Ted Kennedy

Mr. KENNEDY

Mr. KENNEDY. Mr. President, I have how much time?

Mr. KENNEDY. I thank the Senator. When we are talking about these technicalities, we have to remember that some of these items, particularly those medical devices that enter the body, have enormous health implications. I remember chairing, in 1974 or 1975, the Dalkon shield hearings where we found that 2,300 American women died from a perforated uterus from the Dalkon shield. That was before we had a Food and Drug Administration that really looked into medical devices. We have the Shiley heart valve that passed through the FDA, and then eventually the FDA was able to uncover some of the difficulties with that and took steps. I think, if my memory serves me correctly, they were going to use a perfected Shiley heart valve over in Europe, and they altered some opening where the blood went through by just about 10 degrees, and that resulted in a rather significant increase in the failure of that medical device which was actually marketed abroad. The FDA was very much involved in seeing the termination of that. So even very modest changes or alterations can have important kinds of health implications. We are not going to be able to solve all the problems and we are not interested in producing a bureaucracy that is going to halt innovative and creative ways of dealing with some of these issues. But it is important that we are talking about a Food and Drug Administration and public health. As I mentioned briefly at the outset, this is the one agency that is intimately involved with public health. It has broad jurisdiction on a wide variety of items, and it has important responsibilities for the public health. This is where the buck stops. Some feel it ought to just be the agency to fast track various kinds of devices or fast track various pharmaceuticals without considering the health and efficaciousness of those products. That is why I think it is useful to pause here for a little while to give some focus to exactly this legislation and what its implications are going to be in terms of public health. I thank the Senator. Mr. JEFFORDS addressed the Chair.

