biggest discovery began, as often happens in science stories like this one, with a brilliant failure. Back in 2005, when he was still a traditional developmental biologist and the accolades and attacks were still in the future, a distraught research fellow went to his office to apologize for taking an experiment one step too far. In his laboratories at Washington State University, she and Skinner had exposed pregnant rats to an endocrine disruptor—a chemical known to interfere with fetal development—in the hope of disturbing (and thereby gaining more insight into) the process by which an unborn fetus becomes either male or female. But the chemical they used, an agricultural fungicide called vinclozolin, had not affected sexual differentiation after all. The scientists did find lower sperm counts and decreased fertility when the male offspring reached adulthood, but that was no surprise. The study seemed like a bust.

By accident, though, Skinner’s colleague had bred the grandchildren of those exposed rats, creating a fourth generation, or the great-grandchildren of the original subjects. “It’s OK,” Skinner told her. “You might as well analyze them.” If nothing else, he thought, the exercise might take her mind off her mistake. So she went ahead and studied the rats’ testes under a microscope.

What they found would not only change the direction of Skinner’s research but also challenge a bedrock principle of modern biology. And Skinner would become the forerunner of a new way of thinking about the possible long-term health consequences of exposure to environmental chemicals.

His discoveries touch on the basic question of how biological instructions are transmitted from one generation to the next. For half a century it has been common knowledge that the genetic material DNA controls this process; the “letters” in the DNA strand spell out messages that are passed from parent to offspring and so on. The messages come in the form of genes, the molecular equivalent of sentences, but they are not permanent. A change in a letter, a result of a random mutation, for example, can alter a gene’s message. The altered message can then be transmitted instead.

The strange thing about Skinner’s lab rats was that three generations after the pregnant mothers were exposed to the fungicide, the animals had abnormally low sperm counts—but not because of a change in their inherited DNA sequence. Puzzled, Skinner and his team repeated the experiments—once, twice, 15 times—and found the same sperm defects. So they bred more rats, and tested more chemicals, including substances that lead to diseases in the prostate, kidney, ovaries and immune system. Again and again, these diseases also showed up in the fourth- and fifth-generation offspring of mothers exposed to a chemical.

“In essence,” Skinner explains, “what your great-grandmother was exposed to could cause disease in you and your grandchildren.”

And, startlingly, whatever disease pathway a chemical was opening in the rats’ fur-covered bodies, it did not begin or end at a mutation in the genetic code. Skinner and his team found instead that as the toxins flooded in, they altered the pattern of simple molecules called methyl groups that latch onto DNA in the fetus’ germ-line cells, which would eventually become its eggs or sperm. Like burrs stuck to a knit sweater, these methyl molecules interfered with the functioning of the DNA and rode it down through future generations, opening each new one to the same diseases. These burrs, known to be involved in development, persisted for generations. The phenomenon was so unexpected that it has given rise to a new field, with Skinner an acknowledged leader, named transgenerational epigenetics, or the study of inherited changes that can’t be explained by traditional genetics.

A study by Skinner and colleagues published last year in the journal PLOS One has upped the ante considerably. The burrs were not just haphazardly attached, Skinner found. Instead, they fastened themselves in particular arrangements. When he bathed the insides of his pregnant rats in bug spray, jet fuel and BPA, the plastics component recently banned from baby bottles, each exposure left a distinct pattern of methyl group attachments that persisted in the great-grandchildren of exposed rats.

Not only is your great-grandmother’s environment affecting your health, Skinner concluded, but the chemicals she was exposed to may have left a fingerprint that scientists can actually trace.

The findings point to potentially new medical diagnostics. In the future, you may even go to your doctor’s office to have your methylation patterns screened. Exposure of lab rats to the chemical DDT can lead to obesity in subsequent generations—a link Skinner’s team reported in October. Hypothetically, a doctor might someday look at your methylation patterns early in life to determine your risk for obesity later. What’s more, toxicologists may need to reconsider how they study chemical exposures, especially those occurring during pregnancy. The work raises implications for monitoring the environment, for determining the safety of certain chemicals, perhaps even for establishing liability in legal cases involving health risks of chemical exposure.

These possibilities have not been lost on regulators, industries, scientists and others who have a stake in such matters. “There are two forces working against me,” Skinner says. “On one side, you have moneyed interests refusing to accept data that might force stronger regulations of their most profitable chemicals. On the other side, you have genetic determinists clinging to an old paradigm.”

Michael Skinner wears a gray Stetson with a tan strap, and leans back easily in his chair in his office on the Pullman campus. His fly-fishing rod stands in the corner, and a colossal northern pike is mounted on the wall. An avid fly fisherman, Skinner, age 57, was born and raised on the Umatilla Indian Reservation in eastern Oregon. The Skinners are not of Indian descent, but his parents owned a family farm there—“a good cultural experience,” he says. His father worked in insurance, and he and his four brothers grew up just as five generations of Skinners had before them—hunting and fishing and cowboying, learning a way of life that would sustain them into adulthood.

He loved the outdoors, and his fascination with how nature worked prompted a school guidance counselor’s suggestion that a career in science might be just the thing. He was about 12, and true to form he stuck with it. In high school and then at Reed College he wrestled competitively, and today his supporters and critics alike may detect a bit of his old grappling self in how he approaches a problem—head-on. “It probably taught me how to confront, rather than avoid challenges,” he says now. The sport also led him to his future wife, Roberta McMaster, or Bobbie, who served as his high-school wrestling team’s scorekeeper. “I was fascinated that someone so young knew exactly what he wanted to do with his life,” Bobbie recalls. He proposed marriage before heading for college, and the two have been together ever since and have two grown children.

He attended Washington State University for his PhD in biochemistry, and during that time he and Bobbie often lived on game that he’d hunted. It was not unheard of to find a freshly killed deer hanging in the carport of their student housing. “They were lean years,” Bobbie says. “But they were good ones.”

After positions at Vanderbilt and the University of California, San Francisco, Skinner returned to Washington State University. “I wanted a big research college in a rural town,” he says. He spent the next decade studying how genes turn on and off in ovaries and testes, and how those organs’ cells interact. He wasn’t aiming to take on the central idea in biology for much of the 20th century: genetic determinism, the belief that DNA is the sole blueprint for traits from hair and eye color to athletic ability, personality type and disease risk.

In some sense this interpretation of genetic determinism was always oversimplified. Scientists have long understood that environments shape us in mysterious ways, that nature and nurture are not opposing forces so much as collaborators in the great art of human-making. The environment, for example, can ramp up and pull back on gene activity through methyl groups, as well as a host of other molecules that modify and mark up a person’s full complement of DNA, called the genome. But only changes in the DNA sequence itself were normally passed to offspring.

So certain was everyone of this basic principle that President Bill Clinton praised the effort to complete the first full reading of the human genome, saying in June 2000 that this achievement would “revolutionize the diagnosis, prevention and treatment of most, if not all human diseases.” When stacked against such enthusiasm, Skinner’s findings have felt like heresy. And for a while, at least, he was criticized accordingly.

***

Critics of the Skinner-led research pointed out that the doses of vinclozolin in his rat studies were way too high to be relevant to human exposure, and injecting the rats as opposed to administering the toxins through their food exaggerated the effects. “What he’s doing doesn’t have any real obvious implications for the risk assessments on the chemical,” EPA toxicologist L. Earl Gray was quoted telling Pacific Standard magazine back in 2009. Until the results are replicated, “I’m not sure they even demonstrate basic science principles.”

Skinner responds to assaults on his data by saying that risk assessment, of the type that toxicologists do, has not been his goal. Rather, he’s interested in uncovering new biological mechanisms that control growth, development and inheritance. “My approach is basically to hit it with a hammer and see what kind of response we get,” he says. He remains calm, even when called on to defend that approach. “Conflicts with individuals solve very little,” he says. “The best way to handle these things is to let the science speak for itself.”

That science has received a lot of attention (the vinclozolin study has been cited in the scientific literature more than 800 times). Recently, the journal Nature Reviews Genetics asked five leading researchers to share their views on the importance of epigenetic inheritance. A “mixture of excitement and caution,” is how the editors described the responses, with one researcher arguing that the phenomenon was “the best candidate” for explaining at least some transgenerational effects, and another noting that it might, if fully documented, have “profound implications for how we consider inheritance, for mechanisms underlying diseases and for phenotypes that are regulated by gene-environment interactions.”

Though most of Skinner’s critics have been reassured by new data from his lab and others, he says he still feels embattled. “I really try to be a scientist first and foremost,” he says. “I’m not a toxicologist, or even an environmentalist. I didn’t come to this as an advocate for or against any particular chemical or policy. I found something in the data, and I pursued it along a logical path, the way any basic researcher would.”

Read more: http://www.smithsonianmag.com/ideas-innovations/The-Toxins-That-Affected-Your-Great-Grandparents-Could-Be-In-Your-Genes-231152741.html#ixzz2mIaKLsRH
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Germany’s Master Plan by Joseph Borkin and Charles A. Welsh – 1943. An Introduction by Thurman W. Arnold – Assistant Attorney General heading the Antitrust Division of the U.S. Department of Justice.

This book is a brilliant and arresting exposition of the results of the disease of cartelization. In all commercial civilization great industries rise out of initiative and superior efficiency. At a certain stage in their growth, hardening of the arteries takes place. Industrial leaders believe that the time has come to rationalize and stabilize production. Restricted production, high cost, and low turnover become the order of the day. To maintain that order, new industry must be kept out of production and old industry must not produce too much because, according to this order of new ideas, too much goods is not wealth but distress goods and an undesirable surplus. Prices and production become fixed at levels which will pay dividends on an existing capital structure. Industrial progress becomes sluggish and then stops. The productive capacity of the nation is curtailed. It is an order of ideas that can produce neither wealth in peace nor strength in war.

There is no short way of defining a cartel. For present purposes we may describe it briefly as a small ring of producers or distributors who have acquired control of domestic or foreign markets. That control is justified as a rationalization of industry management for the purpose of expert economic planning. It is used, however, to crush new enterprise and to prevent maximum production.

The first symptom of cartelization is an unbalanced exchange between industry which is restricting production and unorganized farmers and small businessmen who are unable to restrict production. The farmer becomes unable to buy enough industrial goods to keep factories running. Labor is laid off, thus restricting purchasing power further. Goods pile up in domestic markets because they cannot be distributed at the artificial levels maintained by the cartel. People begin to talk about over-production, even in the face of scarcity in terms of actual need.

The next symptom is the attempt of the domestic cartels to control foreign markets so that the nation can get rid of this so-called over-production, this inconvenient wealth that threatens an artificial price structure. International cartels are formed, dominated by private groups without public responsibility, who control the foreign economic policy in the interests of international scarcity. With the growth of these international cartels democracy becomes a shell which conceals the power of private groups. Political freedom cannot exist except when it is founded upon industrial freedom. If a private group controls a man’s livelihood it can control both his actions and his philosophy.

And so with the progression of the disease of cartelization. A new political philosophy arises justifying centralized planning of production and distribution. The competitive race for efficiency which is symptomatic of a young and vigorous commercial organization is denounced as waste.

Socialists eagerly advocate this new order. Their only quarrel with industrialists is in the selection of those who will manage the brave new world. Socialists want to recruit the managers from the ranks of the academic thinkers sympathetic with the underdog. Industrialists want to choose them from the cartel leaders. Both groups are ready to abandon industrial democracy. Thus a culture that is willing to embrace a political dictatorship spreads over the thinking of the Nation.

In the first stage of this struggle between socialists and cartel managers the industrialists win because they start out in the seats of power. They fail to maintain that power, however, because their policy of stabilizing prices at home prevents the distribution of goods–creating idle capital and idle labor–want in the midst of plenty. Before Hitler’s rise to power, Germany had reached a stage under private cartelization when agricultural products, though scarce, sold at ruinously low prices. Industrial products, though plentiful, could not be distributed in Germany. The wheels of industry stopped. There was a minimum of 7,000,000 unemployed.

When private industry fails to distribute goods, Government is compelled to step in. Deficit financing, subsidies, and huge relief rolls grow with alarming rapidity. In this stage the writers and thinkers of a socialistic tinge flood into Government with dreams of a new world arising out of the collapse of capitalism. But, unfortunately, for socialistic dreamers the techniques of acquiring and holding power in times of economic chaos require individuals of a tougher and less humanitarian mould. In other words, only a Hitler had the ruthlessness and cold cruel realism to consolidate a position out of the collapse of the German economic structure which the cartels brought about.

And thus the vast centralized cartel organization of Germany became a tool in the hands of a dictator who no longer operated for private profit but solely to serve a ruthless ambition. The cartels of the democracy were easy dupes. Hitler was able to aid them in restricting their own production, while Germany’s production went ahead by leaps and bounds.

The soft opulent business organizations of England and America were intent on the pursuits of their short-run policies of restricted production, high costs and low turnover. They saw in German cartels an ally, not an enemy.

To such international cartels we owe the peace of Munich. To our own cartels we owe the failure to expand American industry prior to Pearl Harbor. To the interests of these cartels in stabilizing prices and restricting production we owe our present scarcity in all basic materials.

To a large extent our present industrial unpreparedness of this war is due to the fact that Germany through international cartels built up its own production and assisted the democracies in restricting their production in electrical equipment, in drugs, in chemicals, in basic war materials such as magnesium and aluminum. International cartels with the active assistance of American interests have operated to deprive us of markets in our own hemisphere by giving them away to Germany.

We are now faced with the necessity of making our industrial democracies so efficient that we can win this war, which is essentially a war of industrial production. Our cartel structure has weakened us spiritually by introducing an alien philosophy which leads us to distrust our own economic traditions. It has weakened us materially by making us afraid of full production because it creates surpluses which cannot be distributed after the war.

We must, if we are to fight this war with enthusiasm for our own way of life, destroy both the philosophy and the private power of domestic and international cartels over foreign and domestic economic policy. At such a time this book should be read by everyone interested in the economic future of America.

No other book that I know of analyzes in such vivid detail the growth and activities of international cartels. The writers have studied the cartel problem not only from books but from first-hand information and observation. Mr. Joseph Borkin has been for many years Economic Advisor to the Antitrust Division, Department of Justice, particularly in relation to foreign international cartels. The fact that the public is now aware of the international cartel structure is in a large measure due to his work. Mr. Welsh is an authority on international trade and finance, and is a cartel expert for the Office of Price Administration. Both of them have shown exceptional ability in this particular field.

While of necessity the emphasis of this book is upon the war problem, I would suggest that the reader consider it in light of the long-run economic policy for America. We cannot turn over our future economic policy to private groups without public responsibility as we have done in the past. We not only must win the war but the peace which follows. We cannot win the peace if the cartel problem remains unsolved.

I must conclude this introduction with a caveat because of my official position. The research and conclusion the writers of this book have been done outside of their official duties in the Government. They have not been checked or approved in any official way.

Thurman W. Arnold

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COMMISSION OF THE EUROPEAN COMMUNITIES
Brussels, 27.2.2001 COM(2001) 88 final
WHITE PAPER Strategy for a future Chemicals Policy
(presented by the Commission)

INTRODUCTION

This White Paper presents Commission proposals for a strategy on future chemicals policy in the Community with the overriding goal of sustainable development.

