Ted Kennedy

Mr. KENNEDY

Mr. KENNEDY. Mr. President, I yield myself 5 minutes. Mr. President, the fact of the matter is, whether it is the intention or not the intention of those that propose this amendment, one can reach no other conclusion that this amendment is on the floor of the U.S. Senate because of the success of the Teamsters in the recent UPS strike. For the first time in many years, the Nation focused on the particular needs of part-time workers--their future, their security, and their well-being. During that UPS strike, one of the key points that was made--and which I think resonated across the country--was that part-time workers don't have part-time mortgages, don't have part-time bills when they are feeding their children, don't have part-time bills when they are trying to work for their families, and bring up their families, and that in this Nation with our growing and expanding economy--and with the strongest economy that we have had in many years--part-time workers should not be excluded. That is the key issue. There are many of those that fought that issue. But, nonetheless, as a result of collective bargaining, part-time workers' needs were recognized. I think America understood this issue much better. Pension issues were resolved to try to ensure that we are not going to only have Social Security to rely on when they retire but at least have some benefit in terms of their pensions for men and women that work hard over a long period of time. Those were the negotiations. Now there are many, and many in this body, that do not like the outcome of that particular measure. They have put this measure that is before us, which I think is really a reflection of that success. The fact is, Mr. President, if we accept this amendment of Senators Nickles and Gregg, we will be directly interfering with a consent decree that was agreed to by a Republican administration, agreed to by a Republican Attorney General, Attorney General Thornburgh, and it was heralded at that period of time as a great success by Republicans in trying to clean up corruption in a particular union. The fact is that when the Teamsters have a Teamster Union election, the Teamsters pay for it. But under that consent decree, if there are going to be Federal supervisors involved in this, and the Federal Government is going to be involved in ensuring that the election is going to be fair, then the Federal Government is going to be paying for this and participating. We are not saying now and in the future when this matter is before the courts what the future is going to be, or whether there is going to be another election and who ought to pay for it. All we are saying is let the consent decree that is in place now continue to be respected and not be undermined by actions by the legislative body which is a direct interference into the separation of powers and into the judicial decision to have a consent decree by which the executive body agreed to. That is the issue, Mr. President, and there are many important scholars that agree that, if we do have this kind of interference in a consent decree, we are going to subject this body to a contempt action because we will be interfering in a consent decree. Mr. President, it seems to me that we ought to follow the regular order. This overall agreement consent decree is before the Southern District Court in New York. Briefs are being required by the middle of this month. There will be a judgment to be made by the judge in that decision. And we ought to respect that particular decision which has been agreed on and it is now a matter of consent decree. We should not interfere with a consent decree with a legislative intrusion. There are no funds in this appropriations affecting that particular settlement. And we have no business, as the Senator from Alaska has pointed out, a Republican, to be adding these kinds of extraneous issues into an appropriations bill. It makes no sense. I withhold the remainder of my time. Mr. NICKLES addressed the Chair.

Mr. KENNEDY. How much time remains again?

Mr. KENNEDY. And the other side?

Mr. KENNEDY. I yield 4 minutes to the Senator from Maryland.

Mr. KENNEDY. I thank the Senator for the clarification. The lessons that students and their parents learn in the mock elections will benefit American politics for years to come. If the next generation of Americans is well prepared for the challenges of democracy, our liberties will be in good hands. funding for the centers for disease control and its suicide prevention initiatives

Mr. KENNEDY. Mr. President, I yield a minute to the Senator from Maryland.

Mr. KENNEDY. Mr. President, every Member of Congress understands the importance of elections. The votes cast on election day determine the leadership and direction of communities across the country, and of the Nation as a whole. We know that informed voters are the essence of our democracy. The National Student-Parent Mock Election helps young students learn about the importance of the election process. It also offers parents and teachers across the country an opportunity to help students learn about democracy, make decisions about key issues, and understand the meaning of the citizen responsibility on which democracy thrives. On October 30, 1996, millions of students and parents across the country cast their votes for President, Vice President, Senators, Representatives, Governors, and local officials as part of the National Student-Parent Mock Election. Every State called in its votes on who would win the elections and its recommendations on key national issues to the National Mock Election Headquarters, while over 20 million viewers watched on television. The National Student-Parent Mock Election is an on-going project that received $125,000 in Federal funding in fiscal year 1997. I understand that it is the intention of the chairman and ranking member of the Labor-HHS-Education Appropriations Subcommittee to fund the National Student-Parent Mock Election at $225,000 for the fiscal year 1998 so that it can continue to educate students on key issues and the principles of democracy.