Mr. KENNEDY. The fact is that the FDA does not have the authority today--just does not have it. It has the authority to deal with pharmaceuticals and with medical devices but not with the issues which involve health and safety. I will spend a moment or two just going through the Food and Drug Administration Act, the actual law. It is a page and a half. And there cannot be a fair reading of this, of these provisions, section 601 to 603. To believe that there is any adequate protection for American consumers in this page and a half is folly. I mentioned earlier the FDA has no authority to require manufacturers to register their plants or products. It cannot require manufacturers to file the data on the ingredients in their products. It cannot compel manufacturers to file reports on the cosmetic-related injuries. It cannot require that products be tested for safety or that the results of safety testing be made available to the agency. It does not have the right to have access to manufacturers' records. It cannot recall a product. Now, those are powers the FDA has with regard to pharmaceuticals and medical devices, but not with regard to cosmetics that may also be carcinogenic, and may also include toxins. We are not talking about an unimportant matter. We are talking about questions of health and safety. I find it difficult, with all respect, to say, ``Well, look, in California, we've carved that out. All of our Members will probably understand that means. ``We have carved out California.'' California considered this and took action. But if Minnesota--and they have been interested in taking some action on some products--wants to take action down the road in the future to protect its consumers, it cannot do it. In my State of Massachusetts, that has very similar legislation to that of California pending now, and they hope to be able to pass it in the next legislative session--they are out. They are finished. We have taken care of one State, California. I am glad we did not wipe out California because I am interested in the protection of the citizens of California. They are going to get some protection, but not full protection, because you are going to preempt other health and safety statutes in California. This did not provide all the protections in California. Nonetheless, I am glad that the consumers in California are going to get some protection. But I cannot understand why we are denying other States from making a judgment that they want some protection. That is what this legislation does. An additional point others will make is, ``Well, we're just dealing with packaging and labeling.'' But that is where the States act, with packaging and labeling. We do not see the withdrawal of products. They are able to do that and have been effective at it, in California. And I will get into how effective they have been, because they have been very effective in protecting consumers, not only in California, but the rest of the country, because when California, as a result of an extensive kind of medical research, has discovered that various products may contain carcinogens or dangerous and toxic substances, and required those products to be labeled, what happened? The manufacturer changed the product. And I will get into the examples. This is the power that regulations on labeling and packaging can have. This is where they have been effective. These are the key elements, the possibility of developing warning labels. They have not had to develop the warning labels in California because the companies and the manufacturers have changed the products. One of the outstanding examples is Preparation H. Where there were products that were dangerous to consumers, the California regulations were effective in improving product safety. The manufacturer reformulated the product itself and says now it is better than it even was before. That was as a result of research that was done to uncover potentially dangerous substances that had been included in the product. So, Mr. President, we have an agency that cannot practically deal with and has been restricted from packaging and labeling. We have seen a carveout, a carveout in the FDA authority in section 601 that talks about various products. It says they will not be able to deal with either poisonous or adulterated cosmetics, and cannot apply to coal-tar hair. Coal-tar hair dye. There is the cosmetic industry able to write right into the law ``coal-tar hair dye,'' even though the research has shown what that has done in terms of making hair dyes more dangerous than they need to be. The cosmetics industry has been effective enough to get written into this legislatively that, even though it is dangerous, there cannot be any kind of oversight of it. That is the power. That is real legislative power. Mr. President, just on this question of the FDA and its ability to deal with this, let us go back to what the GAO said should be done if we were to have an FDA that would be able to provide adequate protection for the public health. This is a public health issue and a safety issue. That is what we are dealing with with regard to cosmetics. The other items that we mentioned earlier deal with health and safety and are of importance. But on cosmetics, we are effectively talking about health and safety issues. When the GAO last looked at the FDA, and were charged with making recommendations, these are the recommendations that they made. They said: We recommend that the Congress amend the Food, Drug and Cosmetic Act to give FDA adequate authority for regulating cosmetic products. Specifically, we recommend that the Congress authorize FDA to require: Registration of all cosmetic manufacturers. Registration of cosmetic products and filing of ingredient statements [so that they know what ingredients are in the various products]. Manufacturers to submit to FDA data to support the safety of their products and the ingredients in them [to demonstrate the safety of their products prior to putting them on the market. Before marketing, to be able to give the assurance of safety and also to be able to get the ingredients of these products]. Premarket approval by FDA of certain classes of cosmetics or ingredients when the agency deems such approval necessary to protect the public health. Why? Because they take notice that some of these products contain possible carcinogens and some of them have toxic products. They are saying we ought to be able to demonstrate the safety of those products rather than put them out in the marketplace and endanger the public. The GAO report further recommends that: Manufacturers to submit to FDA consumer complaints about adverse reactions to cosmetics. Manufacturers to perform specific testing FDA deems necessary to support the safety of a cosmetic or an ingredient. So if the FDA were to make a judgment that they believe that items may cause birth defects, may cause an assault on the nervous system, may somehow threaten seriously the health and the well-being of the consumer, that they would be able to ensure there is going to be adequate testing. Those are very minimal standards. These recommendations are from the last review for the power and the authority for the FDA. Now, do you think we have any of those today? No, we do not have any of those. And all we have to protect the consumer is what is happening at the State level. That