Chemicals1 bring about benefits on which modern society is entirely dependent, for example, in food production, medicines, textiles, cars etc. They also make a vital contribution to the economic and social wellbeing of citizens in terms of trade and employment.

The global production of chemicals has increased from 1 million tonnes in 1930 to 400 million tonnes today. We have about 100,000 different substances registered in the EU market of which 10,000 are marketed in volumes of more than 10 tonnes2, and a further 20,000 are marketed at 1-10 tonnes. The world chemical production in 1998 was estimated at € 1,244 billion, with 31% for the EU chemical industry, which generated a trade surplus of € 41 billion. In 1998, it was the world’s largest chemical industry, followed by that of the US with 28% of production value and a trade surplus of € 12 billion.
The chemical industry is also Europe’s third largest manufacturing industry. It employs 1.7 million people directly and up to 3 million jobs are dependent on it. As well as several leading multinationals, it also comprises around 36,000 SMEs. These SMEs represent 96% of the total number of enterprises and account for 28% of chemical production.

On the other hand, certain chemicals have caused serious damage to human health resulting in suffering and premature death and to the environment. Well-known examples amongst many are asbestos, which is known to cause lung cancer and mesothelioma or benzene which leads to leukaemia. Abundant use of DDT led to reproductive disorders in birds. Though these substances have been totally banned or subjected to other controls, measures were not taken until after the damage was done because knowledge about the adverse impacts of these chemicals was not available before they were used in large quantities.

The incidence of some diseases, e.g. testicular cancer in young men and allergies, has increased significantly over the last decades. While the underlying reasons for this have not yet been identified, there is justified concern that certain chemicals play a causative role for allergies. According to the Scientific Committee on Toxicity, Ecotoxicity and the Environment of the Commission (CSTEE), links have been reported between reproductive and developmental effects and endocrine disrupting substances in wildlife populations. The CSTEE concluded that there is a potential global problem. This concern is based on the recent findings of high levels of persistent potential endocrine disrupting chemicals in several marine mammalian species inhabiting oceanic waters3.

The lack of knowledge about the impact of many chemicals on human health and the environment is a cause for concern. Understandably, the public is worried when hearing about the exposure of their children to certain phthalates released from toys and about increasing amounts of the flame retardant pentabromo diphenyl ether in human breast milk. Though these too are the subject of Commission proposals for bans, legislative action takes too long before yielding a result.

These examples expose the weaknesses of the current EU chemicals policy. However, the problem is not unique to the Community. Government agencies in Canada and the United States have recently launched initiatives to acquire testing data for large numbers of chemical substances currently on their markets in high volumes on which little is known about the risks. In fact, not one country has yet been successful in overcoming the huge gap in knowledge of substances.

EU chemicals policy must ensure a high level of protection of human health and the environment as enshrined in the Treaty both for the present generation and future generations while also ensuring the efficient functioning of the internal market and the competitiveness of the chemical industry. Fundamental to achieving these objectives is the Precautionary Principle4. Whenever reliable scientific evidence is available that a substance may have an adverse impact on human health and the environment but there is still scientific uncertainty about the precise nature or the magnitude of the potential damage, decision-making must be based on precaution in order to prevent damage to human health and the environment. Another important objective is to encourage the substitution of dangerous by less dangerous substances where suitable alternatives are available.

It is also essential to ensure the efficient functioning of the internal market and the competitiveness of the chemical industry. EU policy for chemicals should provide incentives for technical innovation and development of safer chemicals. Recent experience has shown that innovation (e.g. in developing new and often safer chemicals) has been hindered by the burdens of the present notification system. Ecological, economic and social aspects of development have to be taken into account in an integrated and balanced manner in order to reach the goal of sustainability.

THE EU CHEMICALS POLICY

Increasing concern that current EU chemicals policy does not provide sufficient protection led to a debate at the informal Council of Environment Ministers in Chester in April 1998. Recognising that a review of the current policy on chemicals was necessary, the Commission made a commitment to assess the operation of four important legal instruments governing chemicals in the Community5. The report on the findings6 was adopted by the Commission in November 1998 and welcomed by the Council in December 1998.

These four instruments cover a broad range of substances of different origins (e.g. industrial chemicals, substances produced from natural products, metals, minerals etc.). They regulate the testing of these substances and determine risk reduction measures. Furthermore, they establish duties regarding the safety information to be provided to users (labelling, safety data sheets). Beyond these four instruments, specific legislation exists for certain sectors and areas, for example plant protection products or cosmetics or the transport of dangerous goods.

In view of the findings, the Commission held a Brainstorming with more than 150 stakeholders in February 1999 – regulators, scientists, industry, environmental and consumer NGOs as well as representatives from applicant countries – providing the Commission with an all round view of the problems and potential solutions.

In June 1999, the Council adopted a set of conclusions for a future strategy on chemicals in the Community which provided important input to the recommendations in this White Paper, which concerns revision of the above mentioned four legal instruments.

Major problems identified by review

The present system for general industrial chemicals distinguishes between “existing substances” i.e. all chemicals declared to be on the market in September 1981, and “new substances” i.e. those placed on the market since that date.
There are some 2,700 new substances. Testing and assessing their risks to human health and the environment according to Directive 67/548 are required before marketing in volumes above 10 kg. For higher volumes more in-depth testing focussing on long-term and chronic effects has to be provided.

In contrast, existing substances amount to more than 99% of the total volume of all substances on the market, and are not subject to the same testing requirements. The number of existing substances reported in 1981 was 100,106, the current number of existing substances marketed in volumes above 1 tonne is estimated at 30,000. Some 140 of these substances have been identified as priority substances and are subject to comprehensive risk assessment carried out by Member State authorities.

There is a general lack of knowledge about the properties and the uses of existing substances. The risk assessment process is slow and resource-intensive and does not allow the system to work efficiently and effectively. The allocation of responsibilities is inappropriate because authorities are responsible for the assessment instead of enterprises which produce, import or use the substances. Furthermore, current legislation only requires the manufacturers and importers of substances to provide information, but not the downstream users (industrial users and formulators). Thus, information on uses of substances is difficult to obtain and information about the exposure arising from downstream uses is generally scarce. Decisions on further testing of substances can only be taken via a lengthy committee procedure and can only be requested from industry after authorities have proven that a substance may present a serious risk. Without test results, however, it is almost impossible to provide such proof. Final risk assessments have therefore only been completed for a small number of substances.

Under Directive 76/769 on restriction of marketing and use of dangerous substances and preparations, the Commission has committed itself to carry out risk assessments and adequate analyses of the costs and the benefits prior to any proposal or adoption of a regulatory measure affecting the chemical industry. Indications of unacceptable risk (typically arising from notifications of restrictions at national level) are the subject of reports, which are peer-reviewed by the Scientific Committee on Toxicology, Ecotoxicology and Environment (CSTEE) of the Commission.

Current liability regimes are insufficient to remedy the problems found by the review. Liability is usually based on the principle that those who cause damage should pay compensation for that damage. However, in order to be held liable, it is generally requiredthat a causal connection be proven between the cause and the resulting damage. This is often virtually impossible for injured parties if cause and effect occur far apart in time and if adequate test data on the effects of substances are not available. Even if a causal connection can be established, compensations awarded by courts of EU Member States are generally not as high as, for example, in the US, and hence have a limited deterrent effect. In order to improve this situation and to make producers assume responsibility for their products, the Commission has announced its intention to propose Community legislation in this field7.

Political objectives of the proposed Strategy

In order to achieve the overriding goal of sustainable development, the Commission has identified a number of objectives that must be met in order to achieve sustainable development in the chemicals industry within the framework of the Single Market.

– Protection of human health and the environment.

– Maintenance and enhancement of the competitiveness of the EU chemical industry.

– Prevent fragmentation of the internal market.

– Increased transparency. Consumers need access to information on chemicals to enable them to make informed decisions about the substances that they use and enterprises need to understand the regulatory process.

– Integration with international efforts. The global nature of the chemicals industry and the trans-boundary impact of certain chemical substances have made chemical safety an international issue.

– Promotion of non-animal testing. Protection of human health and the environment, including wildlife, should be balanced against protection of the welfare of laboratory animals. The Commission will therefore promote further development and validation of non-animal test methods.

– Conformity with EU international obligations under the WTO. No unnecessary barriers to trade should be created and there must not be discrimination against imported substances and products.

The strategy which is proposed must meet these objectives.

Key elements of the proposed strategy

Protection of human health and promotion of a non-toxic environment

The Commission proposes that existing and new substances should in the future, following the phasing in of existing substances until 2012, be subject to the same procedure under a single system. The current new substances system should be revised to become more effective and efficient and the revised obligations be extended to existing substances. The proposed system is called REACH, for the Registration, Evaluation and Authorisation of CHemicals. The requirements, including the testing requirements, of the REACH-system depend on the proven or suspected hazardous properties, uses, exposure and volumes of chemicals produced or imported. All chemicals above 1 tonne should be registered in a central database. At higher tonnage special attention should be given to long-term and chronic effects.

Setting deadlines: The Commission proposes to implement a step by step process to address the ‘burden of the past’ and develop adequate knowledge for existing substances that industry wants to continue marketing. Given the vast number of existing substances on the market, the Commission proposes that first priority is given to substances that lead to a high exposure or cause concern by their known or suspected dangerous properties – physical, chemical, toxicological or ecotoxicological. All such substances should be tested within five years and subsequently be properly assessed for their impact on human health and the environment. The other existing substances should follow in accordance with the proposals in Chapter 6.

Making industry responsible for safety: Responsibility to generate knowledge about chemicals should be placed on industry. Industry should also ensure that only chemicals that are safe for the intended uses are produced and/or placed on the market. The Commission proposes to shift responsibility to enterprises, for generating and assessing data and assessing the risks of the use of the substances. The enterprises should also provide adequate information to downstream users.

Extending the responsibility along the manufacturing chain: Downstream users, as well as manufacturers and importers, of chemicals should be responsible for all the aspects of the safety of their products and should provide information on use and exposure for the assessments of chemicals. Producers of preparations and other downstream users will be obliged to assess the safety of their products for the part of the life cycle to which they contribute, including disposal and waste management.

Authorisation of substances of very high concern: Substances with certain hazardous properties that give rise to very high concern will have to be given use-specific permission before they can be employed in particular uses. Evidence demonstrating that the specific use only presents a negligible risk or, in other cases, that the use is acceptable taking into account socio-economic benefits, lack of ‘safer’ chemicals for the same task and measures minimising the exposure of consumers, workers, the general public and the environment will be considered before granting an authorisation. Uses which do not give rise to concern may be subject to general exemptions from the authorisation procedure.

Substitution of hazardous chemicals: Another important objective is to encourage the substitution of dangerous by less dangerous substances where suitable alternatives are available. The increased accountability of downstream users and better public information will create a strong demand for substitute chemicals that have been sufficiently tested and that are safe for the envisaged use.

Maintenance and enhancement of the competitiveness of the EU chemical industry

Stimulating innovation: It is essential to promote the competitiveness of the chemical industry and encourage innovation, and in particular the development of safer chemicals. Regulations are a major factor in shaping the innovation behaviour of firms in the chemical industry. The Commission proposes to increase the current thresholds for notification and testing of new substances, to extend the conditions for derogation for research and development and enable test data to be used and submitted in a flexible way.

Realistic timetable for submission of data: In proposing a timescale for the submission of data, the strategy takes account of resource implications. Together with the measures to increase testing thresholds and more flexible test data, this should limit the cost for enterprises to the absolute minimum needed.

Prevent fragmentation of the internal market

Any Commission strategy on chemicals should aim at ensuring a high level of health, safety and environmental protection while at the same time ensuring the proper functioning of the Internal Market in that sector – as in any other industrial sector within the Union. The achievement of these objectives requires that the new policy be based on full harmonisation at Community level.

Increasing transparency

Providing full information to the public: The public has a right to access to information about the chemicals to which they are exposed. This will enable them to make informed choices and to avoid products containing harmful chemicals, so creating pressure on industry to develop safer substitutes. However, commercially sensitive information will be suitably protected.

A more transparent regulatory system: The creation of a single system to be applied to all chemicals, once the existing substances have been phased in, will improve the transparency of the regulation of chemicals.

Integration with international aspects

Contributing to safe use of chemicals at a global level: A global network of industrialised and developing countries and international organisations has developed over the past decades to promote global safe use of chemicals. The Intergovernmental Forum on Chemical Safety (IFCS) was established to co-ordinate the many national and international activities, to promote chemical safety and to oversee implementation of the programme on environmentally sound management of chemicals as set out in Chapter 19 of Agenda 21, adopted by the 1992 UN Conference on Environment and Development (UNCED) at the Earth Summit in Rio. The recommendations in this White Paper will feed into the international programmes and make a major contribution to achieving safe use of chemicals at a global level.

Testing in a global market: Testing obligations will not only affect the EU chemicals industry. Importers will also be obliged to assess the safety of their chemicals, to deliver information and to share the costs of testing. This avoids distortion of the global market and ensures that the competitiveness of the EU chemical industry is not compromised.

Recognising non-EU test results: The lack of data on existing chemicals is a global concern. For example, the US have recently launched initiatives. The US initiative aims to complete testing of 2,800 high production volume chemicals by 2004 (the Gore initiative). This initiative is regarded as the first approach to systematically obtain toxicological and ecotoxicological information about the most abundant existing chemicals on the US market. Studies on the dangerous properties of chemicals performed in the US will not have to be repeated in the Community and vice versa, since testing must be carried out using globally harmonised testing methodology. Accordingly, test results of the HPV/ICCA SIDS programme of the OECD will be taken into account to reduce the number of tests to be performed in the EU.

Complying with OSPAR: The Convention for the Protection of the Marine Environment of the North East Atlantic8 aims to prevent and eliminate pollution and to protect the maritime area of the North East Atlantic against the harmful effects of human activities (land-based sources, off-shore sources, dumping and incineration of wastes). The strategy supports this aim, in particular through the proposals for improved controls on downstream users of chemicals.

Persistent organic pollutants (POPs): POPs represent a special threat since they persist in the environment for a long time, they travel over long distances from their sources, accumulate in the tissues of most living organisms and poison humans and wildlife. It has been internationally recognised that there is a need for strict control of these substances. Following a mandate issued by the Governing Council of the UNEP, negotiations on an international treaty to eliminate production, use, emissions and discharges of initially 12 specified POPs – a group of highly stable organic substances – have recently been concluded. Criteria have been developed to identify further POPs among the existing substances. Furthermore, parties to the Convention will be obliged to prevent the production and use of new substances with POPs characteristics9.

Developing countries: One of the Community’ s major objectives is to strengthen developing countries’ capabilities and capacities for managing chemicals. Many developing countries do not have adequate legislation, administrative capacity or infrastructure to ensure the safe use of chemicals. The Rotterdam Convention on prior informed consent (PIC Convention, 1998) for certain hazardous industrial chemicals and pesticides obliged exporters of such chemicals to get the consent of the receiving country before delivery and by bilateral and multilateral programmes of training and technical assistance in respect of particular chemicals.

