Judd Gregg

Mr. GREGG

Mr. GREGG. Mr. President, I ask unanimous consent to consume as much time as I may require under the pending debate.

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 President, I ask unanimous consent that the order for the quorum call be rescinded.

Mr. GREGG. Mr. President, today, we are debating, in part, the FDA Modernization Act, which is a very important piece of legislation because it goes to the issue of the health and safety of the Nation. I congratulate the Senator from Vermont for having the foresight, ability, and acumen to bring this bill to the floor after a considerable amount of negotiations and debate and discussion and activity within the committee. In fact, we have been working on this ever since I have been on the committee. I believe that would be almost 5 years now. The need to modernize the FDA is obvious. I think it is obvious to anybody who represents any group of people, as we hear constantly from folks in our States about problems that they have had with getting drugs, getting devices in a prompt way and in a manner that will help them live better lives. I, for example, had an instance where Helen Zarnowski came to my office fairly regularly over the years as she sought to get approval, or wanted to be able to use various Alzheimer's drugs, drugs being developed that were experimental, in order to help her husband, who, unfortunately, had Alzheimer's. She would come and talk about how terrible this disease is--and it is a horrible disease-- and how much she would like to be able to try this drug she had heard about, or that drug which she knew was having positive effects. She had heard about some in Europe that had positive effects, which had been approved there. Yet, unfortunately, the process of approval in the FDA involved considerable delay, delay really well beyond what one would consider to be common sense. Regrettably, her husband died in 1995. Some of the drugs that might have been able to be helpful were not approved by then. Of course, we all, I suspect, have friends or people we know who have contracted the AIDS disease and have had problems with AIDS. They are historic. The FDA has started to address that more aggressively in the last few years. In the latter part of the 1980's, that was not the case. Approval was delayed for an extended period of time in a variety of other areas, especially the device area, where people's lives could be improved dramatically by getting a medical device that would assist in their rehabilitation. Or the testimony which was so heart rending and stark, given within our own committee by our own committee member, Senator Frist, a nationally prominent heart surgeon prior to becoming a U.S. Senator. He made it so clear that if he had simply had a device that was available in Europe, he could have possibly saved some of his patients. But he could not get it because the FDA would not approve it in a manner that was timely enough to have it available for those patients. So this is a very personal issue. It is brought up in the context of the bureaucracy and the question of this huge institution called the FDA, but when you get right down to it, like most Government, this is a very, very personal issue of people being impacted by their need to obtain care, by their belief that certain types of care that are available maybe in other countries would help them, and their inability to get it in a timely manner in the United States. The FDA has had some real problems. There has been, without question, an attitude that ran well into the early part of this decade that caused FDA to be ponderously bureaucratic in the manner in which it dealt with drug approvals and especially device approvals. That has changed. It has changed for the better. It hasn't gone as far as it needs to go, no. But that is what this bill is about--to give the FDA the capacity to go even further down the road toward being a positive force for the approval of drugs that may help people live longer, live better lives, and for the approval of devices that would help people live better lives. So especially for those individuals who are going to be impacted, this is a very significant piece of legislation. In addition, of course, it has the PDUFA language in it, which is critical because PDUFA is the manner in which we fund the expedited approval process for all intents and purposes. And we need to have that fee system reauthorized so that we can keep on board the 600 or so people who are employed through the PDUFA fee process to help us expedite approvals. So that is one approval. In addition, it deals with the question of a variety of questions such as health plans and what can be said. And we approve that language in the bill. The issue of uniformity and how we deal with that--we have improved that language in the bill for a variety of areas. But, most importantly, it is a piece of legislation which will--to use a nice term-- ``modernize'' the FDA and help us move more promptly to the approval of drugs and devices which will cause for better caring for Americans. There has been a lot of discussion on this floor about the question of national uniformity in the area of over-the-counter drugs, and national uniformity in the area of cosmetics. Certainly the Senator from Massachusetts has expanded considerably on this topic. I must say that at an entry point I do find it ironic that this bill would be filibustered because when this bill is filibustered it slows down the approval process for people who have problems, for people who confront diseases and who need new drugs and new devices. And the filibuster by very definition when it was initiated on this floor in opposition to this bill means people are going to have further delays--delays beyond just the bureaucratic delays, which are bad enough --delays which are created by the politics of the process. That is just not right. If the Senator from Massachusetts has a serious concern, which he, obviously, does about one or two items in this bill, he shouldn't be filibustering this bill. He should be offering amendments to the bill letting us vote them up or down and decide whether or not his position has the support of the body, or the bill as it was reported has the support of the body. Clearly a filibuster is totally inappropriate and tremendously ironic in the context of an issue which we are trying to expedite the approval of. And we run into a filibuster. It is bad enough, as I said, to have a bureaucratic slowdown of the approval process. But to have a political slowdown of the approval process is really, I think, unconscionable. Independent of that point, let's go to some of the specifics here of the concerns. The issue of uniformity is an issue which has been addressed and discussed at dramatic depths and lengths over the last decade, at least--probably prior to that. That is the only time I recall over the last decade. There have been commissions of very thoughtful people who are extraordinarily expert on the issue of how we deal with the approval process and management of the drug and device delivery system in this country, and who have looked at this. In fact, there was a study, a group, a commission put together headed up by Carl Edwards, who was at one time head of the FDA, and the conclusion of that commission, which was put together at the request of the Congress as early as 1991, was that Congress should enact legislation that preempts additional and conflicting State requirements for all products--not a few, all products--subject to the FDA jurisdiction. States should be permitted to seek a preemption in areas where the FDA has acted based on convincing local needs. States should in addition be allowed to petition for the adoption of national standards. That is exactly what is proposed in this bill relative to the two items that the Senator from Massachusetts appears to have problems with--over-the-counter drugs and cosmetics. It should, also, according to this language, have been proposed for food. We should have done uniformity for food if you follow the presentation of this commission proposal. And maybe there will be an amendment coming as we move forward on FDA reform which addresses the issue because I know there is a lot of support on both sides of the aisle for the issue of uniformity on food regulation as well as