is all we have. With this legislation, we are effectively preempting the States from providing those protections to the consumers in their States. I find it extraordinary how quickly we are to be willing to accept that particular provision without hearings. We understand the power of the cosmetic industry. We understand why this has come up. This has come up, Mr. President, because of the action that has been taken by California. Because California has acted in various cases in order to ensure that the cosmetics that are being used by Californians are safe and effective. They do not want to have to keep dealing with this. Nonetheless, manufacturers have changed their products. They have made them, in so many different instances, safer. That is the way it should be. If we are not going to do it at the Federal level, why do we take away the power of the various States? It is effectively like preempting the States from having State police. All the States have various State police in order to look after safety and security in their States. We are saying, we are not going to provide any kind of help and assistance, but, in addition, we are taking away your safety, a means of protecting your people as well. And that, I believe, is wrong. Mr. President, I want to just mention some of the various items since we have talked in generalities here about some of them. Some of these items that we have addressed here have posed a threat to the health and safety. First of all, we have hair dye, the coal tar in the hair dye. That is a potential carcinogen. It is a danger in terms of the American public and the consumer. One State, California, has a State law. Ohio has tried to deal with this, but they have been basically unable to do so. The industry has been so powerful it has been able to get written into the law, into the bill itself, that we cannot tamper with something we know is directly a public health hazard. In public health we know that, and still it is written into the law. We have the old Grecian Formula. It does not have to go through the FDA. It had lead in it--lead. People thought, well, we can use it because it is just a hairspray. We know what happens when lead is ingested. We know it causes mental retardation, for example, in children. One of the principal problems in inner cities is old paint chips that have the lead content. We know the incidence of mental retardation, and if you go into any urban area in this country and go to the great county hospitals, they have a lead paint poisoning program. You see the incidents of mental retardation that are a direct cause of lead in the paint. The children are either eating the chips or they are playing outdoors and the chips are ingested. They get on the cats and dogs, and children pet them and then scratch themselves or put their hands in their mouths. It just goes on. We understand that. That has been well understood and documented for 30 years now. But we now know there was lead in Grecian Formula. This came out as a result of the various analyses in California. There was a certain amount of concern about it, but then there was action by the company, and they said, look, maybe there is lead in it, but it is on your hair, and you are not ingesting it, so, therefore, it is not a problem. Then other studies showed that people were washing their hair and were also embracing their children and touching their children and working with their animals or their pets, and this was picking up the flakes and, if the dye was being used over a considerable period of time, the lead posed a significant and important threat to children. So what happened? Grecian Formula changed their ingredients as a result of this to make a safer product. They did not miss a beat in terms of being able to market it and being able to be successful. But it was changed, and that is because of local activity--not the FDA, but because of local activity. Mr. President, I will give further illustration, but I will just at this point remind Senators, as we are going through some of these examples, there may be those who say, ``Well, OK, you've got a half dozen out there, but is that really enough to try to resist this provision to preempt State activities?'' Well, the last serious study that was done by a congressional committee was actually done by our colleague, Congressman Wyden, who held landmark hearings in 1988. The industry gave his subcommittee a list of 2,983 chemicals used in cosmetics. The National Institute of Occupational Safety and Health at NIH analyzed the 2,983 chemicals and found 884 cosmetic ingredients had been reported to the Government as toxic substances. Let me just repeat that: The industry, the cosmetic industry, provided to the Congress a list of 2,983 chemicals that are being used in cosmetics. The National Institute of Occupational Safety and Health, what we call NIOSH, which is the center for expertise in being able to analyze various toxic substances, and NIH analyzed these chemicals and found that 884 cosmetic ingredients have been reported to the Government as toxic substances. We have known for 10 years that a third of cosmetic chemicals are toxic, but we have done nothing to strengthen the consumer protections. Instead, we would rather weaken the consumer protections. Instead of trying to make some progress to protect the consumer we are taking steps to put them at greater risk. Does that make any sense? We had debate and discussion about the Delaney amendment with regard to carcinogens and processed food and we debated those issues and said is it not time to alter, change, and modify that? We passed very good legislation dealing with pesticides, insecticides, and fungicides just 2 or 3 years ago because we were looking at the fact that the best estimate is that there are probably 2,600 to 3,000 Americans that were dying because of pesticides and insecticides that were being put on products and were being ingested. We have run into problems. We had extensive hearings about the dangers of insecticides on children, because children eat more bananas and certain types of food and products have more insecticides, and therefore it has more of an impact in terms of their bodily functions. We spent hours and hours and days and days on hearings because we wanted to provide protection against carcinogens in our food supply. Here we have now, according to NIOSH, and according to the NIH, 884 cosmetic ingredients that have toxic substances. Rather than trying to do something about those in terms of examining those in relationship to what is being done in the House and in terms of the well-being of the consumer, we have not only had no enforcement or regulatory protection at the Federal level but we are eliminating what actions could be taken at the State level. It makes no sense, Mr. President, makes no sense at all. That is what the effect of the preemption does. I read the language on the preemption and that is effectively what that language does. Now, Mr. President, we have a situation, for example, that has come up in fairly recent time, a hair spray that might be inflammable, and we find out that the State of Minnesota was looking at trying to make some effort to try and identify the dangers that result from this. Mr. President, there is a Senator here that would like to address the Senate and I am happy to accommodate him.