Developing countries are mostly importers and not exporters of chemicals. The testing requirements in the EU will ensure that imported chemicals, which constitute the large majority of chemicals used in these countries, have been evaluated. This benefit will by far outweigh the potential economic effort, such as for testing, required by chemical companies located in developing countries when manufacturing chemicals for export to the EU.

Promotion of non-animal testing

Maximising use of non-animal test methods: Testing requirements will be met as far as practicable through use of existing non-animal test methods.

Encouraging development of new non-animal test methods: Development of new non- animal test methods will be encouraged.

Minimising test programmes: Measures to increase testing thresholds and more flexible test regimes will limit the need for testing.

Conformity with EU international obligations under the WTO

Trade barriers: The new policy shall not discriminate against imported products. In that respect, the EU should conform with Article 2.1 of the WTO’s Technical Barriers to Trade, which sets out that imported products shall be accorded treatment no less favourable than that accorded to like products on national origin. Without a sound scientific evaluation of the potential threats to human health and the environment, the EU will not be able to defend a measure being challenged by third countries. In accordance with Article 2.2 of the TBT, the EU shall ensure that “technical regulations will not create unnecessary obstacles to international trade”.

KNOWLEDGE ABOUT CHEMICALS

The principal objective of assessing the risks of chemicals is to provide a reliable basis for deciding on adequate safety measures (risk management) when using them. The risk assessment provides an evaluation of whether a chemical used in a particular way could cause adverse effects. This encompasses a description of the nature of these effects and a calculation of the probability that they will occur, as well as an estimation of their extent.
Any risk assessment on chemicals is composed of two distinct elements, (1) an evaluation of the properties which are intrinsic to the chemical, called hazard assessment, and (2) an estimation of the exposure which depends on the use of the chemical. The hazard assessment identifies the hazardous properties (e.g. sensitising, carcinogenic, toxic for the aquatic environment) and determines the potency of the chemical with respect to these hazardous properties. The exposure assessment identifies the sources of the chemicals which lead to exposure and calculates the dose taken up by an exposed organism or estimates the releases of the chemical into a particular compartment of the environment.

Precise knowledge on the intrinsic properties as well as on the exposure arising as a result of a particular use and of the disposal is an indispensable prerequisite for decision making on the safe management of chemicals. Reliable knowledge on intrinsic properties is important because it also constitutes the basis for the classification of chemicals. A large part of the management measures laid down in sector specific legislation to protect human health or the environment are directly linked to the classification of chemicals:

• it triggers the labelling of the packaging of the chemicals to inform the user about the properties of the chemicals and gives advice for the safe use,

• a chemical classified as carcinogenic, mutagenic or toxic for reproduction currently initiates an examination of restriction measures in the consumer sector,

• it triggers numerous safety measures laid down in sector specific legislation in respect of occupational health, water protection, waste management, prevention of major accident hazards and air pollution.

Intrinsic Properties

The extent of testing required for detecting the intrinsic hazardous properties of a substance is often the subject of controversy. While, at first glance, it would seem reasonable to test chemicals until all hazardous properties (i.e. all adverse effects on all organisms at all potential doses) are known, theoretical and practical considerations reveal that it is neither possible nor desirable to meet this objective. First, the available testing methodology has limitations, as demonstrated by the recent discussion on the identification of endocrine disrupters. The review and the development of our testing methodology must therefore be regarded as a continual challenge. Second, ethical considerations on animal welfare as well as on the costs of testing strongly advocate for a balanced approach to the testing of chemicals so that the acquired knowledge offers proportionate benefits in terms of managing risks. This is particularly important for testing requirements for substances marketed in low volumes where extensive testing is not compensated by the income from sales.

New substances: Current EU legislation on new substances is generally considered to have been successful in testing and assessing chemicals. The testing requirements are tiered according to the volume placed on the market. The lowest volume triggering the need for testing amounts to 10 kg. More extensive testing is required when the volume reaches 100 kg, 1 t, 10 t, 100 t and 1,000 t, respectively. Generally, testing requirements at the lower volumes (10 kg to 1 t) focus on acute hazards (immediate or slightly delayed effects after short term exposure) while those at the higher tonnage levels include more expensive studies on the effects of (sub-) chronic exposure, on reproductive toxicity and on carcinogenicity. The testing package at 1 t is termed ‘base set’ while those triggered by higher tonnage are called Level 1 (100 t) and Level 2 (1,000 t).

Existing substances: In contrast to new substances, existing substances have never been subjected to such a systematic testing regime. When the requirement for testing and notification of new substances was introduced in 1981, substances already on the market were exempted. A study performed by the European Chemicals Bureau on the availability of the data for high production volume existing substances10 (substances exceeding a production volume of 1,000 t) revealed significant gaps in publicly available knowledge about these chemicals. This lack of public knowledge was identified as the major deficiency throughout the entire review process.

Action 3A: Equivalent level of information on new and existing substances
The gap in knowledge about intrinsic properties for existing substances should be closed to ensure that equivalent information to that on new substances is available. According to the timetable presented in chapter 6, existing substances will be subjected to the same procedure as for new substances. The available information should be thoroughly examined and best use made of it in order to waive testing, wherever appropriate.

Action 3B: Testing of new and existing substances
Testing and assessment of the many existing substances will require a substantial effort from industry and authorities. To meet this challenge available resources must be focussed on the most relevant chemicals. The current 10 kg threshold for mandatory testing of new substances should be increased. The following general testing regime for new and existing substances is recommended. Waiving of testing will be acceptable on due justification according to recommendations 3A and 3C. Further testing may be required by the authorities as described in chapter 4.2:

• Substances produced/imported in quantities between 1 – 10 t: data on the physico- chemical, toxicological and ecotoxicological properties of the substance; testing should generally be limited to in vitro methods,
• Substances produced/imported in quantities between 10 – 100 t: ‘base set’ testing according to Annex VII A of Directive 67/548/EEC. Waiving of testing will be acceptable on due justification according to Action 3A. This will in particular apply for existing substances,

• Substances produced/imported in quantities between 100 – 1000 t: ‘Level 1’ testing (substance-tailored testing for long-term effects). The scope of the additional testing will be based on the requirements set out in Annex VIII of Directive 67/548/EEC. Guidelines, including decision trees for the testing strategy will be developed tailoring testing according to the results of the available information, physico-chemical properties, the use and the exposure to the substance.

• Substances produced/imported in quantities above 1000 t: ‘Level 2’ testing (further substance-tailored testing for long-term effects). The scope of the additional testing will be based on the requirements set out in Annex VIII of Directive 67/548/EEC. Guidelines, including decision trees for the testing strategy will be developed tailoring testing according to the results of the available information, physico-chemical properties, the use and the exposure to the substance.

Action 3C: Exposure-triggered testing
The current testing regime for new substances has been criticised for not taking sufficiently into account differences in the exposure to chemicals. Hence, the future system should include sufficient flexibility to waive or extend the needed testing as appropriate on the basis of particular exposure scenarios. For example, testing requirements for strictly controlled and rigorously contained intermediates should be reduced.

Action 3D: Exemptions for substances used in research and development
The volume threshold of 100 kg currently in place for research and development should be increased to 1 t. For substances undergoing process-oriented research and development, the current time period limit should be extended from one to three years. This three-year period should be extendable up to a maximum of five years.

Action 3E: Obligations for substances marketed as constituents of products
Current notification requirements cover substances placed on the market on their own or as constituents of preparations. Substances used and placed on the market as constituents of products (e.g. toys, textiles) other than preparations, however, are exempted. Nevertheless, most of the substances included in such products are covered as they are marketed either as such or as components of preparations before being included into products. However, some products, in particular products where the whole manufacturing process has been carried out outside the Community, may contain untested and unregistered substances. Where such substances may be released during use and disposal in significant amounts thus causing exposure of humans and of the environment, they cannot generally be neglected. The issue needs to be properly addressed.

As regards substances in products that can lead to significant exposure of humans and environment, the Commission proposes to set up a working group which would identify the product categories (e.g. toys or textiles), the relevant exposure situations and all other practical implications. On the basis of this working group’s findings, producers or importers should be requested to identify products containing such substances and provide any information, as appropriate.

Research and Validation

Development of alternative methods

International acceptance of results of animal tests has been a major breakthrough in minimising animal testing. This has been achieved by complying with methods developed by the OECD under its Test Guidelines Programme and obtained in accordance with the principles of Good Laboratory Practice. Once a company has carried out such a test, the results can be used for notification purposes in the Community as well as in Australia, Japan or the USA.

The Community has already taken steps to reduce duplicate testing: both Directive 67/548 and Regulation 793/93 contain provisions which avoid the need for different companies to carry out the same test. Chapter 5 describes actions to develop this approach further.

The Commission is fully committed to the legislation on the protection of animals used for experimental and other scientific purposes11. According to this legislation, experiments using animals must be replaced by other scientific satisfactory methods not entailing the use of animals, requiring fewer animals or causing less pain to the animals wherever possible.

The following elements of the new system have been developed with a view to keep animal testing to a minimum:
• existing information on the toxicity and ecotoxicity of substances, including epidemiological studies, will be taken into account,
• the general testing requirements will be modified to incorporate exposure-driven testing where appropriate,
• tailor-made testing programmes for substances will be developed under the control of authorities for Level 1 and 2 testing,
• the development of further alternative testing methods using fewer or no animals will be fostered,
• existing substances will be grouped to minimise testing, where appropriate.

One of the major tasks of the European Centre for the Validation of Alternative Methods (ECVAM) of the Joint Research Centre of the Commission is to validate alternative methods that reduce, refine or replace animal experiments (’3 R approach’). Once these methods are established the Commission proposes their inclusion in the relevant Community legislation. Furthermore it submits them to the OECD Test Guidelines Programme, through which the Commission makes every effort to ensure that the methods are recognised internationally. Some international test methods have already been amended to reduce the number of animals required or the distress caused.

Research to minimise the use of animal tests and develop methods that do not require animal experiments is also a priority within the OECD Test Guidelines Programme, which is actively supported by the Commission.

Action 3 F: To foster research on development and validation of alternative methods both at the Community and at the level of Member States and to enhance the relevant information that can be obtained from testing without simultaneously increasing the number of animals involved.

ECVAM’s central role will be maintained and the development of alternative methods should be accelerated. Further research will be carried out both at Community and national level in order to develop and validate novel testing strategies involving fewer or no animals and enhancing the relevant information that can be obtained from testing without simultaneously increasing the number of animals involved.

Other research priorities

In order to meet the goals of this White Paper, a continuous effort of research has to be made both at the Community and at the national level in order to cover the many knowledge gaps. At the community level, the Commission, through its Framework Programmes for Research, Technological Development and Demonstration, is supporting research in several other areas, like:

• Improvementandsimplificationofrisk-assessmentprocedures.

• Improvementanddevelopmentofnewtoxicologicalandeco-toxicologicalmethods;

• particular research efforts need to be made for developing and validating in-vivo and in- vitro test methods as well as modelling (e.g. QSAR) and screening methods for assessing the potential adverse effects of chemicals on endocrine systems of humans and animals. Research on endocrine disrupters is also – among others – addressing the effect of low doses, long term exposure and exposure to mixtures of chemicals, and the impact of the endocrine alterations on carcinogenesis.

• Development of clean chemical production processes to reduce and to eliminate the use and generation of hazardous substances.

• Research on improved Life Cycle Assessment methodologies for chemicals.

Exposure and Use

Adequate knowledge about exposure is an absolute requirement for any reliable risk assessment. However, the process under Regulation 793/93 highlighted a general lack of knowledge on the exposure to the existing substances under review. Furthermore, in many cases, the Member State authorities responsible for the assessment were not able to establish all the relevant uses of these chemicals. This lack of knowledge and restricted access by authorities to these data hampers efficient surveillance of the chemical sector.

Action 3 G: Obligation of manufacturers, importers and downstream users to assess exposure
The general shortage of exposure data must be addressed. Exposure estimates or, if appropriate, analytical determination of the exposure should be obligatory for manufacturers and downstream users (formulators and industrial users) of chemicals. Further detail on this proposal is given in chapters 4 and 5.

Action 3 H: Information system on environmental concentrations
An information system should be established on environmental concentrations and releases. Monitoring data ascertained by the Member States or by industry should be made available in an easily accessible form.

Cost and benefit

It is estimated that base-set testing will cost about € 85,000 per substance. The cost of long- term testing is more uncertain as there is less experience. However, level 1 testing for new substances costs approximately € 250,000 per substance and level 2 testing costs approximately € 325,000 per substance. It would not only be EU industry that has to pay these costs: everyone who imports substances into the Community would make a fair contribution to these costs ensuring a global approach, see section 5.5 below. It is estimated that the testing of the approximately 30,000 existing substances would result in total costs of about € 2.1 billion, over the next 11 years until 2012.12

The administrative costs of the system will be recovered through a fee-based system.

As a result of the systematic testing of new substances about 70% have been identified as being dangerous. On the other hand, as little is known about the intrinsic properties of existing substances it can be assumed that the majority of these chemicals cannot be properly classified today and adequate risk management measures cannot be taken. Introducing mandatory testing for these substances would generate the necessary information to substantially improve the risk management for existing substances. If as a result the adverse impacts could be even slightly reduced, the money spent for these tests would have proven to be well spent.

The potential benefits of this policy would stem from improved risk management, in all likelihood leading to safer handling of substances, and to less exposure of consumers and the environment to dangerous substances. Although it is difficult to estimate accurately and in monetary terms the potential benefits from this change some indications are possible. Indeed, if as a result of this improved risk management some human lives could be saved or the incidence and prevalence of allergic or chronic diseases could be reduced by some percent the money would have been well spent.13 Further details are given in annex I.

A NEW SYSTEM OF CHEMICALS CONTROL – THE REACH SYSTEM

The current volume-triggered notification system for new substances has resulted in substantial and reliable knowledge about these chemicals. However, it involves a considerable workload for the authorities requiring a large amount of their resources even though all this effort only addresses a limited part of the chemicals on the market. Existing substances dominate the market over new substances by a factor of 15. The challenge therefore is to establish a system that can cope with the large number of existing substances. The overriding goal must be to ensure adequate information, made publicly available, and appropriate risk management of existing and new substances within the timeframe set out in chapter 6.

Action 4: To establish a single coherent system focussing public resources on those substances, where, according to experience, the involvement of authorities is indispensable and the added value in terms of the provision of safety is substantial.

