Childhood Obesity Reduction Act

I thank my colleague for his statement about this matter. We worked very hard on the Dietary Supplement Health and Education Act back in 1994. It has served this country very well. There are now almost 150 million Americans who, daily, take dietary supplements much to the betterment of their health.

Amendment No. 3225 offered by our colleague from Illinois, Mr. Durbin, is a solution in search of a problem. It is neither wise nor necessary. The Harkin-Hatch substitute should be approved in the alternative.

The Durbin amendment is yet again another attack on dietary supplements and it should be rejected.

Instead, I ask colleagues to vote in favor of the second-degree amendment Senator Harkin and I have drafted, an amendment which will put us firmly on record in favor of enforcing the law we passed--not once but twice--by unanimous consent.

This law gives FDA all the enforcement tools it needs to act against problem supplements, a fact that has been confirmed by the FDA Commissioner in

the Clinton administration, Dr. Jane Henney, by the first FDA Commissioner in the Bush administration, Dr. Mark McClellan, and by today's head of the FDA, Dr. Lester Crawford.

The law I reference, the Dietary Supplement Health and Education Act, provides all the tools we need to ensure consumer access to safe dietary supplements and information about their benefits and potential problems.

But for that consumer protection to be a reality, the law must be implemented through regulation and enforced in the courts, and Congress must provide the resources for the agency to do its job.

There is no question that FDA has been slow to act on problem supplements. But it is coming around and is doing a much more vigorous job, taking many more enforcement actions against illegally marketed products in recent months. By the way, they did not have this power before the DSHEA.

I believe this new emphasis on enforcement, albeit under our prodding, is due to both the leadership of Dr. McClellan, who has committed to me and Senator Harkin that he would compel the agency to implement DSHEA more vigorously, and to our colleagues, Chairman Bob Bennett, before him Chairman Cochran, and Ranking Minority Member Herb Kohl, who have acted to put more funding in the hands of the FDA to enforce the dietary supplement law.

By and large, dietary supplements--vitamins, minerals, herbs and amino acids--are used safely by hundreds of millions of Americans each year in order to help them lead healthy lifestyles. Critics of the industry point to the very few supplements that raise safety or labeling concerns, concerns that I firmly believe the law is adequate to address.

I hope it comes as no surprise to Senators that Senator Harkin and I have been as critical as Senator Durbin about the agency's lack of action in enforcing against problem supplements.

We have pressed FDA to remove from the market products which are harming young athletes, products such as androstenedione or ``andro.'' Earlier this year, under the leadership of Dr. McClellan and HHS Secretary Tommy Thompson, andro was removed from the market. I was there. I was there at the announcement. I was one who backed that. It can no longer masquerade as a dietary supplement.

We have also been concerned about ephedra. I have said for a number of years that if the agency believes this product is unsafe, it should remove it from the market under the abundant authority we provided in DSHEA, the Dietary Supplement Health and Education Act. This includes seizure, fines, and injunctive relief against misbranded or adulterated dietary supplements. Again, although belatedly, the agency has acted against ephedra products, although there is litigation over this because there is some body of evidence that indicates properly used ephedra can be beneficial in weight reduction and perhaps in other areas as well. But we backed whatever the FDA did, we, the authors of the dietary supplement act.

As my colleagues are aware, I am one of the original authors of the Dietary Supplement Health and Education Act of 1994. I would like to take a few minutes to talk about the history of DSHEA, which will shed some light on why the Harkin-Hatch language is preferable to the Durbin amendment. This may be helpful for some of our colleagues who were not here when President Clinton signed DSHEA into law. It may also help reassure those who voted for the measure that it is working.

At the outset, it is important for Senators to realize the Dietary Supplement Health and Education Act established a rational, regulatory framework that provides the Food and Drug Administration with the tools it needs to assure the safety of products consumed by the American public, and to provide consumers with access to safe products and information about those products.

Indeed, the DSHEA law allows the more than 150 million Americans who regularly consume dietary supplements to have access to products in order to achieve the health benefits they desire. DSHEA enables Americans to buy relatively inexpensive dietary supplements, including vitamins and minerals, which may achieve a wide array of health improvements.

The passage of the Dietary Supplement Health and Education Act followed decades of Food and Drug Administration antipathy toward dietary supplement products. This animosity, well documented by hearings in the Labor and Human Resources Committee and by the committee's 1993 report, and the lack of clear regulatory structure for supplements, was the basis for our Senate votes.

That is also why a majority of the Senate--two-thirds of our membership--cosponsored the bill. That also helps explain why the bill passed without one dissenting vote in the Senate.

As I believe Senator Harkin has noted, there is a great need to set the record straight. Dietary supplements are regulated by the Food and Drug Administration. In fact, the FDA has had this authority for a century. What we did in 1994 was to clarify and strengthen FDA's authority. Thus, media reports that supplements are ``unregulated'' are patently false.

The basic structure of DSHEA allows all products marketed as dietary supplements at the time the bill was enacted to continue to be marketed as dietary supplements unless they are determined to be unsafe or otherwise violate prohibitions in the Federal Food, Drug, and Cosmetic Act with respect to labeling, purity, and manufacturing.

This so-called grandfather provision was enacted into law. In addition, for new dietary ingredients, those not marketed in the United States before the law was enacted, manufacturers must provide evidence of safety to the FDA 75 days in advance of marketing. Again, new dietary ingredients must also comply with the Food, Drug, and Cosmetic Act requirements for safety, purity, and labeling.

Responsible companies have followed the rules. Over 150 times they have notified the FDA, as the law requires. About half of those were rejected because there were safety concerns or because the products were not appropriately marketed as dietary supplements.

The Dietary Supplement Health and Education Act works. The law specifically prohibits supplements that present ``significant or unreasonable risk of illness or injury under . . . conditions of use recommended or suggested in labeling.'' A supplement not meeting that requirement is deemed adulterated, and, thus, illegal. This requirement does not require the agency to prove harm to anyone, rather, to make a determination that a significant or unreasonable risk of illness or injury is present.