Mr. KENNEDY. Mr. President, it is not just one Senator. Let me read from ``The National Governors' Association, The National Conference of State Legislatures.'' When the Senate Labor and Human Resources Committee considered the Food and Drug Administration Reform legislation . . . the committee adopted an amendment proposed by Senator Gregg that preempts state regulations, disclosure requirements, labeling, and warning requirements as they apply to nonprescription drugs and cosmetics. The National Conference of State Legislatures and the National Governors' Association, vigorously oppose this provision and hope that it will not be part of the bill when it is reported by the Senate. These are the Governors, the State legislatures. The Secretary of Health indicated that ``We and the administration all agree PDUFA is in the best interest. However, as maintained in its present form, with the outstanding issues not addressed, we will be forced to recommend to veto the legislation.'' We are talking about health and safety. And we will have a chance to develop that in the postvote of this. But this bill contains too many important provisions with PDUFA and the medical devices and the drug provisions to go forward. And I believe that it should go forward, but not with this provision.

Mr. KENNEDY. I yield myself 6 minutes.

Mr. KENNEDY

Mr. KENNEDY. Mr. President, I have just been notified about the death of Mother Teresa. I think I speak for all of the Members of the Senate, and I know that I speak for all of the members of my family and the people of Massachusetts that feel a sense of loss with Mother Teresa. She was really an extraordinary, inspirational, spiritual person whose life was devoted to others. She was a woman of enormous tenderness, gentleness, faith, and spirituality. I had the chance to visit with her in Calcutta in the late 1970's and was first exposed to her extraordinary work with the homeless and destitute in that community. I saw how she was able to minister unto the poorest of the poor in ways that were absolutely inspiring, in terms of her gentleness and in terms of her capacity for caring. Anyone whose life she touched will never forget her. She was really a very, very special person. This world is a better world because of her life. I know that all Americans will feel deeply about the loss of Mother Teresa. I just hope that we will all say a prayer for her. Thank you very much. Mr. President, I suggest the absence of a quorum.

Mr. KENNEDY

Mr. KENNEDY. Will the Senator yield on that issue?

Mr. KENNEDY. I welcome the Senator's focus on that particular provision. We had attempted to address that question, but it was done very unsatisfactorily. I think the Senator has raised a very important issue with regard to what we have done in the legislation and the power of the FDA to deal with tobacco in this legislation. We will have an opportunity to address that when we move toward the legislation itself, but I think it is important and one of the principal reasons for taking the additional time on the legislation for the reasons that the Senator has just identified. For example, I think we have heard from responsible legal authority that if the manufacture of tobacco products were to label them as ``intended for smoking pleasure'' or ``intended for weight loss'' or ``intended to be used twice weekly,'' then there is a real question whether FDA can get safety data on the addiction of those health hazards. We know how creative--and the Senator from Illinois knows well because he has been a leader in the House of Representatives and in the Senate with regard to the activities of the tobacco industry--how creative they can be in terms of packaging, so to speak, their intercessions with the FDA in ways that can circumvent the kind of protections that all of us are so concerned about, primarily with youth, and also as part of this whole tobacco negotiation. I commend the Senator for the work that he is doing and welcome the opportunity to join with him to try and address the actions of the tobacco industry in the recent budget item to circumvent the agreements that the tobacco industry had made with the attorneys general. That is another issue for another time. What it does reflect is how the industry is working tirelessly at every junction to try and foreclose the opportunity of meeting their responsibilities, either under the agreement or under this legislation. I think they undermine the authority of the FDA in their agreement, which they signed with the attorneys general, and that agreement should not pass under any circumstances unless that measure is addressed. I know the Senator will work with us closely in doing that. But the Senator has identified another potential loophole that ought to be addressed. I am very hopeful that we will be able to do that. I thank the Senator for raising this because this is another very important aspect, as we are being asked to rush through this legislation. There are only two or three Senators evidently concerned about this particular proposal. We have seen the fact that the Governors, all of the Governors, the State legislatures sent in their resolution and their letter saying, ``Go slow,'' in opposition to the legislation. As the Secretary of Health and Human Services has also indicated, go slow. I thank the Senator for his comments on these other items, but particularly with regard to tobacco.

Mr. KENNEDY. I yield back the remaining time this afternoon.

Mr. KENNEDY. Mr. President, there is a possibility of one speaker but not more than that, although I have some remarks related to the legislation which I will look forward to presenting.