Mr. KENNEDY. Mr. President, in the past the Senate has supported, through the Labor-HHS appropriations bill, music training as an educational tool. I support the continuation of support for this type of program. I urge the Department of Education, through its fund for the improvement of education, to give favorable consideration to a proposal that will stimulate students' interest in and attention to music by airing the work of young and gifted student performers and which will also involve the public through supplemental educational tools. A young performance series, which affords 6-18-year-old musicians the opportunity to publicly demonstrate their talents would be especially suited to carry out such a demonstration. If we are to encourage innovation and talent, we must foster that talent by recognizing the developing skills of our Nation's youth. Public broadcasts of a quality young performance program will encourage youth involvement in classical and other serious music.

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

Mr. KENNEDY. Mr. President, as I understand it, the time between now and 9:30 is evenly divided on the Nickles and Gregg amendments. Am I correct?

Mr. KENNEDY

Mr. KENNEDY. Mr. President, as I have on other occasions, I pay tribute to my friend and colleague from Vermont, Senator Jeffords, who has been shepherding this very complicated but enormously important health policy issue through the Senate. As he has correctly stated, there has been broad agreement on a number of the very important aspects of the bill that relate to the drug and medical device provisions. We have made considerable progress on one other aspect of the legislation, and that deals with an amendment which was added by the Senator from New Hampshire, which I will address momentarily. There are still some very important issues that are still being considered by Members. All of us are hopeful that we will have a positive outcome, but we are not quite there yet. Mr. President, just on another item, I want to identify myself with the excellent remarks of my friend and colleague from Iowa, Senator Harkin, on the vote that was taken just an hour or so ago about the block granting of various education programs. I think all of us have understood that the role of the Federal Government is very limited in terms of its help and assistance to local communities in terms of education. We have a much more profound responsibility in the areas of higher education. But our responsibilities in the elementary and secondary education respects that education is a local function but also an important State responsibility. That is why for every dollar that is expended, only about 6 cents of that dollar really comes from the Federal Government. The targeting of those programs has been in the areas where there has been, as he pointed out and others have recognized, general recognition nationwide of very important national objectives, and that is with the most disadvantaged students, primarily in the areas of basic skills--basic skills--math and science programs in the title I programs across this country, the neediest children in the most disadvantaged areas. It is a very important program. It has been evaluated, has had broad support. That is one of the very important areas. There have been adjustments about what programs will be in and what programs will be out, but you cannot get away from the fact that these programs that have been included are targeted and by and large go to local communities where there is wide discretion. If you take the Goals 2000, 90 percent of that fund is spent at the local level. You can't get any more in terms of local control than what we have at the present time. You find that there is 2 percent administrative costs by the Department of Education in the overall programming, 6 percent at the State level of all of these various programs. A great percent of that 6 percent is technical assistance, goes to local communities that are trying to deal perhaps with special-needs children. Maybe it is a small community that has two or three members of a class that have special needs. They do not develop a whole program, but there are other schools, other school districts that have similar kinds of needs. This technical assistance helps and assists those local communities: the School to Work Program has had strong bipartisan support--we still remember the strong Republican support to try to help young people move from school into the employment programs and into employment--the drug- free schools to try to do something about the problems of drug addiction and violence in our various school districts. Now, we do not know. There is no accountability in this particular program. There is no requirement for reporting on how the money is expended. It bypassed even the States, so the States will not have an understanding of how these resources are going to be spent. We do not know which States are going to be advantaged, which disadvantaged or communities advantaged or disadvantaged. So I join in expressing strong reservations. I want to say very clearly that if this comes back, this particular provision, we are going to take some time on the floor of the U.S. Senate to really make sure that not only every Member of this body understands it but all Americans understand it. If the local States want to expend additional resources, let them go out and tax their local communities to do so. If they want it, let them do it. But if we are going to commit ourselves to trying to raise resources to meet targeted needs for the neediest children in this country, we ought to be able to do it. If you are going to take that and block grant it