In addition, the law prohibits any poisonous or deleterious substances in dietary supplements. A supplement is illegal if it is ``unfit for food,'' a very broad authority which allows the agency to act against a product that is not fit for human consumption, and an authority that was not there before DSHEA.

Under DSHEA, a dietary supplement cannot claim that it will diagnose, cure, mitigate, treat, or prevent a disease. Any labeling to that effect immediately makes the product subject to regulation as a drug and, thus, illegally marketed as a supplement.

Under DSHEA, the labeling for a product must be truthful and informative. If the labeling is ``false or misleading'' in any way, the product is misbranded, and, thus, illegal.

Senators should be aware there are substantial sanctions for violations of these requirements, sanctions that did not exist before. Violations subject the product to recall, seizure, condemnation, and destruction. Persons committing the violations could be subject to both injunction and criminal prosecution. So the Dietary Supplement Health and Education Act has teeth, teeth that were not there before.

The hallmark of DSHEA is the balance between allowing for beneficial dietary supplements while at the same time maintaining regulatory authority for FDA to remove any supplements that are detrimental to health. Any objective analysis of the law must conclude that it has produced public health benefits of enormous dimensions.

The growth in the dietary supplement market since enactment of DSHEA is astounding. Today, there are hundreds of thousands of safe, well- labeled products on the market offering consumers who want to maintain or

improve their health a panoply of options. Many of these products are manufactured in my own home State of Utah.

There also is much greater information available to consumers about these products as a result of DSHEA. Indeed, the provisions of the law clarifying what information could be provided with a supplement are nothing but consumer friendly. Before the law, it was FDA's official position that it was illegal for a store owner to distribute a Centers for Disease Control, or CDC, publication touting the benefits of folic acid use for pregnant mothers.

That is interesting because CDC knew that if mothers would take 400 micrograms of folic acid--I think it is micrograms or milligrams of folic acid--that would help to prevent neurotube defects. Even though they knew that, FDA would not allow that claim to be made, and about 1,250 children a year were born with spina bifida as a result that could have been avoided. We have come a long way since then.

Congress wisely recognized that had to change, and public health authorities believe hundreds of babies have been born without spina bifida because of the now wide use of folic acid--something we knew 11 years before DSHEA of which the FDA was aware but would not allow pregnant women to understand.

Now, are there problems with DSHEA? If there are problems, I believe they lie largely in the fact it has not been enforced vigorously. We certainly have given FDA the power to enforce the law. Both Senator Harkin and I have complained that up until recently they had not been enforcing the law, almost sitting aside waiting for something to occur that was out of the ordinary. I have to say, since Dr. McClellan took over, and now Dr. Crawford, I believe the law is being enforced, and we have seen some very strong evidence of that.

As many of our colleagues, I have been frustrated with the agency's slowness in implementing certain provisions. For example, the law authorized FDA to develop good manufacturing practice guidelines, or GMPs, specific to supplements. The agency failed to act on this provision until 1999--5 years later--only submitting a proposal to the Office of Management and Budget in the last month of the Clinton administration. Delays and rewrites occurred for 2 years. Finally, the proposal was published earlier this year--almost 10 years after we gave them the power to do this.

Why are GMPs, good manufacturing practices, so important? They are the standards FDA inspects against to make sure the products are manufactured with purity and sanitation, to make sure they are properly labeled. So these are very important rules to have on the books, and this delay has been very troubling, especially to us as authors of the bill giving them the authority to do this.

But that has changed, as I cited earlier, noting the FDA's actions against androstenedione and ephedra, among other products. We have a carefully crafted safety standard in the law, a standard that was agreed to by then-Chairmen Kennedy, Dingell, and Waxman. When the FDA took action against ephedra-containing products earlier this year, it was the first time in the 10-year history of the law that the safety standard was invoked, even though we have been pushing to have it invoked. It is hard to maintain a law is not working if its powers are not used. I am heartened that the FDA acted to remove andro from the market earlier this year, thus helping to protect young athletes from its numerous adverse health effects, but it should not have taken that long for the agency to act.

We do have tools within the law that give the FDA the authority to act against problem supplements, as I have outlined.

I might add that to assure Chairman Dingell, we also gave the FDA a very broad safety authority, a tool so broad that I was reluctant to provide it to the FDA given the agency's animosity against supplements. That authority, the ability of the Department of Health and Human Services to declare a product an ``imminent hazard'' and remove it from the market, no questions asked, has never been invoked either. Some have alleged it has not been invoked because it is ill-defined. On the contrary, it was deliberately crafted to be defined by HHS to meet any safety concerns the agency may raise. So here is another powerful tool the agency can use against a product if it has safety concerns.

Finally, with regard to the safety profile of so-called stimulants, I am aware this is a special concern of Senator Durbin and Senator Kennedy. Under the law, as it currently exists, as we enacted it, a dietary supplement--be it what Senator Durbin considers to be a stimulant or any other product--must be safe. If it is not, the FDA can immediately act against it under the law. It is hard to segregate one type of product or define it, an inherent problem in trying to tailor the law to address stimulants only. Should we include caffeine? Everybody knows that is a stimulant. What about colas? What about chocolate? Why shouldn't they be included? What about over-the-counter stimulant products? Generally, there are no requirements for adverse events reporting for them either. Why the differentiation?

In 2002, estimates are that 182 persons died from taking acetaminophen as directed. Yet this is a broadly sold drug, over-the- counter drug. Why should there not be AER requirements for such over- the-counter products as well, or maybe that is where we are headed with this type of an amendment.

Perhaps we should look at the very notion that an AER system would prevent death or injury. AERs tell us that 55 men died in the first few months Viagra was marketed. What was the response? The FDA did not move to pull the product from the market. Instead it moved to include warnings for those men who may have been at risk due to cardiac disease, which is what you would expect. Believe it or not, Congress didn't have to take any action. It is the same situation here.