Mr. KENNEDY. I thank the Senator. I think we had earlier comments by our chairman, which we welcome, about the fact that California has been able to be grandfathered in and they will have the protections. But Massachusetts, my State, is about to pass this legislation. The people of my State of Massachusetts are concerned about the public health of citizens in that State, and want to provide the protection for those people. The action here in this legislation, as it is prepared, will basically wipe out those protections. I have been on this floor so often and have heard that we want to get away from the Washington solution to these problems, that what we want to do is get away from this one-form-fits-all solution; what we want to do is let the States make judgments and decisions. And here we are writing legislation that is going to preempt States from taking action in the future. We grandfather in one State, California, but are denying any other State the opportunity to take action. I find that very difficult to understand, or to be able to accept. (Mr. JEFFORDS assumed the chair.)

Mr. KENNEDY. I will give my assurance that if there is a Senator on the other side coming over here on the floor and wants some time, we will be delighted to make sure they have an opportunity to do so. Mr. President, again, I thank my friend and colleague from Vermont. We have worked long and hard on this issue, although there are areas where we do have differences, and I mentioned those here today. It is very important. It doesn't negate the point of the substantial progress that has been made on a wide variety of different matters, which we all believe will make a difference in terms of the health of the American people. Mr. President, I want to just, first of all, address and respond to some of the comments made by my friend from Indiana, Senator Coats, about the FDA, come to their defense because it was a rather blistering assault on the FDA. I have heard those comments made by the Senator on previous occasions. But as we are here on the floor of the U.S. Senate, I want to say a few words about the FDA and where it is now. Perhaps those comments might have been relevant some years ago. I don't believe that they are relevant today. Out of fairness not only to the men and women that work at FDA day-in and day-out and toil to protect the American consumer because the protection for the American consumer sets an example for the rest of the world, and for the agency itself, and for respect for that agency, I would like to point out that there are few more important agencies of the Federal Government than the Food and Drug Administration. The FDA is responsible for assuring that the Nation's food supply is pure and healthy. The FDA provides a guarantee that the drugs and devices we rely on to cure and treat diseases are safe and effective. It does its job. The FDA can speed miracle drugs from the laboratory bench to the patients' bedside. If the agency does its job poorly, it can expose millions of Americans to unsafe devices and medical products and jeopardize our food. I think even the most zealous supporters of the FDA recognize that there have been troubles in the past. But we would also recognize there has been the sincerest effort to address those deficiencies in the past. To listen to some of the speeches we have heard on the floor today, you would think that the FDA was a regulatory dinosaur, mired in the past, cumbersome and bureaucratic, imposing unnecessary and costly regulatory burdens on industry and denying patients speedy access to life-saving drugs. That is a myth. Those who want to destroy the FDA in the service of an extreme ideological agenda, or in the interest of higher profits at expense of patients' health, would love you to believe that. But it isn't true. The FDA's regulatory record is the envy of the world. It sets the gold standards for the protection of patient health and safety. The agency's recent performance under the leadership of former Commissioner David Kessler and the Clinton administration represents a model of how to transform the regulatory process so that it is more flexible, responsive, and speedy, while maintaining the highest standards of patient protection. Indeed, a large number of the positive elements of this legislation simply codify or extend actions the agency has undertaken administratively. The landmark PDUFA reauthorization contained in this bill was essentially negotiated by the agency and the industry, working collaboratively with the bipartisan efforts here in the Senate and in the House of Representatives. I welcome the chance to work closely with Senator Hatch in the passage of this legislation to improve the review process. In recent years, in partnership with Congress and the administration, FDA has responded to growing criticisms of delay in approving new products by taking impressive steps to improve its performance. The PDUFA Act of 1992 was one of the most effective regulatory reforms ever enacted. The bill established a new partnership between the agency and the industry. The industry agreed to provide additional resources and agreed to measurable performance standards to speed the review of products. This was unique instance where, in receiving the additional funding, they established criteria to be measured by over a period of time and those were strict criteria and a strict challenge. Every goal set by the legislation has not only been met, but it has been exceeded. Today, the FDA is unequaled in the world in its record of getting new drugs quickly to market without sacrificing patient protection. In fact, last year, the average review times in the United States were twice as fast as in Europe. Fifty new drugs were approved in both the European Union and in the United States. In 80 percent of the cases, the United States approved the new drugs either first or at the same time as the European Union. More companies chose the United States for the introduction of breakthrough drugs than any other country. In addition, to speeding the review times, the FDA has taken far- reaching steps to reduce unnecessary regulatory burdens on industry and modernize its regulatory process. More needs to be done, but these steps have added up to a quiet revolution in the way the FDA fulfills its critical mission. When PDUFA was originally passed, the device industry refused to agree to user fees that would give the FDA the additional resources and performance standards that have contributed to so much to the agency's outstanding record on drugs and biologics. I remember the negotiations. They were unsatisfactory, regrettably. But even in the device area, the FDA's recent achievements have been impressive. The so-called 510(k) applications, devices approved based on their substantial equivalence to a device already on the market, accounts for 98 percent of all the device admissions. FDA has now essentially eliminated its backlog. Last year, it reviewed 94 percent of these devices within the statutory timeframe, compared to only 40 percent just 4 years ago. Even in the area of class 3 devices, where the most problems remain, the FDA has improved its performance substantially. According to a study by the General Accounting Office, median review times dropped 60 percent between 1991 and 1996. In a recent survey of device industry executives reported that the business climate for the industry is in the best shape in the 5-year history of the survey. I introduced that in the Record in our markup. The industry publications are virtually uniform in terms of the progress that has been made and the atmosphere that has been created and the current very positive atmosphere. The sponsor of the survey attributes this favorable response in large measure to improvements at FDA and concludes that the agency has not only reduced the delays to allow new products to be introduced but, more importantly, has also greatly reduced executives' and investor's uncertainty about the timeliness of future product introductions. So, Mr. President, the FDA must continue to improve many of the provisions in this legislation. The idea that the reforms in this legislation must be passed at whatever cost, because the agency is doing a bad job, is simply incorrect. Now, Mr. President, I want to just return to what I consider the most troublesome part of our legislation. We have had very important discussions and representations by our colleagues and friends, the Senator from Rhode Island, Senator Reed and Senator Durbin, on particulars of the legislation, which I think need further attention. In my remaining time here, I would like to talk again about the whole issue of protection of the health and safety of the American consumer as it relates to cosmetic products. That is the most egregious and, I believe, unjustified provision in the bill, which would effectively cripple consumer protections by preempting State regulations on cosmetics. I note for the Record that these provisions, as I mentioned, were not in the chairman's mark, they were not the subject of significant hearings, and they have no place in the bill, whose primary purpose is to reauthorize the Prescription Drug User Fee Act. That is the principal purpose of the bill, the reauthorization of that program and to try and accept these adjustments, incorporate into the law some of the measures which have been so successful administratively by the FDA. And also to incorporate the great majority of the measures which have been included in the bill that relate to pharmaceutical products and device products. If the Congress were earnest about addressing over-the-counter drug and cosmetic regulation, it would have undertaken a serious and detailed inquiry into the regulatory structure and authorities which assure that consumers are adequately protected before even remotely contemplating the possibility of preempting active and essential State protections. The preemption of cosmetic regulation is especially outrageous and shows a callous disregard for the health of American men, women and children. Cosmetics are broadly used by Americans, far more broadly than prescription drugs and medical devices and biological products. Mr. President, I want to mention why we find ourselves where we find ourselves today and why this issue is of such importance. I have here the testimony of Commissioner Young from some years ago, 1988. It points out that Congress, in 1938, recognized the public health problems associated with cosmetics and addressed them in the laws they enacted based on the science available to them. But science and the cosmetics industry have changed. In 1938, at most, only a few hundred ingredients were used to formulate cosmetics, and the industry was small in numbers of manufacturers that marketed products. Today, tens of thousands of cosmetics are in distribution, and the number of ingredients used has risen to an estimated 4,000 for producing a multitude of base formulation in equal number for compounding fragrances. Regulatory sciences have also progressed. When the law regulating cosmetics was enacted in 1938 the science was based on a less sophisticated concept for evaluating the safety of chemicals used on the skin. If you saw a reaction, you treated it; then avoid it. Today, science can take into account the effects produced under chronic long-term exposure to trace contaminants in addition to acute toxic effects, such as immediate skin irritations, contact allergic reaction, systematic reaction resulting from inhalation and ingestion. In 1938, the skin was considered to be an impenetrable barrier to cosmetics or other substances. As the number of ingredients and products has multiplied through scientific and technological innovation, our ability to measure minute amounts of residual contaminants and unwanted substances also has taken a quantum leap. At the same time science has developed more precise ways to assess risk, taking into account relevant factors such as use and exposure over a lifetime. (Mr. GRAMS assumed the chair.)

