Ted Kennedy

Mr. KENNEDY

Mr. KENNEDY. Madam President, I would like to have consent to be able to speak for 7 minutes.

Mr. KENNEDY. I thank the Chair. Madam President, there are items that we will be dealing with--the McCain amendment, the Durbin amendment, and also the other Gorton amendment which we will be voting on in just a few moments--and I would like to speak very briefly on each of them. I strongly support the Durbin amendment which will repeal language in the budget agreement that deducts the cigarette tax devoted to children's health from the amount of the settlement. In effect, this last-minute loophole inserted in the budget bill by Big Tobacco in the dead of night behind closed doors reduced the value of the settlement by $50 billion. It was one of the most devious and reprehensible actions that I have witnessed in my years as a Senator. The lesson is clear. When tobacco issues are debated in the public, the American people win. But when the debate moves into the backrooms of Congress, the tobacco industry's interests come first, and the public interest comes last. It's time that Congress stood up to the tobacco industry and said ``no'' to Joe Camel and the Marlboro Man. This tobacco loophole has no place in the budget agreement, I urge my colleagues to support the Durbin-Collins amendment. I strongly oppose the McCain amendment which would have a devastating effect on our essential efforts to address physician work force issues. Medicare pays approximately $9 billion per year for graduate medical education. Over the years, these payments have been a strong incentive for hospitals across the country to increase the size of their residency programs. The increase has resulted in turn in widely reported concerns about an oversupply of physicians. The Institute of Medicine, the Pew Health Professions Commission, the Association of American Medical Colleges, and the Council on Graduate Medical Education have all emphasized the urgency of dealing effectively with this problem, and Congress can't ignore it. In addition, the longstanding hospital reimbursement policies have been more generous for specialist residents than primary care residents. As a result, most of the growth in the number of residents has come in specialist positions, not in primary care, and has produced an extremely serious oversupply of specialists. Congress addressed these issues in the balanced budget legislation enacted this summer. We expanded the New York graduate medical education demonstration project into a national program to encourage teaching hospitals across the country to adjust the numbers and types of physicians they train. The program provides incentive payments to teaching hospitals to voluntarily reduce the number of medical residents in training, and to increase the proportion of residents training in primary care. The program pays hospitals for residents who are not being trained. But the payments are reduced over time and phased out completely after 5 years. These payments help cushion the blow for institutions heavily dependent on the Federal funds, and allow an orderly downsizing of residency training programs, with minimal disruption to the provision of health services. The McCain amendment, however, would eliminate incentives for hospitals to downsize the overall number of resident positions and recalibrate the number going into primary care. The glut of physicians and the imbalance between general practitioners and specialists would go unaddressed. The McCain amendment could also have a harmful effect on rural and underserved areas. The budget agreement established a hospital-specific cap on residents, based on 1996 levels. It gave the Secretary of the Department of Health and Human Services the authority to lift the cap for residency programs in rural and underserved areas if the total number of positions does not exceed the national cap. By eliminating these payment incentives under the McCain amendment, large residency programs will no longer downsize. This result will hamstring efforts to establish new residency programs to address the health care needs in rural and underserved areas due to the overall cap. Finally, the amendment would result in over $300 million in lost savings, according to CBO estimates. A critical part of health reform is responsible action to reduce the over-supply of physicians and correct the imbalance between primary care practitioners and specialists. The Budget Act is helping us put a more effective policy in place, and we should not reverse the progress we have made. I urge my colleagues to reject the McCain Amendment. The second Gorton amendment hurts students and goes against the Nation's commitment to helping the poor and educationally disadvantaged students who need our strongest support. Although meaningful education reform happens not at the Federal level, or even at the State level, but at individual schools, the State and Federal Governments are important partners in helping to improve education for all children. We all need to work together to improve the Nation's public schools. This amendment does not support meaningful reform. Instead, it shifts Federal dollars away from the neediest communities to the wealthier ones. It guts carefully crafted and widely supported programs with specific purposes. And it undermines the State's role as a crucial partner in improving the achievement of all students. This amendment is the wrong direction for the Nation's children and the wrong direction for the Nation's future. It is not an attempt to offer a helping hand for local schools. It is simply a thinly veiled attempt to dismantle the Federal role in education. Currently, Federal funds help schools and school districts improve reading and math skills of disadvantaged students, help teachers get the extra skills they need to teach all children to high standards, help communities create safe and drug-free schools, and help communities modernize their schools. This amendment would strip Federal funding of these crucial, targeted purposes intended to help children who need it most. Time and time again, research has indicated that it is in high- poverty communities that children are most likely to fall behind and drop out of school. This amendment disregards the research and the testimony that we have heard over and over about the need to help disadvantaged and low-achieving students. This amendment would shift funds from poor school districts to wealthier ones. Currently, some States depend heavily on Federal funds. Alabama, Arkansas, and Louisiana get more than 10 percent of their schools funds from the Federal Government. Mississippi depends on the Federal Government for a full 21 percent of its education funds. We should not do anything to weaken that support. As a Nation, we have made a commitment to help all students have the opportunity to get a good education. We have a responsibility to make sure that public tax dollars are well spent. This amendment provides no accountability mechanisms and it is not fiscally responsible. Reforming the Federal role in education is neither a casual nor quick decision, and it should not be taken lightly. Federal education laws are more flexible and school-friendly than ever before. States and local education agencies are working in greater and more effective collaboration. Schools are helping all children meet high standards of achievement. We should not undermine these efforts when they are just getting off the ground. We should support efforts to improve education for all students, not undermine them. I also strongly support and am a co-sponsor of Senator Daschle's sense-of-the-Senate amendment with two key provisions--that Pell grants should be funded at a total of $7.6 billion, and that a child literacy initiative should be funded at $260 million this fiscal year. Pell grants are an indispensable source of college aid for low- and middle-income students. But too often, the current eligibility rules shortchange too many students. Today, single independent students at public 4-year institutions are not eligible for a Pell grant if their annual income is over $10,000. Many of these students will not benefit from the tax credits for college expenses recently enacted in the budget law. Greater Federal assistance is needed to help them meet their most basic college expenses. A similar problem faces parents trying to pay for college for their children. Current law is actually a disincentive for college students to work part-time to help pay for the cost of their education. Yet over three-quarters of undergraduates now work part-time while enrolled in college. It makes no sense for the current law to penalize students who are willing and able to work their way through college. Many students work full- time during the summer and part-time during the school year. But if they do so, the response by current law is to reduce their eligibility for Pell grants. We should be encouraging students to take part-time jobs, rather than take out additional loans, as long as their jobs do not become so burdensome and time-consuming that they interfere with the students' education. The budget agreement contained a clear commitment to allocate $700 million to reform the needs analysis formula for Pell grants. The House appropriations subcommittee provided $500 million to meet this commitment, but that is not sufficient. The Senate bill is far worse-- it contains no funds at all for this needed change. The second part of the amendment will help more children learn to read well. We know the dimensions of the current problem. Some 40 percent of the Nation's fourth grade children cannot read at the basic level. Low achievement in reading is a national crisis, and it demands immediate attention. Children who lack good reading skills by the fourth grade are far more likely to fall farther and farther behind, and eventually drop out of school. President Clinton is right to focus on this critical problem, and Congress should respond. This amendment will provide $260 million for a child literacy initiative--and it will provide the funds this year. As the ranking member of the Labor and Human Resources Committee, I am strongly committed to seeing that legislation authorizing the initiative is enacted as soon as possible. But it makes no sense to delay the appropriation. I urge my colleagues to support these two important sense-of-the- Senate provisions. We all know that the final bill will be written in the conference between the Senate and the House. I hope we will have an overwhelming vote of approval to insist that the conferees find a way to pay for these two essential reforms in school and college education. Another essential reform for elementary and secondary students is the President's proposal for a voluntary national test for fourth grade reading and eighth grade math. Schools need clear standards of achievement and realistic tests to measure their achievement. These tests are a tool they can use to measure their progress and identify areas of need to bolster student achievement. I strongly support having the National Assessment Governing Board take responsibility for formulating policy guidelines for the voluntary reading and math tests. NAGB is in the best position to oversee this important issue. This bipartisan group has done an excellent job managing the National Assessment of Educational Progress. As we all know, NAEP has served to point out how we are doing as a nation and helped educators think about ways to improve our education system. The voluntary national tests, however, will go further. They will help each school district, each school, each student to identify areas of need in order to make the necessary changes to improve individual student achievement. The tests are linked to national and international standards. They will show whether individual students are meeting widely accepted standards in reading and math. No current test is available to provide this essential information to students, parents, teachers, and school administrators. For families that move from community to community or State to State, there is no current way to measure the performance of students on a comparative basis. The President's proposal for voluntary national tests has broad support from business leaders, including the Business Roundtable, the U.S. Chamber of Commerce, the National Business Alliance, and many others. It also has strong support from the education community, including the Council of Great City Schools, the Chief State School Officers, and the National School Boards Association. Seven States, including Massachusetts, and 15 major cities have already agreed to use the voluntary test. Voluntary national tests are an excellent way to support local school reform and hold schools and districts accountable for student achievement. I urge the Senate to reject any effort to deny Federal funds for these tests. Finally, the Nickles amendment is a blatant attempt to punish the Teamsters Union for winning the UPS strike, and it does not deserve to pass. The amendment would require the Federal government to abdicate its responsibility under the court-approved consent order signed by the Justice Department under the Bush administration. If the Federal Government abdicates this responsibility, it could be subject to contempt proceedings in Federal court. This is an unacceptable result. It would substitute the Senate's judgment for that of the Federal court about the meaning of the consent order. This is not how the judicial process was meant to operate, and I urge my colleagues to oppose the amendment. Mr. NICKLES addressed the Chair.

Mr. KENNEDY. Madam President, I suggest the absence of a quorum.

Mr. KENNEDY. I have listened to the Senator from West Virginia. I agree with his position. I heard earlier today Chairman Roth's opposition to this effort. And I understand other members of the Republican leadership also intend to speak on their concerns and opposition to this amendment. Even under the proposal as it was recently passed, we will only reach about half of the currently uninsured children. As the Senator remembers, we had a more expansive and robust program that might have provided the kind of extensive coverage that the Senator from Washington was talking about. And with the work of the Senator from West Virginia and the Senator from Rhode Island, we explored options to expand coverage among working families in a manner that would have also helped states that have already acted to expand Medicaid eligibility guidelines. However, that proposal failed, and the program signed into law was designed instead to fit on top of what each state is currently doing. The new $24 billion investment in children's health is supposed to provide assistance to the 10 million children in working families whose parents are unable to afford health insurance and are not currently eligible for Medicaid. So, with all due respect, it is difficult to argue in the abstract that we are pitting one type of uninsured child against another. The point of this new program is to build upon current state efforts to work up the income scale from what is currently being done in a state to ensure that the sons and daughters of working parents receive coverage. We are talking about teachers, nurses aides, janitors, and other professionals whose salaries are too low to enable them to purchase health insurance but too high to qualify for Medicaid. These are hard-working Americans who put in 40 hours a week, 52 weeks of the year. I would join with the Senator from Washington and the Senator from West Virginia to see an expansion of this program. Through the work of the Senator from West Virginia, Senator Roth, Senator Moynihan and others in that conference, we were able with the leadership of the President to get a good program enacted. But we are still probably going to need to enhance that program or strengthen it down the road. As I understand the Senator's position, we ought to put the new program in place, find out what those needs are, and then I am sure the Senator from West Virginia will be a leader here in the Senate to make sure that we are going to help and assist families in the State of Washington, West Virginia, or Massachusetts to try to make sure that the sons and daughters of working families that are not covered are going to be able to get some coverage. Is that correct?

Mr. KENNEDY. Mr. President, will the Senator be good enough to yield?