drugs--over-the-counter drugs and cosmetics. But the point here is that an independent, thoughtful, congressionally supported commission headed up by the former head of FDA concluded that this type of uniformity is exactly what we need in order to effectively administer and protect--administer the issue of food and drugs and protect the public. In their 1-year review of their report--1 year later. That was a unanimous agreement, I should have mentioned, reached by the commission, and 14 of the 17 people on this commission said, ``We reaffirm our original recommendation that Congress should enact legislation preempting conflicting or additional requirements for products subject to FDA regulation with provisions for the States to be able to demonstrate a genuine need for distinctive requirements to seek an exemption. Failing action by Congress, FDA should adopt regulations to accomplish the same rules for national uniformity.'' They went a step further. They said even, ``If the Congress doesn't go the uniformity route, the FDA ought to do it unilaterally with regulation.'' I don't agree with that. I think it is the prerogative of the Congress to decide this type of issue. But the fact is they felt so strongly about this as a group of commissioners who had expertise in this area that they asked for that type of an extraordinary action. That would have meant uniformity for drugs, food, over-the-counter drugs, and uniformity for cosmetics. Then Commissioner Edwards reaffirmed this point in a letter that he sent to Chairman Jeffords by saying ``national uniformity should play a greater role in FDA-State relations. If not, the agency's ability to protect''--this is the issue; how do you protect? --``to protect consumers will be further eroded and unnecessary concerns will be imposed on the national Congress.'' Former Commissioner Arthur Paul Hayes wrote in July 1997, ``I write in strong support of the national uniformity provisions in S. 830 for the nonprescriptive drugs and cosmetics, I have long believed that a single national system for regulations for these FDA-regulated products is essential and now overdue.'' So you have a commission which was the brainchild of the Congress to determine what FDA should do and how they should manage the issue of drugs, cosmetics, over-the-counter drugs, and food; a commission saying: Use uniformity. Why did they say that? They said it because they believe that to have 51 FDA's running around the countryside--50 States plus the Federal FDA--would create chaos. It would confuse the consumer and create a situation where a consumer in one State was to be given one piece of advice and the consumer in the next State was being given another piece of advice, and as a result, rather than having an encouragement of a comprehensive, thoughtful approach to health protection, you would have confusion and anarchy in the public's mind as to what was correct in the area of health care and protection. It is a pretty logical position. I have to say as someone who comes from the States' rights viewpoint, and who has spent most of my life defending States' rights, that it runs against my grain to want one Federal agency to run the country on one issue but, when you think about it, to do it any other way would be to undermine the health, and certainly the veracity and the confidence of the public on the issue of health care provided. This is especially true in the area of FDA because even though the FDA has been excessively bureaucratic, nobody would argue that they haven't been extremely professional. They are an agency which has and maintains the view that they are the world's premier reviewer and protector of public health. And I think they have credibility in taking that position. That is why I think as a States' rights advocate I am willing--or one of the reasons I am willing--to say yes in this area. The role of the FDA is unique, and to undermine the role of the FDA--that is what you would be doing--to undermine the role of the FDA by allowing the 50 States to basically pursue arbitrary independent views in areas where the FDA has the authority to regulate would be a big mistake. It would run counter to the basic goals of having a strong system of health protection in this country. So we are talking here about how you protect the public health. And what we have is a commission set up with the support of the Congress which concluded--we have experts; they weren't Members of Congress on this--concluding that the way to protect the public health is to have uniformity. So let's give that a fair amount of credibility. Let's not just discard that. I think that is a fairly persuasive point in favor of the language in this bill which tracks the proposal of the commission, the Edwards Commission, for all intents and purposes, and which was brought forward out of committee with a vote of something like 14 to 4-- overwhelming support because the people on the committee who have taken a long time looking at this sort of thing understand that the commission made sense when it came to these conclusions. Before I get into the specific responses to some of the points made here, there is another general theme that comes out which is that if you take the argument coming in opposition to the uniformity standards in this bill you are essentially taking an argument that says the FDA can't do its job; the FDA isn't competent; that the States are more competent than the FDA. The corollary to that is you are saying the FDA doesn't care; the FDA isn't really interested in health and safety; that there are areas of health and safety under its regulatory responsibility, under its portfolio, that it has no responsibility, and that it is going to walk away from it. Those are heavy charges to make against the FDA. But that is essentially the subtlety of the position in opposition to uniformity: It is that the FDA isn't capable of administering its portfolio and it doesn't care about safety. I personally disagree with that. If anything, the FDA consistently errs in favor of safety, which is probably the right way to do it. We are asking in this bill that they streamline their efforts, that they expedite their procedures, but we are not asking that they do it at the expense of safety. And to imply that they aren't going to fulfill their obligations--which is not an implication but basically a statement made here on numerous occasions--citing that only two people are doing this, three people are doing that, to imply that they are not going to fulfill their obligations is I think incorrect. I think the track record shows that the FDA does fulfill its obligations in many ways, and it maybe is a little slow in doing it sometimes. But it sure does get into the issue of safety. And to presume that it would not is I think inappropriate or inaccurate. ``Inappropriate'' is not correct. Obviously, you can presume anything you want. So that is another point. First, we have the commissions' support for this proposal. Second, we have the logic of the committees' support for this proposal. Third, we have the fact that the FDA is perfectly capable of pursuing this proposal and should be pursuing this approach because a single uniform approach is what makes sense for the health and safety of the American citizenry. There were a number of specific points made in representations relative specifically to cosmetics. But you have to remember that cosmetics isn't any different here than over-the- counter drugs for all intents and purposes. Thus, I am surprised with the intensity of opposition of the colleagues; that we don't have the same intensity of opposition to over-the-counter drugs. It seems to be inconsistent to me. And it may just be that the photographs are better for cosmetics than over-the-counter drugs. I doubt that. You can probably find some pretty heinous photographs that relate to over-the- counter drugs. But the fact is that, I think, that is inconsistent. In specific, the statement was made that the States will no longer be able to regulate, or to paraphrase it, the States will no longer be able to regulate the packaging and labeling of cosmetics. That isn't really accurate. Nothing preempts State enforcement powers. States may seize, embargo, or pursue judicial proceedings whenever necessary to enforce the law; Federal law; the FDA law. (Ms. COLLINS assumed the chair.)