and send it back to the States and just use the Federal tax system to raise these funds, that ought to be done in a different forum. We will have a longer time to debate it if it comes back. But we should not permit a vote in support of the general appropriations to go by without some comment. Now, Mr. President, I am pleased that we have achieved an important compromise on one of the most important issues in the FDA reform legislation, the issue of Federal preemption of State regulation of over-the-counter drugs and cosmetics. I compliment Senator Gregg, Secretary Shalala, and others involved in working out this responsible agreement. It will assure that States have the ability to step in to protect consumers from cosmetics when necessary while also providing companies reasonable guarantees that when the FDA has acted effectively to protect consumers, they will not be subjected to conflicting and potentially duplicative labeling requirements. Under the agreement, the Federal Government will not preempt State regulation of the safety of a cosmetic. This is appropriate. If a State feels strongly enough about a particular ingredient or a product to ban it or to take similar actions, it should be free to do so. States virtually never use this authority. But even though it is rarely used, it should be preserved. In the critical realm of packaging and labeling where States have been most active in ensuring consumers receive the information they need to protect themselves, this amendment strikes a fair balance. The reason preserving States' ability to act is so important is that FDA regulation has been weak. Under this agreement, States would continue to have the ability to act to protect their consumers except in those cases where the FDA has already taken appropriate action in a specific area. The compromise reached in section 762, which relates to the preemption of the State regulation for the packaging and labeling of cosmetics, will assure that the States retain full authority to regulate cosmetics in those circumstances when the FDA has not acted. As you know, I think it is essential for the States to be able to regulate the labeling and packaging of cosmetics whenever the FDA has not acted. This is especially important because there is so little FDA regulation in the area of cosmetics. Section 762 would preempt a State labeling and packaging requirement only when FDA has specifically acted on the same aspect of the labeling or packaging of that cosmetic. Thus, if FDA issues a regulation that requires cosmetic manufacturers to include a specific warning about an aspect of an ingredient in a cosmetic, a State cannot require a different warning about the same aspect of that ingredient. For example, if the FDA required a warning label for a particular product regarding its use by pregnant women, the State would be prohibited from requiring a different warning label for the same hazard and product. On the other hand, where the FDA has not taken action, the States would be free to fill the gap. So, if we are going to breathe new life into the FDA to take on more and more kinds of responsibilities to assure the public in terms of some of these health hazards, as a result of the debates we have had in the past days, they are free to do so. On the other hand, if a State wants to require a warning on a cosmetic and FDA has not acted, the State can require that warning. For example, Minnesota has required a caution statement on flammable products. This provision would not preempt that requirement because FDA has not acted. Similarly, if FDA requires a warning about a specific ingredient contained in a cosmetic, ingredient A, and a State wants to require a warning about another ingredient in the same cosmetic, ingredient B, the State would not be preempted. Likewise, if FDA requires a warning about a certain aspect of an ingredient for example, ingredient A causes cancer, a State can require a warning about a different aspect of the same ingredient for example, ingredient A causes birth defects. The bottom line is that the States are preempted only when FDA has acted on the same ingredient and the same health concern. Finally, this provision does not in any way affect the State's ability to regulate the safety of cosmetics. Thus, if FDA has a specific labeling requirement for a cosmetic ingredient about a particular concern, the State may take additional steps, such as a ban on the ingredient, to protect the public health, although the State cannot require additional labeling about the concern for that ingredient. This may very well be an invitation to give the FDA the authority and the resources to adequately regulate cosmetics, but if they do not do it, which is the condition today, we are not going to be interfering with the States. That is very, very important. The debate on this issue has highlighted the potential hazards that cosmetics pose to consumers, especially women, which are too often underestimated. A study by the respected, nonpartisan General Accounting Office reported that more than 125 ingredients available for use in cosmetics are suspected in causing cancer. Other cosmetics may cause adverse effects on the nervous system, including convulsions. Still other ingredients are suspected of causing birth defects. And a carefully controlled study found that 1 in 60 users suffered a cosmetic-related injury identified by a physician. The fact is, Mr. President, there are enormous numbers of new compounds, an enormous expansion of the use of various products, including toxic products, that are being utilized in cosmetics. We want to make sure that the States, through their own public health agencies or through various