The system, called REACH, will be composed of the following three elements:

(a) Registration of basic information for around 30,000 substances (all existing and new substances exceeding a production volume of 1 t) submitted by companies in a central database. It is estimated that around 80 % of these substances would only require registration;

(b) Evaluation of the registered information for all substances exceeding a production volume of 100 t (around 5,000 substances corresponding to 15 %) or, in case of concern, also for substances at lower tonnage; the evaluation will be carried out by authorities and include the development of substance-tailored testing programmes focussing on the effects of long-term exposure;

(c) Authorisation of substances with certain hazardous properties that give rise to very high concern (CMR substances14 (categories 1 and 2) 15 and POPs). Authorisation requires authorities to give a specific permission before a substance can be used for particular purposes demonstrated to be safe. The number of substances subject to authorisation is estimated at 1,400 (5% of the registered substances). This estimate is based on

– 850substancescurrentlyclassifiedasCMRsubstances(categories1and2)

– Substances with POPs characteristics16

– 500 additional CMR substances (categories 1 and 2) which may be identified through future testing.

The REACH-system will be applied to new and existing substances. However, in contrast to new substances, a transitional period of 11years is required to phase in the large number of existing substances. In general, existing substances produced in higher volumes will have to be registered first. Yet the system will be flexible enough to allow for earlier registration of substances of concern produced in lower tonnage. The work programme and timetable for the transitional phase is described in detail in chapter 6.

Registration

Registration requires a manufacturer or importer to notify an authority17 of the intention to produce or import a substance and to submit a dossier containing the information required by the legislation. The authority puts this information into an electronic database, assigns a registration number and performs spot-checks and computerised screening of the registered substances for properties raising particular concern.

Registration will be obligatory for new and existing (according to the time table set out in chapter 6) substances produced in volumes exceeding 1 t. The currently required general conformity check for new notified substances above 1 t will be replaced by spot-checks and computerised screening. The registration dossier will include the following information:

– Data/information on the identity and properties of the substance (including data on toxicological and ecotoxicological properties as set out in chapter 3),

– Intended uses, estimated human and environmental exposure,

– Production quantity envisaged,

– Proposal for the classification and labelling of the substance,

– Safety Data Sheet,

– Preliminary risk assessment covering the intended uses,

– Proposed risk management measures.

Evaluation

Evaluation requires authorities to carefully examine the data provided by industry. It also requires them to decide on substance-tailored testing programmes, following industry proposals, as set out in chapter 3 .

Substances above 100 t: When the quantity produced or imported reaches 100 t or 1,000 t (or, for existing substances, already exceeds these volume thresholds), the manufacturer or importer will be required to submit to an authority all available information and to propose a strategy for further testing based on the general information requirements defined in the legislation. The authority will evaluate the information and the testing strategy submitted by industry and will decide on the appropriate course of action.

In essence, the current approach for new substances will be maintained for substances above 100 t. The availability of a risk assessment drawn up by the manufacturer or importer will reduce the workload of the authorities. Testing programmes at Level 1 (100 t) and Level 2 (1,000 t) will be substance-tailored as set out in chapter 3.

Substances below 100 t: Substances which are suspected to be persistent and liable to bioaccumulation, substances with certain hazardous properties such as mutagenicity or high toxicity, or substances with molecular structures giving rise to concern (e.g. identified by quantitative structure activity relationships, QSAR) will require an evaluation by the authorities at volume levels below 100 t. Based on this evaluation, immediate safety measures and/or further testing may be needed. Thus, the authorities’ right to request additional information for low volume substances on a case by case basis, as possible under the current notification system, will be retained. Furthermore, authorities should be empowered to require additional testing, when the aggregate volume produced and/or imported by all manufacturers and/or importers exceeds the next higher tonnage threshold for a single producer or importer to a considerable degree.

Authorisation of substances of very high concern

For substances of very high concern, authorities will have to give a specific permission before such a substance can be used for a particular purpose, marketed as such or as a component of a product. The scope will be clearly defined and strict deadlines will be set for both industry and authorities.

Substances subject to authorisation: The following new and existing substances, including those produced in volumes below 100 t, which either have hazardous properties giving rise to very high concern will be progressively subjected to an authorisation regime. However, uses that do not give rise to concern will generally be exempted:

• Substances that are carcinogenic, mutagenic or toxic to reproduction (CMR substances categories 1 and 2)

• Substances with POPs characteristics.

Further research: Further research is needed to develop criteria for the identification of PBT and VPVB19 substances other than POPs. The Commission will decide at a later stage how substances with these properties should be treated.

Endocrine disrupters: The majority of the endocrine disrupting chemicals would have to undergo authorisation in the REACH system. Serious human health effects which have so far been associated with endocrine disrupting chemicals are testicular cancer, breast cancer, prostate cancer, decrease in sperm concentration and semen volume, cryptorchidism, hypospadia and impaired development of the immune system and the nervous system. All these effects would qualify a substance either to be classified as carcinogenic or as toxic for reproduction and so would trigger its submission to authorisation. Furthermore, adverse effects on the endocrine system of wildlife species have been causally linked to certain POPs, which will be subject to authorisation.

Implementation of the authorisation process: A substantial number of substances qualifying for authorisation will be identified only through Level 1 and Level 2 testing when they are already used in substantial amounts. In order to allow for implementation of the authorisation procedure, transition periods to generate the required information and to draw up the dossiers for authorisation are necessary. Also, the time period needed to decide
upon the authorisation needs to be taken into account. A two-step decision-making process is therefore proposed:

• Step 1 – identification of the substances, or particular uses of substances, which will be subject to authorisation. Once identified, a precise date when all unauthorised uses of the substance will be prohibited. Furthermore, step 1 will identify, as appropriate, the scope of the uses to be exempted generally from the requirement for authorisation. Relevant substances will be fed into the system as soon as practicable, with substances of most concern being considered first.

• Step 2 – particular uses of a substance will be authorised on the basis of a risk assessment submitted by the applicant to the authorities. This assessment will cover the whole life- cycle of the substance, including disposal, with respect to the particular use. Manufacturers and importers will be permitted to submit jointly this information and/or to submit simultaneously for the use of several substances (group applications). The authorities will generally not require the applicant to carry out further testing but to establish the required exposure data to allow authorities to take a decision. An authorisation will be granted if the use presents a negligible risk. A conditioned authorisation may be granted if this is justified by the overall socio-economic benefits arising from the use. The authorities will be required to decide upon the authorisation within a reasonable time from submission of the risk assessment to avoid banning of substances by default.

Exemptions: Uses which do not give rise to concern – such as well controlled industrial uses or uses in research laboratories – may be subject to general exemptions from the authorisation procedure.

Pro-active role of industry: The current approach requires authorities to provide convincing arguments, usually in the context of a risk assessment, before restriction measures are taken. Their task is further complicated because the current system does not encourage industry to support the assessment. On the contrary, delaying the process is “rewarded” with an extended marketing period. Industry has usually provided data when such data were deemed suitable to avoid the restrictions under consideration. An apparent lack of data aggravates the situation and often leads to a risk assessment conclusion that ‘further information is required’ before an informed decision on risk management can be taken. Other delays are caused in cases where analytical methods must be developed to check compliance with a potential restriction. Authorities have to carry the main burden of the development of the analytical methodology. Such an approach is not amenable to attaining a high level of safety.

Authorisation, in contrast, requires industry to take a pro-active role in the evaluation process. If analytical tools need to be developed to control exposure, their availability should be a prerequisite for authorisation.

Increased flexibility: At the authorisation stage, a consideration of the socio-economic impact may be required. In contrast to the current system, which requires authorities to carry out cost/benefit analyses, the producer or user of the substance should be obliged to provide information substantiating any claim that the benefits from the continued use of a substance outweighs the potential adverse effects on human health and the environment. The REACH-system offers clear advantages to industry. Currently, Directive 76/769 restricts certain uses of substances without providing a mechanism to reverse such provisions on a case by case basis. In this perspective the REACH-system offers increased flexibility on condition that adequate safety measures are taken. It is more open to technological developments and will lead to a custom-tailored safety net for problematic substances.

Accelerated risk management of other substances

Specific uses of substances which do not have one of the properties listed under the authorisation system but for which restrictions are needed should be addressed in an improved and accelerated procedure.

Accelerated risk assessments: the following four elements will bring about the necessary acceleration of assessments:

(1) Due to the registration requirement of all chemicals above 1 t there will be extensive data available on the health and safety properties of all substances marketed (see chapter 5 below).

(2) The obligation on enterprises to submit a preliminary risk assessment will provide the authorities with valuable and comprehensive information on whether or not the chemical substance in question can be handled safely thereby avoiding unacceptable risks for workers, the population at large and the environment. Thus, for the large majority of substances (estimated at more than 80 %), there would be no need for further assessment. In the minority of cases where there is need for further assessment, it would be clear where the further assessment should be focussed. The gain in time would be substantial compared to the present system.

(3) Under the new system, the industry will be responsible for preliminary risk assessments and will assume responsibility for the safety of its products. It will be under an obligation to co-operate on the establishment of Community Risk Assessments where these are considered necessary. The delays encountered under the present system, where Member State authorities assumed full responsibility for risk assessments without the necessary means at their disposal, will be eliminated.

(4) Targeted risk assessments will in most cases replace the comprehensive risk assessments of the past. The latter were the main cause of delays under Regulation 793/93 as they required consideration of all dangerous effects, all exposed populations and all environmental compartments.

These four factors taken together will substantially reduce the time needed for assessment.

Accelerated legislation: two factors will contribute to an acceleration of the legislative process:

(1) The precautionary principle will be invoked whenever the risk assessment process is unduly delayed and where there is an indication of unacceptable risk. In particular, should a producer of a given substance delay the filing of information or test results, the central entity would be entitled to conclude the assessment. It would then pass the dossier to the Commission with a recommendation to apply the precautionary principle and to proceed to risk management measures to the possible extent of a total ban.

(2) A further acceleration is needed in order to proceed to risk management decisions for other substances in a reasonably short time frame. Thus, the Commission should be authorised to use the Committee procedure under Directive 76/769 more extensively than in the past.

This approach would take account of the full range of implications of possible restrictions; in particular, it would consider whether possible substitutes are more or less dangerous.

ROLE, RIGHTS AND RESPONSIBILITIES OF INDUSTRY

There is already legislation in place along the whole manufacturing chain generally allocating the responsibility for the safe use of chemicals to manufacturers and users of chemicals. Directive 92/59/EEC on General Product Safety20 extends the responsibility to products intended for consumer use, which should not present unacceptable risks under normal or reasonably foreseeable conditions of use. The review found that this general allocation of responsibilities has not led to a satisfactory evaluation of the safety of chemicals. Additional legal provisions stating more precisely the obligations of industry are essential. These provisions shall include ensuring that the substances they place on the market are safe for their intended use, irrespective of the tonnage produced.

Data Generation

The current system only established duties for producers and manufacturers to test chemicals, but not for downstream users. The role of downstream users in testing of chemicals needs to be further considered.

Action 5A: Obligation of downstream users to perform testing
Downstream users must assume responsibility for the safety of their products. Authorities should be empowered to require downstream users to carry out additional testing where uses differ from those originally envisaged by manufacturers or importers and the resulting exposure patterns also differ substantially from those evaluated by them. Additional testing programmes should be developed in close consultation with the authorities.

Risk/safety Assessment

Directive 67/548 and Regulation 793/93 oblige the authorities to carry out risk assessment. This imposes a considerable burden on them, particularly in assessing existing substances. As industry is responsible for safe use and disposal of chemicals and risk assessment is the preferred method to assess safety, the current work distribution between authorities and industry is inappropriate. Chemicals are used in millions of products so it is impractical for authorities to perform or be involved in these assessments. Instead, the Commission believes that, as the Council suggested, authorities should focus on areas of major concern.

Action 5B: Manufacturers and downstream users to perform risk assessment
Industry should have responsibility for performing risk assessments. This will require the manufacturer or importer as well as the downstream user to carry out adequate risk assessments for substances and preparations.

Information to be provided by Industry to the Authorities

Industry should provide authorities with information about all substances as set out in Chapter 4. Below the Chapter 4 thresholds, industry should generate the necessary safety data and keep the records available.

Action 5C: Obligation of downstream users to inform authorities
The Commission proposes that the authorities must be informed about any downstream use which has not been envisaged by a manufacturer or importer and which has not therefore been addressed in the preliminary risk assessment.

Information to be provided by manufacturers and importers to downstream users, other professional users and consumers

Information relevant for the safe use of chemicals must be available to all users, including consumers. Fundamentally, the safety system depends on the quality and the comprehensibility of the information passed on down the production chain. Safety data sheets and the Labelling of the packaging are the main carriers of this information. Shortcomings have been identified in both information systems. Safety data sheets are considered below while classification and labelling is addressed in chapter 7.

Action 5D: Information to industrial and professional users through safety data sheets

Safety data sheets are generally considered to be suitable communication tools to provide safety information to users, in spite of the noted shortcomings. The Commission proposes to establish a working group of Member States experts including participation of the European Chemicals Bureau to advise it on:

• ensuring better quality of safety data sheets,

• examining the current information requirements with a view to expand them in order to enable users to carry out risk assessment.

Property rights for test data

The specific provisions in Directive 67/548 and Regulation 793/93 for the sharing of test data and testing costs were designed to avoid duplicate animal testing. However, such provisions also have a benefit for industry because they reduce the overall testing costs. Furthermore, legislation for sharing of test data and the costs of testing is essential to ensure fair competition, otherwise some companies might delay testing in the hope that competitors producing the same substance would be obliged to do it before them and pick up the full costs.

The introduction of exposure-triggered testing and new obligations on downstream users to test could accentuate this problem. For example, if a downstream user carried out additional testing because of substantially different exposure patterns than those foreseen by a manufacturer of the substance, the latter might use these data to enlarge the scope of the uses of the substance. This would increase the number of potential customers and the marketed volumes, in some cases at a disadvantage to the original downstream user. Such a system would encourage the manufacturers to strictly limit the number of intended uses to a minimum, waive testing as far as possible and wait for downstream users to complete the testing. This would be a clear distortion of the market.

Action 5E: Property rights for test data

Anybody who generates testing data under the new system should be encouraged to share them and anyone who uses such data obliged to pay a fair and equitable contribution to the generator of the data.

Action 5F: Discouragement of duplicate testing

Specific provisions should be included in the legislation that duplicate tests involving vertebrate animals should be avoided. Any duplicate testing will not result in an exemption from the duty to reimburse the party who owns the property rights for the first test.

TIMETABLE FOR EXISTING SUBSTANCES

The testing and evaluation of the large number of existing substances on the market requires a phased approach. This chapter describes the necessary provisions and a timeframe for the testing and evaluation of existing substances. It also addresses the future role of the authorities in risk assessment.

Action 6A: Tiered approach for registration

Precise deadlines will be established for the submission of registration dossiers for existing substances. In general, substances produced in higher volumes will have to be registered first. However, the system will be flexible enough to allow for earlier registration of substances of concern (e.g. intended for consumer use or having particular proven or suspected hazardous properties) produced in lower tonnage. Under these presumptions and given rapid progress in adoption of the revised legislation, the suggested deadlines for submission of registration dossiers are basically:

• substances exceeding a production volume of 1,000 t – at the latest by end of 2005,

• substances exceeding a production volume of 100 t – at the latest by end of 2008,

• substances exceeding a production volume of 1 t – at the latest by end of 2012.