It is important for our colleagues to understand this background about the law as it is useful for evaluating the Durbin amendment, which I hope our colleagues on the Senate floor will vote down. I hope it will help my colleagues understand why voting in favor of the Durbin amendment at this time is very premature.

This amendment would amend the DOD reauthorization bill to prohibit military installations from selling stimulant-containing dietary supplements unless the manufacturer agrees to mandatory reporting of any serious adverse events to the FDA related to the use of the product. It may surprise some to know that I am not opposed to better reporting of adverse events connected with supplements; nor, for that matter, am I opposed to better reporting of adverse events for over- the-counter drugs which many erroneously believe are generally subject to adverse event reporting or AERs, as this debate calls them. Indeed, Senator Harkin and I have been working to improve adverse event reporting for dietary supplements and over-the-counter drugs. Funding has been included in a number of appropriations laws to give FDA resources for adverse event reporting for supplements. If there is a serious problem with an aspirin, a vitamin, an herb, or a cold remedy, should not our policy be the same, that authorities are alerted to that serious problem?

But the Durbin amendment is not the way to go about this. First, it is an extraneous amendment to the Department of Defense bill, especially at a time when our Nation is at war. This is the wrong time and the wrong place for this discussion. I wonder if the families of our service members are bewildered watching us spend so much time talking about what products they can buy at the commissary, especially when the DOD already has the authority to limit any sales. If there is an issue with a dietary supplement or supplements--and in this case, I do not believe there is--it should not be considered only in the context of military installations but, rather, as a matter of overall food and drug policy. Indeed, it is inconsistent with standing food and drug law to establish a policy governing a regulated product sold throughout the Nation and apply that policy only to certain facilities such as military installations.

Surveys have shown that 70 to 90 percent of soldiers are users of dietary supplements. Military personnel and their families, as all other Americans, benefit from the protective effects of

supplements and from their positive health benefits. What is the rationale for singling them out for different treatment? I find this particularly peculiar given that the Department of Defense has the ability to decide what is marketed on military bases. In fact, DOD removed ephedra from commissaries long before the FDA banned the product for general use.

If the Department of Defense perceives a problem with these supplements, it can preclude their sale to the military, as the DOD has already done with regard to ephedra. But beyond that, I am not aware of any reported problem relating to the sale of ``stimulant'' dietary supplements on military bases and, thus, see no reason to place the restrictions contained in the Durbin amendment.

Second, in a similar vein, in view of the FDA's too-long, ridiculously long lag time in coming to grips with the regulation of ephedra, which I can only assume gave rise to this amendment, I recognize that the Durbin amendment has a certain curbside appeal. I urge my colleagues to look beyond that. As a matter of food and drug law, there is no basis for separating one type of dietary supplement from another. I maintain that if there are serious adverse events associated with any legally sold dietary supplement, then there should be a better reporting system so FDA can take appropriate action. I remain ready and willing to work with any or all of my colleagues to create such an adverse event reporting system.

Third, as a matter of food and drug law, it does not make sense to have what amount to interparty agreements between a manufacturer and a defense installation for an FDA-regulated product to be marketed. We have a long history of tradition in this country, grounded in the Federal Food, Drug, and Cosmetic Act, that policies governing FDA- regulated products are national in nature, applying across points of sale, across manufacturers, and across the various States.

Let us say for the sake of argument that a certain dietary supplement is found to cause respiratory problems. Should the FDA only become aware of the problems when the product has been sold in a commissary? As a matter of public health, wouldn't we want to know if that is the case wherever the product is sold and in whatever store and in whatever State so appropriate public health safety measures can be considered?

Fourth, the timing of this amendment is premature. It has not been studied by the committee of jurisdiction, nor has the Food and Drug Administration, the administering agency, taken a position. Surely they should have a hand in the development of any such policy, as I believe should Senator Harkin and I as the prime Senate authors of the 1994 law governing regulation of supplements.

I am deeply troubled that the Senate HELP Committee, which has jurisdiction over the Federal Food, Drug, and Cosmetic Act, has not even been able to consider this proposal. Since this is such an important matter, I believe it must be considered by the committee of jurisdiction before it is considered by the full Senate. That is the way we usually operate in these very serious Food, Drug, and Cosmetic Act and food supplement areas.

I have learned after many years in the Senate that the most successful legislative proposals are those that are properly considered and debated by and within the committees of jurisdiction. I would like to see consultation with the HELP Committee, with the Food and Drug Administration, and other scientific organizations, with appropriate input from the dietary supplement industry before any proposal is voted upon by the full Senate. That would be the fair and reasonable way to go about this, not just some off-the-cuff amendment that specializes in a particular area--in this case the military commissaries--that has no real backing to it other than that some people think it might be helpful.

The final reason this amendment is unnecessary is the FDA is already investigating products the Senator from Illinois terms ``stimulants.'' The FDA is well aware of issues associated with products Senator Durbin refers to as stimulants, although there is no such category in food and drug law. FDA is looking closely at products such as ephedra, which it recently banned, and ephedra substitutes such as citrus aurantium or bitter orange. FDA and the National Institutes of Health are studying the safety of citrus aurantium. The proposed amendment singles out supplements that contain stimulants, including those that contain caffeine.

As a point of fact, some military personnel are encouraged to use stimulants. Pilots use them on long flights. I submit that many service members use more caffeine through coffee, tea, and soft drinks such as Coca-Cola, Pepsi, Mountain Dew, and Dr. Pepper than they do in dietary supplements. For all of the concerns of the distinguished Senator from Illinois, I am not aware of many adverse reports that would come from their use, nor am I aware of real serious adverse reports that would come through the use of basic dietary supplements. But if they do, then the FDA should consider those. And they would be important. At least we would have a system that works. I could see groups in this society ginning up adverse event reports for no other reason than to damage some manufacturer. We want to prevent that. That is another reason why we want to look this over.

I got an e-mail from a service member's father this morning about his son who is currently serving in Baghdad. His division commanders have now banned the consumption of Red Bull, the highly-caffeinated energy drink, after reports of several soldiers collapsing and perhaps dying while patrolling in 120-degree heat after consuming this drink.