studies or through their research, are going to be able to raise health concerns necessary to protect their consumers. Mr. President, we have outlined at other times on the floor various items which raise some important concerns--alpha-hydroxy acid, feminine hygiene products, and talcum powder. We have heard from Dr. Wallinga, a physician at the Natural Resource Defense Council. He points out the dangers of these products citing studies in prestigious medical journals. We have in this compromise preserved the right of the States to protect the public. We have seen recently the impact of State laws on public health. In California, for example, action has been taken against Grecian Formula and toluene in nail polish. We also know of other States that have introduced legislation aimed at further regulation of cosmetics. New York, for example, is pursuing expiration dating of certain cosmetics. Ohio and Texas are also considering additional regulation of cosmetics. My own State of Massachusetts is pursuing a consumer right-to-know law similar to that in California. Nothing in this legislation will infringe upon these or similar activities by the States to protect the public. The agreement we have reached today is a very reasonable one. I commend Senator Gregg for his hard work in making it a reality. The fact is neither the Food and Drug Administration nor the States are doing enough to protect women from the dangers posed by cosmetics. This issue deserves to be a high priority. I intend to see that it is. Mr. President, regarding remaining issues in the legislation, I hope we can have the same hard work and accommodation in addressing these issues before we turn to the legislation. They deal with important questions about the procedures of the Food and Drug Administration in reviewing medical devices. We want to make sure that the medical devices that are going to be used on the American public are safe and effective. We want to make sure that FDA reviewers look at data on the use of a medical device that is clearly indicated by the technical design of the device--whether or not it is on the label. Under the current language, FDA would be unable to make a complete review of the device. The public would be deprived of assurances they have today that devices are truly safe and effective. We talked about this previously on the floor of the U.S. Senate. We will have further opportunity to address this issue. It is an extremely important one. A second item we hope to address is ensuring that FDA can consider certain manufacturing practices that produce an unsafe product in clearing a medical device for marketing. The language requires FDA to allow a new device on the market even if the manufacturer is producing defective devices. This provision endangers the public health by putting unsafe products on the market. It also requires the Food and Drug Administration to spend its resources chasing after unsafe medical devices already on the market rather than simply requiring that the device be produced safely in the first place. These are important items and in my full statement, to a considerable degree, I expand on them. There are environment considerations, the effective removal of the environmental impact statements under NEPA. I do not remember considering this provision as part of our hearings on this legislation. I do not feel that we should start taking various agencies and exempting them from considering the environmental impact of their actions. I think this is an issue that we should address. My colleagues have raised other questions in terms of the ethical issues that surround the payment of third party reviewers. These individuals are going to be reviewing products that are manufactured by the same companies that are paying them. This raises important ethical issues. I will have an opportunity to debate and take action on some of those. I thank very much, Mr. President, the chairman of the committee, for his continued cooperation, and the other Members for their help and assistance. I am particularly grateful to Senator Gregg for his cooperation in helping us work out a satisfactory resolution of the amendment on cosmetics. Consumers have suffered painful, permanent injuries from hair treatment products that have caught fire. They have suffered serious urinary tract infections from bubble bath. They have suffered life- threatening allergic reactions to hair dyes, and severe chemical burns from skin creams and sun tan lotions. The GAO concluded that ``cosmetics are being marketed in the United States which may pose a serious hazard to the public.'' And these are only the acute injuries that require immediate medical care. The poisons in cosmetics can also cause long-term injuries and illnesses that do not develop for years after exposure. Three specific products highlight the risks consumers face. Alpha- hydroxy acid is one of the hottest selling cosmetic products on the market, with sales of roughly a billion dollars a year. It is sold to erase fine lines and tighten the skin. FDA has received numerous complaints of adverse effects from the use of these products. Alpha- hydroxy acids have been linked to severe redness, burning, blistering, bleeding, rash, itching, and skin discoloration. Most troubling, there is concern that alpha-hydroxy may promote skin cancer by increasing sensitivity to sun exposure. Yet these products are in the marketplace--with no warning labels and no limits on the concentrations that may be sold. Under this bill, every State would be prohibited from requiring these sensible warnings. I ask unanimous consent that I may put a fact sheet laying the issues on alpha-hydroxy in the Record.