Mr. KENNEDY

Mr. KENNEDY. First of all, I want to just comment about the devotion and duty of our friend and colleague from Vermont. I am sure there may be those who are watching the proceedings this morning who may not know, as many of us know, the Senator and his daughter were rear-ended last Friday morning. Nonetheless, he came in here during the course of the consideration of this legislation, and now he is here doing his duty in spite of the inconvenience and discomfort he is feeling. So I think all of us have great respect for Senator Jeffords. His devotion to duty is again reflected in his presence here this morning and his commitment in moving ahead this legislative process. Mr. President, I also want to, as I did at the opening of the discussion and debate, congratulate Senator Jeffords on his efforts in the consideration of this legislation. We considered this legislation-- FDA reform--in the last Congress. We reported legislation out of the committee. It did not move toward a successful resolution. There were a number of features there that were extremely troublesome in terms of the protection of the public. There were areas of strong difference. Although the process did move forward, it was not successful. Senator Jeffords has built upon a strong record and made every effort to try to work through an important public policy area, reform of the Food and Drug Administration, in ways that recognize its primary responsibility, which is to protect the public. As we go forward with this debate, FDA reform should serve the public interest and also take into consideration the innovation of the pharmaceutical industry and the medical device industry in bringing new products onto the market in ways that can improve the health care of the American people. That is always a balance. Men and women of good judgment can differ. There are two important provisions in this legislation, which eventually will be subject to further debate and discussion, dealing with what we call sections 404 and 406, labeling and manufacturing. I will come back to those measures a little later in the course of the debate. We heard references to those items by our friends and colleagues, Senator Reed and Senator Durbin, on Friday last. We will have a chance to outline at least some of the concerns about those measures, and, ultimately, the Senate and the conference will have an opportunity to deal with those. I personally feel that they pose important public health issues that need to be addressed. But I agree with what Senator Jeffords has outlined, which is the broad sweep of this legislation, and the areas of broad agreement that have been an impressive legislative achievement. Senator Jeffords should receive commendation for that because all of us who were part of that process feel that there are many features in here that should move forward. Some of us are hopeful that we can address the medical device legislation and also address what I consider to be one of the important amendments that was passed in the consideration of the legislation in one of the last markups--passed with a strong vote, after some discussion, but nonetheless, poses what I consider to be an important and unnecessary health hazard to the American people. That is, the provisions which are known as the cosmetic preemption provisions, which were added to this legislation, not included in the original mark of the chair, not included in the original mark of Senator Kassebaum a year ago, but added at the behest of the industry. As a matter of fact, the language itself was drafted by the industry. It was advanced in the committee considerations and now is part of the legislation. As I mentioned last week, I am absolutely convinced that if this had been introduced as a separate bill, it would be far back in the recesses of the Labor and Human Resources Committee, in terms of its consideration. But nonetheless, action was taken by the committee and that action has resulted in the inclusion of the cosmetic preemption provision. If this legislation is passed, it will effectively say to the 50 States that you virtually have no rights or opportunities for protecting your consumers from unsafe or dangerous cosmetics. Now, I listened with interest to what the Senator outlined in regards to the powers of the FDA, in terms of protecting the public. But the fact is, as we know, the food and drug law has 126 pages that relate to drugs or prescription drugs and medical devices, it has 55 pages dealing with labeling and nutrition labeling, it has 8 pages dealing with definitions in the food and drug law, and it has a page and a half on cosmetics. There are only two members of the Food and Drug Administration who oversee cosmetic packaging, labeling and warning. We have seen where the various studies that have been done by governmental agencies, like the General Accounting Office, have stated that what is necessary to give assurance and protection to the American people regarding cosmetics is more significant regulatory authorities for FDA to make sure that the ingredients that are going into cosmetics are going to be safe. We do that with the pharmaceutical industry; we do it with the medical device industry. We do not do that with cosmetics. The American people go into their drugstore and get a prescription drug or an over-the-counter drug. They know that, in effect, there is a warranty from the FDA that bears the gold standard for safety in the world, that those products are going to be safe. They get a medical device and they know it is going to be safe. But the fact of the matter is, Mr. President, we are not so sure when it comes to cosmetics. For example, when we consider the safety of our cosmetics, we know that, the Consumer Product Safety Commission, more than 10 years ago--and the utilization of cosmetics has grown exponentially since that time-- reports 47,000 emergency room visits as a result of the use of cosmetics and cosmetic products in one single year. Does that sound very safe to all of you? What is the record? Where is the testimony to say how safe it was? You do not have it. You do not have it because we have not had any hearings. It would have been a good hearing if we had two or three former heads of FDA that appeared before the committee and said this is what the safety issues are, these are what the health issues are, these are why either we agree or we differ on the issues of preemption. But we didn't have them in the Senate. And you have not had them in the House. You didn't have them in this Congress. You didn't have them in the last Congress. You have not had them in the Congress before. You have not had them for 20 years. The only documents you have are from the GAO. And they don't talk about how safe everything is. They have a series of recommendations, which I have read into the Record, that say what we ought to be doing in order to guarantee safety and security. That is what the GAO said. That isn't the Senator from Massachusetts. That isn't the four other Senators that said let's stop, look, and listen. But we are going to go ahead pell-mell with this particular provision. We have looked at the results of the GAO study. They have not been refuted, and we have not had any hearings providing evidence that can refute the GAO. Mr. President, is this something that just now a single Senator, or three, or four, or five Senators should be concerned about? It is interesting that the administration has targeted this provision, as well as the two to three other provisions that I mentioned earlier, as matters that have to be addressed. The National Governors' Association: This is what they say about this provision. When the Senate Labor and Human Resources Committee considered reauthorization of the Food and Drug Administration, 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. All the Governors are saying virtually the same thing. Let us, in the 50 States, be able to take actions with regard to cosmetics, allow us to protect our people. That is what all the Governors are saying. But oh, no. ``Washington knows best.'' Remember those old statements that we used to hear all across the country by many of our colleagues. Let's not have a one-solution-fits all. Let's not have that. Let's not have ``Government knows best.'' Well, here you have Government knows best. They don't know best. They can't handle and protect their people in California, or Ohio, or Massachusetts. Absolutely not, even though there have been strong efforts in each of these States to try and move ahead and to protect their people. But we are saying not after we pass this law. Mr. President, as I said last Friday here on the floor of the U.S. Senate, we are making tough decisions on matters over which reasonable people can differ. And these are in many instances heartrending decisions. I mentioned last Friday, the decisions that we had in our Human Resources Committee where you have a limited amount of money. You have to make a decision for Meals on Wheels; whether you are going to provide all of the money to the congregate sites to feed elderly people--and you can feed more elderly people if you put it in the congregate sites--or are you going to take a third of that money and feed people that are shut-ins? The money will not go as far. You are not going to reach as many people if you take those scarce resources and reach the shut-ins. What should be the public policy question? Should we give the money to feed more people, or should we allocate some to the shut-ins, or should we just leave this up to the local community? These are important public policy issues that affect the lives of real people. But not on this cosmetic issue. What are the public policy considerations on the other side? Money. Greed. Cosmetic industry. Greed. What are the public health considerations of preemption? How are they advanced? How are they preserved? How are the American people further protected by a preemption? They are not. We have not heard that argument made on the floor of the U.S. Senate. We have not heard it, because it is not there. This legislation is proposed because of what has been happening in the area of California, and some of the other States which have been looking at the kinds of concerns being raised by so many consumers day in and day out--I will mention those in just a few moments--that are really wondering whether some of these products are safe. And there is good reason to ask whether they are safe because as we have seen from the GAO, many of these products are potential carcinogens. What is a carcinogen? It is a cancer-causing agent. We wouldn't permit these products to go into processed food because the Delaney clause would protect the American people from carcinogens in processed food. But can you add them to cosmetics? You can add them to cosmetics. They are added to cosmetics today. That is another reason, Mr. President, why the Environmental Defense Fund says no to this provision; why the Natural Resources Defense Council says no to this provision; why the Patients Coalition Consumers Union says no to do this provision; why the Consumer Federation of America says no; why AIDS Action says no; why the American Public Health Association, the association to protect the American public health, says no to this provision. All of these organizations say no to this provision. Why? Because it doesn't protect and advance the interests of the public health in the States. It advances the bottom line of the cosmetic industry, but it does not advance the interests of the public health. Mr. President, I will mention what the National Women's Health Network says in a letter that I will include. I ask unanimous consent that this letter be printed at an appropriate place in the Record.