This shows the defects in the Durbin amendment--since it would not even address high levels of caffeine use--and the fact the system works, since military leaders are taking action to preclude unwise use of this product or any other product, for that matter.

As many in this body are aware, Senator Durbin has a companion bill, S. 722, which proposes one way to set up an AER system for supplements. The Durbin bill, as with the present Durbin amendment, is very troubling.

One huge concern I have with this bill is it could lead to premarket approval of so-called ``stimulants.'' For this body to impose a premarket approval system on dietary supplements would be a blunder of vast proportions.

If my colleagues contemplate the matter, they will quickly realize it would not be practical for manufacturers to seek marketing approval of dietary supplements, most of which cannot be patented. How would a company underwrite the high costs of FDA approval, costs which can run into hundreds of millions of dollars in the case of pharmaceutical products?

The answer is simple: Companies cannot sustain this cost and consumers will lose their ability to choose the dietary supplement products they will purchase. If the Members of the Senate and Congress want hundreds of thousands of letters and phone calls to come from the users of dietary supplements, if that is what it takes, we will accommodate them because the people out there know these products are helpful to them. They know they are more healthy because of them. They do not want the Senate telling them what to do. They would, I think, prefer the FDA to determine what is and what is not efficacious, only after there has been serious compliance with the Dietary Supplement Health and Education Act which gives FDA the authority to do some of the things that can be done to protect the public.

A premarket approval requirement would be the death knell for the dietary supplement industry. That is one reason why we fought through the Dietary Supplement Health and Education Act. We fought it through because we knew it would kill this very important industry that 150 million people benefit from every day. Beyond that, there is no need for preapproval of dietary supplement products.

Indeed, the grandfather provision in the law was suggested by House Democrats, who no doubt recognized the majority of supplement products on the market pose no safety concerns. That, coupled with strong enforcement authority for the FDA, gives consumers assurance that they are taking safe products.

Back to the amendment at hand.

It is obvious to me the target of this amendment is FDA regulation of certain stimulant-containing dietary supplements, not the health and readiness

of our Armed Forces. Let me emphasize that the DOD reauthorization bill is the wrong vehicle to amend the Dietary Supplement Health and Education Act. This amendment will not--I repeat, will not--ensure the health and readiness of the members of the Armed Forces.

For these reasons, I urge my colleagues to vote against the Durbin amendment. The Hatch-Harkin amendment is a much better alternative. It states the sense of the Congress that the FDA should make it a top priority to fully and effectively implement the Dietary Supplement Health and Education Act, including taking appropriate enforcement action against unsafe supplements.

Our amendment urges the Department of Health and Human Services to work with outside scientific organizations and the industry, as appropriate, to develop a proposal for better adverse event reporting both for dietary supplements and for OTC products for the Congress to consider.

Finally, our amendment restates the obvious: that adequate resources must be made available for the effective oversight of dietary supplements and sound, scientific research about their benefits and/or problems.

On April 19, just 2 short months ago, Dr. Crawford, currently running FDA, outlined a science-based plan for dietary supplement enforcement. He said:

FDA is absolutely committed to protecting consumers from

misleading claims and unsafe products.

He noted that in the past 6 months, the agency had inspected 180 domestic supplement manufacturers, sent 119 warning letters to distributors, refused entry to 1,171 foreign shipments of supplements, and seized or supervised voluntary destruction of almost $18 million worth of mislabeled or adulterated products.

``We will continue to aggressively enforce the DSHEA against unsafe and mislabeled products,'' the Acting FDA Commissioner said. Congress should support him in that effort, and this amendment does not constitute that type of support. That is the aim of the Hatch-Harkin amendment, and I ask our colleagues to join with us in supporting this measure.

Millions of Americans enjoy the daily benefits of dietary supplements. Among them are military families. Let's not act precipitously. Let's not upset an agency that is finally starting to do its job and enforce the law we gave them 8 years ago giving them the powers to do the job. Let us adopt the Hatch-Harkin amendment and guarantee American consumers have continued access to the safe, beneficial products they want.

I am proud of DSHEA. DSHEA has given FDA the authority it never had before. There is no excuse for FDA not to do the job. Since Dr. McClellan took over at FDA and now Dr. Crawford, they are doing the job. It took us almost 10 years to push them to do that, and now all of a sudden, they are doing a great job in this regard, and I do not want to undermine what they are doing. There is plenty of authority within the DSHEA law for them to do the job and do it right.

Mr. President, I yield the floor.

Will the Senator yield for a question?

I have been enjoying listening to the distinguished Senator. Let me ask this: Would the Senator be willing to resolve this problem by working with Senator Harkin and me to come up with a broad- based law that handles the adverse events reporting matter? Because my objection is that this is a helter-skelter approach to doing it, that will not solve the problems that the distinguished Senator thinks exist. I would be willing to work with the Senator rather than do this in this fashion on this particular bill, because I am not against adverse event reporting.

I am against premarket approval, which is what the Senator seems to be arguing for, which would price vitamins, minerals, and other products off the charts so that the average person, the 150 million people who use them for their health benefit, including, I am sure, the distinguished Senator and myself, would not be able to afford them.

I think it is going to take some very careful workmanship, working with the HELP Committee and with other Senators and Members of the House, to do an appropriate adverse events reporting enactment or statute that makes sense rather than do this on an ad hoc basis without defining how it is done, defining what adverse event reporting is, how they report, what they report on, and what is meaningful. I would be more than happy to work with my friend. I am sure I can speak for Senator Harkin as well. Our goal is not to allow companies that are not doing appropriate dietary supplements to be in business. If the Senator would withdraw his amendment, I am willing to work very carefully with him in good faith and work hard to try to resolve this problem, because I think the Senator also would--and I would ask him if he would know this as well--know that there are people in this world who do not like anybody and there could be a lot of phony adverse event reporting.