Mr. GREGG. I agree 100 percent with what the Senator from Vermont is saying, being from New Hampshire, an equally small State, and knowing it would be confusing to our consumers who cross the borders all the time to purchase products, if they were not able to rely on a nationally regarded, highly expert agency to evaluate their health care products instead of a hodgepodge from the States.

Mr. GREGG. States are also free to publicize any information or warning they deem necessary. They simply cannot force the manufacturers to post warnings unless they can get the FDA to agree that that warning is legitimate. What is wrong with that? Nothing. FDA is certainly going to want a warning on a bottle if it is proven to cause cancer. It is absurd to think they will let the bottle or whatever it is out on the market. If there is some threat that is created by something, the FDA is going to step forward. States will have two specific options under this legislation. The States may use the existing authority provided under 21 CFR 10.30 to petition the FDA to make any requirement a national requirement. So they can ask that their proposals, their ideas, be moved up to the national level. Under this provision, States may seek an exemption. If you have a law or requirement that is different from the FDA's, the States can come to the FDA and say we think there should be a national protection. For example, the Senator from Massachusetts was talking about the studies in the State of Alaska and what the State of Massachusetts was doing in the area of caring for women. If they feel strongly about that, they can go to the FDA and ask that those types of disclosures which they think are appropriate in the State of Washington and the State of Massachusetts be national. Why shouldn't they? The other side of that argument is that, well, women in Washington and women in Massachusetts should get a different warning label than women in New York State or women in Oregon. Why? If it is that serious, why would you want the people in Washington to know something different than the people in Oregon? Obviously, you would not. The logic is that the FDA should make the determination as to whether or not it is serious enough to require national disclosure or to make a determination whether it isn't so that you don't arbitrarily scare the people in one State versus another State. It really makes no sense to have a hodgepodge of disclosures on these over-the-counter drugs and cosmetics, requiring that over-the-counter drugs and cosmetics are not drugs in the traditional sense that they are defined by the statute. Drugs are clearly something that the FDA is going to be involved in. So it is just an inconsistency here to this argument that the FDA should not be making the decisions but that the States should be making decisions because you end up with inconsistency from State to State by definition. So I don't think that argument really applies. Now, there was another representation that I believe 47,000 injuries resulted last year from cosmetics use. This calculation was not analyzed in its representation, the specifics of it. I think it should be. The Consumer Product Safety Commission's National Electronic Emergency Injury Surveillance System came up with this figure in a 1988 House hearing. I believe that is what is being referred to here. Their calculation included things such as slipping on soap in the shower, suicide attempts, injuries from broken bottles, plus in the context of total usage 47,000 injuries, some of which clearly weren't involved in the character of a cosmetics, represents .00044 percent, which I believe is less than five ten-thousandths--five ten-thousandths--of the number of products sold in the country; 10.5 billion products sold in the country and 47,000 potentially caused injuries, some of which involved slipping on soap or broken bottles or possibly ingesting things intentionally to cause harm, and that represented .00044 percent or less than five ten-thousandths of the products sold. You have to put that in a little bit of context here because, as studied by the same group, injuries caused by couches and sofas were 70,000. Almost twice as many injuries were caused by couches and sofas as were caused by cosmetics. And 117,000 were caused by drinking glasses. Are we going to have that be State regulated--drinking glasses? And 253,000 were caused by pillows, mattresses, and beds. What is that, almost six times the number caused by cosmetics studied by the same group. So when that number is thrown out here, I think it has to be put in context, and I think that puts it in the context of ``less than persuasive'' would be the adequate term to put to that statement. Now, also, the point was made that cosmetics pose an inherent threat to a person's health and safety. I think we just saw from the numbers it is not very inherent if it is less than five ten-thousandths of a percent that are impacted. But cosmetics by definition are inherently the safest products FDA regulates. Cosmetics, as defined by the Federal Food, Drug and Cosmetics Act, section 201(I), means: Articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and (2) articles intended for use as a component of any such articles; except that such term shall not include soap. We are not talking about products that affect the structure of any function of the body. Such products are viewed as drugs. So if it affects structure, if it affects function of the body, it is a drug; it is not a cosmetic. In fact, former Commissioner Kessler stated in a hearing in the House, again in 1991: People can take comfort from the fact that the cosmetics industry is as safe as they come. So cosmetics are not inherently dangerous, which would be what you would think if you listened to the debate here for the last couple of days. There are problems with cosmetics. Nobody is going to deny that. And that is what we have the FDA for. When there is a problem, that is what the FDA is there for. Now, there was another statement, I believe, made that 884 cosmetic ingredients have been found to be toxic. That is a pretty strong statement. Of course, we all know that things that are toxic are things that we deal with every day. Salt is toxic if you take too much of it. In fact, that list included chemicals such as water, salt, and vinegar. This was a list derived from a list published by the National Institute of Occupational Safety and Health Registry of Toxic Effects of Chemical Substances, which list, as I mentioned, included such things as water, salt, and vinegar. So toxicity depends on the manner in which it is used and the manner of application as versus by definition that the substance is toxic. ``Many substances that are common in everyday life are obviously toxic.'' Mr. President, 884 ingredients were evaluated by the Cosmetic Ingredient Review Expert Panel to determine if they were toxic. This was not mentioned, I don't think, during the debate. They found no significant health effects with the cosmetic use of any of them. So, again, I don't think that argument is persuasive. Then there is the GAO report on which a considerable amount of discussion has been spent. I believe the Senator from Massachusetts was referring to the 1978 GAO report that listed 125 ingredients which were then available for use in cosmetic products that were suspected of causing cancer, 25 that were suspected of causing birth defects, and 20 that were suspected of adversely affecting the nervous system. The GAO report goes on to state that: Neither we nor NIOSH-- Which is the other Federal agency that would have responsibility here; I just quoted their numbers-- has reviewed the adequacy of the tests performed or the applicability of the tests performed or the applicability of the results to exposure to the ingredients through the use of cosmetics. They haven't reviewed that. In fact, much of the limited scientific work done before this list was first compiled by NIOSH was done at extremely high exposure levels, rather than against a relative baseline. Anytime the FDA would like the Cosmetics Review Panel, in its capacity as an independent expert panel meeting the same criteria as any FDA review board, to review the data, to review the safety data on anything that can be used as a cosmetic ingredient, they may request that it be done. But the FDA has never asked them to do that. The CIR has never denied such a request. The FDA may have asked, but the CIR has never denied the request. The fact is that if something causes cancer and if it were being used in some sort of cosmetic and as a result cancer was being generated, you would have FDA action. What do we think the FDA is, a potted plant? They are not going to sit around if there were any cancer-causing substances that were being generated by any cosmetic that were a threat. The idea that a State is going to step up and do a better job of evaluating whether or not there is a carcinogenic effect to anything is, I think, a bit of an affront to the FDA. The fact is the FDA takes cancer pretty darned serious. And they aren't about to walk away from anything or not get involved in anything that has a cancer issue, a serious cancer issue. So bandying around numbers like that may create headlines, but I don't think it is persuasive if you look at the substance of this. Now, there has been some representation that FDA doesn't have a whole lot of regulatory authority here. It has a lot of regulatory authority, as was shown again by the Edwards Commission. FDA is the regulatory agency, and that's why there should be uniformity. Just let me read a few of these. Section 301 prohibits the introduction into, or receipt of, any cosmetic that is adulterated or misbranded in interstate commerce. Section 303 lists the penalties for violating section 301, starting at imprisonment for up to 1 year and a $1,000 fine. Section 601 defines ``adulterated''--if it contains a poisonous or deleterious substance; contains a filthy or decomposed substance--we are not even talking about things that are going to cause you cancer here; we are talking about a filthy or decomposed substance--if it was prepared, packaged or stored under unsanitary conditions; its container is made of an adulterated substance; or if it contains a color additive not approved by the FDA. We heard a lot about color additives earlier. Section 706 requires FDA to approve color additives as safe before they can be used in cosmetics. Again, we heard a lot about color additives, but the FDA has authority here. Section 602 defines ``misbranded'' as: False or misleading labeling; if the package is not labeled with the name and place