Dossiers drawn up in the context of the voluntary initiative on the part of the International Council of Chemicals Associations (ICCA) which comply with the OECD format will be valid for this purpose. However, the information contained in these dossiers will have to be supplemented in order to meet the requirements described in the previous chapters.

Action 6B: Tiered approach for testing and evaluation of high production volume existing substances

There should be a tiered approach for the testing and evaluation of high production volume existing substances. Level 2 testing should be completed for substances above 1,000 t by 2010 and Level 1 testing of substances above 100 t should be completed by 2012.

Action 6C: Establishment of a task force to review available data

An advisory task force composed of around 15 Member States experts, should be seconded to the European Chemicals Bureau in the interim period before the new legislation is implemented. This task force will be assigned the following responsibilities:

An advisory task force composed of around 15 Member States experts, should be seconded to the European Chemicals Bureau in the interim period before the new legislation is implemented. This task force will be assigned the following responsibilities:

– evaluation of the information of the IUCLID database submitted by industry for substances exceeding 1,000 t:

(a) examination of the proposed classification and labelling

(b) assessment of IUCLID information on properties, exposure and uses

(c) proposal of additional testing programmes in co-operation with ECVAM

CLASSIFICATION AND LABELLING

Current legislation requires that dangerous substances are either classified and labelled in accordance with Annex I of Directive 67/548 (harmonised classification) or, if they are not included in this Annex, in accordance with the principles laid down in Annex VI of this Directive by industry (self-classification). Annex I covers around 5,000 dangerous chemicals and has been established over several decades.

Systematic evaluation of new substances has revealed that around 70 % of them are classified as dangerous (e.g. carcinogenic, toxic, sensitising, irritant, dangerous for the environment). In view of the large number of existing substances and assuming that a comparable percentage of them need to be classified, the establishment of a comprehensive harmonised list of all substances is not a viable option using the current approach.

Classification according to some hazardous properties has automatic consequences for the risk management of these substances (see chapter 3). To avoid ambiguities in respect of the required management measures, the new system must retain parts of the harmonised classification.

Action 7A: Restrict harmonised classification to the most relevant properties

Authorities’ resources should be focussed on the most relevant hazardous properties, such as carcinogenicity, mutagenicity and reproduction toxicity (CMR), where classification gives rise to important risk management measures.

Action 7B: Commission to seek industry list of dangerous substances
The Commission will ask Industry to provide a list containing comprehensive information about the classification and the labelling of all dangerous substances on the market. This list should be made available on the Internet and be publicly accessible free of charge.

Action7C: To simplify the current labelling system and improving comprehensibility through Globally Harmonised System.

The current negotiations on the elaboration of a Globally Harmonised System provides an opportunity to fundamentally review the current labelling provisions, to consider simplification and to improve comprehensibility of the labels.

ADMINISTRATION OF THE SYSTEM

This chapter summarises the administration of the REACH system presented in chapter 4.

Decision-making in the REACH system

There are basically two different kinds of decision to be taken under the REACH-system: decisions on the information to be submitted following the evaluation of the substances and decisions on risk management in the context of the authorisation procedure.

Decision-making at the Evaluation stage: The system must provide a mechanism to ensure that, on the basis of the preliminary risk assessments provided by industry, decisions on further information or substance-tailored testing programmes can rapidly be taken for a large number of substances. The procedure under Regulation 793/93 to request additional testing for existing substances from industry has proven extremely slow and cumbersome. Under the new system, the approach taken for new substances will be followed: Member State authorities will be responsible for deciding on the additional testing and a committee procedure will only be invoked in cases where agreement cannot be reached between Member States authorities.

Decision-making

Decision making at the authorisation stage: Depending on the anticipated impact of a substance, an authorisation for actual use should either be granted by Member States or by a decision at Community level. Member States should grant authorisations for uses, which mainly need to be considered for their potential impact on workers and on the local environment. In contrast, the authorisation of the use of a substance of concern in products marketed in the Community may have a wider impact on human health or the environment as well as on the functioning of the internal market. This would imply that a Community- wide decision on the actual use of a substance is justified.

As described in chapter 4, the authorisation would encompass a two step procedure:

• Step 1 – the identification of substances or particular uses of a substance which will be subject to future authorisation, establishing a precise date when all uses which have not been authorised will be prohibited;

• Step 2 – the actual authorisation of particular uses.

Given the Community-wide internal market impact of prohibiting the use of a substance, the step 1 decision, together with identification of the uses that Member States may authorise, should be taken at Community level. Step 2, the authorisation of specific uses, would be taken at the appropriate level defined in step 1. Generally, a committee driven mechanism will be applied for all decisions taken at Community level.

Decision making in the accelerated risk management procedure:

The accelerated risk management procedure will work as follows:

• Step 1 – the identification of substances or particular uses of a substance which will be subject to future restriction, defining the scope of the restriction,

• Step 2 – the actual decision restricting or banning the use of the substance.

Given the Community-wide internal market impact of prohibiting the use of a substance, both decisions should be taken at Community level. Step 2 would imply legislation in the framework of a modernised Directive 76/769. Generally, a committee driven mechanism will be applied for all decisions taken at Community level. It would leave present working arrangements intact.

Establishment of a central entity

The Commission proposes at this stage to establish a central entity (an expanded European Chemicals Bureau) for the administration of the REACH-system and the provision of technical and scientific support. Building on its existing experience, the expanded European Chemicals Bureau should be a receiving body for the registration dossier, and forward the copies of the registration dossiers to the Member State authorities, establish and maintain a comprehensive central database on all registered chemicals, perform spot-checks and computerised screening of the registered substances for properties raising particular concern. It will also support Member States authorities in the evaluation of substances.

The central entity will provide access to non-confidential submitted information for the general public and establish an efficient and secure data exchange network with Member States for commercially sensitive information. It should support and co-ordinate the Member States with respect to the decision-making at the evaluation stage in order to ensure a coherent approach. Furthermore, the European Chemicals Bureau would provide the operational framework for the authorisation procedure and seek the views of Member State experts and of the CSTEE . Prior to the establishment of the central entity, the Commission will carry out a feasibility study and a cost/benefit analysis.

Role of Member States

Member States authorities would broadly retain their current responsibilities. They would be collectively responsible for substance registration and evaluation, similar to their current responsibilities for new substances notifications. Better consistency of decisions between Member States authorities would be achieved by the co-ordination through the European Chemicals Bureau and by developing guidelines for substances-tailored testing. The experience gained by the task force (see chapter 6) will help to prepare such guidelines.

To rectify the current unequal workload distribution between Member States authorities, the registered substances will be allocated to Member States on a proportionate basis. Current provisions concerning information exchange and the option to invoke a committee procedure in cases where agreement cannot be reached between Member States authorities should be retained.

INFORMATION TO THE PUBLIC

The Commission has consulted and involved all stakeholders and in particular the NGOs representing consumer interests. Full openness is essential if the public is to understand the intended benefits of the Strategy and to ensure the Commission has addressed the public interest. The Commission is therefore committed to ensuring the continued involvement of stakeholders representing the full range of interests in the implementation, management and review stages of the Strategy.

EU citizens should have access to information about chemicals to which they are exposed. Information must be presented in such a way that it enables a person to understand the risks and to develop a sense of proportion in order to make a judgement on the acceptability of those risks. Better public access to information on chemicals will increase public awareness and will lead in turn to greater accountability on the part of industry and authorities. The Commission already publishes an up-to-date multi-lingual collection of chemical substances data and this could be further developed. Furthermore, indicators on the risk of chemical use should be established.

The Commission acknowledges consumers ‘right of choice’. Information should enable the consumer to make a judgement on whether alternative products on the market are more favourable in terms of their intrinsic properties and risks.
The findings of the review highlighted the need of consumers for information about the health effects, environmental effects, other serious hazards and safe instructions for use of chemical products. The Commission believes that industry, including downstream users, should mainly be responsible for providing this information to consumers. This will lead to better informed purchasing decisions about such products.

There is currently no central tracking system by which the public can determine whether regulatory measures are in place or in progress for individual chemicals. There is a lack of public awareness of the requirements of current chemicals legislation. The new system should be more easily understood by the general public helping to address this lack of awareness.

Action 9A: Stakeholder access to non-confidential information in the new-system database

All stakeholders, including the general public and SMEs (small and medium sized enterprises employing less than 250 workers), should have access to the non-confidential information on the central system database (see Chapter 4). Easy to read summaries for substances will promote use by the general public. These summaries will include a short profile of the hazardous properties, labelling requirements and relevant Community legislation, including authorised uses and risk management measures.

IMPLEMENTATION AND ENFORCEMENT

The Commission proposes to review the effectiveness and the efficiency of the chemicals strategy following implementation of the new legislation. The review will include an element of testing and questioning of all stakeholders.

Member States will be responsible for the enforcement of the new legislation in their territories. However, a number of enforcement projects and studies have highlighted shortcomings in compliance by industry of the current legislation on chemicals and inconsistencies in the level of enforcement activities by the Member States. Even if non- compliance can be demonstrated and damage to human health or environment has occurred, compensations awarded by courts of EU Member States often have a limited deterrent effect. The Community must address these problems by requiring Member States to establish dissuasive, effective and proportionate sanctions.

Recent studies in the Netherlands and the United Kingdom found high levels of non- compliance with the Safety Data Sheets legislation. Flaws in compliance and enforcement activities related to current legislation for new and existing substances were also noted by recent Community-wide enforcement projects (SENSE, NONS and EUREX21).

Action 10 A: Review of the chemicals policy

The Commission proposes to review the effectiveness and the efficiency of the chemicals policy including all the different elements that constitute its information policy, following implementation of the new legislation. The review will include an element of testing and questioning of all stakeholders.

Action 10B: Network of Enforcement Authorities

The Commission proposes to create a network of the Member States and Candidate Countries authorities responsible for enforcement of new legislation on chemicals to spread good practice and to highlight problems at Community level. This will be of increased importance when the current Candidate Countries join the Community, thus enlarging the Internal Market. One of the issues this network will be asked to consider is the need to develop minimum criteria for enforcement of the proposed legislation in the Member States. Such criteria might be set out in a Commission Recommendation in future.

GLOSSARY OF TERMS AND ABBREVIATIONS

Burden of the Past: The 30,000 ‘existing’ chemicals estimated to be on the EU market, for which little or no information is available, in particular about their long-term effects on human health or the environment.

Chemicals: General term to cover both substances and preparations (see separate entries).

Competent Authorities: A national authority or authorities designated by each Member State to
implement legislation.

CMR chemicals: Chemicals classified as carcinogenic, mutagenic or toxic to reproduction under Directive 67/548 (see ‘legislation’).

CSTEE: Scientific Committee on the Toxicity, Ecotoxicity and the Environment of the Commission. Downstream users: Formulators and industrial users of chemicals. ECVAM: the JRC’s European Centre for the Validation of Alternative Methods.

ELINCS: European List of Notified Chemical Substances. ELINCS, currently contains some 2,700 substances and is an ever expanding list, following notification to Competent Authorities of the placing of a ‘new’ substance on the market.

EINECS: European Inventory of Existing Commercial Chemical Substances, deemed to be on the EU Market between 1 January 1971 and 18 September 1981. It is a closed list of 100,106 ‘existing’ chemicals governed by Regulation 793/93 (see ‘legislation’).

Existing substances: Substances in use within the EU before September 1981 and listed in EINECS. EINECS contains 100,106 entries including chemicals, substances produced from natural products by chemical modifications or purification, such as metals, minerals, cement, refined oil and gas; substances produced from animals and plants; active substances of pesticides, medicaments, fertilisers and cosmetic products; food additives; a few natural polymers; some waste and by-products. They can be mixtures of different chemicals occurring naturally or as an unintentional result of the production process.

‘Existing’ substances do not include: synthetic polymers (which are registered in EINECS under their building block monomers), intentional mixtures, medical preparations, cosmetic preparations and pesticide preparations as intentional mixtures; food; feedstuffs; alloys, such as stainless steel (but individual components of alloys are included); most naturally occurring raw materials, including coal and most ores.

Global Harmonisation: The Community together with its trading partners is committed to developing a global system for managing chemicals. Work is underway with the candidate countries for accession to the EU, in the framework of the OECD and at a global level in the framework of the United Nations.

Hazard assessment: Hazard identification and establishment of dose-response relationship for observed adverse effects in the specified (eco)toxicological endpoints.

Hazard identification: Identification of the adverse effects that a substance has the inherent capacity to cause.

HPV chemicals: High Production Volume chemicals. Chemicals placed on the EU market in volumes exceeding 1000 tonnes per year per manufacturer or importer.

ICCA: International Council of Chemical Associations.

IFCS: Intergovernmental Forum on Chemical Safety.

ILO: International Labour Organisation.

IUCLID: International Uniform Chemical Information Database. A Commission database used to store and distribute information collected under Regulation 793/93.

JRC: Joint Research Centre of the Commission.

Legislation: Reference in the White Paper mainly refers to four legal instruments on chemicals currently in force in the Community:
• Council Directive 67/548/EEC relating to the classification, packaging and labelling of dangerous substances, as amended,
• Directive 88/379/EEC relating to the classification, packaging and labelling of dangerous preparations, recently replaced by 1999/45/EC,
• Council Regulation (EEC) 793/93 on the evaluation and control of the risks of existing substances,
• Directive 76/769/EEC relating to restrictions on the marketing and use of certain dangerous substances and preparations.

LPV chemicals: Low Production Volume chemicals. Chemicals placed on the market in volumes between 10 tonnes and 1000 tonnes per year per producer/importer.

New substances: Substances not in use in the EU before September 1981 and so not in EINECS. They must be notified before being placed on the market, after which they are registered in ELINCS. New substances are governed by Directive 67/548, as amended by Directive 92/32.

NGOs: Non-governmental or ganisations representing particular stakeholders’ interests (e.g. consumers, environment).

Notification procedure for a new substance: Submission of a technical dossier by industry to a Competent Authority, containing information specified by Directive 67/548, as amended by Directive 92/32 (see ‘legislation’).

OECD: Organisation for Economic Co-operation and Development. OSPAR: Oslo – Paris Convention for the Protection of the Marine Environment of the North East Atlantic.

PBT chemicals: Persistent, bio-accumulative and toxic chemicals. POPs: Persistent Organic Pollutants.

Precautionary Principle: This principle is contained in Article 174 of the Treaty and the subject of a Commission Communication of 2 February 2000. It applies when there is a preliminary objective scientific evaluation indicating reasonable grounds for concern that the potentially dangerous effects on the environment, human, animal or plant health may be inconsistent with the high level of protection chosen for the Community.

Preparations: Intentional mixtures or solutions composed of two or more chemicals. They are governed by Directive 88/379/EEC, recently replaced by Directive 1999/45/EC.

QSAR: Quantitative Structure Activity Relationship. Models used to predict the properties of chemicals from the molecular structure.

REACH System: Registration, Evaluation and Authorisation of Chemicals.

Regulatory Committee: A committee composed of representatives from the EU Member States and chaired by the representative of the Commission. Its opinion is delivered by a qualified majority.