Mr. KENNEDY. They say: The spectrum of the cosmetic industry is broad and not simply limited to lipstick, mascara, or eye shadow. Hair gels and dyes, soap, toothpaste, baby powder, and lotions also fall under the umbrella of this $20 billion industry. Most women use one or more of these products every day, and assume that they are safe for themselves and their families. Sadly, this is not the case. There is virtually no federal oversight of cosmetic products which, according to a 1987 Consumer Product Safety Commission study, led to an estimated 47,000 emergency room visits in one year. Just to depart for a minute, if you have 47,000 people going to the emergency room, how many other thousands are going back to see their doctors? How many other thousands have gone to their dermatologists? How many other thousands have gone to their own doctors, and not to the emergency room and willing to pay the other $150, $175, or $200 to just visit the emergency room? How many others knew that? There were 47,000 emergency room visits in one year. Additionally the General Accounting Office reported that a number of cosmetic products marketed in the United States ``may pose a serious hazard to the public.'' That is the GAO-- `` * * * may pose a serious hazard to the public.'' It would seem to me this morning that we ought to be debating how we are going to advance public health, and how we are going to protect those individuals whose health may be in danger. Are we debating that? No. To the contrary. We are going to say as a result of this legislation that the health of the consumers of cosmetics are going to be at greater risk. That is the only conclusion, and that the bottom lines of the cosmetic industry are going to be higher. I continue: The Women's Health Network ``* * * believes that S. 830 puts the financial bottom line of the cosmetic industry ahead of the health of millions of women by banning states from regulating the industry's products.'' There it is. There is the heart of the argument right there by the National Women's Health Network, one of the effective organizations that looks out after the public health of American women. Does it get it right here? The Network believes that S. 830 puts the financial bottom line of the cosmetic industry ahead of the health of millions of women by banning states from regulating the industry's products. That is it. That is what we got tagged onto this bill that is dealing with pharmaceuticals and prescription drugs, dealing with medical devices, dealing with the extension of PDUFA, which is a source of revenue to ensure that the FDA can be tops in the world in terms of approving new products. We support those various provisions. But now we have added onto this train this cosmetic preemption that the principal organizations that are dealing with public health say to the U.S. Senate: ``Stop. Say no. Do not move ahead with that.'' It continues, Mr. President: It is absolutely crucial that provisions in S. 830 preempting states' rights to regulate cosmetics be removed from the bill. Women and their families deserve to have complete information about the safety and effectiveness of these products and states who are willing to step forward to safeguard the health of their residents must be allowed to do so. Mr. President, let me just continue on with the groups just so that we understand the breadth of the opposition. It isn't just a few Senators. As I mentioned, the principal public health associations, those that are primarily concerned about women's health, the ones that use these products to the greatest extent--the administration, the State legislators. The State legislators were joined by the Association of State and Territory Health Officials. They emphasized State laws provide consumers with important protections in areas where the FDA has insufficient resources to act and represent a legitimate exercise of State authority. As I mentioned before, Mr. President, if we were debating the regulatory authority of the FDA to protect the public health, that is a legitimate debate. But that is not where we are. We are not out here debating what would be appropriate power for the FDA to have to ensure protections for the American consumer on cosmetics. If there are those that can say with a straight face with the $6 million budget that they are allocating through FDA and two people that are overseeing the areas of packaging and labeling, which is the only thing that the States can do in terms of trying to get at these health considerations--if we were out here to say, ``Look, they have too much power, they have been abusing that power, and they are inefficient with that power,'' that would be one thing. But we are not out here debating that. We are just saying we know, as the cosmetic industry does, that the agency does not have the wherewithal in order to protect the consumer, that the historical protections for the consumer on health and safety have been the States and local communities, and what we are out here now saying is that we are going to take all of their power away. That is the issue. It isn't that we have a strong FDA. We don't have it. It is not represented. It was never discussed in the course of our markup. We had no hearing that would be able to represent it. Let me just take a few minutes to indicate how we have gotten to where we are with regard to the FDA power on drugs, pharmaceuticals, and on cosmetics. As I mentioned, the FDA has less than two people to regulate the labeling, packaging, and warning for a $20 billion a year industry. The FDA has less than 30 people to work on cosmetics, and FDA's authorities are grossly inadequate. The FDA regulation of cosmetics is a dinosaur, an anachronism from the time when drugs didn't have to be effective, when food additives didn't have to be safe, and when medical devices didn't have to be safe or effective. Just go back with me in terms of the times so we understand where we are. I chaired the hearings that we had in the 1970's about medical devices. Twenty-three women died from perforated uteruses as a result of the Dalkon shield. And that was the beginning of the changes in our medical device legislation--in the mid-1970's. Because of the danger with the sophistication of medical devices, we were going to have to make sure they were going to be safe and efficacious. And we did. Mr. President, in 1938, the last and only time the Congress acted specifically to regulate cosmetics--1938 is the last time--FDA was given authority to regulate products that were misbranded or adulterated. FDA had the burden. FDA had to find the problem. FDA had to do the studies. FDA has to bring a court action. The entire burden is on the agency. In the last 60 years, we have progressed in other areas of public health and safety. In 1954, we passed the Miller pesticides amendment. In 1958, we passed the Food Additives Amendment requiring manufacturers of food additives to demonstrate safety before putting potentially harmful chemicals in the food supply. Now manufacturers have to demonstrate that their products are safe in order to go in the food supply. Do you have to do that with regard to cosmetics? No, you do not have to do that with regard to cosmetics. Two years later, we passed the color additives amendment to establish a premarket approval system for additives used in food, drugs and cosmetics. The drug amendments of 1962 fundamentally restructured the way FDA required premarket approval of safety and effectiveness for every new drug. Prior to that it was not there, not necessary. They have to prove safety and effectiveness. In 1976, we enacted the medical device amendments following long years of study and debate. So now we have the agency requiring that each of the products in terms of the prescription drugs and with regard to medical devices have to be proven safe and efficacious. Do they have to do that with regard to cosmetics? No. No, they do not have to do that today. Among the most recent changes in FDA's authority were the infant formula amendments of 1980 and the 1990 Nutrition Labeling and Education Act, and the 1990 Safe Medical Device Act. Under these laws Congress held manufacturers responsible for safe and effective products. We asked the manufacturers to provide data to FDA to demonstrate safety before they could sell the products. We went ahead again with regard to prescriptions and again with regard to medical devices. Do we do it with cosmetics? No. Despite all this progress and advance in public health and safety, cosmetic regulation has lagged far behind. FDA's authority and regulation of cosmetics is still stuck in the framework of the 1938 law that Congress found it necessary to update in every other product area. This is not to say that Congress has not revisited the area of cosmetic regulation. In fact, every time that Congress has revisited cosmetic regulation it has resulted in a call for additional protection and additional safety measures--every single time. But here we are on this FDA reauthorization bill, to reauthorize the FDA and bring it up into the modern period in terms of medical devices and pharmacy. Here we are with a change, significant change in terms of the relationship of the protection of the American people from cosmetics. And here we are without the hearings, using the exact language of the cosmetic industry which is going to mean health threats to the American consumer--at what benefit? Well, as I mentioned, the bottom line of the cosmetic industry. So we have each and every time, with regard to pharmaceuticals and medical devices, we see what we have done and we have seen each time that Congress has gotten into it or the GAO studies have gotten into it, they say it is an area which cries out of the need for greater protection of the public. In 1948, George Larrick, who became the Food and Drug Administrator, said: Real scientific appraisal of cosmetic ingredients should be made before an ingredient is marketed. Did we do that? No. In the 1952 hearings, James Delaney in the House found that partial regulation of cosmetics resulted in insufficiently tested cosmetics that are a source of discomfort and disability. Further, the House report found that cosmetics should be subjected essentially to the same safety requirement as applied to new drugs. Yet today that is far from the case. In 1978, the U.S. GAO report strongly recommended the FDA be given adequate authority to increase safety of cosmetics. Among its findings: Although there is increasing evidence that some cosmetic products and ingredients may carry a significant risk of injury to consumers, the FDA does not have an effective program for regulating cosmetics. Some coal tar hair dyes may pose a significant risk of cancer because they contain colors known to cause or are suspected of causing cancer in humans or animals. However, the exemptions granted to coal tar hair dyes in 1938 prevented FDA from effectively regulating hair dyes. The industry was sufficiently powerful at that time to write an exemption in the law. And there is increasing evidence that people with darker hair who use these darker colors have higher incidence of troubles in terms of not only their scalps but also their general health conditions and there are increasing studies concerning the exposure these individuals may have had to carcinogens and cancer. Serious burns have been reported from the use of flammable cosmetics. Among those likely to ignite at the time of application are perfumes and colognes which usually contain a high concentration of alcohol and nail polish removers which contain flammable ingredients such as acetone and ethyl acetate. In 1975 FDA sponsored a 3-month survey of 35,000 users of cosmetics. Participants kept a diary and reported adverse reactions. These reports were reviewed by a team of physicians to determine if the injuries were cosmetically related. One of every 60 participants suffered an injury confirmed by a physician as cosmetically related. One in every 450 participants suffered a severe or moderate injury. These are studies that were done back in 1975 by the FDA. Do you think we have updated those studies? No. Do you think we have had hearings about that? No. And yet each and every time there is a serious evaluation we are finding these incidents involving health hazards. We have seen the varying degrees of the hazards in the examples and in the pictures that are here behind us. And we could go through picture after picture of the damage done by various kinds of products. The GAO report concludes that cosmetics are being marketed in the United States which may pose a serious hazard to the public. That is not the Senator from Massachusetts. That is the GAO, not Democrat, not Republican. In drawing on the best scientific information, this is what they conclude. Cosmetics are being marketed in the United States which may pose a serious hazard to health. Some contain toxic ingredients which may cause cancer, birth defects or other chronic toxic effects and contain contaminants known to cause cancer in animals because exposure to these ingredients can occur through skin absorption and inhalation as well as oral ingestion. It is important that the hazards posed by them be carefully assessed. I tell you, Mr. President, if this provision passes, those hazards are not going to be assessed by the States because of the way the language is written in the legislation. I am talking about what will be preempted on page 119, line 8: Shall be deemed to include-- This is the preemption-- any requirement relating to public information or any other form of public communication relating to the safety or effectiveness of a drug or cosmetic. There it is. Here you have the last studies being done, nonpartisan. Individuals are reviewing the most recent, up-to-date scientific studies. Cosmetics which are being marketed in the United States which may pose a serious hazard to the public. Why are we asked to take a chance on it, Mr. President? Why are we being asked to take this action? One reason and one reason only--the bottom line for the cosmetic industry. There is no public health argument that can be made on the other side--absolutely none--just the greed of the cosmetic industry. Every American ought to understand that. Here you have the GAO saying cosmetics are being marketed which may cause a serious hazard to your health. You have the several States: Texas, California, Ohio, my own State of Massachusetts, and a number of other States that are attempting to deal with some of these potential and real hazards to us and they are going to be preempted. Sure, we exempted California from this provision, but there are other health protections in California that are going be precluded. I have my differences with the attorney general, Dan Lundgren out there in California, but you read through his letter about this action and about the efforts California is making trying to protect its public and how it is completely contrary to the interests of California. Here is the Attorney General of California: Regulation of health and safety matters has historically been a matter of local concern, and the Federal Government has been reluctant to infringe on state sovereignty in these traditional areas. And he says: As noted above, S. 830 would, in the absence of specific FDA exemption, appear to prevent the State of California from enforcing their Sherman Food Drug and Cosmetic Law which is there to protect the people of California. And it goes on to make the case in opposition to this particular provision. So now we have the GAO report and we have what this statute does. The 1988 hearings held in the House of Representatives raised the same issues about the FDA's lack of authority and resources in this important area. Nothing has been done. Let me review one more time what FDA cannot do under its current authority. It cannot require cosmetics manufacturers to submit safety data on their products--cannot require that. It can require it with regard to pharmaceuticals. It cannot require cosmetic manufacturers to register their plants or establishments or require cosmetic manufacturers to register their products or require premarket approval of any cosmetic or cosmetic ingredient even when such approval is necessary to protect the public health; cannot require manufacturers to submit consumer complaints about adverse reactions to cosmetics; cannot require manufacturers to perform specific testing necessary to support the safety of a cosmetic or an ingredient. So, Mr. President, this is what we have under current law. I would like to mention just some of the dangers associated with this limited authority. We have talked in generalities. We talk about jurisdiction. We talk about preemption. We talk about inspection. But here are examples of dangerous cosmetics. These injuries took place this year, and there are dozens and dozens of them in graphic detail. I want to read a few of them for you. Do any of you use Alberto Hot Oil Treatment for your hair? There was a complaint just last month of eye dermatitis from this product. Do you know what that means? It means blisters, chemical burns, rash, redness, swelling, and inflammation. All that from a simple hair treatment. Everybody in America uses toothpaste every single day. In August, a consumer used a type of Colgate toothpaste with baking soda and peroxide. What happened? Mouth pain and dermatitis. That's a fancy way of describing itching, burning, and swelling of the lips, tongue and gums. In case you are thinking of switching brands, think again. Somebody else used Crest Tartar Control toothpaste in January and developed the same symptoms of burning, itching, and swelling in the mouth--not what you would expect from brushing your teeth in the morning. Here is another example. In August somebody used Gillette Cool Wave clear stick deodorant. Instead of being clean and presentable, they ended up with armpit dermatitis and bleeding. Can you imagine bleeding from using deodorant. How about a product called Revlon Outrageous Shampoo and Conditioner? It is outrageous all right. The user developed scalp sores, swelling, and inflammation from the shampoo. Have you ever used Bath salts? You may not want to after you hear this. In March, someone developed ``nervous system and urogenital tract reactions'' from Essential Elements Bath Salts. Can you imagine expecting a nice relaxing hot bath and end up with dizziness and headaches. These examples go on and on. Prestigious manufacturers L'Oreal, Avon, Clairol, Neutrogena, familiar names like Procter and Gamble, Revlon, Maybelline, Mr. President, this list provides a dismaying parade of horrors from products we rely on every single day. Here are just a few examples of the injury complaints received by the FDA. Dermatitis includes rash and redness, swelling, blisters, sores, weeping and lumps, inflammation, chemical burns, and irritation. Pain ranges from itching and stinging to soreness and tingling. Tissue damage, other than thermal burn, can include dryness and peeling, splitting, cracking, hair and nail breaking, hair and nail loss, ulcerations, hair matting, and scars. Nervous system reactions range from dizziness, and headache to irritability, nervousness, and numbness. How many people using these products have symptoms like dizziness, headache, irritability, nervousness, or numbness, and wonder where in the world this is all this coming from? It may very well be coming from their cosmetics, from their shampoos and toothpastes and other types of cosmetics. If these examples aren't striking enough, there are respiratory system reactions, like upset stomach, nausea, loss of appetite, vomiting, and diarrhea. Or urogenital tract reactions: painful urination, discharge, stopping of urination, and on and on it goes. Mr. President, I asked for the complaints that we have gotten in just the last few months. Here in my hand is the list of them from the FDA. It is interesting to note that, a number of years ago, we tried to get authority for an FDA hotline so people could call up with their cosmetic injuries. It was struck out in the Appropriations Committee at the behest and intervention of the cosmetic industry. We tried to get a hotline so that at least we would be able to get more information and the FDA would be able to act on that information about specific products. What is the lesson we can draw from this? The industry does not want more information about cosmetic injuries. They don't want others to have that information. So they eliminated funding of the cosmetic hotline. We have successful and important hotlines in many other areas. They have been a strong success. I have been a strong supporter of them, because they assist people in obtaining information and, most important, help in a timely way. But they also allow the Government to register various complaints and gauge the seriousness of public health problems. We tried to get the hotline. We had it authorized, it went on to the Appropriations Committee a few years ago, but it was knocked out by intensive lobbying. So I am truly amazed that the FDA has the kinds of reports I will describe, and the sheer number of cases that they do. The truth is, most people who suffer injuries or adverse reactions from cosmetics simply don't know who to tell, other than their doctors. They in turn don't have anyone to tell or don't know who to tell. Certainly, the companies are under no obligation to tell the FDA--nor do they. I will return a little later to the efforts that were made to try to get the manufacturers to voluntarily assist the FDA in reporting complaints. At the end of the day, only about 3 percent of the manufacturers cooperated in that effort. When hearings were held in 1988, there appeared to be a consensus to do more to protect the public. The industry itself said, give us an opportunity to voluntarily provide the FDA the complaints that we receive. Well, it ended up being about 3 percent of the companies that actually participated. I will get to this in just a few moments. Let's begin with the injury complaints. In August, Alberto Culver & Co.'s hot oil treatment for color-treated and permed hair: Eye dermatitis, including rash, redness, swelling, blisters, sores, weeping, lumps, inflammation, sunburn, chemical burn, and irritation. Clairol Helene Curtis, the brand was Nice N Easy Natural Lite Ash Brown No. 114 and Degree antiperspirant; upper trunk and shoulder pain, including burning and stinging. Clairol's Nice N Easy Medium Brown No. 118: Hair tissue damage other than thermal burns. Procter & Gamble's Covergirl Makeup Master, facial and nose injury including dermatitis; Revlon's Professional Nail Enamel Remover: Finger injury, including cuticle, irritation, dermatitis. Neutro-gena's Clear Pore Facial Treatment, facial injury; Dixie Health, Dermal KK is the brand: Face, including nose bleeding. In July, Maybelline's Great Lash Mascara: Face pain and dermatitis in the nose. Realistic's, which is Roux Labs, Revlon Super Fabulayer Hair Relaxer Conditioner: Scalp dermatitis; Shark Products' Africa Pride Relaxer is the brand: Hair tissue damage. Procter & Gamble's Pantene Shampoo: Upper trunk dermatitis, neck tissue damage. Vidal Sassoon Shampoo: Upper trunk dermatitis. Clairol Hydrience Permanent Hair Color: Permanent discoloration of the hair. I can't imagine a product that could unintentionally make hair permanently discolored, but that is what has been reported. The list goes on. It lists the names of just about every major kind of cosmetic maker in the book. Andrea International's eyelash adhesive: Eye pain. You have perfume from Stern & Co., the product is Oscar: Respiratory system reactions. And the list goes on. I have page after page of these kinds of complaints. It seems to me if the States want to bring these matters up and it was the desire of the States to try to protect their consumers, they should have the opportunity to do so. Just as California has done and just as other States which are presently studying these issues will do. These States could go and talk to the manufacturers and the manufacturers can make changes, which they have on product after product sold in California. Proposition 65 is the basis for this California system, which works by inducing product improvements without having to remove products from the market or even putting labels on them. That is the way it has worked in California. Safer products. And time in and time out, the manufacturer comes out and advertises that they have upgraded their product. It is a better product now than it ever has been--an interesting and desirable outcome. But in this bill we say no. We just say no. We tell consumers, you cannot have the remedy of the State and you cannot have the remedy at the Federal Government. The result will be more individuals like the 59-year-old California woman who was almost killed by an allergic reaction to hair dye. Or the woman who lost her hair and was horribly scarred when her hair caught fire from a flammable hair treatment gel. The 6-year-old daughter of an Oakland, CA, woman who used a hair product on her child who suffered second-degree burns. Two women who used eyelash dye, one of whom died and the other who went blind. A 16- month-old toddler died of cyanide poisoning after swallowing artificial nail remover, and a 2-year-old child from Utah was poisoned by the same cosmetic. If there is a State that wants to do something about children, like putting a warning label on these items in order to protect children, it will never happen under this bill. We know that children get into all kinds of products in the household and there is the chance of them ingesting some of these items. Obviously, some may be considerably more dangerous than others, and consumers will want to have labeling that says if the child ingests this, take the following steps or contact the following people. But under this bill, if the State wants to do that, they are virtually prohibited from doing so. They are denied the opportunity to protect their children in their own States. What if a review is made of the scientific information in these States on these products if ingested by children, asking do they present serious threats of poisoning among children that may be life- threatening? Should warnings be placed on the labels? The result under this bill will be: No, you are out. You can't do that. I just find it difficult to understand why can't the States do this? Why can't they if they want to in Massachusetts or any other State? The reason will be because the Congress of the United States, at the request of the cosmetic industry, says you can't do it. Congress and the industry say you can't do it. That is what we are dealing with, Mr. President. It is just why I think this makes absolutely no sense. We reviewed earlier this morning some of the groups that were opposed to this provision: The Governors and State legislatures, virtually all of the public health and consumer groups like the National Women's Health Network, the wide range of agencies and officials with primary responsibility over the public health. They are virtually unanimous in their opposition. I will happily wait to hear from public health groups in support of the provision. We will have time during the course of the debate for other Members who are able to get that kind of information and place it in the Record. In the face of such unanimous opposition, they will be few and far between. Here is a letter from the United Food and Commercial Workers, Beth Shulman, the international vice president. We are appalled that the Senate is considering preempting state cosmetic safety regulation in the almost complete absence of any Federal protection. Unlike all other products governed by the Food and Drug Administration, such as food and drugs, the FDA has essentially no authority to assure the safety of cosmetic products prior to entry into the marketplace. The FDA has no legal authority to require manufacturers to conduct safety testing, submit lists of ingredients to the agency, company data, or consumer complaints. Most consumers would be shocked to learn that there is no Federal government regulation or testing to assure the safety of cosmetics before they appear on store shelves or are used by hair care professionals. It is scandalous that the Senate is now considering stripping states of their legal authority, so that the safety of cosmetic products used by millions of consumers will now be completely unregulated. The United Food and Commercial Workers Union, which represents barbers and cosmetologists among its 1.4 million members, has a long history of campaigning for stronger Federal regulation of cosmetic products. Over the past twenty years we have testified repeatedly about the hazards of cosmetic products and the need to protect not only the 750,000 professional cosmetologists, but the millions of consumers that use these products daily. They point out they take strong exception to those protections. Now, why should they be concerned? They gave some excellent testimony several years ago to the Congress. Let me give an example. After 2 years as a wig stylist, a cosmetologist from San Francisco began to experience memory loss, nausea, and dizziness. She had troubles with vision and balance. She stated, ``I can't remember things I did just a short while ago. I have to write everything down.'' Her condition was blamed on the ingredients in hair spray and other products she was using in her work. She appeared as one of the witnesses where Congress was working to regulate the largely unregulated industry. Another example: Christy Smith enrolled in a beauty college in 1984. Christy began to have trouble breathing, a problem that worsened over the years. She dropped out of beauty school after 10 months. She was found to have irreversible occupational asthma. Again, her condition was attributed to cosmetics present at her school. A 1997 study in the Journal of Environmental Medicine found evidence to support the claim that female hairdressers are at a higher risk of asthma as a result of occupational exposure to chemicals found in various hair products. This prompted a related study by the Palmer Group, which found an increased prevalence of respiratory symptoms and diseases among female hairdressers. These diseases included asthma, bronchitis, emphysema, and other chronic lung diseases. Female hairdressers face daily exposure to many harmful chemicals that are used in a wide array of hair care products on the job. I will give a few examples. These chemicals include persulfates, which are used in hair bleaches and can cause allergic skin and respiratory symptoms. Several indications of occupational asthma among hairdressers have been reported. Polyacrylates mixed with chemicals and hydrocarbons in hair styling agents can cause irritation of airways and adversely affect other respiratory functions. Ammoniac and sulfur compounds released in hair dying and permanent waving can cause irritation of the airways. The relative risk of asthma and chronic bronchitis among hairdressers was measured almost twice that of a reference group between 1980 and 1995. This study found that the youngest cohort of female hairdressers experienced the greatest occurrence of asthma, 42 percent; and chronic bronchitis, 44. These women ranged in age from 35 to 44. Mr. President, this is what is happening in the beauty parlors among beauticians across the country. Why? Because they are inhaling these products. They suffer from the higher concentrations of these toxins, but the women of this country who use these products at home are also inhaling them and endangering their health. I am not here to say precisely what the extent of this problem is, but we know now that it is happening as a result of studies that the compounds that are being used are more toxic and there are more of them being used every year. The health hazards have