of business of the manufacturer, packer, or distributor, and with accurate quantity; if any word required by Federal law or regulation to appear on the label is not prominently displayed in a readable and understandable manner; if the container is misbranded; if the color additives don't conform with requirements; or if the packaging or labeling violates the Poison Prevention Packaging Act. Section 201(n) states that misbranding must also calculate the extent to which the required facts are not revealed. The FDA has broad authority--broad authority--here. And they will use that authority. The FDA can ban or restrict ingredients for safety reasons, mandate warning labels, inspect manufacturing facilities, issue warning letters, obtain court orders to seize illegal products, obtain court orders to enjoin activities, prosecute any violators, publicize public health issues, and work with manufacturers to implement nationwide recalls. There are 41 pages--41 pages--in the FDA, in the Federal Food, Drug and Cosmetic Act applying to cosmetics--41 pages. There are 32 pages of FDA regulations of cosmetics in the Code of Federal Regulations. The fact is that the FDA knows this issue and has the capacity to deal with this issue. The idea that the States are going to do a better job-- well, I suppose that if they are they can come to the FDA, under the law as proposed in this bill and say, ``We have done a better job. Change the Federal rule.'' And the FDA will do that, because that is what the law gives them the authority to do. Or if they think it is a unique situation, then the States can come and say we want special treatment for this, and the FDA will give them that authority. But the point here is that you should not have--and my colleague uses the term women or children a great deal. I think it is just about anybody who would be impacted. But you should not have women in Washington State getting a different instruction from women in the State of Oregon, because it is going to confuse people. Who is going to know who is getting the better instruction, the people in New York versus the people in Massachusetts? Let's have it done consistently, across the country. That is why the commission decided in favor of uniformity. Uniformity on over-the-counter drugs, uniformity for cosmetics, uniformity for food. We don't have food in this bill. Maybe we will. Maybe there will be an amendment. There is some representation--I couldn't get it clear but I think there was a representation relative to California's status. Let's define California's status. This law is prospective. It doesn't affect the California situation at all. Prop 65 remains effective in California. So that bit of red herring should be put to bed. There has been this representation there are only two people over at the FDA doing this or that. The FDA regulates cosmetics. It has the financial capability--and we will give it the financial capability if it feels it doesn't have it--to have the personnel to do the job right. And I believe that, as part of its portfolio, the leadership of the FDA will do the job right. To say they will not or imply they will not, which is the representation, I think, as I said earlier--the subtle undercurrent of these representations in opposition to this language that the FDA cannot do its job is, I think, incorrect. I think the FDA has shown its capacity. So, resources, here, is not really an issue at all. Resources may be an issue for us as the Congress. But I can assure you that, as a member of the Appropriations Committee--sitting not on the FDA subcommittee but on the overall committee--I would have no problem funding whatever is needed in this area. I suspect none of my colleagues would either. In fact, this bill is about that, with the PDUFA language. It is about funding the FDA in a more effective way. In fact, I put an adjustment in this bill so we would not end up cutting FDA, as a result of the PDUFA funding from base funding, which is critical. There was also, I believe, a representation that this prevents the States from providing public information. No, it does not. Under this provision, the States remain free to publicize any information or warning they deem necessary. They simply cannot force manufacturers to post the warning unless the FDA says they agree with it. As I said earlier, what's wrong with that? If a State decides that something needs to be put on a warning label, they can come to the FDA, say, ``This is important.'' The FDA will evaluate it and tell them, ``Yes, it works,'' or, ``No, it doesn't work.'' If you do it another way, you get into this confusing, anarchic situation I spoke about earlier. This is a transient society. People coming from different States are going to see different statements, different warnings. They are not going to know what to think, and that undermines health because it undermines confidence. It's better to have a single agency making that decision because, when you are dealing with health, you have to have confidence. There are a couple of specific claims--lead in hair dye was one, I believe. In 1980 the FDA approved the use of lead acetate as a color additive, ``safe for use in cosmetics that color the hair.'' That approval was based on extensive testing that showed there was no toxicological risk of lead absorption through the skin from lead acetate in hair dye. Hair dye is one of the most stringently tested products on the market today. The FDA has the authority to impose any warning it chooses to promote the continued safety use of hair dye. The fact is, the FDA is engaged in the issue and has made the decisions which it deems appropriate for safety. We should have a consistency across this country, based on what they have decided. Mercury in lipstick and nail polish was also cited as an example. Mercury, through the Code of Federal Regulations, has been affirmatively banned for use in all cosmetic products except eye area preservatives, so I am not sure why this idea was thrown out. Maybe it was a red herring. ``Alpha-hydroxy in face creams causes cancer.'' That was, I believe, the representation. Certainly it has been discussed at considerable length as a concern. In 1995, the Office of Cosmetics and Colors' Director stated that appropriate actions can be taken in product characterization or through proper label warning statements in regards to reactions to alpha-hydroxy. So the FDA stepped up to this issue. He noted that the adverse reactions reported--often allergy-type symptoms--could be due to the pH factor in the product and not the actual concentration. He did not raise any concerns about it causing cancer. If the FDA is concerned that this type of product is causing cancer, it already is investigating such products generally and why would it leave this product on the market? Obviously, it would not. Alpha- hydroxy has been used literally for 3,000 years, in hundreds of different ways. Just this past June the Cosmetic Ingredient Review of this independent group I mentioned before, unanimously confirmed after public debate that alpha-hydroxy is safe for use in a variety of products. However, if there is evidence now, or that comes to light later to the contrary, I am certain that the decision would be reversed and these products would be prohibited nationally. And they should be prohibited nationally if they are that much of a problem. Why should they be prohibited in just one State? Obviously, they should not be. Why would you protect one State over another State? If the legitimacy of the science is such that it is determined that the product is a problem, then obviously the FDA is going to sign on to that debate at that point, and you are going to have a national ban or national warning. But to have the people in the State of Washington told one thing and the people in the State of Oregon told another thing and the people in the State of Nevada told another thing--six States in New England that sit right on top of each other such that you can't go shopping without going to one of the other States. At least that is what we hope. We hope that everybody from Massachusetts goes to New Hampshire to go shopping. The fact is, What are you going to do? Are you going to tell them they are going to get a different labeling than they get in Massachusetts? Foolish, worse than foolish, because it undermines confidence in the health care delivery system and the safety and efficacy of it, which has always been the core, always been the core, really, of one of the great strengths of our health care system in this country, which is that we have public confidence in its safety, primarily as a result of the work of the FDA. If you have a lot of different States moving into this area you have confusion, and confusion leads to lack of confidence and that is why, again--it was not my idea. It was not the committee's idea to go to uniformity. It was a commission, set up by the Congress, with professionals, who said uniformity makes sense. It not only makes sense, it's essential--essential. So the alpha-hydroxy, I think is, again, a matter of hyperbole, maybe, in this debate. Certainly the photographs have been aggressively used. But is it substantively an issue? No. Because the FDA is already involved in that debate, has made initial decisions on that debate, and if it were determined that there were further decisions that had to be made on that product, it would make them. A side point--I believe there was a statement there is no cosmetic hotline. There is a cosmetic hotline. It's at the FDA. In fact I'll give it to people, 1-800-270-8869. Call it up if you have a question. As I mentioned, Prop 65 has been addressed. So, overall this goes, not only to uniformity of cosmetics, that's just one, the uniformity of over-the-counter drugs, uniformity of management of our health care system in the area of drug protection and quality of the drug delivery system in our country is something that has been concluded to be essential. This bill tries to accomplish that and pursues that course. I am not sure what energizes the opposition with such enthusiasm, except the leader of the opposition is an enthusiastic individual. But I do not feel the facts or the substance support any of the--or even a marginal amount of the presentation made from the other side. The facts and the substance support the position of the committee; the position of the committee, which it passed out 14 to 4, which is that uniformity protects the public. It protects the public health, maintains confidence in the public system, and allows us as a nation to deliver better health care. I yield the floor to the Senator from Vermont.