The Senator uses the term ``serious.'' I am not against having serious adverse event reporting but what the Senator is asking for here is not definitive. It would not be accurate. It could be interpreted to place severe burdens on the whole dietary supplement industry, which has been a very health-promoting industry over the years and which is one of the great industries of our country.

Those who are the top people in the industry want the industry to be totally honest in its approach toward everything that is manufactured as a dietary supplement. Certainly I do and certainly Senator Harkin does, and I acknowledge that the distinguished Senator from Illinois does.

I would be happy to work with the Senator. I do not think this is the way to do it. In fact, I know it is not the way to do it. All we are going to do is get in big arguments without getting anything done.

Then why do you not withdraw the amendment.

Those are broad categories.

Is the Senator aware the pharmaceutical industry is willing to keep going because of the hoped-for benefits in the dietary supplement industry? There are 100,000 people a year who die from toxicity. Even in the cases the distinguished Senator has quoted, there is a real question whether the deaths occurred from dietary supplements or from other factors. I think it is very difficult. Naturally people want to blame it on dietary supplements, but we have had 100 years or more--actually centuries of dietary supplements without deaths. All of a sudden, every time somebody dies they blame it on a dietary supplement.

We are a far cry from defining what it means to report adverse events. I would be willing to work with the Senator. I believe we could come up with something that really would work, that would be accepted by the industry and accepted by the FDA, and would give the FDA even more teeth than it has perhaps now, although we gave them plenty in DSHEA. I went over that in my remarks on the Senate floor, but I would be happy to do that.

I do.

If the Senator will withdraw his amendment, I will commit to do exactly that. What I do not want is a Dietary Supplement Health and Education Act adulterated with helter-skelter amendments that do not apply across the board. Frankly, I think the amendment of the distinguished Senator is in that nature, even though I know it is well meaning and sincere. But I am saying if you work together, we will do that.

You will withdraw the amendment if I am willing to do that?

As long as the industry is being consulted and is not just being pushed around. If the industry is consulted.

I believe responsible people in the industry--and most all of them are--if they are consulted, I believe they can help us in this area. I believe we can do the consuming public a great service in coming up with an efficient, workable, well-thought-out adverse event reporting system that FDA would appreciate as well. Yes, I am willing to work with the distinguished Senator, and I am willing to work--I can't speak for Senator Biden, but I believe he would be willing to work to add that to the ban on steroid use.

If we could get our leadership to do that on both sides, I would like nothing better than to pass that Hatch-Biden bill. I would like nothing better than for us to come up with an appropriate way of handling adverse event reporting that really makes sense, that helps the industry and yet makes sense for the consuming public as well, and to FDA. But it would have to have consultation with the industry as well.

No problem.

We will withdraw ours if the Senator withdraws his.

Amendments Nos. 3463, 3462, and 3225 Withdrawn

Under these circumstances I ask unanimous consent to withdraw my substitute amendment as part of that unanimous consent agreement, and you will withdraw the underlying amendment?

All three amendments.

Will the Senator yield for just a minute?

I would like to thank my colleague from Illinois for his willingness to withdraw his amendments. I want to work very closely with him in resolving these problems we have been discussing on the Senate floor. I am grateful to do that, and I think it is important.

Mr. President, I concur in the observation of our distinguished colleague. All I am saying is we should look at each one individually rather than establishing a policy at this point--certainly with regard to this bill because, as the distinguished majority leader said, the Senate has devoted extensive time to this piece of legislation. It is very important. I am optimistic that we can meet the schedule for completion tomorrow night. I hope that optimism is shared on the other side.

At this time, the bill is open to amendment. The managers await the arrival of the first Senator.

Mr. President, I hope we can perhaps reach the Byrd amendment today. It is an important amendment. I have shared many debates with my good and valued friend from West Virginia, and we are prepared. I cannot join him in support, but we will have a good, strong debate on it. It will be, I believe, a historic debate to initiate today.

Mr. President, I will be available tonight should the senior Senator from West Virginia desire to take up that debate tonight.

Mr. President, we are where we are. In the mortal words of someone smarter than I, we have to deal with the cards which have been dealt.

I have a suggestion. We are trying to work out how we could protect the parliamentary situation as it now exists with regard to the Burns second degree such that we could proceed now with the debate on the amendment of the distinguished Senator from North Dakota and at least have the debate in place in the hopes that perhaps we could resolve this dilemma as the day goes on.

Mr. President, I so note that observation.

May I inquire of the Senator from North Dakota: Is the parliamentary situation on his amendment now clear?

I presume the Burns matter would require a recorded vote, so at this point in time I don't know whether the Senator is willing to use this available time to explain his amendment, although it will not be a pending matter before the Senate.

We will try to resolve the underlying parliamentary situation with regard to both amendments, the underlying amendment and the Burns second-degree amendment, so the Senator will have his opportunity.

That is a reasonable request, and I suggest the absence of a quorum.

Mr. President, together with the Senator from Nevada,

the Senator from Virginia, in consultation with leadership, presents to the Senate this UC: I ask unanimous consent that at 5:30 today the Senate proceed to a vote in relation to the Warner amendment No. 3458 which is to be drafted as a first degree; to be followed immediately by a vote in relation to the Lautenberg amendment No. 3291; provided that no second degrees be in order to the amendments prior to those votes.

Amendment No. 3291, As Modified

No objection.

Mr. President, the leadership is working with the managers to see what we can do to resolve the question of one of the amendments which is pending before the Senate with regard to matters relating to the Commerce Committee. We see the Senator from North Dakota prepared to speak to his amendment. As soon as we can work out the parliamentary situation, we will proceed to that point.

It would be a valuable use of the time if we were to do so. We encourage that.

Mr. President, I think the Senator's understanding coincides with that of myself and the distinguished Senator from Nevada. In due course, several parties who have an active interest in not only the parliamentary situation but the substance are soon to arrive in the Senate. We have to wait a bit.

Mr. President, we understand. A Senator asked for a few minutes of morning business and then I would be prepared to engage with Senator Bingaman on his amendment, if that is agreeable.