Risk Assessment: A process to determine the relationship between the predicted exposure and adverse effects in four steps: hazard identification, dose-response assessment, exposure assessment and risk characterisation. See also ‘targeted risk assessment’.

Risk characterisation: Estimation of the incidence and severity of the adverse effects likely to occur in a human population or environmental compartment due to actual or predicted exposure to a substance.

SIDS: Screening Information Data Set (SIDS) outlining the minimum data elements for determining whether an existing HPV chemical requires further investigation in the OECD’s HPV/ICCA programme.

SMEs: Small to medium size enterprises employing less than 250 workers.

Substances: Substances are chemical elements and their compounds in the natural state or obtained by any production process, including any additive necessary to preserve the stability of the product and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition. While ingredients of pesticides, biocides, medicaments or cosmetics might be included in this definition, intentional mixtures or preparations of them for final use would not.

Sustainable Development: Enshrined in Articles 2 and 6 of the Treaty, it was defined by the World Commission on Environment and Development (the Brundtland Commission) as development that ‘meets the needs of the present generation without compromising the ability of future generations to meet their own needs’. This objective includes the economic, social and ecological aspects of development as set out in the Final Document of the 19th Extra Session of the UN General Assembly, which was held on 23-27 June 1997. These three aspects are mutually dependent, and in order to achieve sustainable development they must be integrated and taken into account in a balanced manner. These notions are at the core of the Fifth EU Environment Action Program ‘Towards Sustainability’ and the Cardiff Strategy on Integration.

Targeted risk assessment: A less extensive, more specifically focused evaluation (because of a specific concern) than a comprehensive risk assessment.

Tiered Approach: Proportionate effort in relation to the volumes, intrinsic properties, exposure and/or use of chemicals; see chapter 3 for further explanation.

UN: United Nations.

UNCED: UN Conference on Environment and Development at the 1992 Earth Summit in Rio.

VPVB chemicals: Very persistent and very bio-accumulative chemicals.

WHO: World Health Organisation.

ANNEX I

Costs and Benefits of the new Chemicals Policy

Model

• Single coherent system for all chemical substances. REACH model (registration, evaluation and authorisation/rapid restriction of chemicals);

• Management by Member States and European Chemicals Bureau (ECB).

Coverage

• 30,000 existing substances (= all existing substances above 1tonne/year/manufacturer);

• Acute and long-term toxicity tested. Tailor-made testing for long-term effects (such as cancer,
reproductive effects) for substances above 100 tonne/year/manufacturer;

• Waiving of testing on due justification, all available test data used and registered;

• Reduced testing for low exposure substances and R&D (research and development) substances.

• Limited in vitro testing for substances between 1 and 10 t.

Costs

Cost of action. It is very difficult to give a reliable estimate of the “cost of action” implied, such as for the testing of existing substances where availability of test data generated earlier is largely unknown. However, a first estimate is given in the following.

• Testing costs for existing substances. € 2.1 billion over 11 years = € 0.2 billion/year, to be borne by the chemicals industry.

• Human resources for an expanded European Chemicals Bureau (ECB). A staff of 190 people at the ECB to provide the technical and administrative framework.

• Public human resources in the Member States. Member States will reallocate their current staff. Extra resources will be allocated to evaluation of existing substances. These resources will be freed from their current tasks by the following measures:
– Computerised screening and sport checks will replace the current general conformity check for new substances below 100 t
– Risk assessments will generally be carried out by industry rather than authorities
– in view of the expanded ECB and the reduced efforts needed for the authorisation process instead of the current restrictions process under Directive 76/769.

• Industry human resources. An estimate is hardly possible because an increase can be expected for processes such as the authorisation process, but a reduction can be expected because of
– no notification of substances between 10 kg and 1 tonne/year/manufacturer;
– less strict requirements for certain substances such as intermediates with low exposure;
– less strict requirements for R&D substances (research and development).
(The staff for the testing of existing substances is already covered by the above-mentioned testing costs.)

Benefits

Better protection of the environment and human health through appropriate risk management based on adequate information about the dangerous properties of chemicals. This will reduce the incidence of certain diseases related to chemicals (such as cancer or allergies) and reduce the risks that chemicals can pose to the environment (such as through the accumulation of persistent chemicals in the food chains). The main difficulty is that neither the dangerous properties nor the uses of chemicals are sufficiently known. For illustrative purposes reference is made to allergies.

Allergy costs are estimated at € 29 billion/year in Europe. Chemical substances are considered to play a major role in inducing allergies either directly or by increasing susceptibility to natural allergens (e.g. pollen). For example a US study has shown that asthma cases have risen by 40% since the 1970s. If the new strategy makes even a small reduction in the € 29 billion of allergy costs, this will outweigh the costs of the strategy.

• Improved framework for innovation in the chemicals sector. This will

– contribute to the development of novel chemicals that may substitute current chemicals of concern,
thus decreasing the risks from chemicals;

– strengthen the competitiveness of the EU chemicals industry.

• Increased transparency and better access of the public to information, thus enabling them to make an “informed choice” about the chemicals they want to use.

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Vanishing of the Bees 2010 Documentary

“The bee is more honored than other animals, not because she labors, but because she labors for others.” – Saint John Chrysostom

Colony Collapse Disorder is the canary in the coal mine of our food supply system. Are we going to listen to this grave warning? Seed and Chemical companies control food production and government subsidies.

“We’re in a war somewhat and we’re going to lose a percentage of our troops consistently. We’re going to keep fighting.” – David Mendez Beekeeper 7,000 hives from Fort Myers, Florida

“Only when the last tree has died and the last river been poisoned and the last fish been caught will we realize we cannot eat money.” – Cree Indian Proverb

“Whatever affects one directly, affects all indirectly. This is the interrelated structure of reality.” – Martin Luther King, Jr.

“It would be possible to describe everything scientifically, but it would make no sense; it would be without meaning, as if you described a Beethoven symphony as a variation of wave pressure.” – Albert Einstein

CODE ON PESTICIDES URGED FOR NATION By PHILIP SHABECOFF, Special to the New York Times Published: May 21, 1987

The nation’s food supply is inadequately protected from cancer-causing pesticides, according to a report issued today by the National Academy of Sciences.

The report, requested by the Environmental Protection Agency, found that a ”crazy-quilt” of laws and regulations governing allowable residues of carcinogenic insecticides, herbicides and fungicides was permitting relatively high levels of some of these chemicals on or in foods reaching the consumer.

It did not attempt to describe the probable risk of cancer caused by these levels, but it recommended that the Government adopt a new uniform standard for residues of new and old pesticides on both fresh and processed foods. It recommended allowing a ”negligible” risk of no more than one cancer case per million people over a lifetime of exposure, saying that such a standard could reduce dietary cancer risks from pesticides by 98 percent. Impact on Regulation

Carrying out the report’s recommendations would require policy changes by the E.P.A. and probably in some cases changes in the laws governing pesticides. John A. Moore, the E.P.A. assistant administrator for pesticides and toxic substances, said that the agency would make careful use of the report’s recommendations, which he said were sound and reasonable.

The report is cautiously worded and technical, but the fact that it acknowledges undefined deficiences in protection from cancer-causing substances in foods makes it a potentially explosive document.

Environmental and consumer groups said that the study underestimated the risks because it included only 28 of the 53 chemicals identified by the E.P.A. as possible causes of cancer in human beings that are used on food crops and omitted other factors, including the presence of these pesticides in drinking water.

There was general agreement, however, that the report made a persuasive case for changing the way that pesticides were regulated.

Jeffrey Nedelman, vice president for public affairs of the Grocery Manufacturers of America, an association of food companies, said that his organization endorsed the concept of a single uniform standard allowing a minimum pesticide risk on foods. He noted that the Food and Drug Administration has been following such a procedure in carrying out the law, although its practice has been challenged in court.

Members of the panel that wrote the report, as well as spokesmen for the E.P.A. and industry, emphasized that the numbers used to describe current risks of cancer from pesticides in foods were theoretical ”worst case” estimates and that actual risks to consumers were much lower.

Ray Thornton, president of the University of Arkansas, who is chairman of the committee that prepared the report, emphasized that it ”does not address actual exposure to pesticide residues,” and added: ”Nor does it comment on the safety of individual foods. It does not suggest any change in eating habits.” E.P.A. Request for Report

The National Academy is a private, nonprofit group chartered by Congress. The E.P.A. asked it to prepare the report two years ago. While the report’s findings and recommendations are likely to be debated sharply, they may also provoke changes in the way the nation deals with dangerous chemicals in its food supplies. Last year Congress narrowly failed to pass major changes in the pesticide law and this Congress is currently preparing to try again.

The immediate controversy generated by the report, however, involved the numbers it used to describe the risks of pesticides on food.

The report listed 15 foods, starting with tomatoes, beef and potatoes, that presented the greatest ”worst case” risk of cancer because of the presence of 28 specified chemical pesticides, based on the theoretical worst case estimates. According to these estimates, 8.75 of every 10,000 people eating tomatoes over a theoretical 70-year lifetime will develop cancer from the pesticide residues. For beef the risk is 6.49 cancers per 10,000 people, and for potatoes the risk is 5.21 cases of cancer.

In order, other foods in the list of 15 with the greatest cancer risk are: oranges, lettuce, apples, peaches, pork, wheat, soybeans, beans, carrots, chicken, corn and grapes.

In regulating other cancer hazards, the environmental agency often will permit a risk of no more than one in a million. But agency officials take the view that the law requires them to consider other factors, including the benefits of pesticide use, as well as health risks. ‘Theoretical Maximum Risk’

Mr. Moore emphasized that the numbers of the report represented a ”theoretical maximum risk,” adding, ”Where we do get actual data, the numbers come way down.”

The academy report, Mr. Moore said, shows that while ”the American food supply is wholesome and safe, at the same time, it can be improved.”

Charles J. Carey, president of the National Food Processors Association, an industry group, said, ”In the real world, where we live and operate, the risks reported do not exist.”

”Years of testing by our laboratories and others show conclusively that consumers need not worry about pesticide residues in foods,” the industry spokesman said.

But Lawrie Mott, a senior scientist for the Natural Resources Defense Council, an environmental group, said that the report ”graphically illustrates the fundamental problem of pesticides in our food.”

Using the worst-case risk estimates, she said, the number of cancer cases caused by the 28 pesticides in this country is 1.46 million over the 70-year lifetime exposure. But she added that the risk numbers ”significantly understate” the perils of cancer to consumers because many cancer-causing pesticides are not included in the estimates, because contaminated drinking water is not included and because there is a serious lack of adequate information about the health effects of many of the older pesticides that were approved for use before adequate testing methods were developed.

”But the issue is not if the numbers are correct,” she said. ”The issue is how to correct the problem.” Regulation of Pesticides

Pesticides are regulated under both the Federal Insecticide, Fungicide and Rodenticide Act and the Food, Drug and Cosmetics Act. One section of the Food and Drug law, called the Delaney clause, after a former Democratic Representative, James J. Delaney, prohibits any amount of cancer-causing substances in processed foods or raw foods that are to be processed. Chemical pesticides tend to accumulate in processed foods.

But raw foods that are not processed are permitted to contain specific levels of cancer-causing pesticides in cases where economic benefits can be shown. The report found that 45 percent of the nation’s food supply was not subject to regulation under the Delaney clause. It also found that the E.P.A. had failed to impose the restrictions of the clause on pesticides that had been on the market for many years.

Under the law, new chemicals are subject to more stringent regulation than old chemicals. The E.P.A. is retesting the older chemicals and imposing stronger restrictions on them, but the process is very slow and, at the current rate, will not be completed until the next century.

The academy report found that 98 percent of the cancer risk from pesticides came from chemicals registered for use before 1978. It also found that a large proportion of the cancer risk came from chemicals used to kill funguses on crops. Disparity in Impact of Rules

The report argued that the regulatory process as it now exists tended to keep relatively safer new pesticides off the market because of the more stringent requirements.

As an example it cited the case of a new fungicide called Fosetyl Al developed for use on hops. The agency found that residues of the new fungicide had a ”weak” cancer-causing effect that would produce one cancer for every 100 million people exposed over a lifetime and cited the Delaney clause to keep it off the market. But the risks of this fungicide are ”several magnitudes” less than fungicides currently and legally used on hops that presented cancer risks of as high as one in 100,000.

A single uniform standard for all foods that permitted a risk of cancer from pesticides of no more than one in a million would virtually eliminate the dietary risk from the 28 major pesticides, the study contended. Strict enforcement of the Delaney clause for processed food would eliminate only slightly more than half the existing cancer risk because it would not protect raw foods, the report said.

While setting a ”zero risk standard’ prohibiting any cancer-causing substances in any foods could theoretically remove the threat of cancer in the food supply entirely, the disruptive impacts of such a decision could impede efforts to reduce the cancer risk, the report said. Moreover, Mr. Thornton said, ”pesticides are essential to our agricultural productivity” and policies should not be adopted that would ”jeopardize our goal of providing an adequate and economic food supply for the American public.”

Industry officials said that cancer risks from pesticides in foods were much lower than than other cancer risks routinely faced by most people. They cited a recent report by Bruce N. Ames of the University of California at Berkeley, and others, which found that natural cancer-causing agents in foods, such as afflotoxin in peanut butter, presented a much higher risk than pesticides.

But Charles M. Benbrook, executive director of the National Academy’s Board on Agriculture, which oversaw preparation of the report, disputed the conclusions of the Ames report, saying they did not take into account of ”the most recent and complete data.”

The Academy committee that prepared the new report included a total of 17 academic scientists, corporate executives, lawyers and other experts.

To access the archived article click on the link below

http://www.nytimes.com/1987/05/21/us/code-on-pesticides-urged-for-nation.html?pagewanted=all&src=pm

Who funds the research in the US? The manufacturers do. The EPA does not do the research. It is submitted to them by the corporations.

Chemical Industry’s Influence at EPA Probed By Lyndsey Layton
Washington Post Staff Writer
Friday, April 4, 2008

A congressional committee is investigating ties between the chemical industry and expert review panels hired by the Environmental Protection Agency to help it determine safe levels for a variety of chemical compounds.

Rep. John D. Dingell (D-Mich.), chairman of the House Energy and Commerce Committee, and Rep. Bart Stupak (D-Mich.), chairman of the oversight and investigations subcommittee, have demanded documents from the EPA and the American Chemistry Council to probe the roles of nine scientists who are serving on EPA panels or have done so in the past.

The lawmakers sent a letter to the chemical industry Wednesday, expanding a probe that began earlier this month.

“Americans count on sound science to ensure that consumer products are safe,” Dingell said through a spokesman yesterday. “If industry has undue influence over this science, then the public’s health is endangered.”

Dingell and Stupak want to know how much the chemistry council has paid consultants, lawyers, scientists and a scientific journal in efforts to affect public policy.

“I don’t remember the last time Congress investigated a trade association like this,” said Richard Wiles of the Environmental Working Group, which contends that the chemical industry has stacked EPA panels. “Maybe for the first time, we might find out the extent of industry influence. It’s a landmark investigation and has called into question the ethics of the entire industry.”