Mr. GREGG

Mr. GREGG. Mr. President, I would like to take this opportunity to thank Senator Specter for his leadership and support in my recent efforts to provide full funding for the Individuals With Disabilities Education Act [IDEA]. For the past 2 years, one of my top priorities has been to ensure that the Federal Government lives up to its promise to provide 40 percent of the funding for the costs of complying with Federal special education mandates. The current level of 8 percent or 9 percent is unacceptable. In addition, I believe that it is important to secure increased funding for IDEA to ease the burden on local schools and communities. For these reasons, I am grateful to Senator Specter for helping us move closer to full funding to help these communities. As a result of our combined efforts, in the fiscal year 1998 Labor- HHS appropriations bill, State grants for part B of IDEA are allocated $3.94 billion, which is a $834 million or 27 percent increase over last year's funding level. As chairman of another appropriations subcommittee, I know how difficult, if not virtually impossible, it is to provide such a significant increase to a large account. Thus, I truly appreciate Senator Specter's efforts and leadership on this issue. I'm sure that the Nation's special education students and the local communities that educate them are equally as grateful to Senator Specter for his support. Mr. President, I suggest the absence of a quorum.

Mr. GREGG

Mr. GREGG. Mr. President, as Chairman of the Aging Subcommittee, I have spent a great deal of time concentrating on how to improve the ways the nutrition programs and senior services that are part of the Older Americans Act. I appreciate the work of the Senator from New York on this related funding issue. In March 1995, I was pleased to have New Hampshire meals provider Debbie Perou-Hermans come to Washington to testify before the Aging Subcommittee; she emphasized the role these programs play for our seniors in New Hampshire and across the Nation. I also know that what we accomplish through the funds spent on other senior services--such as supporting congregate centers, transportation services, and health programs and counseling--is vital to the meeting the requirements of this population. I think it is important to note, in addition, that this program has several other important qualities: The Older Americans Act requires the States to invest in these critical services; it has a great track record for leveraging private funds; and it generally makes its services available to all seniors, many of who are suffering from the challenges of social isolation, not just those in financial need. Need wears many faces in America. I believe that we should work hard to ensure that the benefits are maximized through more flexibility in the funding of needed services, to be certain that the decisions about how and where these dollars are being spent are made at the State and local level. That will be the goal of the reauthorization bill that I am assembling which will be based on the bill I introduced in the 104th Congress. However, I would like to quickly ask a question of my colleague from New York, Senator D'Amato. You stated in your introductory remarks that your goal is to increase the availability of services to our seniors through the infusion of this additional $40 million. But I do not note any specific assignment of these funds. Would the Senator clarify again for me his intention to ensure that these dollars are spent on services that are proven to be effective and efficient, and not to pad the administrative accounts over at the Administration on Aging, or to allow them funds to try new things?