Yes.

Mr. President, I thank my colleague for bringing up that point. I, too, am concerned, as is every Member of this body, about the daily, weekly loss of life and limb by our brave men and women in the Armed Forces. As the Senator says, this is their bill. That is what it is. It is their bill, whether they are privates or generals or admirals.

Might we accommodate the Senator from Ohio?

Mr. President, we are awaiting, and there is diligence on the other side in every respect, either the amendment of Senator Dayton or the amendment from Senator Bingaman. We have given them our second degrees in each case, which are now being studied. Until such time as one of the managers on the other side or these Senators appear, I suggest the absence of a quorum.

Mr. President, I send an amendment to the desk.

Mr. President, I ask unanimous consent that reading of the amendment be dispensed with.

Mr. President, let me first say I think our colleague has brought to the attention of the Senate through his amendment a very important subject. It is my hope and expectation that we can eventually have a meeting of the minds. I don't take great joy in putting a second-degree amendment up on important subjects such as this, but I felt it imperative so we can frame for our membership what I perceive as a very conscientious presentation by the Senator of a set of goals in which I concur with two-thirds of the Senator's objectives. But where I ask there be a reservation, those reservations are of such severity that I am compelled to put in the second-degree amendment.

I would like to walk through the amendment which the distinguished Senator put forth page by page.

The first section says:

Reports on matters relating to detainment of prisoners by

the Department of Defense.

Ordinarily, a report is something we are happy to grant a colleague. But in this instance, I will point out where my concerns are. First:

Reports required. Not later than 90 days after date of

enactment of this Act, and every six months thereafter, the

Secretary of Defense shall submit to the appropriate

committees of the Congress a report on the population of

detainees held by the Department of Defense and on the

facilities in which detainees are held.

That is, have been held more than 30 days.

My understanding was originally it didn't have that, and 30 days to me is reasonable. The Senator also added that the report can be submitted now in classified form. Again, that is a very essential improvement.

But we then continue:

(b) Report Elements. Each report under subsection (a) shall

include the following:

(1) General information on the foreign national detainees

in the custody of the Department during the six-month period

ending on the date of such report, including the following:

(A) The total number of detainees in the custody of the

Department . . .

I think that is an important fact, and I simply say ``as of the date of such report.'' I think that should be something which would be acceptable to the Senator.

Section (B) we leave standing.

The countries in which such detainees were detained, and

the number of detainees detained in each country.

That is acceptable.

Section (C) we take out simply because we modified (A) to state as of date of such report, and I think (C) is cared for by modifying (A) with date of such report.

Then we drop down:

The total number of detainees released from the custody of

the Department during such period.

We accept that fully.

(D) The nationality of the detainees covered by

subparagraph (A), including the number of detainees of each

such nationality.

That, too, seems to us to be fine.

Then section (F)--no objection there. That says, ``The number of detainees covered by subparagraph (A) that were transferred from jurisdiction of another country,'' so you can track them.

The Senator modified the original amendment. I am working from the original to show to date how much we have had meeting of the minds.

The Senator took out section (G). I will not trouble to talk about it.

We take out subsection (2). That is subsection (2) of the first paragraph of the amendment, report elements under (b).

As drafted, we delete for each foreign national detained by the Department of Defense during the 6-month period ending on the date of such report: No. 1, the name of the individual; No. 2, his or her nationality; the place at which they were taken into custody; the circumstances of being taken into custody; the place of detention; the current length of detention, or at least the duration of detention at the time of release. And on it goes.

Here is the problem. That bit of information, even though it were classified, were it ever to leak out--and regrettably, we know things of this nature will happen from time to time--it would be devastating because the enemy would know a great deal about custody and what we are trying to do with those individuals.

It seems to me there is far greater benefit to an enemy in such engagements as we must take prisoners than it would be of benefit to the legislative body to monitor that prisoners are properly being cared for. For example, the Durbin amendment we had the other day goes to potential abuses. That has been accepted. It is a major step forward to codify prohibitions against abuse of prisoners. We are all troubled by that.

To have in the custody of the Congress this type of information, even though it is locked up in S-407, or wherever it may be, potentially there is a document that could do great harm to our ability to conduct military operations during which we obtained detainees.

Then there is the following paragraph:

(3) Information of the detention facilities and practices

of the Department for the six-month period ending the date of

such report, including for each facility of the Department at

which detainees were detained. . . .

That is fine.

(A) The name of such facility.

(B) The location of such facility.

We have no objection to that. In fact, the entire next page of the amendment, we accept. We come to the conclusion of the amendment and no further objections. It simply is to the creation of a document that would have such detailed information that is not essential to the Congress in our oversight of these detention facilities and the practice of detention, and if that document would ever get out, it would be a devastating blow to the intelligence system, to giving the information to the enemy, who we have among their presumably lost and missing persons, and the like.

I urge my colleagues, this is something we should scrutinize carefully. I have framed it in such a way that colleagues will have to decide whether it

is a second-degree amendment that prevails or the underlying amendment that prevails.

Therein, with the exception of one other mention just this morning, the committee staff, the majority and the minority, were briefed on this document. It roughly looks to be 30 pages of unclassified material entitled ``Department of Defense proposed''--just being proposed at the moment--``administrative review of the detention of enemy combatants at Guantanamo Bay, Cuba.''

This is one of our facilities. The Secretary of Defense has established administrative review procedures to determine annually if enemy combatants detained by the Department of Defense at the U.S. Naval Base at Guantanamo Bay should be released, transferred, or continue to be detained, and so forth.

Much of it parallels what the Senator has in mind. I am confident after this morning's briefing the Congress will make several edits. I encourage the distinguished ranking member to engage our colleague, Senator Bingaman, a former member of our committee, to look at it also and see how we can improve and strengthen this. So this will soon be in effect.

I yield.

Mr. President, that is a very good question. I will take a few minutes to answer. It deserves a very considered answer.