Mr. KENNEDY. Fine. I thank the Chair. I want to prepare to yield back the balance of my time this afternoon. As I understand, from a previous agreement, we will have time to continue this debate, I believe, on Monday next for a period of 4 hours, with the time evenly divided, starting at 11 o'clock, is that correct?

Mr. KENNEDY. Mr. President, earlier I reviewed for the Senate the actions that have been taken by the States which have resulted in additional kinds of protections for safety for the American consumer in those States, primarily in California. I reviewed some of the items that posed the principal health hazards for citizens--the lead, the mercury, and other items and what has happened by the States when removing those items. Then I also mentioned, Mr. President, the limitations we have in terms of the Food and Drug Administration in taking any actions to protect people and the power of the cosmetic industry in refusing to even have a hotline. We have hotlines in so many different and important areas for American people. We have them with regard to battered women, as one of the principal sponsors for that. We are not comparing that need with this one but there is enormous importance and enormous justification and that has been a powerful, powerful instrument for battered women in our society. We wanted to try and have at least a hotline for people that might be able to have been impacted adversely by these cosmetics. We mentioned already that there are 46,000, at the last count, people going to emergency rooms--46,000. And we know the dangers which are out there in terms of impacting the American consumer and they have increased dramatically with the increase in products. It has been recognized by the companies and the industry itself by the number of products and the complexity and the toxins that have been included. So the only real opportunity that we have other than going to the States and reviewing the kind of complaints that they have has been from the various agencies of government. I mentioned just a few moments ago about these various items and I will go into greater detail with the companies and what the allegations are and what the results are on Monday. I have them here but I will not take the additional time. The fact is, these are the kind of results we are having, Mr. President. When California runs into those circumstances they can do something about it. When California found out about a particular product, the State was able to do something about it. Now, under this legislation, on this preemption, 49 States will not be able to do something about it. California has been grandfathered in, but all of the rest of us that come from other States will not be able to get that kind of a protection. Now, I just mention the kind of injury complaints that have been included. They include, going through this code which we are gradually going through, injury code 14 includes rash, redness, swelling, blisters, sores, weeping, lumps, inflammation, sunburn, chemical burn and irritation; code 19, pain, to include itching, stinging, burning, soreness, and tingling; injury code 20, tissue damage--other than thermal burn, peeling, splitting, cracking, hair, or nail breakage; code 21, discoloration; code 22, infection; code 23, nervous system reactions, to include dizziness, headache, irritability, nervousness, numbness; injury code 24, respiratory reaction, to include choking, coughing, sneezing, shortness of breath, wheezing; code 25, digestive system reaction, upset stomach, nausea, loss of appetite, vomiting, diarrhea; code 26, bleeding, code 27, urinary tract infections; code 28, flammability resulting in thermal burns; code 29, blurred vision; code 30, death as a result of inhalation or sniffing deaths, and code 31. These are serious, Mr. President. These are serious health hazards. Before we in this body and the House of Representatives see a piece of legislation tagged on to the important Food and Drug Administration, the medical device and the pharmaceuticals which are so important, on which we have made so much progress, on which all of us are hopeful will finally result in a bipartisan agreement, we see the greed of the cosmetic industry go right out there and tag on this amendment as one of the last amendments to preclude the States--they have gotten the Government effectively precluded, unlike the European countries. The European Union, and most of the other industrial countries of the world, have some protections. They have been able to preclude the Federal Government, and now they are precluding the States from protecting the consumers and putting them at risk for all those kinds of illnesses and sicknesses that I have talked about here that are resulting from all of those products. That is what we are being asked to embrace. That is what we are being asked to embrace. For those that understand the importance--the Attorney General of the State of California, who has been working on this, makes it so clear: Don't do it, Senator. Don't do it, Senate of the United States. Don't do it in the Congress and Senate. Mr. President, don't sign that legislation. He wants to be able to protect the people in California, as other public health officials want to be able to protect their people in the other 49 States. That is the issue. That is the issue. We are going to come back to it again and again and again, Mr. President, because it is of such enormous importance to the health and safety. The other side of the balance is the question of greed by the cosmetics industry. Usually, when we are making tough decisions around here--and we have made them--we have limited funding; for example, for the food programs for our elderly people. We have to make a judgment, are we going to treat more people in congregate sites where you can feed more elderly people with limited resources, or are we going to carve out some and feed them at home, which means you will get to less people, you will get those people that are homebound. What do you do under those circumstances? You are placing needy people of one side against needy people on the other. No easy answers on this. Painful judgments and decisions on that. We don't always get it right. We understand that. People of good will can differ on that and feel strongly about it, and we respect them here in this body. But under this circumstance, we are talking about the profits of the cosmetics industry and the risk to the American consumer. That is what the balance is. That is what is unacceptable. That is what is outrageous and that is why that cloture vote was necessary, so we begin to wake up America as to what is happening to these States. That is what we are going to have an opportunity to debate as we go to this bill, plus the other measures. Mr. President, the last unacceptable element of this bill is an assault on the basic environmental protections contained in the National Environmental Protection Act, which is a key Federal environmental statute that regulates the Government's own actions through environmental impact statements. Under NEPA, Federal agencies must undertake a comprehensive environmental planning process for every major action they take. This law is a crucial statutory assurance that the work of the Government, the actions of regulated industries are consistent with the guiding principles of environmental protection. Section 602 of the bill broadly exempts FDA's activities from environmental impact assessment under NEPA. This is the first preemption of NEPA in a regulatory agency and is the beginning now of cutting back very, very important environmental issues. For what reason? Why are we, in our committee that is responsible in terms of the education and the health and basic research, and the basic oversight of laws dealing with labor and management, pensions, and some of the older Americans activities --why in the world are we going around here in terms of preempting NEPA from the FDA? Who do you think was interested in that? Perhaps some of the industries who want to get out from under filing the environmental impact statement. If we are starting off with this agency, we know exactly what is going to happen in each of the other agencies. This week, I spoke with the Vice President who expressed his serious personal concerns about this provision. Just a few sentences: This bill opens the door to weakening environmental protection, and lays a welcome mat down for future exemptions and attacks on the effective and essential environmental statute. This is an act of environmental extremism, which should have no place in this or any other bill. The reauthorization of the prescription drug and user fee is tremendously important to assure that the FDA will have the resources to review the new drugs. That is what we ought to be addressing. Mr. President, what is the parliamentary situation?

Mr. KENNEDY

Mr. KENNEDY. Yes.