Mr. GREGG. Then I am pleased to have the opportunity today to support the Senator from New York's increase in funding to the services provided by the Older American's Act.

Mr. GREGG

Mr. GREGG. Madam President, as the excellent chairman of the labor subcommittee of the Appropriations Committee mentioned earlier, there is a pending issue which is of considerable significance which has arisen in the last few weeks as a result of the question of how we are going to pursue national testing. The chairman of the committee has mentioned he would hope this issue, from the standpoint of an amendment to the bill, would be taken up for final vote tomorrow sometime. I am certainly agreeable to that. However, it had been my intention, along with Senator Coats, to offer an amendment today on this issue, and in talking it over with the chairman he suggested we offer the amendment and then hold the vote until tomorrow. That certainly is an approach which I am perfectly happy to follow. This amendment, which is basically directed at codifying what we understand now to be the President's position--and we say ``now'' because the President's position on national testing appears to have undergone a transformation at some fairly high level of significance. It reflects that decision by the President to no longer push national testing as something that should be controlled and directed by the Department of Education but rather to have national testing to the extent it be developed by independent agencies. Using the term ``independent,'' I mean agencies which are independent of the Federal Government and which are not under the Federal Government or even under the Federal Government's control through the use of the appropriations process. Why is this important? There are a large number of us involved in the issue of reforming education who feel very strongly that national testing makes sense, but to have it controlled by, designed by or in any way managed by the Department of Education here in Washington does not make sense. That would be a fundamental flaw. We are encouraged, and we think it is appropriate that the President appears to have come to this conclusion himself over the weekend. Although his initial reaction was to have the Department of Education run this type of a national testing program, his decision now is to move it to the private sector and allow the private sector and the private nonprofits to develop the proper testing standards. Why is this important? Because the issue of national testing is important at a variety of different levels. In a positive way it is important because it will give communities an opportunity to compare how their students are doing with other students, to compare how their schools are doing with other schools, compare how their educators are doing with other educators across the country. That is very significant. It is not unique, national testing. We have in this country one of the most expansive national testing programs probably anywhere in the world called the SAT test. It comes at the end of the school system, the end of the educational experience, at least as far as elementary and secondary schools are concerned, and juniors and seniors and sometimes sophomores, students in their high school years, will take tests. They have the SAT, the SAT 2, they have achievements, they have advanced placement tests, a whole series of tests which they take, quite a battery of tests. Anybody who has a child going through the SAT experience understands its intensity and recognizes this is one heck of a testing system which we have which is nationally driven which is, in fact, nationally directed, which is, in fact, nationally developed, and which is, in fact, a heck of a good system. I think the reason it worked so well is it has been energized and directed by the private sector of our country, not by the Federal Government. The downside of national testing is that if it is done by the Federal Government, at the direction of the Federal Government, under the control of the Federal Government or funded by the Federal Government, you are stepping, in my opinion, and I think in the opinion of many of us who view education as a critical asset of the community, of the State, of people at the lowest level of government who have the right to control how their children's lives are determined in their school systems rather than having it be controlled from Washington, those of us who view that education should be directed locally and not nationally, you are stepping on the slippery slope of once again the issue of national control over curriculum, national control over contents, national control over teachers' standards in the educational system because a federally designed, federally paid for, federally controlled national educational testing system would be, in my opinion and I think the opinion of many people who view this issue and who have looked at it for a while as I have, as being one of the first steps toward a nationally directed curriculum, a nationally directed content in education, and a nationally directed standard for our teachers. That is something that I would most vehemently object to and have objected to, and in fact when we went through Goals 2000, raising the issue of national curriculum was the core question. We amended that law dramatically from its initial structure so that it would not end up as a national curriculum exercise. Now that we have pushed forward onto the playing field a national testing system, at something other than the end of your high school years, a national testing system which will probably be targeted on the third grade or the eighth grade or maybe both grades, to determine competency, especially in objective types of discipline such as mathematics and science, such a national testing system has to be entered into with some caution to be sure that we do not end up going down the wrong path, that we use it for the purposes for which it should be used, which is to give our local communities the capacity to evaluate how their local school systems are doing in educating their children--not use it with the capacity of taking away from our local communities the capacity to control their local school systems by taking away control over curriculum or taking away control over content. So this amendment is basically directed at saying it is not appropriate for the Department of Education to be an aggressive participant, a funded participant in the designing of a national testing system. Rather, that should be left to the private or quasiprivate or nonprofit sector which presently does such a good job in areas such as SAT's. The view, which was not the original view of the President and now is the view of the President, is something which we congratulate him on changing his position on and coming to a conclusion that is of that position and which we want to support by passing this amendment. Senator Coats and I have put this amendment together. It tracks what was passed in the House, or what is being proposed in the House--I am not sure it has been passed yet--by Representative Goodling from Pennsylvania, chairman of the authorizing committee which deals with education in the House. I appreciate the courtesy of the chairman of the committee in allowing us to go forward with it and in his support in going forward with it. We are certainly sensitive to his desire to have the vote tomorrow if there is to be a formal vote, if it is not adopted by agreement, which I hope would be because it does reflect, we believe, the administration position. I yield the floor.

Mr. GREGG. I move to lay it on the table. The motion to lay on the table was agreed to. Amendment No. 1070

Mr. GREGG. I ask unanimous consent the reading of the amendment be dispensed.