I have thought this through. It is interesting, coincidentally over the weekend I dealt with the Department of Defense. I did not have a chance to brief my distinguished ranking member yet on the question of the Red Cross's participation in our situations, both in the Afghanistan detention facilities and the Iraqi detention facilities. I am speaking for myself.

I am very concerned about those problems over there. Our committee had several hearings on it. The issue comes up, as it should. It came up in the Judiciary Committee the other day, about the role of the Red Cross. I have learned a great deal about that role in a short period of time.

I had some familiarity when I was Secretary of the Navy and during the Vietnam conflict. The Secretary of Defense was at that time--I have served under three of them--Secretaries Melvin Laird and Jim Schlesinger. They were very conscientious about working with the Red Cross.

The Red Cross has done a remarkable job in this very difficult area, going into these prisons, monitoring them, and going back to the government host of the prisons and making corrections and trying, in some instances, to benefit the incarceration detainees in terms of their individual personal status.

The success of that program has been dependent on the absolute sanctity of that material and the fact that the observations of the Red Cross have not gotten into the public domain. We are working with the Department of Defense now, such that the Senate can be given the benefit of the Red Cross inspections in our facilities in Afghanistan and in Iraq. It will be my recommendation to the committee that we will have it in a classified briefing. But we are not, hopefully, going to retain any of those documents in the Senate.

Were that material to get out in some manner, we are told by the Red Cross, it would seriously limit their ability to do this magnificent work they do all over the world. If some nations--and only in a classified forum can I give those names--but some nations that now allow the Red Cross in to get information and to hopefully provide corrections to prisoners' treatment, if that had gotten out, that is the last time the Red Cross would get into that country to examine those prisons.

So we come down to the very basic fundamental issue about those detainees, whether they are in the United States or wherever they are in the world in these prisons, the Red Cross is helping in many instances. But they say if the information they write up and send back to the host country of the prisons gets into the public domain, forget it; they will be precluded from going on. So we would face a similar situation.

It is very difficult for me, one who has been privileged to be in this body now my 26th year, to just say I am concerned that some material in classified form in the possession of the Senate could get out. But, regrettably, whether it got out from under the Senate or got out from another source and that source would then blame the Congress for leaking it--I don't know, we have all been through the leak scenario--it leads to a never-never land in this Government of ours.

But I urge that we consider this very detailed information which our colleague is seeking. The amendment in the second degree, which I am perfectly willing to withdraw to the extent we can come to a resolution and make it your first-degree amendment and no second--I believe we have to observe the practices with regard to this detailed information you are seeking.

Fine.

Mr. President, I do not disagree in how you frame the issue, but I maintain my stance. Let me parse it very carefully. I say to the Senator, you are saying that what we give the Red Cross--not what the Red Cross comes back and tells us we are doing right or wrong--what we give to the Red Cross can be shared with Congress?

Here is where I respectfully differ. If the information we give to the Red Cross were to leak out, then other nations that are similarly following that practice will see this is now in the public domain and say: We are stopping, Red Cross, because we see it has gotten into the public domain of another country. Therefore, we don't want that to happen.

Mr. President, I say to the Senator, I concede your point. You need not deliberate further. Fault lies on both sides, both branches of Government. All I am saying is--and I am informed by those who have greater knowledge about the procedures of the Red Cross than I; and I don't know whether it comes out of the executive branch or the Congress--further distribution of this information beyond one branch of Government to another branch of Government does increase the likelihood that somehow it gets out. And it will deal the Red Cross a very serious blow, I am told.

Mr. President, in other words, rather than the individual's name, that his number is No. 224--whatever it is? I would have to defer until I go to the heart of the experts. All I know is that the name--if we are detaining certain individuals and the enemy does not know whom we have captured, and they, therefore, have to shelve some of their plans, knowing that the persons who are missing from their roster, if they were to talk about the plans, they would make the plans less valuable to the enemy--I mean, I am just working through the obvious scenarios here.

Now, whether a number would suffice, I would like to go back to those who are dealing with this on a daily basis.

Mr. President, it is interesting, over the weekend I had the opportunity, I say to my distinguished colleague, to visit the Department of Defense, and I was greatly impressed with an individual, who was a Member of the U.S. House of Representatives a decade or so ago, who is in charge of it. I will seek to have him come over right away and provide both sides with the expert to propound these questions. They are good questions. Let's see what we can do to work this thing out.

Yes. Mr. President, I think all that can be accommodated, so I join in the request at this time to lay aside the pending amendment in the second degree and the underlying amendment by our distinguished colleague from New Mexico and to then let the other Senators seeking recognition have the floor.

Mr. President, will the Senator yield for the purpose of allowing me to put a second-degree amendment at the desk so our colleagues can then begin to examine both as this very important debate is underway?

Mr. President, I send to the desk, on behalf of Senator McCain, an amendment in the second degree.

I thank my colleague for his courtesy. We now undertake a very important debate on this subject.

Mr. President, before I get into the substantive debate in rebuttal to my distinguished colleague--and I say distinguished. We are very proud of his participation on our committee. Indeed, I remember vividly our trip together to Iraq. That was his first trip. It was helpful for all of us. I thank him for his remarks about the old Senator from Virginia. It is kind of nice to hear those after being on this bill now our 15th day. But we are making progress.

First, I think inadvertently--and I say to my friend inadvertently-- he made reference in his opening statement that the language of the authorization bill for this year changes the status of the Barry amendment. Did the Senator make mention of that?

I wonder if I might bring to the Senator's attention--the bill is at the desk--if he would look at page 175 of the bill. He will see section (f), ``Laws Not Waivable'':

The Secretary of Defense may not exercise the authority

under subsection (a) to waive any domestic source or content

requirement contained in the following laws. . . .

No. 4 is the Barry amendment. We do not touch it. I assure the Senator, section 2533 A(a) of title X is the Barry amendment, and that remains untouched.

The Senator is doing his best, and I have lived with these things for so many years.

The other is interesting. No. 1, we do not waive the Small Business Act, 15 U.S.C. 631, which sets aside 23 percent of the dollar volume of all defense contracts must go to small business.