Mr. KENNEDY. Mr. President, a critical point is that an industry- appointed panel itself set out safety tolerance levels for use of the product with regard to short-term effects and warned that the product should not be used without sunscreen. Yet, there is absolutely no binding requirement that manufacturers follow these recommendations-- and virtually none of the products carry the information or warnings developed by the industry's own committee that would enable consumers to help protect their own safety. And, in point of fact, there has been no truly independent evaluation of the work of the industry panel. In fact, the FDA is so concerned about the safety of alpha-hydroxy acid that it has chosen it has its top priority for review by the prestigious National Toxicology Program. A second example is feminine hygiene products, which have sales of $100 million a year. More than one-third of women use them--but they pose serious health hazards. They have been shown to cause upper reproductive tract infections, pelvic inflammatory disease, ectopic pregnancies, and infertility. They may place women at additional hazard for cervical cancer. Women using these products should have the right to warning labels informing them of these hazards. But the FDA has done little to protect or warn women against these dangers. There are a substantial number of studies on the safety of these products. The evidence that they are dangerous seems incontrovertible-- but this legislation would prevent States from acting to simply warn women of the dangers. How outrageous it is that women should face illness and sterility without being warned of the danger of a seemingly harmless and beneficial product. A third example is talc, or talcum powder is widely used in popular bath and cosmetic products. But it is chemically similar to asbestos, and it has long been suspected of causing cancer. A number of studies have suggested the possibility of a link to ovarian cancer, which afflicts 26,000 women annually--but there are no warning labels on these products. American women deserve better protection from their Government. These three issues have been carefully analyzed by Dr. David Wallinga, a physician and the senior scientist at the Natural Resources Defense Council. He points out the dangers of each of these three products based on studies in prestigious medical journals from researchers at institutions like Yale and the Mount Sinai Hospital in New York. I ask unanimous consent to enter his comments in the Record, along with the articles analyzing these issues. Federal oversight of this $20 billion industry today is extremely limited. The basic Federal law regulating cosmetics has not been updated since 1938. The FDA has less than 30 employees overseeing this huge industry--and only two employees dealing with the critical issues of packaging, labeling, and consumer warnings. The FDA has no authority to require manufacturers to register their plants and products. It cannot require manufacturers to file data on the ingredients in their products. It cannot compel manufacturers to file reports on cosmetic- related injuries. It cannot require that products be tested for safety or that the results of safety testing be made available to the agency. It does not have the right of access to manufacturers' records. It cannot require recall of a product. In the Federal Food, Drug and Cosmetic Act there are 126 pages devoted to the regulation of drugs and devices; 55 pages are devoted to foods regulation. A full eight pages of the act is dedicated to definitions. But less than two pages are devoted to cosmetic regulation. In 1938, there was no requirement that industry show safety of drugs, medical devices, food additives, or cosmetics before they were marketed. Today, the public demands higher standards of protection, and they have been established for drugs, for medical devices, and for food additives--but not for cosmetics. The agreement we have reached today is a highly reasonable one. I especially commend Senator Gregg for his hard work to make it a reality. But the fact is that neither the FDA and the States are doing enough to protect women from these dangers. This is an issue that deserves a higher priority, and I intend to do all I can to see that it gets it. There are important remaining issues in this legislation, and I hope that with the same hard work and spirit of accommodation we can reach agreement on these issues before we return to consideration of this legislation on Tuesday. Two changes in the regulation of devices in particular put consumers at unacceptable and unnecessary risk. They should be removed in this bill before it goes forward--and the administration has made it clear that they put the whole bill at risk of a veto. A great deal of negotiation has taken place on the medical device provisions of this bill, and I compliment Senator Jeffords, Senator Coats, and my other colleagues on the committee for resolving most of the device provisions in a way that is consistent with protection of the public health. But there are at least two medical device provisions in the bill which still raise substantial concerns. They could be corrected very simply and with negligible effect to the basic purpose and intent of this bill. Yet these corrections have not been made and my colleagues deserve a clear description of the hazards they pose. A brief explanation of how the FDA regulates and clears medical devices for marketing may first be in order. Under 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 it can show 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 patent 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 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 the 510(k) process, 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. And in fact, 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 the public health which simply cannot be ignored. The first problem raised by this bill relating to medical devices is its 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 that this approach makes sense--why should the Agency consider the use of a device if the manufacturer has not specified that 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, which is used on breast lesions. Most biopsy needles for breast lesions currently on the market take a tissue sample that is about the size of the tip of pencil lead. Let's assume the manufacturer of a new biopsy needle comes to the FDA with a 510(k) submission. But this new biopsy needle takes a tissue sample that is 50 times as big--the size of a 1-inch piece of a hot dog. 