to be greater. At a time when the health hazards have to be greater, why are we taking away the rights of the States to render judgments to protect their citizens? This is especially true in an area of traditional State authority. What if the States want to take some kind of action? We are prohibiting them from doing so. We are denying them that chance to do so. It makes absolutely no sense--no sense at all. It does make dollars and cents because the industry is going to benefit from it, but it doesn't make any sense in terms of the public health. That is why virtually every public health agency committed to protecting women and women's health wants this provision out. It undermines their ability at the State level to give additional protections to consumers, and for no other reason than the financial interest of the cosmetic industry. Mr. President, I will mention here how the United States compares with the rest of the world. That doesn't happen to be the most important argument made this morning, but we heard on the floor of the Senate last Friday about how we have fallen behind other countries in terms of the FDA's work. In reality, the United States has been compared with the rest of the world, and impartial sources such as the General Accounting Office have found that the United States has the fastest and most vigorous product approvals. American consumers expect the best and that is what they get from the FDA. But when it comes to cosmetics, the U.S. motto should be: ``Expect the best, but settle for less.'' Looking around the world, it is remarkable how inadequately the United States stacks up against other countries. The European Union requires documented proof of good manufacturing practices and similar proof that extensive testing be carried out on all its products. What do they know that we don't know? What are their scientists and research scientists finding? Are we taking the time of the Senate to go through their various studies that point out the health hazards in their communities? They have done it, and they are providing additional protection. Let us examine another major economic power: Japan regulates cosmetics likes drugs, requiring the companies to do safety tests before marketing. Why? What is it they understand about cosmetic safety? Is it possible they have reviewed and found the same things that we have talked about this morning? The same things that the GAO has found out about the dangers posed by cosmetic products? Japan requires testing before marketing. That is exactly what the Congress said in 1952 we should be doing in the United States. Forty- five years later, we are still waiting for safety testing. The Japanese are not. Let's look at North America. Mexico adopted a regulation mandating expiration dates on all cosmetics. To the north in Canada, manufacturers submit data to show the product is safe under normal use conditions. The Scandinavian countries: Sweden and Denmark are initiating product registration for cosmetics, something the FDA can't require. Malaysia already requires mandatory registration of cosmetics. That is something the cosmetics industry would fight tooth and nail. The bottom line is that the American consumers have less protection than consumers in any other country that I have mentioned. The United States is a First World country with a Third World cosmetics safety system. That is the way it is today, and this legislation is going to make it worse. Much worse. That, Mr. President, is wholly unacceptable. I want to mention more specifically the products of which I think people should have some awareness. These are five common cosmetics products with potentially devastating health effects: Alpha-hydroxy acid, used in face cream, causes skin cancer. Feminine hygiene products cause infertility in young women; Talc used in baby powder that may cause cancer; and Mascara that can cause blindness. Alpha-hydroxy acid is one of the hottest selling cosmetics on the market with sales of roughly $1 billion a year. This product is sold to erase fine lines and tighten the skin, but has devastating health effects that are unknown to most consumers. The agency has received 100 reports of adverse effects with alpha-hydroxy acid products ranging from mild irritation and stinging to blistering and burns. More importantly, these products make users more sensitive to ultraviolet radiation from sunlight which causes skin cancer. To find out if a cosmetic contains an alpha-hydroxy acid, the consumer has to look for one of the following ingredients: glycolic acid, lactic acid, malic acid, citric acid, L-alpha-hydroxy acid, mixed fruit acid, triple fruit acid, sugar cane extract. All of these are alpha-hydroxy acids, although you'd hardly know from their names. The cosmetics industry sponsored a study linking alpha-hydroxy acids to increased ultraviolet sensitively and, most likely, skin cancer. An industry panel concluded that alpha-hydroxy acid cosmetics are safe at concentrations less than equal to 10 percent at a pH of greater than or equal to 3.5 percent when directions for use include daily use of Sun protection. Equal to less than 10 percent. This is what the cosmetic industry says will be safe if used along with these other items. Wouldn't it be useful for someone else or someone impartial to get a chance to look at the basic science and research that the industry has used to make a judgment? Wouldn't that be worthwhile? Wouldn't it be valuable if the FDA had a chance to have that data submitted to them? They could have their researchers look at it and see whether they come to the same conclusion as to the safety. But, no, there is a recognition by the industry itself that if there is something wrong, they want to do their own study and make their own recommendations. We, the public, don't know. We don't know whether they are accurate. We don't even know whether there is going to be any kind of enforcement, or by whom. By the industry? How? All we have is the industry's record and their willingness to comply voluntarily with the FDA. We have less than 3 percent of them willing to submit adverse kinds of reactions to the FDA. So we have no way of knowing about the true safety of cosmetics. What we do know is that the industry itself understands that there are health hazards with this specific product and want to control what's on the warning label. Don't we want researchers out in the great centers of research in this country to say, ``Look, we'd like to try to find out if and how we can protect people.'' Maybe States with broad exposure to the Sun, such as the South and Southwest, should have particular interest in trying to do this. They might want to do some studies to find out. Would they be able to try to make some kind of a judgment under this bill? Mr. President, the answer is no. We are preempting those States. Let us look at alpha-hydroxy acids again. Here we have one of the most highly advertised products on the market today. We have the industry's own recognition of their health hazards. Again, are we doing something on the floor of the Senate to protect the consumer from those hazards? Absolutely not. We are undermining what protection there is out there among the States. Consumers should be aware that alpha-hydroxy acid concentrations and pH are generally not noted on these products, not unless FDA's two employees find the time and resources to initiate rulemaking to establish such a regulation. FDA is reviewing the industry report, as well as other data, about these products and may initiate rulemaking sometime in the future, but do not expect the States to protect their citizens from alpha-hydroxy because under the law, States could not warn their citizens about alpha-hydroxy acid creams. Feminine hygiene products are other harmful, largely unregulated products, with roughly $100 million a year in sales. Many women who buy these products will be surprised to find the overwhelming majority of these feminine hygiene products are regulated only as cosmetics. These products have been known to cause upper reproductive tract infection, pelvic inflammatory disease, ectopic pregnancies, infertility in women. This reduction in fertility is even greater in young women. Researchers at the Center for Health Statistics in Seattle, WA, have published studies regarding the risk of pelvic inflammatory disease from the use of feminine hygiene products. These researchers have found that the risk of ectopic pregnancy doubles in women who use feminine hygiene products. Researchers at Brigham and Women's Hospital, Harvard Medical School also published data regarding the adverse health effects of feminine hygiene products. We had better hope that those two people at FDA working on cosmetics labeling and warnings have time to work on adequate labeling for feminine hygiene products. The National Women's Health Network has testified before an FDA advisory committee that more has to be done to protect the reproductive health of women, which is clearly affected by these cosmetics. Just look at the science. But the industry doesn't want the States to have the authority to warn consumers. So, for the women of the State of Washington, we should say goodbye to the research studies conducted in Seattle and what they found out--because we are preempting what those States can do with them. Even in my own State, research conducted at Brigham and Women's Hospital found that the risk of ectopic pregnancy doubles in women who use feminine hygiene products. It is worthwhile to inquire if there are other researchers who come to contrary conclusions. These are studies being done. What State is going to go out and perform studies, and which research centers, when they know they are preempted from doing anything about it? That is why the Women's Health Network is opposed to this provision. And for what reason are we risking women's health? Why are we risking lives? It is because of the cosmetic industry. It is going to be cheaper for them, allegedly, when they don't have to deal with warnings and disclosure of health risks. It's too much trouble for them. Talc is something widely used in baby powder and other body powders. In 1992, the National Toxicology Program published a study of the effects of talc inhalation in animals and an epidemiology study on exposure to talc and ovarian cancer risk. The researchers reported an elevated risk of ovarian cancer associated with talc use. Workers at Columbia University have reported the detection of talc particles in the ovaries of patients undergoing surgery. The Cancer Prevention Coalition has submitted a citizen's petition to FDA addressing their concern about the possible health risks posed by talc and requested the agency establish regulations to require carcinogen warning labels on cosmetics containing talc as an ingredient. FDA is reviewing the information and may respond sometime in the future. Those two workers are going to be hard pressed with this one, too. If the State wanted to warn its consumers about the potential carcinogen, they would be prohibited under S. 830. A technique that has been used to extract ovarian tumor material found talc particles in approximately 75 percent of ovarian tumors examined. Subsequent evaluations have appeared to support the contention of an association between talc and ovarian carcinoma. The most recent study reported by the American Cancer Society has validated the claim that talc exposure increases the risk of ovarian cancer. Since the use of talcum powder is not an unusual practice for women, further studies need to be conducted to further understand the effects on a woman's female reproductive system. We had hoped that perhaps some of these research centers, some of these States would be interested in this. They might have done some work and might have been able to provide some health and safety recommendations in this area. But now we are saying that if the State of Washington, that was interested in alpha-hydroxy, or if we are going to find out from Columbia University the work they have done with regard to the finding of talc particles in the ovaries of patients undergoing surgery, if they wanted to do something in warning people in the State of New York, those would effectively be off the table. Why are we not debating how we are going to provide greater protection for women? We have seen important research done up in Seattle, WA. Why are we not out here debating what we are going to do about it? How can we provide protections? What about these kinds of recommendations in terms of the talc? How dangerous is that to our children? Why are we not out here debating that rather than saying, look, even though we have seen this kind of study, we are not going to permit the States to get into this--into this at all--because the cosmetic industry does not want it. On mascara, the FDA had numerous reports of corneal ulceration associated with mascara products, some of which caused partial blindness of the infected eye. In addition, many other reports of conjunctivitis caused by contaminated mascara were received. In a 1969 FDA survey of hand and body lotions and creams, about 20 percent of the products sampled contained microbial contamination. Researchers at the Medical College of Georgia demonstrated that 10 percent of eye cosmetics were contaminated when sold. Bacteria were isolated from about 50 percent of all used eye cosmetics. Popular brands of mascara were marketed without preservative systems and are particularly vulnerable to contamination. Mascara cosmetics can become easily contaminated during customary use because human skin is not sterile, and contact between the skin and a cosmetic leads to microbial contamination of the products. FDA published a notice asking the industry to provide information covering microbial testing methods and standards of performance suitable to assure that cosmetics do not become contaminated with microorganisms during manufacture as well as use. However, FDA's request for information resulted in no substantive response from the industry. The industry just said no. What can FDA do about it? Since FDA has no authority to request the safety data from the manufacturers or look at industry records, FDA's inquiries likely stops there. Can the States perhaps do something down the line? Perhaps they could have at some point, but not under this proposal. Expiration dates would help remind consumers to get rid of cosmetics before the bacterial contamination becomes dangerous. Under this legislation, States could not act to require expiration dating on cosmetics. So, Mr. President, the cosmetic provision of the bill is utterly irresponsible. It is a flagrant example of a special-interest lobby using its back room muscle to attain unfair advantage over the public interest. You bring that bill out separately, Mr. President, and let us have an opportunity to debate that on the floor of the U.S. Senate. The votes are not there to carry that individually. And they should not be there. But now we have seen that the cosmetics industry has added this on to legislation that was initially devised for the extension of PDUFA, to ensure adequate funding for FDA's drug review program so that the United States can be first in the world in terms of approving new products in the pharmaceutical industry. It is time for the Senate to stand up for the health of the American people, reject this unjustified, unwise, unacceptable provision that is nothing more than a tribute to the greed and recklessness of the cosmetic industry. The political power of the cosmetic industry is not a license to ride roughshod over the rights of the States and the health of the Nation's men, women, and children who use their products every day. The American people deserve safe cosmetics. They have a right to full and fair information about the actual and potential danger of their products. The last thing Congress should do in a bill called the FDA reform is to give the cosmetic industry a blank check, poisoning the American people with its products. Mr. President, we allow States to decide whether their bottles will be recycled or buried or whether their barbers are going to be licensed, whether their pets will be registered, how close to a crosswalk you can park your car, what hours the stores can be open. But this bill prohibits the States from protecting the consumers from cosmetics that can give you cancer, catch on fire, or cause birth defects. As I mentioned, the language broadly preempts any public information or public communication. That is an ironclad guarantee that the consumers will know less about their cosmetics. States will not be able to require warnings to parents or children about the dangers of a particular product. American consumers are going to know less about their products. The cosmetic industry introduces 1,000 new ingredients every single year into our cosmetics, everything from lipsticks, hair creams, soap, deodorant, and hair dyes. Do you think we will know how safe they are if this language becomes law? Who will be looking out after the public interest under this language? I suppose it is left to the two employees at FDA--an agency with limited authority and resources--who are charged with regulating $20 billion worth of cosmetic labeling and packaging. This language that we are considering was drafted by the cosmetic industry itself so make no mistake who it is intended to benefit. Many challenges to State action have been rejected by the Federal appellant courts because the courts interpret preemption narrowly. This is because the courts cannot imagine that Congress would want to preempt the States from protecting their citizens. So what does the cosmetic industry do? They carefully drafted this language to give them their broad preemption. They have admitted that they drafted this law specifically to force the Federal judges to interpret preemption very broadly. Mr. President, this provision should not become law. Mr. President, beyond this issue, I will mention two other important items that I hope we will have a chance to debate in the form of amendments when we move to the bill itself. Others have spoken to them, and I will work with them or introduce legislation on these particular provisions. The overall legislation includes a number of provisions that will significantly improve and streamline the regulation of prescription drugs, biologic products, and medical devices. I am pleased that, through a long process of negotiation both prior to and subsequent to the markup of the legislation, many provisions that seriously threaten public health and safety were dropped or compromised. But despite our best efforts, this legislation includes several Trojan horses that I think undermine important positive proposals in this bill. I would like to discuss the changes in the regulation of devices that put consumers at unacceptable and unnecessary risk. They should be removed from the bill before it goes forward. The administration has made it clear that these provisions put the whole bill at risk. A great deal of negotiation has taken place on the medical device provisions of this bill. I compliment Senator Jeffords and Senator Coats and other colleagues in the committee for resolving most of the divisive provisions in a way that is consistent with the protection of the public health. I see in the chair Senator Gregg. We worked with Senator Gregg on the health claims issues in a constructive manner. But there are at least two medical device provisions in the bill which still raise substantial concerns that could be corrected very simply with negligible effect on the basic purpose and intent of the bill. Yet these corrections have not been made. My colleagues deserve a clear description of the hazards they pose. A brief explanation of how the FDA regulates and clears the medical devices for marketing may be first in order. Under the current law, manufacturers of new class I and class II devices can get their products onto the market by showing that they are substantially equivalent to devices already on the market. For example, the manufacturer of a new laser can get that laser onto the market if they can show the FDA that the laser is substantially equivalent to a laser that is already on the market. Similarly, the manufacturer of a new biopsy needle can get that biopsy needle onto the market by showing that it is substantially equivalent to a biopsy needle already on the market. And the manufacturer of new patient examination gloves can get those gloves onto the market by showing that they are substantially equivalent to patient gloves already on the market. Mr. President, these manufacturers are obliged to demonstrate substantial equivalence to the FDA by showing that the new product has the same intended use as the old product and that the new product has the same technological characteristics as the old product. If the new product has different technological characteristics, these characteristics must not raise new types of safety and effectiveness questions in order for the product to still be substantially equivalent to the older product. The logic of this process for bringing medical devices onto the market is quite simple: If a product is very much like an existing product, it can get to market quickly. If it raises new safety or effectiveness questions, those questions should be answered before the product can be marketed. This process for getting new medical devices on the market, commonly known as 510(k), is considered by most to be the easier route to the market. Devices that are not substantially equivalent to a class I or class II device already on the market must go through a full premarket review. Thus, device manufacturers have an incentive to get new products on the market through the 510(k) process. In effect, well over 90 percent of all new devices get on the market through the submission of a 510(k) application. This legislation seriously compromises the FDA's ability to protect the public health through its regulation of medical devices that are marketed through the 510(k) process. Of the dozens of provisions that we have negotiated and discussed which affect medical devices in this bill, these two still raise fundamental public health problems. Although few in number, these provisions raise substantial risks to public health which simply cannot be ignored. The first problem raised by the bill relating to medical devices is a prohibition on the FDA from considering how a new device will be used if the manufacturer has not included that use in its proposed labeling. You may think this approach makes sense. Why should the agency consider the use of a device if the manufacturer has not specified the use on the label? I'll tell you why--because that proposed label may be false or misleading. How would the FDA know that? Because the design of the new device may make it perfectly clear that the new device is intended for a different use. Let me provide my colleagues with a few examples. Let's talk about the biopsy needle I mentioned before used on breast lesions. Most biopsy needles for breast lesions currently on the market take a tissue sample the size of a tip of a lead pencil. Assume the manufacturer of a new biopsy needle comes to the FDA with a 510(k) submission. But the new biopsy needle takes a tissue sample 50 times as big, the size of a 1-inch stack of checkers. The manufacturer of this new needle has proposed labeling that says that the needle will be used like the old, marketed needles to biopsy breast lesions. But FDA knows the chunk of tissue being ``biopsied'' will exceed the size of the lesion. This makes it clear to FDA--and any impartial observer--that the needle in most cases will be used to remove the lesion. Under these circumstances the FDA should be able to ask the manufacturer to provide information on this use. Is it safe to remove lesions? Does it really work? The bill, however, categorically bars FDA from asking these essential questions. This means the FDA would be unable to make a complete review of the device and the public would be deprived of existing assurances that devices are truly safe and effective. The proponents of this provision have argued that the FDA could simply say that the change in device design or technology--such as the change and size of the biopsy needle--renders the new product not equivalent to the old product. But that is not always true. The manufacturer could argue that there are no new questions of safety or effectiveness for the purpose claimed on the label. In the case of the biopsy needle there are times when a large sample is needed--a sample larger than a pencil tip. So long as the larger needle is safe and effective for removing a sample, FDA could be barred from obtaining data about the new use of removing lesions and to the extent the needle is used for the new use, women could be put at risk for effective or unsafe treatment of breast cancer. Another example is surgical lasers that have been used for decades to remove tissue. Several years ago, a manufacturer added a side-firing mechanism to their laser to improve its use in prostate patients. While the manufacturer did not include this specific use in its proposed labeling, it was transparently clear that the new side-firing design was intended solely for this purpose of treating prostate patients. As a result, FDA required the manufacturer to submit data demonstrating the laser's safety and effectiveness in treating prostate patients. This is precisely how the device review process should work. Manufacturers must prove their devices live up to their claims, while patients and doctors receive all of the information needed to make the best possible treatment choices. Under this bill, FDA would be prohibited from getting adequate safety data on the laser's use on prostate patients, even though that would be the product's primary use. This defies common sense, yet this is the result of one troubling and indefensible provision. Other examples in the way this provision could allow unsafe and ineffective devices onto the market abound. A stent designed to open the bile duct for gallstones could be modified in a way clearly designed for treatment of blockages in the carotid artery. Without adequate testing, it could put patients at risk for stroke or death. But under this bill, the FDA would be prohibited from looking behind the label to the actual intended use of the device. A laser for use in excising warts could have its power raised so it was also possible for use in smoothing facial wrinkles, but without FDA's ability to assure adequate testing, the use of the laser for this purpose could lead to irreversible scarring. Most companies, of course, will not try to bypass the process in this pay. But some bad actors will. This legislation should not force the FDA to fight these bad actors with one hand tied behind it. This provision is like asking a policemen to accept a known armed robber's assurance that the only reason he is wearing a mask and carrying a gun is that he is going to a costume party. The second way this bill undercuts the FDA's ability to protect the public's health and adequately regulate medical devices is the way it forces the FDA to clear a new device for marketing even if the agency knows that the manufacturer cannot manufacture a safe device. Let me repeat that. It sounds, frankly, preposterous but it is true. One of the bill's provisions actually requires the FDA to allow a new device on to the market even if the manufacturer is producing defective devices. Surprisingly, the proponents of this provision freely admit that this is true. Under the current law, let's assume that a maker of a new examination glove submits a 510(k) to the Food and Drug Administration and claims that the new gloves are substantially equivalent to gloves already on the market. If the FDA knows for a fact from its inspectors that the company uses a manufacturing process that often results in the gloves having holes, FDA would simply not clear the gloves for marketing. FDA would find that these gloves are not substantially equivalent to gloves on the market because gloves on the market don't have holes. That is common sense, and fortunately that is also the law. In contrast, this bill would force FDA to clear the gloves for marketing. These defective gloves would be sold to hospitals, clinics, and HMO's where they would be used routinely by doctors, nurses, paramedics, and other health professionals every single day. Every single glove would expose these professionals needlessly to AIDS and hepatitis. Here is the response of the provision's supporters. They argue that once these defective gloves are in the market and being used by health professionals, FDA can simply institute an enforcement action to remove them from the market. But when hundreds or thousands of defective devices have been distributed, and when dozens or hundreds of facilities may be using these devices, an enforcement action entails more than blowing a whistle or picking up the phone to place a simple call. In reality, FDA must coordinate with the U.S. Attorney's Office, U.S. Marshal's Office, and persuade the court of jurisdiction to issue appropriate papers. As any attorney or law enforcement professional can tell you, that takes precious time. In the case of a defective device which is exposing people to unnecessary risk, time is absolutely critical. The sooner a defective glove is pulled from the market the sooner the public is protected. All this makes no sense when the FDA can prevent this from arising. If this provision becomes law, the debater's point distinguishing between different forms of FDA authority will be paid for in the health and safety of American consumers, placed at needless risk of death and injury. In fact, even the regulated industry is willing to compromise on this provision because they recognize it is so unreasonable and should be removed from this bill. In the end, there is simply no justification for these troubling medical device provisions. Our overriding priority in regulating medical devices should be distinguishing between reforms which preserve the public health and protections and those which endanger the public health. Mr. President, we have had arguments on the other side of that provision which say, well, on the labeling provision are we going to have to require the manufacturer to dream up every possible use and be able to answer the charges that some nameless person at FDA can possibly imagine that a particular medical device would be used for? We say, no, that is not what we are looking for. We are looking for what would generally be defined as the predominant or dominant use of the device as a criteria. That ought to be the key. We know many devices are used in different kinds of ways. We are looking here at the predominant or dominant use for the device. That is what we are concerned with. You might have a pacemaker which can speed up the activities of the heart and some treatment might require that you slow down the beat of the heart. You might have one pacemaker that has already been approved, and someone else wanted to get on stream and say that they have a pacemaker that speeds up the heart but also may slow it down. So they come in and say, ``We want this approved because it will speed up the heart but it also has the possibility of slowing it down,'' in order to circumvent the safety requirements. It seems to me we ought to be able to work that out. We are looking, as I said, as a criterium of the predominant and dominant device use as the key. We are not looking for these other, incidental uses. It seems to me we ought to be able to work that through. For the reasons I outlined in discussing the good manufacturing practices provision, it seems to me we also ought to be able to find some common ground in that area, as well, but we are not there yet. I suggest the absence of a quorum.