Mr. KENNEDY. Mr. President, we are mindful now that we are only a few short days from the time that the UPS strike was resolved and settled, and settled in a way which benefited many thousands of workers. There are 186,000 workers that were involved, and there was important progress made in the areas of pensions and part-time work. There was great progress made in a number of different areas which we may or may not have an opportunity to discuss here this evening. But, quite frankly, Mr. President, I doubt whether this amendment would be before us if we had not seen the success of the Teamsters as a result of a collective-bargaining process. We saw 15 days where the Nation was focused on the issue about whether the workers of UPS were going to participate in the extraordinary kinds of successes that UPS was involved in. Americans around the country responded to the fact that many of those that had been on part-time were not having part-time mortgages, part-time payments in terms of food bills, part-time payments in terms of children's clothing bills. Finally, the UPS and the Teamsters worked out an agreement. It was important for those working men and women. There are some here, some here in the Senate who just cannot stand the fact that workers were able to have their rights considered and to have their rights resolved in a positive and constructive way. And there are those who just want to somehow get back at these workers, somehow get back at them. I believe here we are seeing some attempt to try to do so by the mischievousness of this particular amendment. The amendment which I have proposed is an amendment to the Nickles amendment that does not require the American taxpayers to pay. The Senator from Oklahoma believes that the judge does not have the authority to require the payment for the election by the taxpayers. All the amendment that I have offered is saying is that if the consent agreement does not require it, it does not have to be expended; if it does require it, we are not going to take any action that is going to interfere with a judicial process and a consent agreement that was signed under the Bush administration, was initiated by a Republican, Mr. Giuliani, in New York, was ratified by the Attorney General, Mr. Thornburgh, who is on record in strong support of this agreement. This agreement is still applicable. As a matter of fact, the respondents are required, under the Southern District Court, to file their briefs on September 19--on September 19. This is a court order that is in effect at the present time. All we are saying in support of the amendment that I have offered is, let us not interfere with the court order that was established in 1989 that was agreed to by the participants. It is part of a judicial process and procedure. What we are basically asking, under the Nickles amendment, is that we are going to interfere with a legitimate judicial procedure. All my amendment says is, let the judicial procedure flow as it was designed and agreed to at an earlier period of time. That is the extent of my amendment. We are not requiring, in my amendment, that taxpayer money be used. We are not saying that it will not be used. We are saying, whatever the judge, under that consent agreement in 1989, understood that agreement to be, that we will not interfere with it. But that is not satisfactory to Senator Nickles. He wants to rig, evidently, or change the consent agreement. We believe that the consent agreement ought to be maintained for the reason that consent agreements are put into place and agreed to by the different parties. When the consent agreement goes in and the different parties agree, we do not see that they agree on one day and the next day we are going to have interference with that particular agreement. That is really what is at issue. Here is Rudolph Giuliani, in 1988, saying, ``Today the U.S. Government is bringing a lawsuit to attack and reverse, once and for all, a major American scandal.'' This is not an issue that is just brought up today. This has been the result and consent agreement from a long, long history which I reviewed earlier in the debate. Richard Thornburgh said, ``This settlement, which union leaders agree to today, culminates 30 years of efforts''--30 years of efforts--``by the Department of Justice to remove the influence of organized crime within the Teamsters Union,'' and then indicates support for it. Thirty years of effort and the consent agreement in 1989. We have seen a continued consent agreement, as these cases are going on to the Southern District Court today. The briefs are required by September 19. So this issue is very much alive, Mr. President. All we are saying in support of our amendment, which is basically an add-on to the Nickles amendment, all our amendment says is nothing in this section under the Nickles amendment shall be construed to apply to the expenditures required by the consent decree in the U.S. v. International Brotherhood. We do not say you are going to have to pay for them. We don't say you will have to pay part of them. We don't say that they are not going to or we are going to restrict the judge. That is effectively what we are basically attempting to do with this particular amendment. Mr. President, I think there are strong reasons for accepting this amendment. I will speak just for a few more moments on this particular issue. Mr. President, as I mentioned, in 1988, the Justice Department under President Bush sued the Teamsters Union under the racketeering laws, and the U.S. attorney who prosecuted the case was Rudolph Giuliani, another Republican, who now, of course, is the mayor of New York City. In 1989, Mayor Giuliani negotiated a resolution to the suit with the Teamsters that imposed sweeping reforms on the union. A critical part of the election reform was the supervision of all aspects of the union elections by a court-appointed election official. Thus, the consent decree establishes the position of election officer and gave the officer substantial authority to regulate the entirety of the electoral process. Under the consent order the expenses of the 1991 Teamster election were borne by the union itself, including the expenses of the election officer. But the 1996 election was different as to that election. The consent order stated the union defendants consent to the election officer at Government expense to supervise the 1996 election. The election officer and all parties to the suit complied with this provision of the consent decree. The Republican refusal to appropriate funds for fiscal year 1996 for the Labor and Justice Department forced the election officer to seek a court order requiring the Justice Department to fund the critical preelection activities. The Justice Department and union joined in the election officer's request for that order which ultimately was granted in October of 1995. Ultimately, however, the funding was obtained and the election was conducted. Protests were filed with the election officer to resolve them and an opinion issued late last month. In that opinion, the election officer found that misconduct by consultants to one candidate required that the election be rerun. The officer specifically declined to find wrongdoing by any officer or member of the union and noted that President Carey had conducted himself throughout the investigation in a manner inconsistent with guilt. So, there is a judicial finding and conclusion that there has been no conclusion to this current election and has not been certified and therefore the election officer maintains the jurisdiction. In accordance with this decision, the election officer did not certify the 1996 election. She did, however, apply to the Federal court for an order requiring that the election be rerun. That application is pending. The parties' briefs will not be filed until September 19 and the court will not rule until after that time. The court may order that the election be rerun or it may not. It may require the Government to fund the election officer's supervision of the election or it may require the union to do so or it may require each party to bear some part of the cost. Let me repeat that: The court may order the election be rerun or it may not. It may require the Government to fund the election officer's supervision of that election or it may require the union to do so. Or it may require each party to bear some part of the cost. We do not know that. We do not know that. That still has to be resolved. Under the Nickles amendment it would prejudge that. All we are trying to do is say we had the agreement in 1989. It is under active consideration before the Southern District Court of New York and we should do nothing that is going to affect that agreement which has been agreed to by all the principle parties and negotiated under the previous administration. The point is we do not know how the court will rule. But this amendment would tell the court that regardless of its ruling the Government will not be permitted to fund the election, even if the consent order requires the Government to pay, this amendment will refuse to permit that. Thus the amendment would interfere with an ongoing judicial process. That is, basically, the issue. Are we going to permit legislative interference in an ongoing judicial process? It is as simple as that. Moreover, the amendment would renege on an agreement that a Republican- controlled Justice Department entered into 8 years ago by repudiating part of that agreement. The amendment would order the Government to subject itself to a contempt proceeding, and that is an outrage and an untenable result. Why do those on the other side of the aisle seek to achieve this result? It can only be because they want to punish the Teamsters Union for their tremendous success in the recent UPS strike. That is what is at the bottom of this, make no mistake about it. Does anybody think if they had not been successful in that strike we would be considering this here? It is a basic, fundamental assault on the fact that they were able to negotiate some protections for part-time workers and for pension rights for workers. There are those in this body and in this country that cannot stand that. They want to give those workers a comeuppance. That is really what is at issue here. That is what is being attempted, to try to interfere with this judicial process. That strike resulted in significant improvements for 185,000 workers at UPS. It sensitized the entire Nation to the gross abuses in many work forces that forced hard-working men and women into part-time jobs with lower wages and lower benefits than they deserve. Let me highlight a few of the achievements of the Teamsters in the UPS strike: 10,000 new full-time jobs by combining existing low-wage part-time positions. That is in addition to the full-time opportunities that are normally created through growth in the company, retirements or people leaving for other reasons. Pension increases that are the same or better as the increases the company had already said it would make, but under the Teamster pension plan, not a company-controlled pension plan. Under the Teamster's central pension fund, a UPS worker could retire at 30 years with a pension of $3,000 per month, 50 percent more than the current amount. Limits on subcontracting--to replace some contractors with UPS workers, so that as UPS grows, full-time UPS jobs grow as well. Wage increases of $3.10 an hour for full-time plus an extra dollar an hour for part-time workers. That may not sound like a lot to the Members of this body but that is important for working families. Safety protections for workers who handle heavy packages may not sound important to a lot of people around this body but that is important for a lot of workers who are handling those heavy packages. The list goes on, and the list goes on. Our Republican colleagues seem to think that the Teamsters deserve to be punished for these gains and I think the union deserves praise. Mr. President, I believe, for the reasons I have outlined here, this is a consent decree, that the consent decree is still active, that there is pending action that is before the Southern District Court, and the amendment which I introduced would effectively accept the Nickles amendment but it would indicate there would be no interference with any decision that is going to be made by the judge in that decree that will be forthcoming, and the outcome of which we do not know. Let me mention, Mr. President, some of the observations of the Judge, David Edelstein, approving the consent decree. Just over two months ago I signed a consent decree between * * * Teamsters and the government. The decree contains an acknowledgment by the Teamsters leadership that there are severe shortcomings in the way it has conducted its affairs in the past, and it embodies the standards by which the leadership of the * * * Union should conduct its affairs in the future.* * * These goals alone, however, are merely statements of good intentions--and we all know where those can lead. Without a dedicated effort to put these ideals into practice, the good intentions will become empty promises and unfulfilled hopes. * * * The public has a significant stake in the outcome of the decree. The IBT exercises vast power and cuts across every segment of society--political, social, and economic. It affects every aspect of our lives. Such power must be insulated against corruption and criminal elements and must be reserved for legitimate use to achieve legitimate ends. * * * The conditions that have necessitated and justified such unprecedented measures are extreme. The remedy therefore is necessarily extreme. The court expects that all parties involved--the union, the government, and the three individuals I am about to appoint--live up to the spirit and letter of the laws and Constitution of the United States as well as the consent decree.