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 that the chunk of tissue being biopsied will usually exceed the size of the lesion. This makes it clear to FDA--and to any impartial observer--that the new needle will in most cases be used to remove the lesion. Under these circumstances the FDA should be able to ask the manufacturer to provide information on this new use. Is it safe to remove lesions? Does it really work? The bill, however, categorically bars FDA from asking these essential questions. This means that 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 in size of the biopsy needle--renders the new product unequivalent 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, Mr. President, there are times where 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 would still 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 an effective or unsafe treatment of breast cancer. Another good example is surgical lasers. Lasers 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. But 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 that this provision could allow unsafe and ineffective devices abound. A stent designed to open the bile duct for gallstones could be modified in a way that clearly was designed to make it a treatment for blockages of the carotid artery. Without adequate testing, it could put patients at risk of 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 to use to excise warts could have its power raised so that it was also possible to use it 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 way. But some bad actors will. And this legislation should not force the FDA to fight those bad actors with one hand tied behind it. This provision is like asking a policeman 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 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 statement. It sounds frankly preposterous but it is true. One of the bill's provisions actually requires the FDA to allow a new device onto the market even if the manufacturer is producing defective devices. Surprisingly, the proponents of this provision freely admit that this is true. Under current law, let's assume that a maker of new examination gloves submits a 510(k) to the FDA 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 these 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's common sense, and fortunately, that's also the law. In contrast, this bill would force FDA to clear the gloves for marketing. At this point, these defective gloves would be sold to hospitals, clinics, and HMO's, where they will be used routinely by doctors, nurses, paramedics, and other health professionals every single day. Every single glove would expose these professionals needlessly to the risk of fatal blood-borne diseases like 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 far more than blowing a whistle or picking up the phone to place a simple call. In reality, the FDA must coordinate with the U.S. Attorney's office, the U.S. Marshal's Service and persuade the court of jurisdiction to issue the appropriate papers. As any attorney or law enforcement professional can tell you that this takes precious time. And in the case of a defective device which is exposing people to unnecessary risks, time is absolutely critical. The sooner a defective glove is pulled from the market, the sooner the public is protected. But all this makes absolutely no sense when the FDA today can prevent this situation from ever arising. If this provision becomes law, the debater's point distinguishing between different forms of FDA authority will ultimately 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 that it is so unreasonable. So I hope we can continue to work to compromise these important devices issues over the weekend. We have been successful on so many other issues in this bill. These should be resolvable as well. The last unacceptable element of this bill is an assault on basic environmental protections contained in the National Environmental Protection Act. The National Environmental Protection Act of 1969 is a key Federal environmental statute which regulates the Government's own actions through environmental impact statements. Under NEPA, Federal agencies must undertake a comprehensive environmental planning process for every major action they take. This law is a crucial statutory assurance that the work of the Government and the actions of regulated industries are consistent with the guiding principle of environmental protection. Section 602 of the bill broadly exempts the FDA's activities from environmental impact assessments under NEPA. In fact, the provision even precludes the FDA from taking environmental considerations into account in its work. The administration unequivocally opposes this provision. This week, I spoke with the Vice President, who expressed his serious personal concerns about this provision. In just a few sentences, this bill opens the door to weakening our environmental protections and lays a welcome mat down for future exemptions and future attacks on an effective and essential environmental statute. This is a terrible precedent, but it also directly affects the environment. The FDA regulates products which constitute a quarter of our gross domestic product. When it makes decisions on food containers, or manufacturing plant approvals, or handling and disposal of medical supplies, it can have an immense impact on the environment. Ironically, this antienvironmental extremism is not even demanded by the regulated industry, which regards the reforms of the NEPA process recently announced by the Clinton administration as fair and balanced. We all agree on the importance of FDA reform. The reauthorization of the Prescription Drug User Fee Program is tremendously important to assure that the FDA will have adequate resources to review new drugs and biological products quickly and effectively. This legislation contains many significant reforms that can streamline the regulatory process and codify improvements that FDA has already taken administratively. I compliment Senator Jeffords, the chairman of our committee, and many other colleagues who have worked hard on this bill and have been willing to work together to eliminate many other troublesome provisions in the bill as originally introduced. Let us now move to complete this work by fixing the remaining contentious issues included in this legislation.