Mr. KENNEDY

Mr. KENNEDY. Mr. President, I support the education amendment offered by Senator Reed to appropriate $35 million to maintain the State Supplemental Incentive Grant Program. The SSIG Program is effective in encouraging States to allocate funds for need-based student aid programs. Elimination of SSIG will cause a significant loss of funds for many needy students and will discourage States from providing this important type of student aid. Continued funding for SSIG is supported by the American Council on Education, the United States Student Association, US PIRG, the National Association of Graduate-Professional Students, the National Association of State Student Grant and Aid Programs, and the Education Trust. SSIG is a Federal-State partnership in student aid. States must match the Federal funds on a dollar-for-dollar basis. Eliminating the Federal share will inevitably result in many States dropping their programs entirely. SSIG constitutes a significant percentage of need-based aid in several States. It is also an incentive for State legislatures to provide their own need-based student aid. In 13 States, Federal SSIG is 20 percent or more of the total need-based aid in the State. In Hawaii and Mississippi, the elimination of SSIG funds would cut the State need-based aid in half. In Rhode Island, the State legislature provided need-based aid in order to obtain the Federal SSIG funds. The Connecticut Legislature increased need-based aid in order to meet the SSIG requirements. Louisiana will end all need-based aid if Federal funds for SSIG are not appropriated. One of the fundamental goals of the Higher Education Act is to provide greater access to higher education for all qualified students, regardless of income. Expanding this access is still a major challenge. In the upcoming reauthorization of the Higher Education Act, we will be considering all aspects of the roles of the Federal Government, the State governments, colleges, students, and their families in meeting the costs of higher education. SSIG is a program that works. It's a sensible Federal-State partnership, and it may well be a model for other steps to leverage the use of Federal funds. I urge my colleagues to support the Reed amendment to appropriate adequate funds for SSIG, so that needy students across the country will not lose this critical aspect of college aid.

Mr. KENNEDY. Mr. President, Senator Graham has introduced, on behalf of Senator Abraham and me, a 2-year extension of the Refugee Act. That act is the core of U.S. refugee policy. It sets the criteria under which persons can be designated as refugees and provides funds for refugee resettlement. Last year, the United States admitted more than 75,000 refugees under the Refugee Act's criteria. In addition to determining who qualifies as a refugee, the Refugee Act allows the Department of Health and Human Services, through the Office of Refugee Resettlement [ORR], to provide services to refugees resettled in the United States. For example, ORR provides job training and employment assistance to new refugees to help them become economically self-sufficient. ORR helps States provide English language classes, preventive health services, and cash assistance to new refugees to help them get on their feet in the United States. Refugees often arrive here terrified and with few possessions. Most have fled persecution in their home countries and left virtually all their possessions behind. These programs make a refugee's assimilation into the United States a little easier. In addition to providing assistance directly to refugees, the Refugee Act makes funds available to the Public Health Service to provide overseas medical screening for U.S.-bound refugees for the protection of public health against contagious diseases. ORR also provides targeted assistance to States and counties with large refugee populations and has matching grant programs for voluntary agencies to assist States in refugee resettlement. For example, the Boston Tech Center in Massachusetts received $250,000 in discretionary targeted assistance to give refugees short-term skills training and teach basic English and math. The International Rescue Committee in Boston received funds under the Refugee Act to provide a youth program for newly arrived Somali children. The Refugee Act is the heart of our refugee law and policy. If it is not re-authorized, the United States will send a signal worldwide that refugees are no longer welcome here. We cannot let that happen. The act deserves to be extended and I urge the Senate to approve this amendment.

Mr. KENNEDY

Mr. KENNEDY. Mr. President, I ask unanimous consent that Diane Robertson be given the privilege of the floor during the consideration of this legislation.

Mr. KENNEDY. Mr. President, first of all, I congratulate my friend and colleague, Senator Jeffords, for the attention he has given to trying to bring the FDA into the modern world and to trying to consider a wide variety of different recommendations and suggestions and for working with the members of our committee, both the Republicans and Democrats. This has been a trying process, but I commend him--and I speak for all of those on our side--for the diligence with which he has approached this and the knowledge he has demonstrated on this particular range of issues. We all understand, the American people understand, that the principal responsibility of the FDA is to preserve and protect the public health. This is different from other agencies. Therefore, any alteration or change in the authority of the FDA and in consideration that various aspects of the law have to be balanced against what is in the short- term, medium-term and long-term interest of the public health of the American people. The FDA is the singular agency throughout the world that has demonstrated that it understands that particular commitment and has done an extraordinary job. Many of us have frustrations about the FDA on particular products in our State and about general kinds of process and procedure. But no one can review the history of the FDA and not understand that today the FDA is the principal instrument for approving new drugs and new medical devices. This legislation today is to try to extend what we call the PDUFA, which is a proposal that was enacted under the leadership of Senator Hatch and myself a number of years ago, which provides user fees by the major drug companies to make sure that we will have the expertise to consider various drug products more rapidly. There is an important need for the extension of that particular proposal, and all of us want to see it extended. I am a strong supporter of extending it. There are many, many features of this legislation which I support. But having said that, Mr. President, we have to look at the remaining items that need attention and, in particular, one which is completely unacceptable and enough to warrant and justify the attention of the Members of the Senate about whether we are prepared to move ahead and consider this legislation, with that particular provision in in, that is now before the U.S. Senate. It is a provision that was not a part of either the initial proposal that was advanced last year by Senator Kassebaum or advanced this year by Senator Jeffords. It concerns the whole question of the preemption of the States with regard to cosmetics and over-the-counter medicines, but primarily on the issue of cosmetics. There are other important protection items dealing with unsafe or ineffective medical devices, including provisions that could undercut FDA's ability to regulate cigarettes, and there is a back-door assault on one of the most important environmental protections. We will have a chance to get into those later in the course of the morning. I want to point out what this legislation is going to do with regard to cosmetics, to all of the Members as we are coming over here to consider a cloture vote. We have to recognize and we will have a chance later on in the morning to point out the limitation of the Food and Drug Administration in regulating cosmetics. It has virtually no regulatory authority in this area. The American people should take no satisfaction in extent of the protections regarding the cosmetics they use every single day because the Food and Drug Administration does not have the jurisdiction to determine what is in those cosmetics, whether they are safe and whether they are effective. Absolutely none. There are only two members of the FDA who are out there supervising this issue--only two members of the FDA--in terms of looking out after the packaging and the labeling provisions--two members. The enforcement, in terms of protection of the public health on the issues of cosmetics, are left to the States. That is where the real regulatory authority is today. And now, because of the greed--and it is greed--of the cosmetic industry and because of the success of a referendum in California, they want to preempt any kind of protections for the health and the safety enacted by the States with Federal legislation that will effectively eliminate for all time the possibility of the States providing protection on health and safety. That was put into this legislation as an amendment. That amendment has been objected to, not just by the Senator from Massachusetts, but by all of the Governors of the 50 States. I will submit the correspondence from the National Governors' Association and from a principal Republican Attorney General Dan Lundgren of the State of California, a State that has done more in terms of protecting the American public as a result of the legislation passed in California than anyone else. The last GAO study points out that in the cosmetics used primarily by women in this country every day, 125 ingredients are suspected of causing cancer, 20 ingredients are suspected of damaging the nervous system, 20 ingredients are suspected of causing birth defects. And the list goes on and on and on. And to put that into this legislation without a single day of hearings--without a single day of hearings; the last hearings in the Senate of the United States were in 1978--will amount to a wholesale threat to the health of the American consumer. Primarily the women of this country do not deserve the kind of vote for cloture in moving ahead and effectively denying us the opportunity for a full debate and discussion of the issues that this provision deserves. That is why I hope that the vote on cloture is not successful.