Mr. GREGG. I ask unanimous consent the pending amendment be set aside, and I send an amendment to the desk.

Mr. GREGG

Mr. GREGG. Mr. President, I thank the Senators from Pennsylvania for highlighting the work of this program and its funding history. Since the Small Business Administration funded the program in fiscal year 1997, I assume they will wish to continue funding in fiscal year 1998 for the Center. The absence of report language should not prevent the agency from providing funding in the next fiscal year.

Mr. GREGG

Mr. GREGG. Mr. President, let me begin by congratulating the Senator from Delaware for the extraordinary job he has done in putting together this tax reduction package, which is directed primarily to assisting American families, working families of middle-income means, to make it easier on them to meet the day-to-day expenses of raising a family. It takes giant strides in assisting especially the American middle-income family in dealing with the cost of education, which is absolutely critical. The effort that was put into this by the Senator from Delaware in leading this initiative and pulling this together and getting it passed is nothing short of extraordinary. It will go down as one of the finest hours, I think, in this body and certainly in this Congress. I congratulate him for it. I wanted to speak briefly about a couple of areas in the bill that I think are especially positive and for which I thank the Senator from Delaware for working so hard on them. First is the area of estate tax reform. We have heard a lot about how this bill greatly helps especially the small businessperson and farmer in being able to retain their business and pass it on to their heirs-- their children, in most instances--so they can continue to run the business, so that all the years of sweat equity put in on building a family farm or a small business won't be lost or confiscated on the death of the primary owner of the estate, but rather will be passed on to his or her family, and the tax burden on that small businessman or farmer is dramatically reduced. But there is another item in this bill that has not been talked about at all, which I think is especially important in places like New Hampshire, and that is the conservation tax--a tax break for people who leave their land or keep their land in conservation, or in the silviculture activities, upon the death of the primary owner of the estate. This section of the bill, which was initiated by myself and Senator Chafee from Rhode Island, is basically directed at addressing a problem which we see especially in New England. There is tremendous pressure on our forest areas to convert those areas to development. Many people in New England--especially in New Hampshire--run very small tree farms, or operate a lumber business, or a logging business, or a business that in some way uses the forest lands. In addition, there are a lot of people who, just for the purposes of being good citizens, keep their lands open. They don't develop them. They keep their lands in a natural, or fairly close to natural, state, and their lands in many instances are used for recreation or are used for hunting and used, obviously, to maintain the environment. Unfortunately, when these folks pass on, because of the nature of New England today and the heavy populations that we have and the expansion of population that we have, in most instances these pieces of land aren't valued for the purposes of running a tree farm or maintaining wood lots. They usually are valued for some higher use, defined by the terms of cost, such as a mall or, in many instances, a housing development of some nature. The result of that is that the property in the estate ends up being valued at an extraordinarily high level. The heirs who receive the land have no option but to sell the land, develop the land, and as a result, convert the land from forestry use into some sort of commercial or construction use, which has two events. First, it obviously ends the ability of the forestry industry to use that land for the purposes of maintaining forest and silviculture activity. Second, it ends up developing land. That changes the character of the State in many ways. There are a lot of people who would rather not develop the lands. A lot of heirs are willing to keep the land as a production for forestry activities, or as a conservation area, but they can't afford to do that because the taxes are so high. So in this bill, as a result of the efforts of the chairman of the committee, myself, and Senator Chafee, there is now a new deduction that allows people, who agree to do it, to retain their land as a conservation easement when they receive it from an estate and, thus, keep it as land that is protected for the purposes of keeping it in a fairly natural state--using it for timbering if they desire to do so. There will be a deduction relative to the value of that land of about 40 percent, which is a major plus. It is a major commitment to the community, a major commitment, obviously, to the individuals who will be receiving the land, that the Federal Government isn't going to force people to sell their land in order to pay their taxes by putting a value on the land that is so high that they have no option but to sell their land. That is good news. Now, this only applies to certain types of land. It applies to land which lies within a certain distance of a national forest or an urban forest. So it doesn't apply to all of the land in New England or all of the land in the country. It does apply to land which is basically in the same area as the area which has already been protected for the purposes of maintaining its pristine qualities. That only makes sense that that type of land should be the land that we are targeting, so that we don't end up with large commercial developments surrounding our national forests and urban forests. As a result of this language being put in the bill and the way it was put in, it will actually apply to about 90 percent of New Hampshire because so much of it is a national forest. We have the largest national forest, I believe, east of the Mississippi. Certainly, we have the largest national forest in the Northeast, or the most visited in the Northeast, the White Mountain National Forest, which takes up about 17 percent of the State, I believe. Therefore, it has a very significant land mass within the State. So this is good news for those of us who believe very strongly that maintaining the character of the land, in the State of New Hampshire especially, is critical. This will allow those folks who receive land coming out of an estate to keep that land as forest land, if they desire to do so, and not be forced to sell in order to pay taxes. That is a very big plus. The second element I want to congratulate Senator Roth for deals with retirement provisions in this bill. There is a very positive expansion of the ability of people to save for retirement in this bill. Of course, there is the famous Roth IRA accounts, which we heard a fair amount about, which are a series of expansions of IRA accounts. More important, this is a whole series of initiatives which came out of a working group I chair, the leadership task force on retirement reform. Thirteen of those items are in this bill. They give the small businesspeople in this country much more flexibility in putting in place retirement accounts and gives individuals much more flexibility in the area of being able to participate in saving for their retirement, and they are very strong initiatives. I will say a few words about what this tax bill will mean to American families and to their ability to save for retirement. Earlier this year I was named to chair a Republican Retirement Security Task Force. We introduced a series of reforms as S. 883. Senator Roth's contribution to the task force's work was vital. I also appreciate his willingness to work in favor of many of these provisions in this tax legislation. This Nation faces a dire need to expand retirement saving to meet the retirement needs of an aging 21st century population. But behind this general national picture are the real-life concerns of millions of hard-working American families, who are concerned about their prospects for retirement. This bill will significantly increase their chances to achieve a dignified and secure retirement. I would like to describe some of these provisions and the effect that they would have for families. Consider a family, John and Mary Smith, where John is a full-time paid employee, and Mary is working within the home. Or, perhaps Mary is working full time, and John is working within the home. Between them, they earn $50,000. And suppose that John, but not Mary, is able to participate in a pension plan at work. Under the old law, this couple could not make a deductible contribution to an IRA. But under this bill, now Mary can make a fully tax-deductible $2,000 contribution to an IRA. And the same is true whether this family earns $50,000 or $60,000 or $70,000--on up to $150,000. Because of this tax legislation, a huge number of families will now be able to participate in tax-deferred IRA accounts. An article in the Washington Post this morning indicated that fully 7 million new IRA accounts will be opened because of this measure alone. Think of what that will do for a couple's retirement security--if they are able to put away $2,000, tax-deferred, every year. Consider another couple: Michael and Susan Jones. Suppose they have a family farm. And because of the fortunes of farming, their income goes up and down from year to year. Perhaps one year they earn $50,000--and the next year they only earn $30,000. Under current law, this couple is going to be very concerned about whether they can save in an IRA. They don't know whether their contributions will be tax-deductible or not. One year it is, the next year it isn't. It's very difficult for them to know, as the year progresses, whether they can afford to put the money in. Under this legislation, we have created something new for them--the back-loaded IRA. Now Michael and Susan can make contributions to an IRA without worrying about whether they will get the tax benefits--because those tax benefits will come at the end of the road. They don't get the tax deduction now, when they contribute to the IRA, but they know that at the end of the game, they will have tax-advantaged earnings through the IRA. This legislation gives them a new way to gain tax advantages from savings. And, this legislation also vastly expands traditional IRA accounts-- doubling the income limits for tax deductibility over the next 5 years. As a result, millions of Americans will find it easier to save for retirement. This legislation also contains many of the pension reform provisions which we worked so hard to create in S. 883. This legislation increase the security of employer-provided pensions--by increasing the amount of employer funding to meet those pension liabilities. Under current law, Mr. President, most employers do not have enough funding in these pension plans to meet eventual liabilities. Not because the employers won't do it--but rather because the Government won't let hem. We had sharply limited the amount of funding that employers may put in these pension plans. So when Frank Williams goes to work, there is often only enough funding in his pension plan to support benefits that he would receive if he and everyone else in the company retired today. Frank hopes to work longer, to accrue a larger pension benefit someday, as does everyone in the company. And the liabilities of the pension plan will eventually be much larger, because everyone working there will someday be entitled to much higher benefits than are accounted for in current measures of liability. Under this legislation, we will raise the limits on employer funding of pensions--from 150 percent of current liability to 170 percent. Employers will be permitted to fund at a level that is closer to their projected liability. This means greater retirement security for all Americans. It means that there will be more funds in Frank Williams' pension plan. Now consider the case of another hard-working American, Walter Taylor, an aspiring entrepreneur, starting his or her own business. Under the old law, if he started a pension plan, and he was therefore paying both the employer match and the employee contribution for his own pension benefits, he would not get the same tax treatment that other employers get. This legislation will create a level playing field for the self-employed, and says that they too will receive the same tax treatment of their matching contributions that other employers receive. This will be a tremendous benefit to small businesses, which is where we most need to expand pension coverage. This legislation will also make it easier and more convenient for families to save through IRA's--by facilitating automatic payroll deductions into IRA's. This legislation will also make it easier for State and local government plans to operate, by exempting them from the cumbersome nondiscrimination rules that were not intended for Government plans. This legislation will streamline and simplify paperwork and reporting requirements. It will eliminate the need for obsolete and unnecessary forms, and will also facilitate the use of electronic technology to replace old paperwork. Finally, the legislation will make a number of technical corrections to the law, straightening out inconsistencies between tax and regulatory treatment of pension contributions, inconsistencies that have frustrated employers and pension administrators alike. I am pleased to have been the principal sponsor of these provisions, and I commend and thank those who have worked to bring us closer to enacting them into law. Mr. President, I thank the Senator from Maine for allowing me to precede her. I thank the Senator from Delaware for allowing me to speak and for his extraordinary effort.