Mr. KENNEDY

Mr. KENNEDY. Mr. President, I know that it is the desire of the Senator from Illinois and others to have the Senate make a judgment on this issue. But it is a very, very important issue. I welcome the opportunity to join my colleagues in making comments about the implications of this particular amendment. And I do so at this time. Mr. President, the Sessions amendment is really one more attempt to aid the tobacco industry at the expense of the public interest. Make no mistake about it, its effect would be to set up a major roadblock preventing the States from pursuing their cases against the tobacco industry. The Sessions amendment, as I read it, would restrict the ability of States to retain the attorneys to pursue States' claims against the tobacco industry. As we all know, 40 States have filed suit against the tobacco companies. So far only two of those cases have been settled. Just yesterday, the tobacco industry said that it will no longer be settling cases. The Texas case is scheduled to go to trial within the next few weeks. As Senator Wellstone has pointed out, Minnesota, which has done an enormous amount of work on covering the sordid history of the tobacco industry, is scheduled to go to trial in just a few months. So it would be an outrage for this Senate, acting at the behest of the tobacco industry, to handcuff the States as they seek to compensate their citizens from an industry that kills 400,000 citizens each year. If Senator Session's intent is to regulate the amount of attorney's fees to be paid as part of a national settlement, clearly, this amendment is premature and unwarranted. Congress has not even begun to seriously debate the merits of the national proposal. The issue of attorney's fees in a settlement should be considered after there is a settlement, not before. The real intent of the Sessions amendment is clearly demonstrated by the fact that, as originally drafted, it only sought to restrict the attorney's fees of attorneys representing the States, not the attorney's fees of the tobacco industry. To restrict the plaintiff attorney's fees would dramatically tilt the already uneven playing field even more in favor of the tobacco companies. While Senator Sessions has now added defense attorneys to his amendment, regulating the amount of attorney's fees paid by the private party is highly questionable and probably unconstitutional. Thus the effect of the amendment would still be to place a burden just on the States. Since under the terms of the settlement plaintiff attorney's fees would be paid by the tobacco industry and those funds are not to come out of the proposed $368 billion national settlement, limiting plaintiff attorney's fees would not produce an additional dollar for either the State governments or the Federal Government. It would merely further enrich the tobacco industry. While the amendment says that the money saved would be paid to the Federal Government for use by the National Institutes of Health, the amount saved would never be determinable, and thus no significant payment to the Government would result. So make no mistake about this amendment, blessed by the tobacco industry, it is a ploy to kill the Durbin amendment. We were all outraged when we learned that a paragraph had been slipped into the budget agreement to give the tobacco industry the $50 billion credit. The amendment, if it is allowed to remain law, would cost the taxpayers $50 billion. There has been a justified outcry against that gross abuse of the legislative process. And there is now widespread support for repealing that ill-conceived provision. Big tobacco knows that it cannot prevent repeal directly, therefore, it has embraced the Sessions amendment as a diversionary tactic. Let us decisively reject this cynical gambit, beat the Sessions second-degree amendment, and overwhelmingly approve the Durbin amendment. To do otherwise would be to erect an enormous roadblock in the path of the States pursuing justice for their citizens against the tobacco cartel. I yield the floor.

Mr. KENNEDY. I am merely seeking to modify it.

Mr. KENNEDY. I see. Well, I understand from the discussion of the leaders that we will be addressing the sense-of-the-Senate resolution as proposed by Senator Daschle and cosponsored by myself. I send a modification to the desk on behalf of Senator Daschle to amendment No. 1116, a sense of the Senate regarding Pell grants and child literacy funding. The modification is technical and it has been cleared on the other side. I ask that it might be in order. If it is the desire of the Chair, I will withhold making that request for a moment or two.

Mr. KENNEDY. Madam President, what is the matter before the Senate?

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

Mr. KENNEDY

Mr. KENNEDY. Mr. President, Senator Abraham and I have introduced a 2-year extension of the Refugee Act. The Refugee 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 whom is considered 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 their new country. Refugees often arrive in the United States terrified, jet-lagged, and with few possessions. Most fled persecution in their home countries, and left their clothes and 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 provides funds to the Public Health Service to provide overseas medical screening for United States-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 runs matching grant programs for voluntary agencies that assist States in refugee resettlement. For example, The Boston Tech Center in Middlesex County, MA received $250,000 in discretionary targeted assistance to teach refugees short-term skills training, basic English and math. The International Rescue Committee in Boston received funds under the Refugee Act to provide a refugee youth program for newly arrived Somali children. Mr. President, the Refugee Act is the heart of our refugee law and policy. If it is not reauthorized, the United States will send a signal worldwide that refugees are no longer welcome here. We cannot let that happen. I am grateful to my colleagues for supporting this bill.