Mr. KENNEDY. The cosmetic industry wants the public to believe that no effective regulation is necessary at either the State or Federal level. They are the masters of the slick ad and expensive public relations campaign. But all the glamorous pictures of the world cannot obscure the basic facts. This is an industry that is underregulated and, too often, hazardous. A mother of a beautiful 6-year-old girl in Oakland, CA, found this out when she used a hair product on her child that resulted in second- degree burns on her ears and neck. A 59-year-old California woman almost died from an allergic reaction to hair dye. A 47-year-old woman had her cornea destroyed by a mascara wand. In another tragic case, a woman's hair caught fire as a result of an inflammable hair treatment gel. She lost her hair and was severely scarred. Beauty parlor employees are particularly vulnerable to asthma and other diseases that result from exposure to chemicals in the products that they use. In fact, for every 1 million cosmetic products purchased, there are more than 200 visits to the doctor to treat cosmetic-caused illnesses. In 1987, a study for the Consumer Product Safety Commission found that, in 1 year alone, cosmetic products resulted in 47,000 emergency room visits. These severe reactions are only the tip of the iceberg. As the GAO study points out, available estimates of cosmetic-related injuries do not accurately reflect the extent to which consumers are exposed to toxic cosmetic products and ingredients. Because symptoms of chronic toxic effects may not occur until months or years after exposure. The injury estimates generally account for only the acute toxic effects-- the effects that are seen right away. It is a fact that many of the ingredients, according to the GAO, included in many products are toxic in nature, maybe carcinogens, that take time to work their way through the body system and only later reflect themselves in incidence of cancer, or assaults on the nervous system, or birth defects long after they are used. In the face of limited Federal authority to protect the public against these hazards, and the even more limited resources devoted to preventing them, you would think that the Congress would want to encourage the States to fill the regulatory vacuum. Since the Federal Government is not doing it, you would think we would want the States to make sure that they are protecting their consumers. That is logical. We are talking about a health and safety issue. We are not talking about the economic regulations. We are talking about health and safety issues. If we are not going to have a responsibility in doing it, you would think we would want the States to move ahead and at least ensure the protections. But not in this legislation. Effectively we are preempting the States--telling the States they can't do it. We are not doing it, and we are not going to permit the States to do it either, ever. That is the effect of the provisions that have been included and added on to the bill in Committee--not in the initial proposal offered by Senator Kassebaum, not in the initial proposal offered by Senator Jeffords. It was one of the last of the amendments that were considered. There have been no hearings on this issue since 1978, 1988 in the House of Representatives. Still we have moved ahead, basically at the whim of the cosmetic industry, a $20 billion industry. This bill entirely bars the States from regulating packaging and labeling and places severe limits on the States' ability to establish other forms of regulation. Mr. President, just listen to this language on the scope of the preemption provision on the packaging or labeling of a cosmetic: `` * * * shall be deemed to include any requirement relating to public information, or any other form of public communication relating to the safety or effectiveness of a drug or cosmetic.'' There it is, clear as can be; no more information for the people of California, no more information for the people in the Midwest or the East. This is what it says. ``This preemption shall be deemed to include any requirement relating to public information, or any other form of public communication relating to the safety or effectiveness of a drug or cosmetic.'' We don't do it at the Federal level, and we are denying the States the opportunity. What is the cosmetic industry so afraid of that they are precluding any public information or any other form of public communication relating to safety? What are they so frightened about? Is the almighty dollar worth that much when you are talking about carcinogens and toxic substances? There it is, Mr. President, as clear as can be. The language, no warning labels, no information that a product contains carcinogens or can cause severe allergic reactions; no ``keep out of the reach of children'' labels; no notification that a product has been recalled because it is dangerous or adulterated; no expiration dates. Mexico requires expiration dates. The European Union has expiration dates. Sri Lanka has expiration dates. But no way--particularly in products such as mascara that can deteriorate and adulterate and cause serious threats to people's eyes--no expiration dates. The materials have been held in terms of the danger of mascara over a period of time without endanger rates or warnings to the public that use mascara; no preemption, right here in this legislation. We are talking about health and safety. That is why we voted on this measure--health and safety issues. We have already spent more time on this issue now this morning than we spent in the committee in its discussion. No ``keep out of the reach of children'' labels; no notification that a product has been recalled because it is dangerous or adulterated; no notification. The cosmetic industry seems to believe that for purchases of their products ignorance is bliss. In fact, what you don't know today can severely injury you, or even kill you. Some States are already taking an active role in protecting consumers. Many more may do so in the future. But not if this bill becomes law. Minnesota has passed a hazardous product labeling bill requiring a warning on all products that are ignitable, corrosive, reactive, or toxic. You would think that all consumers should be entitled to that kind of information about products which they put on their faces or spray on their hair or wash their bodies with. But the cosmetic industry disagrees. California requires notification if a product contains carcinogens or reproductive toxins that cause birth defects. You would think every consumer should be entitled to that information. Not after you pass this provision. When you take the time later in this debate to go through each of these and show the medical information, the study, the research which supports that finding, there are products that contain carcinogens and reproductive toxins. The studies have been done by some of the great research institutions in this country, but the data from their studies, warnings to expectant mothers, or to others who are going to use that product cannot be communicated to the American public by the States. That authority will be gone. You can do all the research you want, find everything you want, but that authority will be gone. It is out. You would think that the consumer should be entitled to that information. We had support for nutritional labeling around here for consumers to have information. It is one of our most important achievements, that people have some idea of the nutritional content of their diets, their fiber, and the various nutritional elements included in those. People want to know. That is enormously important in terms of the general health and dietary needs of the American people. But here we are talking about carcinogens. We are talking about toxic substances. We have the information that is being made available to the public on the one hand. But when it comes back to items that are going to endanger the health and safety, we are saying, no way--no at the Federal level and no at the State level. Texas is investigating hormone creams that may affect the reproductive health of young women. You would think the States should be encouraged to take this kind of action. But this law prohibits it. New York requires expiration dates on cosmetics because products can break down and be subject to bacterial contamination after a certain time period. Most of you would think that this is basic information that every consumer should have. But not the cosmetics industry. If you want to try to say, OK; we had a preemption of various States' activities with regard to food and nutrition, yes. We did. We worked that process out. It was worked out with the various interests of the American consumer, and it is protected. If you want to go back and see where you want to have a national program in terms of preemption in terms of these dangers, you are going to talk about a completely different regulation. But that isn't recommended. That isn't suggested. That isn't talked about. That isn't being considered here. No. All it is saying is you are not doing it here at the Federal level. Legislation under the Food and Drug Act doesn't permit you to do it, right in that page and a half. It shows that they don't have the authority to do it. And we are not going to permit you to do it at the State level. Mr. President, this provision of the bill is an example of what I consider to be the worst kind of sweetheart deal for special interests at the expense of the public interest. It is intolerable that it should be included in a bill that purports to be the Food and Drug Administration Modernization and Accountability Act. We are supposed to be out here modernizing the FDA, on the one hand, balancing the very important public health interests and also trying to consider the legitimate interest of the patient and the consumers using medical devices and new pharmacy products. That is a balance. It is a difficult and a complex one. You want to bring on line the new kinds of innovative products. But you don't want to do it if it poses a threat to public safety. That is a balance. And we have differences about the time, the process, and the procedure. Those are legitimate public health debates and discussions. But not with regard to cosmetics. So we have worked through the whole area with regard to pharmaceuticals and with regard to devices. There are two items which I think are of major importance that still need to be addressed. We have made very significant and important progress on the matters that are enormously important to the health and the safety of the American public. And because that train is going down the track, here comes an old industry, the cosmetic industry, to hook this sweetheart deal right on it; hook right on it. I hope we are not going to hear from other Members that we now need to have hearings now on various other issues after what we have seen on the cosmetics. I hope we are not going to have those issues. I heard the other day that we need more study in terms of the testing of children. We need more hearings on all of this. We have had extensive hearings over in the House and some hearings over here. But we need many more days of hearings before we jump into this at this direction-- when you are talking about health and safety. And that has effectively never been done. Another unacceptable part of this bill, Mr. President, contains the two provisions dealing with the safety of medical devices, which I will come to in just a few moments. I see a friend and colleague, the Senator from Rhode Island, here on the floor. I would be glad to yield to him whatever time he might take.

Mr. KENNEDY. I thank the Chair. The legislation we are debating today includes many positive elements. It reauthorizes the important prescription drug user fee program, one of the most effective regulatory reforms ever enacted. It includes a number of other provisions that will significantly improve and streamline the regulation of prescription drugs, biologic products, and medical devices. And I am pleased that through a long process of negotiation, both prior to and subsequent to the markup of the legislation, many provisions that seriously threaten public health and safety were dropped or compromised. But a bill that includes the damaging provisions that remain in this bill, should not become law. I have received a letter this morning from the Administration announcing their opposition to these provisions and their judgment that the bill should be vetoed if they are not eliminated. It would be the height of folly for the Senate to doom this important legislation to failure by taking it up before the provisions that merit a veto are removed or changed. The provisions that make this bill unworthy of passage by the Senate include: The preemption of State regulation of cosmetics and over-the- counter medicines; the elimination of two important protections against unsafe or ineffective medical devices, including a provision that could undercut FDA's ability to regulate cigarettes, and a backdoor assault on one of the most important environmental protections. The most egregious and unjustified provision in this bill would effectively preempt the State regulation of over-the-counter drugs and cosmetics. These provisions were not included in the chairman's original mark. They were not the subject of significant hearings. They have no place in a bill whose primary purpose is to reauthorize the Prescription Drug User Act. If this bill were serious about dealing with issues of over-the- counter drug and cosmetic regulation, it would undertake a serious reform of the whole regulatory structure to assure that consumers are adequately protected and not include a single provision designed to protect the profits of wealthy companies at the expense of the health of consumers. Preemption of cosmetic regulation is fundamentally outrageous and shows a callous disregard for the health of American women, especially those who are pregnant. It shows a callous disregard for the likelihood of birth defects in newborn babies. Cosmetics are used far more broadly than most prescription drugs, medical devices, and biologic products. Whether the issue is hair spray, or shampoo, or lipstick, or baby powder, or suntan lotion, or soap, or toothpaste, Americans assume that the products they use are safe. But this confidence is too often unjustified because Federal oversight of this $20 billion industry today is extremely limited. The basic law regulating cosmetics has not been updated since 1938. The FDA has less than 30 employees overseeing this huge industry. Only two deal with packaging and labeling. The legislation, Mr. President, the food and drug and related law, has 126 pages dealing with drugs and devices. It has 55 pages for foods. It has 1\1/2\ pages of Federal law dealing with cosmetics. It basically does not deal with regulating the cosmetics of this Nation. The FDA has no authority to require manufacturers of cosmetics to register their plans or products. The FDA has no authority to require manufacturers to register their plans or products. It cannot require manufacturers to file data on the ingredients of their products. So there is no information with regard to the ingredients of their products. That is completely different, obviously, from the complex and vigorous review schedules which are places for pharmaceuticals and for medical devices. The FDA cannot require the manufacturers of cosmetics to file data on the ingredients in their products. It cannot compel manufacturers to file reports on cosmetics-related injuries. It cannot require their products be tested for safety, nor can it require that the results of safety testing be made available to the agency. It has no power, as it does with prescription drugs and medical devices, to require that the tests be done or that they gather information as a result of tests. It has no oversight authority in terms of making sure there are safe manufactured products. None of that currently exists with regard to cosmetics. The FDA does not have the right of access to manufacturers' records, and it cannot require recall of a product. The FDA is virtually outside the loop with regard to giving assurances to the American people about the health and safety of their products. This is unlike prescription drugs, it is unlike over-the-counter drugs, it is unlike medical devices. The FDA is outside the loop. A study by the respected, nonpartisan General Accounting Office reported that more than 125 ingredients available for use in cosmetics are suspected of causing cancer. Twenty cosmetic ingredients may cause adverse effects on the nervous system, including headaches, drowsiness, and convulsions. Twenty cosmetic ingredients are suspected of causing birth defects. The GAO concluded that cosmetics are being marketed in the United States that may pose a serious hazard to the public. That is the GAO. They concluded that cosmetics are being marketed in the United States that may pose a serious hazard to the public. The legislation that is before us is saying that the States should not be able to do anything about it. This is the primary issue in terms of the health the American people--may we have order, Mr. President?

Mr. KENNEDY. Yes.

Mr. KENNEDY. Mr. President, I thank the Senator from Rhode Island for raising those issues, because that is a rather technical issue, it is a rather targeted question, but one that is of very significant importance. I certainly agree with the Senator that we don't believe that the overwhelming majority of the medical device manufacturers don't intend to do such things. But what we have to try and do is make sure that those who may want to--and that is basically what happens in any regulatory procedure--you want to try and catch those particular items which are dangerous; that this is one that, with the tremendous expansion, in terms of certainly medical device technology, that we should address. I appreciate the Senator saying that it can be addressed. We had language that we had considered, that I thought the device industry had been very supportive of and was acceptable. Then in the rush at the end, somehow individuals who had been involved in it felt they didn't want to have any further kind of adjustment or change in the language. I think it is significant--and I am sure the Senator would agree and the chairman would agree--that we have had, in the fashioning of this bill great support and cooperation from the industry, from the pharmaceutical and also the device industry. We have perhaps some differences that have been moving along on particular kinds of items, but I must say--and I think the Senator would agree; I know he is proud of the industry in his own State, as I am in my State--we have had enormous cooperation and help. So many of these items are technologically difficult, complicated, and involved. We are basically generalists as Members of the Senate. We have some information and try to develop some expertise in particular areas of responsibility, but this gets to an involvement in detail which is enormously complex. When we have responsible industry involvement trying to help us. I did find that in other parts of the legislation it was very helpful. What we hope to do as this whole process moves ahead is come back and visit this provision and see if we cannot address it.

Mr. KENNEDY. Mr. President, the letter says: The second issue relates to what FDA may consider in making substantial equivalence determinations for newly marketed devices. For example, the bill requires the agency to review the intended use of a new device based on the manufacturer's proposed labeling, even if the device's technology clearly indicates the device will be used for a use not included in the labeling. So I think the point the Senator makes where they get approval for a particular purpose, it might be easier to get it for one purpose but with the clear intention of marketing for another purpose in which there has not been testing, and that can produce a hazard to the individual. We have seen, for example, in some of the laser technologies that they have been approved for certain kinds of cutting procedures, and then they have been in certain instances adopted, for example, for prostate cancer, where they have not been tested and have not been effectively cleared and pose some very important health hazards. So this is something that is very important, as we are moving through innovation, because we want to make sure we get those innovations. We want to make sure that the products are tested and have full information and disclosure. I thought we worked out language to try and deal with that. It is an important health issue, and I appreciate the Senator's focus and attention on it. It is a matter of sufficient importance in terms of public health that we would have this identified by the Secretary as being one of the two or three items that the Secretary has identified would pose sufficient health hazard as to indicate a recommendation for a veto.

Mr. KENNEDY. The Senator is quite correct. In the Secretary's letter, she mentioned several items. I ask unanimous consent that the letter be printed in the Record.

Mr. KENNEDY. I thank the Senator very much for identifying not only this issue on cosmetics, but also the issue of the medical devices proposal. That is an extremely important measure. Obviously, if there is advertisement and an intention for a certain kind of purpose and technologically it is suitable for that purpose, it meets the health and safety standards to be used for other kinds of purposes, that raises some very, very important questions. The particular example that the Senator gave with regard to the biopsy needle is a current one. We understand it might be a suitable device in getting a biopsy in terms of cancer, but there are those actually using it to extract certain kinds of tumors. Whether it does that or not--and people assume it is going to be effective in doing that because it is used for other purposes --this is something that the device has not been tested for or intended. I think they there are very important health issues that are related and can be addressed. There are ways of trying to address those particular issues. We have tried to do this, and we still have important health and safety issues which I think are unresolved.

Mr. KENNEDY. Mr. President, I understand we have a time agreement, am I correct? Would the Chair be kind enough to state it?

Mr. KENNEDY

Mr. KENNEDY. Mr. President, I ask unanimous consent that the order for the quorum call be rescinded.