Mr. GREGG

Mr. GREGG. Mr. President, I am very pleased that the Senator from Delaware [Mr. Roth], included language in this tax bill, H.R. 2014, the Revenue Reconciliation Act, which promotes land conservation through the use of conservation easements and allowing the postmortem election of these easements. Still, I believe that more must be done in the future to ensure that forestland, especially in the Northeast, is preserved. This issue is of particular importance in the Northeast, where 85 percent of our forestland is in private ownership.

Mr. GREGG

Mr. GREGG. Recognizing the importance of this study to the compromise reached on S. 39, funds were added to the fiscal year 1998 Commerce, Justice, State appropriations bill in the Senate to complete the first year of work. We will work together to protect this appropriation in conference. I, too, encourage the administration to follow through on its commitment to include the funds for fiscal year 1999, 2000, and 2001 in its budget requests, and will work to include the funds in appropriations if they are requested.

Mr. GREGG

Mr. GREGG. Mr. President, I ask unanimous consent the amendment be agreed to, and I yield back the remainder of our time.

Mr. GREGG. Mr. President, I move to reconsider the vote.

Mr. GREGG. The Senator is correct.

Mr. GREGG

Mr. GREGG. Mr. President, we are here to consider the Commerce, State, Justice bill. I ask of the Chair, how is the time being allocated relative to the Wellstone amendment?

Mr. GREGG. So the time is still available, the full 30 minutes on each amendment?

Mr. GREGG. I yield the floor. Mr. HOLLINGS addressed the Chair.

Mr. GREGG

Mr. GREGG. Would the Senator yield?

Mr. GREGG. I appreciate the ranking member, Senator Hollings, bringing this oversight to the Senate's attention. Last year, I supported including this program in the conference report, and, I agree with the Senator from South Carolina, it should be included in this fiscal year 1998 bill.

Mr. GREGG. Let me conclude by saying that in conference we will seek to get the House to agree to provide $1.0 million of juvenile justice and delinquency prevention funds for this worthwhile program. I yield the floor.