Mr. KENNEDY

Mr. KENNEDY. Mr. President, I strongly oppose the Gorton amendment because it hurts students and goes against the Nation's commitment to helping poor and educationally disadvantaged students who need our strong support. It also undermines the partnerships that have been created by Federal, State, and local education agencies to improve all schools for all children. We all agree that education is a local responsibility. But the States and the Federal Government 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 rejects that basic principle. It shifts Federal dollars away from the neediest communities to the wealthier ones. It destroys carefully crafted and widely supported Federal programs. And it undermines the States' roles as vital partners in improving the achievement of all students. This amendment would strip the States of their ability to integrate Federal funds with innovative State programs and State standards. Most of the small portion of Federal funding that is retained by the States under current law--only 6 percent--supports technical assistance and training for local school districts that do not have the expertise, resources, or desire to conduct such training themselves. Currently, Federal funds are offering a helping hand to local school districts in meeting high priority responsibilities important to the Nation as whole. The 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 higher standards, help communities create safe and drug-free schools, and help communities modernize their schools. This amendment would take away Federal funding for these crucial, targeted purposes to help children who need it most, but who are often short-changed under current State and local law. Contrary to arguments made by proponents of the amendment, Federal education laws are more flexible and school-friendly than ever before. States and local education agencies are working in closer and more effective cooperation. The result is that schools are doing a better job of helping all children meet higher standards of achievement. The Federal-State-local partnership in education isn't broken and the amendment can't fix it. Congress should be doing all it can to strengthen that partnership, not destroy it. 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 for how these dollars are spent. Reforming the Federal role in education does not mean abdicating that role. This amendment is the wrong direction for the Nation's children and the wrong direction for education. It is not an attempt to offer a helping hand to local schools. It is simply a thinly veiled attempt to dismantle the Federal role in education. We should support efforts to improve education for all students, not undermine them. I urge my colleagues to oppose the Gorton amendment.

Mr. KENNEDY. Madam President, I strongly support Senator Daschle's sense-of-the-Senate amendment and its 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 in the 1998 fiscal year. I also congratulate Senator Specter and Senator Harkin for their leadership in making education a priority in the bill. Education is a national priority and we need to do all we can to make sure that education is accessible and affordable for all Americans of all ages and all income levels. This amount is a significant step toward achieving that goal. 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. Single, independent students at public 4-year institutions are not eligible for a Pell grant if their annual income is over $10,000. At that low-income level, many of them will not benefit from the tax credit for college expenses recently enacted in the budget law. So fair eligibility standards for Pell grants are especially important for these students. A similar problem faces parents trying to pay for college for their children. Current law penalizes college students who work part time to help pay the cost of their education, by reducing their eligibility for Pell grants. We should be encouraging students to work, not take out additional loans, so that they do not graduate under a mountain of debt. The budget agreement contained a clear commitment to allocate $700 million to improve the needs analysis formula for Pell grants. The House bill provides only $500 million to meet this commitment, and the Senate bill contains no funds at all for this needed change. A strong, bipartisan vote in favor of the Daschle amendment is our best hope of achieving the reform we need in the conference because the House of Representatives, with their figures, have some disposable resources that will be available. A strong vote in the Senate will be a clear indication of a strong, bipartisan effort to channel those funds into this needed area. The second provision of the amendment reiterates the budget agreement's promise to provide $260 million for a child literacy initiative this year. The Senate should be strongly committed to seeing that legislation authorizing the initiative is enacted as soon as possible. Forty 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. President Clinton is right to focus on this critical problem, and Congress should respond. It makes no sense to delay the appropriation. Both of these items have been considered over a considerable period of time in the discussion on the budget resolution and, basically, we are conforming this appropriation bill to what was agreed on in the budget resolution by Republicans and Democrats. We believe that there is a very, very important reason and justification in prioritizing these funds, in these two very particular areas, when this legislation goes to conference. So I urge my colleagues to support the amendment. 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 education. It will be a clear indication that education, and particularly for the independent students and also in the area of reading, have the wholehearted support of the Senate, and it will be a clear instruction that those functions should be given the priorities that I think all of us in this body and the American people think they should receive.

Mr. KENNEDY

Mr. KENNEDY. What is the regular order at that time?

Mr. KENNEDY. How much time is there?

Mr. KENNEDY. Mr. President, as was pointed out by the Senator from Alaska and others, this is an extraneous matter. We had a good debate on it the other evening. I believe that it would probably take--we did not really complete the debate on it the other evening, so it will probably take some time to reach a resolution of it. But the majority leader has spoken to the minority leader about it and talked to me about it in terms of time, but I think it will probably take some time. I know the Senator from Maryland was very much involved in it. I don't see him in the Chamber at this particular time.

Mr. KENNEDY. I thank the Senator.

Mr. KENNEDY. I see the other Senator from Washington here who I know has an interest. I will withhold my remarks to permit her to speak. Mrs. MURRAY addressed the Chair.