Mr. KENNEDY. Mr. President, I was pointing out how the change in the complexity of the different products had taken place from 1938 and the number of products that were out there; the number of potentially dangerous products that were out there and the progress that had been made from the time when there were only a few hundred of them; back to 1938. Listen to what we have now at the present time. This is according to the Food and Drug Administration and the studies that have been done. The number of cosmetic ingredients in the industry's own inventory is over 7,500. The industry has been adding new ingredients at a rate of 1,000 per year for the last few years. Virtually none of these ingredients have been properly tested for safety. The industry's safety review process has reviewed only 450 of the most commonly used cosmetic ingredients. That is about 20 a year. At this rate, even using the industry's own process, it will be many years before new ingredients are considered for safety. So the sheer number of cosmetic ingredients in products makes safety assurance difficult. And most adverse reactions for cosmetics are immediate burns or irritation--long-term effects which do not show up for many years, such as cancer or reproductive effects are even more difficult to determine. They require special studies designed to measure this risk, while many ingredients are studied for only short- term effects when they are added to products. Risk of cancer or reproductive effects are not available for the vast majority of cosmetic ingredients. Mr. President, we have been talking here this morning and this noontime about the authority and responsibility of different agencies. We have been talking about the power of the States. We have been talking about rules and regulations. But, when we are talking about health and safety, we are talking about real people. Let me give you the kinds of examples that we are dealing with. A woman from Santa Rosa--this is 1995, April 22--complained about an acrylic product which is for nails. She had the product applied to her nails. The product burned, and the cosmetician tried to remove it. Since the incident, six of her nails have fallen out. That was according to the California Department of Health Services, in April 22, 1995. Here is another one. On her 29th birthday, a woman from New Jersey was supposed to retire from the career she loved. She was a hairdresser for 11 years until a series of ailments, including difficulty breathing, burns in her sinuses and severe headaches prompted her to quit in August 1985. Her doctors had concluded that the beauty products she used on the job led to her medical problems. She had no idea what was actually in the products which she used in her beautician job. Lack of labeling is neither unusual nor illegal, although cosmetic manufacturers are required to list ingredients containing products sold to consumers. They need not do so for products sold for use only by professionals. Another case is Carolyn, a secretary from Rockville, MD. She arrived at a wedding shower and realized the permanent she had received at a beauty salon the day before resulted in a red swollen, face. Carolyn's is a case of cosmetic contact dermatitis, also known as acute allergic inflammation of the skin caused by contact with various substances found in cosmetics, including materials used by the hair stylist. This is a case that was reported to the FDA. A 33-year-old housewife consulted her dermatologist because of inflammation of her hands, face, and neck. She had experienced two similar episodes earlier in the year. After the skin properly healed, the physician determined through appropriate testing, that Swedish formula lotion had caused the adverse reaction. A telephone company supervisor was hospitalized after a 2-year history of chronic irritation of her eyelids. She received a variety of topical medications without relief. Her contact history revealed a long list of cosmetic eye drops, and multiple spray perfumes. All the cosmetics were removed from her hospital environment, and after her skin healed, patch testing showed lanolin in her creams--lanolin in her creams--was causing her condition. That is from a subcommittee hearing on health. The use of chemical skin peeling products caused severe injuries, including reports of skin burns from using a product called Peel Away. FDA sources said such products can penetrate the skin too deeply causing severe skin damages. In several cases persons have been hospitalized with severe burns, swelling, and pain. In one case, a California woman suffered seizures, shock, and second-degree burns after a combination of skin peel chemicals was applied to her legs by a beautician. Skin peeling procedures used to be carried on by plastic surgeons. However, they are now being done by nonmedical professionals, by beauticians and some using newly marketed preparations. Many have inadequate instructions. None has been approved by the FDA as being safe and effective. Again, an FDA consumer report. A letter from the CDC cited nine cases of eye infections due to microorganisms contained in mascara. One was a 47-year-old woman who developed a corneal abscess within days of scratching her eye with a mascara wand. The woman eventually needed a corneal transplant. As I understand it, it is because of the failure to be able to indicate that mascara needs an expiration date. So, Mr. President, this list goes on. I want to show what the States have been doing with regard to the protection for the American consumer. The issue now that is before the Senate on the FDA reform deals with the medical devices and pharmaceuticals and the extension of what we call the PDUFA, which will help to expedite the consideration of those measures. By and large, there is strong bipartisan agreement to those provisions. There are several that have been identified today that need further attention, but men and women of good will can work that out and work it out with the administration so that we can have a successful conclusion. But what was not considered in the original bill is the provisions that apply to preempting the States from giving protections to their consumers on the use of cosmetics. What we have recognized in this debate is that the Food and Drug Administration does not today have the authority, power, or personnel to protect the American consumer on the issue of these cosmetics. What we know overwhelmingly today is that the number of dangerous and toxic products and the number of carcinogens has expanded exponentially and is continuing to expand. All you have to do is look at the past record, of the numbers that have been introduced, and it is continuing and continuing to grow and those products are not being tested adequately today. So who has been protecting the American consumer? Who has been protecting the American public? The States have been doing it, and primarily California has been doing it, under the legislation which they have passed. How important that has been. It has not ended up with actions that have been taken by the State of California as the result of very extensive studies that products have been removed. What has happened is that the producers and the manufacturers have withdrawn the product, addressed the problem, put it back on the market, and by and large, if you look at the advertising, they would say the product is better today than it was yesterday. That has been the record. That has been the record. And that is why this is so important. Just review with me, Mr. President, the extent of this preemption--as I mentioned before, the extent of this preemption of the cosmetic industry in the States. This is the language that there will be the preemption for--``labeling of cosmetics shall be deemed to include any requirement relating to public information or any other form of public communication relating to the safety or effectiveness of a drug or cosmetic.'' There it is in the legislation. They are effectively saying no to the States in providing public information or any public communication relating to safety. If the States are trying to protect their people and they develop public information on the basis of scientific studies, they are prohibited under this legislation. I don't know what the penalties are. I don't know what the civil penalties are, but they must be in there. They are prohibited from providing public information or any form of public communication relating to safety or effectiveness. That is what the cosmetic industry is doing in this legislation. That is the disdain that the cosmetic industry has for those in the States who are trying to protect the public. That is the arrogance that this industry has for legislators or Governors or attorneys general or medical professionals who are interested in the public. This is what this says. You cannot do it. You cannot provide public information even with regard to safety. That is arrogance. That is greed. That is the greed of a $20 billion industry. What do the States say? Well, why are you so worked up, Senator? It isn't just myself. Again, we have shown we have the letters from the Governors, the State legislators. This is not just one Senator's position. This happens to be the position of the Governors and the State legislators. Yes, I listened to the comments of my friend and colleague, Senator Jeffords, about the general statements of two of the Governors with regard to the health provisions on pharmaceuticals and devices, that is, an admirable job has been done. I think we still have areas to deal with. But I would certainly sign on to that. But what we are talking about is what we are saying to the States. The cosmetic industry is saying to the States you are not going to stick your nose in and protect the consumers there. What have they done in the past? Why are the other Governors worked up about it? Because of what these two charts demonstrate, Mr. President. Here we have the issue of lead which is known to cause birth defects and has also been found in hair dye. That is the result of State action, of State analysis, of various hair dyes that are out there that contain lead product. Initially, when there was the analysis, they said, well, this really isn't dangerous because it is just on the scalp. Then they did additional kinds of studies and found that the lead got into the individuals, obviously, who were using it. That lead was passed on to pets, children playing with pets, children ingesting it and when people are washing their hair day after day after day it causes a birth defect. Lead is one of the principal causes of mental retardation among children, period. We find, as a result of State activity, they have found it and it has been changed in many, many of the products--not all of them, because the cosmetic industry was able to get an exclusion from some participation. Mercury, which can cause mental retardation, has been found in lipstick and nail polish--lipstick and nail polish, mercury. With all the implications that has in terms of women's health and in terms of safe pregnancies, it is found in lipstick and nail polish. That was another study that was done in California. Alpha hydroxy, a known carcinogen, has been found in face creams. That was not done by the Food and Drug Administration. That is a result of State activities. There is not a physician in this country who does not know the dangers of lead and mercury and the alpha hydroxy to the American consumer, primarily women. There isn't a doctor who will not tell you that. Yet this legislation is saying, no more. This legislation is saying, no more. ``Any requirement relating to public information or any other form of public communication relating to safety or effectiveness of the drug or cosmetic''--preempted. So we are saying, if you find this out, we are preempting you. You are not going to have to tell the public. As a result of State regulation protecting consumers, we have seen that States forced the removal of reproductive toxins from lipstick and nail polish. That is a result of State action. You have to admire the resourcefulness, the innovativeness, the persistence of the leaders in States that have had the courage and the determination and have been willing to take on the cosmetic industry, the cosmetic industry that by its own agreement spends 70 percent of its lobbying dollars in the States rather than on the Federal Government. You can understand that, because we haven't got any power over it, so they have targeted it in the States. Yet you find the courage of State public health officials who have been willing to force the removal of reproductive toxins from lipstick and nail polish. They didn't take the products off the markets. The manufacturers took them off the market and they addressed those issues. States forced the removal of harmful lead from hair dyes and antacids and calcium supplements. The States forced the removal of mercury from suppositories. These are just examples. How do we know how many other dangers there are out there when we have an explosion of dangerous products that have been agreed to by Republican and Democratic leaders of the FDA over the period of years-- increasing exponentially with the dangers of toxins and carcinogens. The problem isn't getting less. The problem and the danger is getting more as every consumer understands the range of additional kinds of products that are out there and available to them. Nonetheless, we are asked on the floor of the Senate to say no to the States. We are not doing it at the Federal level. As I mentioned before, if you said, well, we are going to have a whole review, regulatory review, we are going back to say, OK, we will preempt the States but we will find out what we are going to do with regard to providing protection--we have had, as I mentioned earlier, the GAO studies that have been done 10 years ago which made a series of recommendations to the Congress about steps we ought to take if we are going to protect the public--then maybe, maybe then it makes some sense. But we have not done that. We have not done that. The FDA has been starved in resources to even fulfill its requirement for protection in terms of the American consumers in medical devices and with regard to pharmaceuticals. So we have a situation where we have limited, limited, limited authority under the FDA to protect the public for a range of these cosmetics. We find a record today where you are getting the explosion of these dangerous products, of toxins and carcinogens. Carcinogens cause cancer--cause cancer. We are seeing those numbers expand. We are finding completely inadequate policing by the cosmetics industry. We find the only breath of air that is out there to protect the public is the States. California is leading the way. Thank God, at least California has been grandfathered in. What we are saying is California is grandfathered in, but my State of Massachusetts, which is just about to pass a similar law, is out. We cannot protect people. Washington knows best. Washington is saying to Massachusetts, no matter how you want to protect your consumers up there, you can't do it because we are preempting you. Come on, Mr. President. This is a health issue. This is a safety issue. This involves primarily women, it involves children, and to some degree men in our society. But it involves health and safety. We have thousands and thousands of complaints about various products. I indicated earlier today--maybe I didn't--about the number of people-- there were 47,000 cosmetic-related injuries in the emergency rooms in American hospitals in 1987--47,000. I wonder how many today, with greater utilization of cosmetics, greater danger, more toxins, more carcinogens. These are just the emergencies. These are not the kinds of situations that maybe--they may be--have long festering, long lasting kinds of implications and have been festering for a long period of time. That is what is happening out there--47,000 cosmetic-related injuries in the emergency rooms. How many others where people go back to their doctor and do not go through the emergency room? How many others? We have scores, scores and scores of complaints that have come to the FDA, and they go down the list. Thousands of consumer complaints in 1996 alone: Equate Baby Oil--these are complaints to the FDA--their complaints are eye tissue damage. Disney Kid Care Bubble Bath: urogenital track reactions. Nat Robins Eye Shadow Pencils: eye rash, burns and irritation. Flame Glow No Mistake Eyeliner Pen, black magic color: Rash, burns, and irritation. Incredible Lex Mascara, Eye Perfector, Dramatic Timing Faceneck, Covergirl Professional Advanced Mascara: rash and burns. These are the companies. You have the Disney Co., the Reckitt & Colman Co., Softsoap Enterprises, Great American Cosmetic. They produce Nat Robins eye shadow pencils. You have Del Laboratories, Estee Lauder eye shadow; Avon products; Procter & Gamble, rash and burns. You have Helene Curtis, Salon Selective Styling, flammable, resulting in thermal burns. You have American Pride, hair relaxer, Alberto Culver lotions, hair tissue damage and hair loss. You have Clairol, Clairol Infusion 23 Shampoo, hair loss and hair tissue damage; Del Laboratories; You have Products Naturistics Mango Shampoo, hair loss and damage; Helene Curtis, Suave Balsam and Protein Shampoo, hair loss, hair damage. Vigoral--we find hair loss and tissue damage. Alberto Culver Co., VO5, hot oil concentrated treatment, hair loss and tissue damage; Hydrox Laboratories, Fresh Moment Mouthwash, mouth infections--mouth infections; Carter Wallace, Arrid deodorant, bleeding and infection with utilization; Apollo Health Care, Baby Bear Lotion, pain, including itching, stinging, burning, and soreness. Mr. President, these are just some of the items. I may very well include the whole list in the Record on Monday. These just give an example of some of the leading companies. Some may say, these are not really accurate. We would know whether they are accurate if we were able to give the assurances that we had those in the States who were looking into this and be able to say, ``Look, this isn't a problem.'' But now we are not going to know because all the States are preempted. Now we are going to find these reports are going to come in more and more. We will have to just presume that they are accurate, because the cosmetic industry will not let us find out whether they are or are not accurate. They will not permit the publication of information that is going to reflect poorly on either safety or effectiveness. Mr. President, these are just some of the items that I think form the compelling case for State action. I think we will on Monday go through some of the particular cases in more detail on the California situation, because I think that they have really had the soundest record. It isn't easy to get this kind of information, but we will go through it. These that I just mentioned are some of the thousands of consumer complaints to Government agencies. This is only for a few months of the year, and I have read just a very few of them. I will perhaps get into even more of them later on. Mr. President, I mentioned earlier a study by the General Accounting Office which reported that more than 125 ingredients used today are suspected of causing cancer. We have scores of cosmetic ingredients that can damage the nervous system, including headaches, drowsiness, convulsions. To all of those watching this program I would say, ``don't discount the fact that perhaps some of your ailments--headaches, drowsiness, and convulsions--may actually be resulting from the use of cosmetics.'' Don't discount that, because the record shows that cosmetics manufacturers are including ingredients that can cause those symptoms. You don't know, your State won't know, the Federal Government won't know, we won't be able to tell you because of the power of the cosmetic industry in foreclosing that kind of study and the publication of information about the real health implications. The GAO found that additional Federal authority is necessary to protect the public. That is the General Accounting Office. It is not this Senator from Massachusetts, not a Democrat, it is not a Republican. Here is the General Accounting Office reaching the conclusion, after reviewing this whole subject matter, that if you want to protect the public, you need greater Federal authority--we are not getting that today. The only authority that we have out there is at the State level, and this bill is taking that away. How much do we have to yield to the greed of this industry? How much? And why? Why should we do it? We patch together something that will take care of California because they passed their law a couple of years ago. But we say to the other 49 States, ``You can't, you are never going to be able to do it again, never be able to do it again, ever.'' They have been able to protect their consumers. Hopefully, they will be protecting the people of Massachusetts, because that is the only way we are going to be protected, not at the Federal level, but through their own leaders, legislature, and representatives. No, we are just saying absolutely not. So, Mr. President, the cosmetic industry wants the public to believe that no effective regulation is necessary or desirable. They are masters of the slick ad and expensive public relations campaign, but all the glamour in the world cannot obscure the facts. Mr. President, I just showed what the results of some of these actions are in terms of affecting people. I mentioned the peelaway product. This is a before and after appearance and complaint of the peelaway product. You can take a look and see what happens to people. These are various ingredients which have been put on an individual's feet. Look at the reactions to it. We are saying, no, we are not going to permit the States to try and do something about that kind of activity. And we could have had a whole series of charts up here. I mentioned just a few moments ago what was happening in terms of burns and irritations that are occurring with skin products and what is happening to eye tissue and what is happening with rash and burns and hair tissue and hair loss and mouth infections and bleeding--the list goes on and on. We could have had charts all around this room. Generally speaking, when you have this kind of circumstance, we would be in here debating what to do about it. Instead of thinking about what we are going to do about it, we are talking about what we are not going to do about it. Mr. President, here we have seen what the States have done, what the problems have been, what the dangers are to the American consumer in terms of mercury, lead, and other substances in products that everyone knows are dangerous and are health hazards. Here we have a problem, and it is getting bigger. The products that are being produced for the market are more dangerous. Yet, we are doing less and less and tying the hands of the local communities to act in our stead. We allow States to decide whether your bottles are going to be recycled or whether they are going to be buried. We permit the States to decide what they are going to do about licensing barbers. States decide and have rules and regulations and laws about pets. We have States that have rules and regulations about how close to the crosswalk you can park your car. We have regulations in the States about what store hours are going to be, how late a store can be open. But this bill would prohibit the States from protecting consumers from lipsticks, hair creams and the soaps, hair dyes, mascara, and deodorants that can give you cancer or can catch you on fire as a result of flammable ingredients, or cause serious birth defects. Now, does that make any sense at all? Does that make any sense at all? When you have the most serious dangers in terms of health and safety, we are denying States the opportunity to do something about it, but we will let them go ahead and look after these other kinds of issues which are not related in any particular way to health and safety. It just doesn't make any sense. It makes no sense at all. The proponents of this provision know they couldn't pass this legislation if it wasn't tagged on to the Food and Drug Administration bill. They wouldn't dare bring this legislation out here on its own. The reason they tagged it on this bill is because they knew the importance of food and drug reform. They knew that we had to pass the extension of PDUFA, which is a key program to provide sufficient resources to the Food and Drug Administration to get the qualified people who can help expedite the more rapid consideration of new products, new pharmaceuticals in the Food and Drug Administration and has been very creatively utilized over there. So what do they do? They tag this on to that train. This legislation would be laughed out of this body if it came up here on its own. Why don't they try to bring it up on its own? We have Members in the Senate say, ``We don't understand, there are just one or two Senators troubled by this.'' All the Governors seem to be troubled by it, and you can't blame them. They have the fundamental responsibility for protecting health and safety. That has been fundamentally a responsibility at the State and local level. It is a fundamental responsibility that is as old as this country. So the Governors don't buy into this. The administration understands that this thing is a phony grab, a greedy grab for profit, because that is what it is. It will mean that the various cosmetic industries are not going to have to be altering or changing their products because you are not going to have the research being done or the authority in the States to bring changes that would make products safer. It is going to mean more profits. On the one hand, more profits for the cosmetic industry and much greater health threats in terms of safety, in terms of potential birth defects for infants, for various kinds of ingested products with a whole range of sensitivity to the body--eyes, mouth, ears, hair--and the problems of lips and the ingestion of various products that are dangerous. (Mr. COVERDELL assumed the chair.)