Tiffany Harrington, a spokeswoman for the chemistry council, said it supports independent scientific research and it will cooperate with the congressional request.

The lawmakers want to know why the EPA allowed the scientists in question to remain on expert panels but removed a public health scientist, Deborah C. Rice, from a panel at the chemistry council’s request.

Rice chaired an EPA panel last year that reviewed safe levels for deca-BDE, a polybrominated diphenyl ether used as a fire retardant in television casings and other electronics. Deca has been found to cause cancer in mice and is a suspected human carcinogen.

As a toxicologist for the state of Maine, Rice testified before the Maine legislature about the health risks associated with deca. Maine and several other states — and this week, the European Union — have since banned the compound.

After Rice’s panel completed its work, Sharon Kneiss, a vice president of the chemistry council, wrote to the EPA and called Rice “a fervent advocate of banning” deca who “has no place in an independent, objective peer review.” The agency informed Rice that it was removing her from the panel, and it expunged her comments from the official record, even removing them from the EPA Web site.

The Chemistry Council “seems to argue that scientific expertise with regard to a particular chemical and its human health effects is a basis for disqualification from a peer review board,” Dingell and Stupak wrote to EPA Administrator Stephen L. Johnson. “This does not seem sensible on its face.”

At the same time, the EPA has allowed at least nine scientists who have received funding from chemical makers or expressed similar opinions about particular chemical compounds to remain on review panels, Dingell and Stupak wrote.

Among those scientists is Dale Sickles, who serves on a panel reviewing acrylamide. He received $93,000 from the manufacturer of the compound and $230,000 from its marketer. “I’ve been totally transparent throughout the process,” Sickles said yesterday.

Four other scientists reached yesterday said that industry funding never influenced their research.

Scientists invited to participate in review panels are asked to disclose any conflicts or perceived conflicts. EPA guidelines say that conflicts do not automatically disqualify an expert but that the agency should make sure the panel has a balance of viewpoints.

Timothy Lyons, an EPA spokesman, said privacy issues prevent the agency from commenting on Rice or the scientists singled out by the congressional investigation. But the agency followed procedures in selecting panel members, he said.

Rice, who has declined to comment, has become a cause celebre among Bush administration critics, who say her case is symbolic of undue industry influence in public health regulation under President Bush.

“This is an administration that has put corporate interests before public health and safety, and ideological zealotry before sound science,” Dingell said. “This disturbing pattern extends to EPA’s peer review panels.”

To access this article click on the link below

http://www.washingtonpost.com/wp-dyn/content/article/2008/04/03/AR2008040304135.html

Colony Collapse Disorder was also occurring in France. The Beekeepers united, hired a lawyer, filed a class action lawsuit, obtained scientific proof and got results.

“We suspended the use of Gracho (Bayer’s systemic pesticide) because it is our job to protect the environment. After hearing about the losses the beekeepers were suffering, I decided to ban it.” – Sec of Ag of France.

Update – “In regions where new products were not applied to crops the bees bounced back within a year. The future of the bee, like water and energy, will define the ability of man to live on the planet.” – President of Beekeepers Association.

“We cannot change the problem with the same mindset that have caused it. Our mindset has to undergo a great transformation.” – Albert Einstein

For additional information please check out the Vanishing of the Bees website at

http://www.vanishingbees.com/

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Max Gerson died in 1959. He was eulogized by one of his long time patients, Albert Schweitzer.

I see in him one of the most eminent geniuses in the history of medicine. Many of his basic ideas have been adapted without having his name connected with them. Yet he has achieved more than seemed possible under adverse conditions. He leaves a legacy which commands attention and which will assure him his due place. Those whom he cured will now attest to the truth of his ideas.

I must confess that I probably never would have bought his book had I not read Albert Schweitzer’s comment. I would like to first present information from his book without declaring its title. I would like you all to discover this man in the same manner in which he was revealed to me. Evidence and information presented in his book is profound especially given its publication was in 1958.

Thomas Edison believed that, “The doctors of the future will give no medicine, but will interest his patients in the care of the human frame, in diet, and in the cause and prevention of disease.” This is the story of one such doctor. The following are excerpts of his 1958 book.

Introduction

At this time, of course, it is not possible to replace a century-long pessimism with an overwhelming optimism. We all know that everything in biology is not as precise as in mathematics or physics. I fear that it will not be possible, at least in the near future, to repair all the damage that modern agriculture and civilization have brought to our lives. I believe it is essential that people unite, in the old conservative manner, for the humanitarian purpose of producing nutrition for their families and future generations as natural and unrefined as possible.

The amount of damage done by chemical fertilizers, spraying, and insecticides which lead to a chronic poisoning of the soil can be estimated when we realize how many poisons go into the fruit and vegetables we eat, into the cattle, the eggs and butter we consume and the milk which we and our children drink.

For the future of coming generations, I think it is high time that we change our agricultural and food preservation methods. Otherwise we will have to increase our institutions for mental patients yearly, and we will see the hospitals overcrowded with degenerative diseases even more rapidly and in greater numbers than the hospitals themselves can be enlarged.

Seventy years ago, leukemia was unknown in the United States. Fifty years ago, lung cancer was so seldom observed in clinics and autopsies that every case was worthy of a publication. But today-what a change for the worse. (O quae mutatio rerum.)

The coming years will make it more and more imperative that organically grown fruit and vegetables will be, and must be, used for protection against degenerative diseases, the prevention of cancer, and more so in the treatment of cancer.

I am more than ever convinced that biochemistry and metabolic science will be victorious in healing degenerative diseases, including cancer if the whole body or the whole metabolism will be attacked and not the symptoms.

The family has to give up some of the social life and do this humanitarian work with deep devotion. The decline in our modern life is evident by this lack of devotion for the sick members of the family.
page 3, 142, 143

Scientists Term Radiation A Peril to Future of Man

A Cumulative Effect

Shock and surprise were expressed by the committee on genetics in its finding that the American public was using up about one third of the safety limit in medical and dental X-rays. Its members called on the medical profession to reduce the use of X-rays to the lowest limit consistent with medical necessity.

This committee also urged a national system of personal records whereby every American would know his total amount of exposure. The effect of radiation is cumulative, it is said, no matter how long the period over which it is experienced.

The six committees studied the radiation problem in the fields of genetics, pathology, meteorology, oceanography, and fisheries, agriculture and food supplies, and disposal and dispersal of radioactive wastes….

Pathological effects: Dr. Shields Warren, Chairman — Recommendations will be made in the future. The committee concluded in agreement with geneticists that radiation, no matter how small the dose, shortens life in some degree…

Dr. Weaver’s genetics committee recommended as a general population safety limit that exposure to radiation should be held down to 10 roentgens for the first 30 years of a person’s life. A roentgen is a unit for measuring the harmful gamma ray from medical and dental X-ray equipment, nuclear weapons explosions and from natural causes like cosmic rays and natural radium.

As a result of medical X-rays it is estimated that each person in this country receives on the average a total accumulated dose to the gonads or sex glands about three roentgens in 30 years. “Of course, some persons get none at all; others may get a good deal….” Dr. Weaver declared it was “stupid genetically” to use X-ray for the fitting of shoes. He was referring to the X-ray devices that have become common in shoe stores and into which children often stare in awe, sometimes without regard to time at the shadows of the bones of their feet.

Dr. Weaver also condemned obstetricians who make X-ray pictures of pregnant mothers to show them how “beautifully formed” is the skeleton of their baby without realizing the “hazards” of the dose of three or four roentgens that is being administered.

In addition to six long summary reports of the committees, the scientists also issued “a report to the public” in the simplest language possible. Here the layman may now read how radiation damage inevitably results from exposure, no matter how small the dose.

Radiation causes mutation or harmful changes in the genes or germ lines of the reproductive organs. Damage manifests itself in shortening of the life span, reduces the ability to produce children, and sometimes, but not often, produces deformed children.

Even if the mutations is in one gene, there is some harmful effect that mutation will go on through every generation until the line that bears it becomes extinct.

The report explained how “every cell of a person’s body contains a great collection, passed down from the parents, the parents’ parents, and so on back, of diverse heredity units called genes.”

The layman’s report went on to explain:
“From the point of view of the total and eventual damage to the entire population, every mutation causes roughly the same amount of harm. This is because mutant genes can only disappear when the inheritance line in which they are carried dies out. In cases of severe and obvious damage this may happen in the first generation; in other cases it may require hundreds of generations.

“Thus, for the general population, and in the long run, a little radiation to a lot of people is as harmful as a lot of radiation to a few, since the total number of mutant genes can be the same in the two cases.”

But damage to future generations due to radiation will be difficult to identify. The study of genetics damage has only just begun, with a report due on genetic effects observed in the populations of Hiroshima and Nagasaki, the Japanese cities destroyed by American atom bombs in World War II …

The following appeared in an article on radiation in the New York Times on July 21, 1957:

Safety Limit Set

As a safety limit, the National Academy of Sciences has recommended, that the average person receive not more than ten roentgens of man-made radiation to the reproductive organs from conception to the age of 30.

The roentgen is a unit of measurement of radiation dose.
The report also lends new support to the repeated warnings of atomic officials and scientists that man faces a far greater danger from medical use of radiation than he does from the radio-active fall-out from atomic testings

A similar warning came last month from Dr. Leroy E. Burney, Surgeon General of the United States Public Health Service, who said that in view of the increasing sources of radiation in the nuclear age, the time had come to reassess the safety levels of radiation from medical treatment.

In recent years there has been an increasing awareness in the medical profession of the potential danger of radiation from X-ray treatments, and steps have been instituted to limit the radiation dose.

Insecticides

We have learned in recent years that spraying with modern insecticides is doing more damage to our food and to our bodies. I cannot emphasize too often that our nutrition is our external metabolism. Whoever is interested in this field may read the Hearings Before the House Select Committee to Investigate the Use of Chemicals in Food Products, House of Representatives Eighty-First Congress, Second Session. There is clearly described in the hearing of Dr. Biskind what he observed in this field and what he recommended ought to be done.

The following is a brief survey of this hearing: “The introduction for uncontrolled general use by the public of the insecticide DDT, or chlorophenothane, and the series of even more deadly substances that followed, has no previous counterpart in history. Beyond question, no other substance known to man was ever developed so rapidly and spread so indiscriminately over so large a portion of the earth in so short of time. This is the more surprising as, at the time DDT was released for public use, a large amount of data was already available to the medical literature showing that this agent was extremely toxic for many different species of animals, that it was cumulatively stored in the body fat and that it appeared in the milk. At this time a few cases of DDT poisoning in human beings had also been reported. These observations were almost completely ignored or misinterpreted.

“In the subsequent mass use of DDT and related compounds a vast amount of additional information on the toxicity of these materials, both in animals and in man, has become available. Somehow a fantastic myth of human invulnerability has grown up with reference to the use of these substances. Because their effects are cumulative and may be insidious and because they resemble those of so many other conditions, physicians for the most part are unaware of the danger. Elsewhere, the evidence has been treated with disbelief, ignored, misinterpreted, distorted, suppressed or subjected to some of the fanciest double talk ever perpetrated.

“Early last year I published a series of observations on DDT poisoning in man. Since shortly after the last war a large number of cases had been observed by physicians all over the country in which a group of symptoms occurred, the most prominent feature of which was gastroenteritis, persistently recurrent nervous symptoms, and extreme muscular weakness.

– Dr. Gerson then goes on to site the case studies in great detail.
pages 163 -164

The Significance of the Content of the Soil to Human Disease

The familiar expression “mother earth” is justified. When we take from and rob the earth we disturb the natural equilibrium and harmony, producing sickness of the soil, sickness of the plants and fruits (the common nutrition), and finally sickness of both animals and human beings.

As a physician who has spent much of his life investigating the nutritional aspects of disease, I have often had occasion to observe a definitive connection between dietary deficiencies and a sick or poor quality soil.

The relationship between soil and plants on the one hand and animal and human nutrition on the other is to me a fascinating subject. This relationship is a natural cycle in which one may distinguish two great parts:

I. The first part, which may be called “external metabolism,” is comprised of the following:
(a) Plants and their fruits.
(b) Composition of the soil in which they grow–thus being the real basis of all nutrition.
(c) Transportation, storage, and preparation of these food stuffs.

II. The second part, known as “internal metabolism” consists of all the biochemical transformations that take place when such foodstuffs enter the animal body and support the nutrition and growth of its cells and tissues.

When foodstuffs are ingested, their metabolism is influenced directly by the biochemical changes of the individual body and indirectly by the condition of the soil from which they came. The type of metabolic change thus directly affects nutrition and growth of body tissues. There is an external and internal metabolism upon which all life depends; both are closely and inextricably connected with each other; furthermore, the reserves of both are not inexhaustible. There are, of course, some exceptions, about five to ten percent of the population who have an extraordinarily well-functioning reabsorption and good storage capacity apparatus.

This is to emphasize the great importance of metabolism to human health, i.e., the soil as the basis of life which is generally neglected to a great extent.

There are then numerous soil studies illustrating relationships between soil health and plant and animal health.

We must conclude from these observations that unless the soil is cared for properly, the depleted soil with its abnormal external metabolism will bring about more and more abnormalities of our internal metabolism, resulting in serious degenerative diseases in animals and human beings. The soil needs activity–the natural cycle of growth; it needs rest; it needs protection from erosion; and finally, it needs less and less artificial fertilizer, but more and more of the use of organic waste material in the correct way, to maintain the soil’s productivity and life. Food produced in that way–we have to eat as living substances, partly fresh and partly freshly prepared, for life begets life. Organic gardening food seems to be the answer to the cancer problem.

page 175-176, 185

Paracelsus’ Dietary Regime

The body needs nutrition through which it is bound to nature. However, that which we have to give to the body as nutrition also contains toxins and damaging substances…

The human being has to acquire knowledge of what to eat and drink, and what he has to weave and wear, because nature gave him the instinct of self-preservation. For the things that one does for the prolongation of one’s life are ordained by Great Nature. If someone eats what is useful for his health and avoids other things that may shorten his life then he is a man of wisdom and self-control. All that we do should serve to prolong our life….
page 49

In themselves, the statements of Paracelsus about diet are not uniform but one can notice everywhere in them the thought that combines them; their chemical effect. Everywhere in his writings it can be perceived how he would like to dissect everything into the finest particles (atoms) and find an interpretation; it seems as if he would like a penetrating power to enable him to look into things microscopically. The layman only sees the surface; the physician must be able to visualize the inside and the hidden facts which combine to form the whole, regardless of whether it is a piece of wood or bone. Marvelous are his ideas about the chemical reactions and his passionate love for all chemical occurrences which he applied to the reactions of the body long before his time. Paracelsus seeks to develop everything from its origin. In that he always observes three things: the heaven, the earth, and the microcosm; it is similar with healing. Man can only be comprehended through a microcosm; not through himself alone. Only knowledge about this harmony perfects the physician.

This short condensation does not take a critical stand in the historical sense towards the statements of Paracelsus as measured against the knowledge of his time. It merely seeks to show how stimulating his writings are and the wealth of ideas which shines through everywhere, how intense his urge to find causal connections in accordance with the eternal laws in nature outside of the body and the same laws ruling inside the microcosm.
page 53

The Concept of Totality-Decisive in Cancer and Other Degenerative Diseases.