Mr. KENNEDY. I do not expect we would go beyond 6 o'clock but I am reluctant just to enter into it at this time since there are Members that indicated to me they wanted to speak and indicated they would like to speak, but I don't anticipate we would go beyond 6 o'clock.

Mr. KENNEDY. I yield for a question.

Mr. KENNEDY. Mr. President, as I indicated, I have talked to some Senators who wanted to speak. I do not anticipate going beyond 6 o'clock. I cannot speak for them at the present time. After Senator Wellstone speaks, I can make inquiries of the Senators and inform the Chair.

Mr. KENNEDY. Objection. Can we have the reading of the amendment? It has not been distributed to the Members. It seems to me we ought to have the amendment read.

Mr. KENNEDY. May we have order?

Mr. KENNEDY. If I could further respond, the consent decree required, as of September 17, the submission of additional briefs--September 17-- to be submitted in the district court of New York on this very issue with regard to the recent election. This is a consent decree that is ongoing and is continuing. What we are being asked is effectively to have legislative interference into a judicial proceeding. That case was made very clearly, I thought, and convincingly by Senator Specter and others, that there is a clear constitutional issue about separation of powers. I think it is very clear from the administration's letter that this will open this measure to a veto. I certainly believe that it should, since it is a clear violation of the separation of powers. We were not either requiring, under the amendment that we had, that there be an expenditure of public funds or not. We are not trying to give guidance to the court to make a judgment. That judgment ought to be made on the basis of the facts and the briefs that are submitted to it.

Mr. KENNEDY. Yes.

Mr. KENNEDY

Mr. KENNEDY. If there was any court order affecting the 1996 elections of Teamsters officers--I would like to try a short quorum call to make sure that would be language, which I think appears to be to the Senator's point, and I think it would meet the objectives. But maybe we could suggest a short quorum call to make sure that we have the language that conforms to both of our understanding. I suggest the absence of a quorum.

Mr. KENNEDY. I would expect that what we would include in that is any court orders that would be related under the consent decree or that would be related to the consent. Is there something in particular--I would be glad to attempt to define that, if the Senator has some particular concerns in some particular way. But it seems to me to be fairly clear. Any of the orders that would be a part of that consent decree. Now that we are retained and we are within the consent decree, there would be any of the court orders with regard to the various elections. And I would expect that as we did before, we would want to comply with the consent decree in those areas.