Mr. KENNEDY. It just defies any logic. So, as we all know--we have been around here--hopefully even the newer Members understand this one, where you get something that is going through and can't make it on its own, and is added at the last or next-to-last markup with just a fraction of the discussion as we have had to date out here today during this consideration, and it is locked in. That cosmetic industry is just smiling. They are smiling now with the votes that they had down there saying, ``Well, it seems we've got through this hurdle.'' I am just telling you, this is a long, long process. And they better get used to the fact there is going to be a long process, because this issue is not going to go away. It is not going to go away today, and it is not going to go away when we talk about this some more on Tuesday and get more information. It is not going to go away on Tuesday and not going to go away in terms of the consideration of the legislation. It is not going to go away for a long, long time. Amazing about how a measure like this can slow something down over a long time so that the American people can begin to understand what is really at risk. I do not believe that they do. I wonder how many Members of this body have read through the legislation and understood exactly what was included in terms of the cosmetic program. So with this particular proposal in there, we are going to have to ensure that we are going to have the kind of full awareness and understanding, not only by our colleagues here but the American people as well, as to what the health implications are. This has important and significant health implications. We deal with a variety of different proposals in terms of education--the HOPE scholarship, the tuition credit, the work-study programs--and we debate those and discuss those and allocate resources to those, trying to decide how much we are going to provide in terms of the Head Start Program. Will it be 59,000 new children this year or 100,000? At the end of the day we may understand that our side does not win, others prevail on it, but we know that we have made the battle and made the fight, and the people that are going to be disadvantaged may be those children who are not going to get that benefit in terms of education. And that is a tragedy in terms of a mind developed. But here we are talking about something else that is even much more important. You are talking about the vital health of the American people and the safety of the American people. You are talking about the dangers to children and infants and about the birth of healthy children. You are talking about the dangers to children's eyes, and you are talking about the dangers to people who are trusting just what they see on the shelves of American pharmacies across the country. I would say that 9 out of 10 Americans who walk into any pharmacy this afternoon and see a product on the shelf are saying, ``Well, this is just sort of like my medicine or just about like the other products that I'm buying here. Somebody's looked at it, the Food and Drug Administration or somebody's looked at it, and it is safe or it wouldn't be out there.'' That is baloney. It is true for prescription drugs. And by and large it is true about over-the-counter drugs. True about medical devices, by and large. You can flyspeck and find instances, but that is true about those. We have the safest regulatory systems in the world. But it is not true for those products that are on those shelves that so many millions of people are using and have resulted in, in 1 year, 46,000 people going to the emergency room. People do not go to the emergency room unless it is serious. I do not know whether it is $300, $800 to go to an emergency room to get any kind of attention. People might go back to their doctors with good health insurance, go back to their dermatologists to ask them to do it, but how many people are going to the emergency room? Someone with a little burn is not going to that emergency room. Particularly if you are working families and have children and you do not have health insurance, you are not going to be going down. How many other people did not go and still were adversely affected? But we say, ``Oh, no, no, no, we're not going to do anything about that.'' Whatever was being done out there by the States--that is out now. You cannot go forward with it. So, Mr. President, the cosmetics industry wants the public to believe there is no effective regulation that is necessary or desirable. They are masters of the slick ad and expensive public relations campaign. But all the glamorous pictures in the world cannot obscure the facts. This is an industry that is underregulated and its products are too often hazardous. The severe reactions may be only the tip of the iceberg. Long-term illnesses, ranging from cancer to birth defects, may not be linked to their underlying cosmetic-related causes. As the GAO points out, ``Available estimates of cosmetic-related injuries do not accurately reflect the extent to which consumers are exposed to toxic cosmetic products and ingredients. Because symptoms of chronic toxic effects may not occur until months or years after exposure, injury estimates generally account for only acute toxic effects.'' The GAO is saying that with those 46,000 people that are going to the emergency room, that is only the tip of the iceberg. And Lord only knows, if you did not have State action in taking away the lead and the mercury and the other kinds of poisonous products that are cancer forming there would be even a much more dramatic number for it. Here we have the GAO effectively saying that because the symptoms of chronic toxic effects may not occur until months after exposure, injury estimates generally account for only acute toxic effects. We see that in 1987 we had 46,000 of what we know now was the exponential increase in the danger of all these products. We can imagine the dangers that exist out there today. In light of this limited authority and even more limited resources to protect the public, you would think Congress would want to encourage States to fill the regulatory vacuum. You would think we would be out here asking, what can we do to help, if anything, the States that are trying to address protections for their consumers? What can we do with the Centers for Disease Control to help Massachusetts, to help Georgia, help North or South Carolina? What are the resources that are out there to assist your State legislatures, Republican and Democrat, to provide protection from some of these toxic or carcinogen problems? But, oh, no, we are not out there asking that this afternoon. We are out there putting more roadblocks in front of the States in their attempt to do so. In fact, the language is so extreme the States have been barred, as I mentioned, from establishing ``any requirement relating to public information or any other form of public communication relating to the safety and effectiveness of a drug or cosmetic.'' So, Mr. President, the last time the Senate looked at the issue of cosmetic regulation was in the late 1970's. We held extensive hearings, and we debated the issue, and we passed a comprehensive bill that included additional authorities for the FDA. Today, we are considering a bill that resulted from no hearings, where there has been little debate, no expert testimony in a product area that touches the American public every day. It should be made clear to anyone that cosmetics are as deserving of adequate regulation as they were 20 years ago. It defies logic that our single action in this important consumer product area is to preempt the States from acting where there is wide agreement that FDA has neither the authority nor the resources to adequately fill the field. An attorney, now with Procter & Gamble, wrote in a 1996 Food and Drug Law Journal article that although cosmetics are regulated by the Food and Drug Administration, ``the agency's regulation is extremely lenient.'' If lenient regulation led to the chamber of horrors documented in the Senate hearings 20 years ago, it is difficult to imagine the impact of preempting the States from acting. The proponents of the bill will tell you their language preempts State safety regulations only--remember we heard that during the course of the day--that their language preempts safety regulations only where the Federal Government has acted. But the actual statutory language is very broad and demonstrates a different intent. The industry admits that the language is drafted specifically to undermine Federal judges that have narrowly interpreted the Federal preemption. For instance, if FDA sets a standard for lead in hair products, this bill would direct a conclusion that the lead level sets the standard for other, unrelated products that might have different routes of exposure. So we know what the industry was doing. You can talk about these issues in generalities, but you have to look at the specific language here. Mr. President, I have no doubt the industry will argue that any little action on FDA's part will preempt State action. Yet we have no assurance the FDA is actually up to the task of filling the void left by the States. Again, we have had no hearings, no public record, no expert testimony. In fact, the industry cannot cite one example of a burdensome State regulation that this law preempts. I hope that if that is not the case, that this record will be clarified. The industry cannot cite--you have not heard in this debate here this afternoon the industry citing one example of a burdensome State regulation. Instead, they suggest that the benefit of this law is prospective. They claim they are concerned about what the States might do in the future. This is legislation for a problem that does not exist. But they see that this was the chance to get on this particular train, and they are riding it. The stark reality is that, according to the cosmetic industry itself, the industry spends 70 percent of its lobbying dollars influencing State legislatures. I suppose we should really call this the FDA Lobbying Relief Act. I find scarce comfort in the fact that this bill will relieve cosmetic lobbyists from having to lobby 50 States, who can now focus on Congress. Even worse, if this provision is enacted, the cosmetic lobbyists will spend their time getting FDA to act in some small way on a safety issue simply to create a broad scope of Federal preemption of the State in that area. This is irresponsible deregulation, putting the proverbial cart before the horse. Let me emphasize that if we want to truly reform the FDA's regulation of cosmetics, we should start with ensuring they are protecting the American public from unsafe cosmetic products. Once the American people can be confident that FDA has the authority and the resources to protect them, that FDA is up to the task, then we can talk about State preemption. That is the way we have always approached State preemption in the past, and that is the only way to approach it now. The proponents of this provision claim that by permitting States to petition for exemptions, there is adequate protection for States rights. In reality, the high procedural hurdles in this provision, especially the extreme, burdensome requirements of formal rulemaking, ensures a lengthy process where industry will entangle States in years of hearings. Given the lack of Federal presence in the area of cosmetic regulation, it is unconscionable to make the States jump through hoops in order to continue to protect and warn their citizens. They finally say, ``Well, OK, you can make some progress and deal with this, but you're going to have to jump through all these hoops.'' How many times have we been hearing on the floor about rules and regulations and the bureaucracy of Federal regulatory agencies, and here we have those that support this proposal on cosmetics setting up hoops for any of the States to jump through--hoops and landmines--hoops for the States to jump through in order to continue to protect and warn their citizens? I assure my colleagues that this is only the first instance of where you will witness efforts at sweeping preemption in the absence of significant Federal activity. We will be faced with a barrage of bills seeking to preempt State authority in the area of public health regulation. It is certainly ironic that this Congress is so determined to undermine States rights. Mr. President, let me emphasize again how this provision hinders States from protecting their citizens at the end of the day. The labeling and packaging of a cosmetic is preempted completely under this language. States will be unable to communicate safety concerns in the most effective and sensible manner--through labeling and packaging. Even if the States retain some vestige of authority over cosmetic safety, this bill ties their hands and prevents them from giving the public the information it needs to make informed choices. ``Right to know'' under this provision means ``right to no information.'' What about the FDA? Today, the FDA has fewer than two people working on labeling and packaging. In fact, most of the 30 people working in the FDA Office of Cosmetics work on the regulation of color additives and not actually on cosmetics. The reason for this underwhelming presence is simple: FDA has put limited resources in the cosmetic program because they simply do not have adequate legal authority to address cosmetic safety. If you can't enforce the law because there is no enforcement authority and because the standards are basically nonexistent, you are not going to squander valuable personnel where there are drugs and medical devices to approve, and foods to keep safe. For example, if the FDA suspects a cosmetic safety problem exists, as they do with the use of alpha-hydroxy, acid face creams, the agency faces high hurdles in bringing any kind of regulatory action. The FDA bears the burden of demonstrating by its own testing that the product is injurious to health. The FDA cannot make the company demonstrate they are selling a safe product. That is important, Mr. President. The FDA cannot come in and say to the company, ``Show us the information for the product you are testing to demonstrate this is a safe product.'' No, they do not have that power or authority. The FDA cannot require the companies to come in, and the FDA, by its own testing has to demonstrate that the product is injurious to health. Today, the FDA knows how many milligrams of aspirin are in a tablet and they know how much sodium is in human or animal food and can require disclosure of this information to consumers, but the FDA does not have to know how much alpha-hydroxy acid is in face cream. The agency cannot even require the cosmetic companies to disclose the presence of a known carcinogen like alpha-hydroxy acid to consumers. We need to understand, Mr. President, that the agency cannot even require the cosmetic companies to disclose the presence of a known carcinogen-- they cannot do it--like alpha-hydroxy, to consumers. It is, frankly, no wonder that 70 percent of the cosmetic industry lobbying takes place in the States because that is where the action is. That is where the standards are being set. That is where the standards are being set and enforced. My colleagues do not have to take my word. We have a letter from the National Governors' Association, Association of Food and Drug officials, and the Association of State Legislatures, voicing strong opposition to this whole provision. We have a letter from the conservative Republican Attorney General of California, Dan Lundgren, strongly opposing this provision, and speaking eloquently about the importance of State laws on cosmetic safety. In my own State we have a bill that would extend the same public health protections enjoyed by California under their right-to-know law, Proposition 65. Proposition 65 is so successful and so popular with California voters that the committee has excluded it from preemption. No one has refuted the positive impact Proposition 65 has had on the public health. No one has. But instead of taking a law that is working so effectively to protect the public and encourage other States to emulate California today, we are debating whether to preempt every State but California. Some of my colleagues have expressed satisfaction with grandfathering Proposition 65. They should delay their celebration. This bill grandfathers Proposition 65 in its current form, which applies to reproductive toxins and carcinogens. But California cannot react to future scientific developments by warning its citizens against other hazardous substances. I will include the whole letter and I ask unanimous consent the complete letter be printed in the Record.

Mr. KENNEDY. Reading from the last paragraph: Proposition 65, as well as the Sherman Food and Drug Law are examples of the type of State regulation that protects the health and safety of its citizens and that coexist comfortably with Federal regulation. The States should be permitted to continue in their historic role as guardians of the welfare of their citizens. We therefore respectfully urge you to seek modification of your bill to address this issue. There it is, Mr. President, from the attorney general of California, a conservative Republican, who understands as a person that has been working and implementing this legislation why this proposal is rotten and why it ought to be adjusted. Mr. President, a few years ago, the agency proposed establishing a cosmetics hotline to receive consumer complaints. The FDA hoped to fill in gaps because their voluntary cosmetics adverse event reporting systems had dismal compliance rates of well below 40 percent. The majority of all cosmetics health problems were going unreported, and here was an ingenious solution. The reason the reporting systems were all voluntary is because the FDA does not have the authority to require companies to tell consumers what kind of problems consumers are having. Put Congress and some heavy lobbying together and you get a congressional prohibition forbidding FDA from establishing the hotline. So we were denying the FDA from having a hotline. When will it stop, Mr. President? We are preempting all of the States, except California, from taking any steps to give the FDA any kind of additional authority. Then when there was the effort to just establish a hotline so people could call in and register their complaints, the funding for that hotline was dropped. I wonder why? I can tell you why. I gave you some examples of why, just a few moments ago, with the consumer complaints to various agencies, including the FDA, with people writing in. No, we are not going to hear from the public. Finally, Mr. President, there was some reference earlier about medical device legislation in Europe. We often hear about FDA's regulation of drugs as the international gold standard. I refer to our country's regulation of cosmetics as the fool's gold standard. Cosmetic regulation in other countries is far superior to our own. The European Union requires full ingredient listing on packaging, documentary proof of good manufacturing practice, and similar proof that extensive testing has been carried out on all products. Mexico recently adopted regulation mandating expiration dates on all cosmetics. Although New York recently adopted just such a rule, it may live a short life--the bill before the Senate would preempt that regulation even if FDA does not have its own regulation in place. Let's continue on our world tour. Canada requires that manufacturers submit data showing that a product is safe under normal use conditions. Sweden is initiating product registration for cosmetics and Denmark is considering a similar law. Malaysia requires mandatory registration of cosmetics. The list goes on, but the point is clear. We are not content to lag behind other countries in protecting our citizens. We prefer to buck the trend and expose them to greater hazards. As experience has shown in other countries and in California with Proposition 65, the industry can readily comply with meaningful safety standards when they are imposed. Unlike food or drugs, cosmetics are not essential to our health. We use them because their benefits are so clear. We need only mention this summer's unprecedented beef recall to illustrate that our food supply is not perfectly safe. But cosmetics are a different matter. We are not compelled to use them. For that reason, we should be far less willing to accept injury and death from such products. I suggest the absence of a quorum.

Mr. KENNEDY. Mr. President, I wonder if the Senator would yield for a question on my time? As I understand, Minnesota has passed a hazardous product labeling bill requiring warning of all products that are ignitable, corrosive, reactive, or toxic, and that that this legislation will effectively be preempted--Minnesota's passage of that particular legislation. I was just interested in the Senator's reaction to that. That has been a judgment made in Minnesota by Minnesotans and passed by their legislature, is now current law, and has not been grandfathered into this legislation. It effectively would be eliminated.

Mr. KENNEDY

Mr. KENNEDY. Mr. President, may I proceed for 2 minutes?