Cancer is a chronic, degenerative disease, where almost all essential organs are involved in the more advanced cases: The entire metabolism with the intestinal tract and its adnexa, the liver and pancreas, the circulatory apparatus (the cellular exchange supporter), the kidneys and bile system (as main elimination organs), the reticulo-endothelial and lymphatic system (as defense apparatus), the central nervous system and especially the visceral nervous system for most metabolic and motoric purposes.

Dr. Nicholas was probably one of the first in our time who recognized the “concept of totality” as applied to disease. He combined the following clinical appearances: Emotional, nutritional, poisons, infections, accidents and inheritance as underlying causes for diseases: “No wonder we are all sick….and science is no longer science when it attempts to violate God’s natural law.”

Some cancer biologists are of the opinion that “cancer is a phenomenon co-existent with the living processes,” “that the cancer cell is not something living exclusively from the body,” and that the cancer cell is not a special “system isolated from the living organism.” They are united with and part of the whole body.

It has been emphasized before that cancer develops in a body which more or less has lost the normal functions of the metabolism as a consequence of a chronic daily poisoning accumulated especially in the liver.” It is important to realize that in our body all the most innermost processes work together, depend on each other, and will be deranged with each other in diseases. That is the reason why all of them together have to be attacked for healing purposes at the base and in combination. My clinical experiences revealed that this is the surest way to success of a therapy. Most parts of the general metabolism can be found concentrated in the liver. The biological function of the liver itself, however, depends on the proper activity and correct cooperation of many other essential organs….

Medical science has eliminated the totality of the natural biological rules in the human body, mostly by dividing research and practice into many specialties. Doing intensive, masterly specialized work, it was forgotten that every part is still only a piece of the entire body.

In all textbooks, we find that single biological processes have been studied and overestimated statements made about them. The symptoms of a disease have become the main problem for research, clinical work and therapy. The old methods sought to combine all functional parts in a body into a biological entity, have been pushed aside almost involuntarily, in the clinic, and especially in institutions of physiology and pathology. Finally, that idea became very remote in our thinking and therapeutical work. The opinion of the best cancer specialists is, as Jessie Greenstein stated, “Emphasis must be laid on a direct study on the side of malignancy itself,” despite the fact that his book is an excellent collection of physiological changes in the other organs, especially the liver. In my opinion, the application of the concept of totality can help us find the true cause of cancer; it could be best worked out in practical examples, not in animal experiments where every little symptom is observed singly (by itself).

In the nutritional field, observations for centuries have shown that people who live according to natural methods in which plants, animals and human beings are only fragments of the eternal cycle of Nature do not get cancer. On the contrary, people who accept methods of modern nutrition on an increasing scale become involved in degenerative diseases, including cancer, in a relatively short time.

In later medical history, the best known cancer-free people were the Hunzas, who live on the slopes of the Himalaya mountains and who use only food grown in their own country and fertilized with natural manure. Imported food is forbidden. Very similar is the story of the Ethiopians who also have natural agriculture and living habits which seems to prove that this type of agriculture keeps people free of cancer and most degenerative diseases.

The damage that modern agriculture brings into our lives begins with the soil, where artificial fertilization leads to the displacement of mineral contents and changes in the flora of microbes combined with the exodus of the earthworms. Consequently, frequent erosion of arable land takes place. These changes bring about, at the beginning, an irritation of the plants; later they cause their degeneration. Spraying with poisonous substances (insecticides) increases the poisons in the soil, and these poisons are transferred to plants and fruits.

We must conclude from these and many other observations that the soil and all that grows in it is not something distant from us but must be regarded as our external metabolism, which produces the basic substances for our internal metabolism. Therefore, the soil must be cared for properly and must not be depleted or poisoned; otherwise, these changes will result in serious degenerative diseases, rapidly increasing in animals and humans beings. The soil needs activity–the natural cycle in growth and in rest–and natural fertilizer, as we have to give back that which is necessary to replenish the consumed substances. This is the best protection against erosion; it also maintains the soil’s microbic flora, productivity and life. Food planted and grown in this way must be eaten partly as living substances and partly freshly prepared, for “life begets life.” Very significant are reports about Eskimos who get degenerative diseases and cancer in those parts of their country where canned food and unnatural nutrition were introduced and accepted.

Dr. Albert Schweitzer, who built a hospital in Lambarene, Central Africa, 40 years ago, reported in his letters of October, 1954, the following:

“Many natives, especially those who are living in larger communities, do not live now as the same way as formerly–they used to live almost exclusively on fruits and vegetables, bananas, casava, ignam, taro, sweet potatoes and other fruits. They now live on condensed milk, canned butter, meat-and-fish preserves and bread.” Dr. Schweitzer observed in 1954 the first operation on appendicitis on a native of this region.” …. The date of the appearance of cancer and other diseases of civilization cannot be traced in our region with the same certainty as that of appendicitis, because the microscopic examinations have only been in existence here for a few years…. It is obvious to connect the fact of increase of cancer also with increased use of salt by the natives…. Curiously enough, we did not have any cancer cases in our hospitals before.”

Dr. Salisbury reported, concerning the Navajo Indians, that he had, in 23 years, 35,000 Indian admissions in the hospital, with only 66 cases of cancer. The death rate among these Indians is one out of 1,000, while it is about one out of 500 among Indians who have accepted part of the nutrition of modern civilization.

The Bantu population of South Africa has 20 percent primary liver cancers. Their diet, of a very low standard, consists chiefly of cheap carbohydrates, maize and mealy meals. Seldom do they have fermented cow’s milk. Meat is eaten only at ceremonies. Two physicians, Dr Gilbert and Dr. Gilman, studied their nutrition habits in animal experiments and placed stress on the diet of the Bantus as a cause of cancer…..

To the great complexity of the biological functions of the body belongs also its capacity of adaptation. A healthy body can adapt itself to different types of nutrition. It reabsorbs the necessary minerals, vitamins, and enzymes as we know from experiments to determine the time for the clinical appearance of one type or another of vitamin deficiency. A sick body has lost this capacity. The deficiencies cannot be restored as long as the essential organs are poisoned. That is true in cancer also, as demonstrated by clinical observations.

Cancer, the great killer, will be prevented and can be cured if we learn to understand the eternal laws of totality in nature and in our body. Both are combined and have to be united in a effective treatment for cancer; in that way we can learn to cure cancer in a higher proportion, even in advanced cases. The limitations of the totality of functions of the whole body, however, also come into action here. The totality of functions is lost if one or another vital organ is too far destroyed. I saw, in several patients, tumors of the abdomen absorbed, and in others, hundreds of nodules and nodes on the skin and some as the base of the brain eliminated, but the patients died of cirrhosis of the liver in a period of one to three and a half years afterwards.

A Cancer Therapy: Results of Fifty Cases and The Cure of Advanced Cancer by Diet Therapy

About the Author

Dr. Max Gerson first came to the attention of the medical profession and the public in 1929, when he developed an effective treatment for tuberculosis of the skin (Lupus), which was until then considered incurable. Under the supervision and sponsorship of the internationally famous surgeon, Ferdinand Sauerbruch, this new therapy has been tested on 450 patients at the University of Munich. Of these 446 made a complete recovery.

Dr. Gerson studied medicine at several well-known German Universities including Freiburg, Breslau, and Berlin. He was associated with some of the finest hospitals and was assistant to the eminent neurologist, Ottfried Foerster. He has lectured at universities and to medical assemblies in the principal cities of Europe. After D. Gerson came to the United States twenty-two years ago, he devoted himself to the study and treatment of cancer.

In July 1946, a Senate Subcommittee under the chairmanship of Senator Claude Pepper, witnessed a demonstration of cancer patients whose health had been restored by Dr. Gerson’s therapy. This was the first time in the history of the United States Senate that a physician was so honored. This demonstration is in the Congressional Record.

Dr. Gerson has published fifty medical papers and three books.

Preface

My approach is mostly in the field of nutritional changes. Most of the details of the findings and application already have been proved by scientific research. The results obtained in the cases presented here were the result of the application and composition of the demonstrated facts. These findings have been combined in the last years with the idea that intensive and maintained detoxification of the diseased body is required for a longer period than described in previous publications. In recent years the public has been educated and alerted towards the difficult problem of malignancies and the unceasing search for a successful treatment. While this book was written for the medical profession primarily, I endeavored to write it so intelligent laymen could understand the main problems involved. Several chapters were written at different times; therefore the reader will find a number of repetitions.

The history of medicine reveals that reformers who bring new ideas into the general thinking and practice of physicians have a difficult time. Very few physicians like to change their medical approaches. The majority practice what they have learned and apply the treatments of the textbooks more or less automatically. Right from the beginning, the physician wants most of all to help the patient. He hesitates to take risks for his patients by applying a not-recognized treatment. The history of science, art and technology shows that each new idea has been fought bitterly; most of the reformers did not live to see the realization of their ideas.

This is one of the reasons why developments in culture made very slow progress all through the centuries; they were restrained forcefully.

I was in a more favorable position. Ninety to ninety-five percent of my patients were far advanced (terminal) cases without any risk to take; either all recognized treatments had failed or the patients were inoperable from the beginning. It takes some time to acquire enough experience to see progress, results or failures.

page xvi

Acknowledgments

I wish to acknowledge with deep gratitude the cooperation and encouragement received from the Foundation for Cancer Treatment, Inc., a non-profit organization formed many years ago by grateful patients for the purpose of perpetuating the treatment as described in this book. To the following directors of the Foundation, I would like to express my special thanks: Professor Dr. Albert Schweitzer, Professor Henry Schaefer-Simmern, Mr. Carl Groper, Rev. Dr. Erwin Seale, Professor Fulmer Mood, Mr. Louis J. Rosenthal and Mr. Arnold J. Oberlander.

This publication is an exemplification of the work of Max Gerson, M.D., on his treatment of cancer as disclosed to the United States Senate in public hearings held July 1, 2, and 3, 1946. It is designed as a report on his continued work in cancer treatment, and will be filed with the United States Senate when it again resumes hearings on means of curing and preventing cancer. The title page of the U.S. Senate Committee report, containing 227 pages, follows:

Cancer Research
Hearings
before a
Subcommittee of the
Committee on Foreign Relations
United States Senate
Seventy-Ninth Congress
Second Session
on
S. 1875

A bill to authorize and request the President to undertake to mobilize at some convenient place in the United States as adequate number of the World’s Outstanding Experts, and coordinate and utilize their services in a Supreme Effort to Discover Means of Curing and Preventing Cancer.

July 1, 2 and 3, 1946

Printed for the use of the Committee on Foreign Relations
United States
89471 Government Printing Office
Washington: 1946

A Cancer Therapy: Results of Fifty Cases

About the Book

The great majority of Dr. Gerson’s patients have been terminal cases, which in most instances had been treated by conventional methods or had been previously diagnosed as inoperable. With fifty years of medical research and clinical experience to guide him in the practical handling of such patients, Dr. Gerson has developed the therapy which this volume describes in detail. Here are its fundamentals, the history of its development and its practical management.

This volume offers a different approach to the problem of cancer based on the concept of totality. Emphasis is placed on the deteriorated metabolism as a whole with the liver as its central organ. Dr. Gerson believes tumors to be only symptoms of cancer since they reappear all too frequently. The real disease affects and weakens the entire body. In order to bring about the healing processes, the liver and other vital organs must be restored and the body functions reactivated to as near normal as possible.

For a more effective prevention of cancer as well as other chronic and degenerative diseases, this book presents a sensible dietary regime–a nutrition that can be followed by the average family in order to maintain health and build the best possible bodily strength for defense purposes.

The fifty case histories selected for this book have been chosen from the many hundreds of cases from Dr. Gerson’s files in the hope that they may be of interest to the members of the medical profession.

Here we find favorable results in far advanced, internal cancer cases.

After more than 25 years of cancer work I can draw the following conclusions:

1) Cancer is not a local but a general disease, caused chiefly by the poisoning of foodstuffs prepared by modern farming and food industry. Medicine must be able to adapt its therapeutic methods to the damages of the processes of our modern civilization.

2) A method is elaborated to detoxify the body, kill the tumor masses and to absorb and eliminate them. (Restoration of the healing power.)

3) A way has been found to restore the liver if not too far destroyed and repair the destruction caused by the tumor masses.

– Dr. Max Gerson

See Abstract of New York Academy of Medicine and reprint of the New York City Cancer Committee in the book, Cancer Alerts, 1957.

I highly recommend reading this fascinating book. I will end this excerpt with his list of necessary foods & forbidden foods and consumer products given to his cancer patients.

Necessary Food

This diet consists mainly of the following organic foods

Fruit
Juices of fruit, vegetables and leaves
Vegetables, salads
Special Soup
Potatoes
Oatmeal, bread, etc.

All Freshly Prepared and Saltless

Forbidden

Nicotine
Salt and all substitutes

Foods

Bottled
Canned
Refined
Salted
Smoked
Sulphured
Frozen
Preserved

Alcohol
Avocados, nuts (too much fatty acid.)
Berries (aromatic acids cause unfavorable reactions)
Fat
Flour (white)
Beverages (commercial)
Bicarbonate of soda in food, toothpaste, gargle
Candy
Cake
Chocolate
Cocoa
Coffee, also instant
Cream
Cucumbers (too much sodium)
Epsom Salts
Ice Cream
Mushrooms
Nuts
Oil
Pineapples (too many aromatic acids)
Spice (Pepper, Paprika)
Soy Beans and Soy Products
Sugar (white)
tea
drinking water (Distilled only)

Temporarily Forbidden until further notice:
Butter
Cheese
Eggs
Fish
Meat
Milk

Fluoride in toothpaste, gargle
Hair dying and Permanents

Utensils

Do not use: Pressure cookers or any aluminum pots or utensils

Use: Stainless Steel, glass, enamel, earthenware, and cast iron.

Utensils for the Preparation of Juices

Use: A separate grinder and a separate press.

Do not use: One-unit machines such as liquifiers, centrifuges, juice mixers or masters, etc.

Fluoridation of the water supply has become very common in many communities. Since fluorides are among the most powerful enzyme inhibitors and since healing requires the reactivation of enzymes, it is obvious that fluorides must be eliminated from all food and water supplies as much as possible. Fluoridated toothpastes or enzyme inhibiting toothpastes must be avoided along with all other toxic substances such as insect sprays, paint sprays..
page 399.

Task of the Saltless Diet in Cancer

The main task of the saltless diet is to eliminate the retained Na, Cl together with toxins and poisons from the tissues all over the body.

All poisons and other substances difficult to eliminate are stimulants for the sick tissues, especially liver and kidneys. That condition seems to be the reason why sodium chloride excretion increases in tuberculosis, cancer and other chronic diseases after two to three days on a saltless diet, and this condition stays at that higher level for about eight to fourteen days, corresponding to a favorable development in the course of the disease. After that is accomplished, it stays near normal level with the saltless diet.
page 165

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