The Javits-Wagner, No. 2, is all products manufactured by the blind and the handicapped. We do not touch that.

No. 3, section 7309, shipbuilding, we do not touch that.

And No. 4 is the Barry amendment, and that covers textile, food, and speciality medicine.

I draw my colleague's attention to those points. He might wish to review it himself and make amendments to his opening statement.

Mr. President, I say to my colleague again, it is fascinating in a sense. He goes on about what we put into this bill, which I think in a very modest way strengthens America's position, in my judgment. For example, his bill goes after one Department, the Department of Defense; am I not correct?

I say to my distinguished colleague, the Department of Defense is among the few Departments of our Government with contracts generating a surplus. The area in which the Senator from Minnesota wants to go to preserve jobs is in other Departments and agencies of the Federal Government. Let me point this out.

We had $63 billion in defense sales in the last year--$63 billion--to nations all over the world. We bought only $5 billion of weapons from other nations. Those nations that sell us the $5 billion are basically the ones that are participating largely in the $63 billion. So there is a mutual trade there. We are selling them, by and large, far more than we are buying from them, and if you were successful, you would begin to bring down significantly the $63 billion, and that translates into hundreds of thousands of jobs in America would be lost because we are saying to those

countries: We are not buying anything from you anymore. And they will say: If that is the case, we have had it, we are not going to buy from you, and down goes our $63 billion surplus.

Mr. President, I am not going to tread beyond the Department of Defense. Our bill goes strictly to the Department of Defense. If there are other areas in which my distinguished colleague and those who are aligned with him want to go, then other Senators who have the oversight responsibilities for their respective departments are the ones who will have to respond. So I am going to stick to DOD.

We have the largest, as far as I know--maybe in agriculture there may be some segments which are somewhat equally or larger in significance.

At the end of my remarks, I ask unanimous consent to have printed in the Record the letters that we have received from a number of nations respecting the pending matter that the distinguished colleague from Minnesota has put before the Senate.

I start off with the Ambassador of the Netherlands:

Dear Senator, Mindful of the long-standing strong

relationship between the United States and the Netherlands, I

would like to express support for several very important

amendments to the Defense Authorization Bill 2005 that were

agreed this week . . .

And he then refers to those sections. Then we have the ambassador from the Embassy of Sweden:

As you are aware, Sweden is a significant supplier and

partner to the United States in several defense technology

areas such as anti-tank weapons systems and naval composite

technology. With almost 50 percent U.S. content, the Swedish

fighter aircraft Gripen is another example of close Swedish-

American cooperation. This extensive cooperation is to the

benefit of our respective defence industries.

I am only reading just a fraction of these letters. Another one from Mr. David Manning, the Ambassador from the British Embassy in Washington:

I am writing to express the strong support of the United

Kingdom for three amendments to the Senate Armed Services

Committee mark up of the 2005 Defense Authorization Bill.

Those are the provisions, Mr. President, that my distinguished colleague seeks to strike. He goes on, ``These amendments are contained in section,'' so and so. He then goes on:

As you know, the UK and US armed services have a

relationship of unparalleled closeness, as our forces fight

side by side in Iraq and elsewhere. . . . I therefore hope

you will be able to support these amendments . . .

And eventually get them into law.

The Canadian Embassy sent a similar letter. We have a similar letter from the Danish Ambassador. We also have a letter from the Aerospace Industries Association of America. They state:

The future of U.S. aerospace is in the global marketplace.

Our industry exports 40 percent of the products it

manufactures in the United States and books the largest

export surplus of any sector of our economy.

I say to the Senator from Minnesota, he is facing a serious issue if he prevails. We have a similar statement from the Government Electronic Industries Alliance. We have the National Defense Industrial Association, Strength Through Industry & Technology:

Dear Mr. Chairman:

NDIA has had a long and productive association with you and

the committee. I look forward to discussing these issues . .

.

They support the bill, and I could go on, but this is a sample.

I will say in recognition of the issues that the Senator raises, in the second-degree amendment we pair down the list of 21 nations to the 7 that we believe absolutely have to be kept intact and not subjected to the strike that the Senator has in hand. The obvious ones are the United States, Australia, the Netherlands, Italy, Sweden, Canada, and Norway. So I think some advancement has been made in terms of limiting the number of nations that have to deal with this, but at this point in time I say to my colleagues that I think the second-degree amendment from the Senator from Virginia embraces the position that is the most important one that we should take versus the distinguished colleague from Minnesota.

I wonder if I might put in a quorum call for a brief few minutes when I have to absent myself from the floor. Does the Senator from Iowa wish to speak to this issue?

I say to my colleague, I think we can accommodate him because this important debate brought by the Senator from Minnesota, to which I have made a reply, will be laid aside because other Senators, hopefully, on both sides of the aisle, will come to support the amendment in the second degree by the Senator from Virginia.

I am anxious to hear from the Senator from Minnesota. Did he want to reply to some of my comments?

Yes, I will yield.

I thank my colleague. I would be happy to consider that if he wishes to bring that forth to change the documents that are presently before the Senate; that is, the underlying and second-degree amendments. So perhaps at this time we could lay aside this package with the understanding that we will bring it up again today for further debate and in the interim we can consider the measures that the distinguished Senator wishes to address.

I ask unanimous consent that this package be laid side.

I suggest the absence of a quorum.

Mr. President, there is a Senator who has concerns about the amendment now pending offered by the Senator from Wisconsin.

Frankly, I find a lot of appeal in this amendment. I am not able to indicate to the Senator how we will deal with this on this side until I have had an opportunity to consult with that particular Senator.

I suggest this be laid aside with the full understanding that it can be brought up again--maybe this evening or possibly tomorrow morning for such further comments as our side may have.

That is the Senator's prerogative.

I will not characterize it as opposition, but a Senator on this side has indicated to me that he wishes to address this amendment before I as manager can speak for the committee. Actually, this is a matter now before our committee. Out of respect for him, I just ask it be laid aside.

I thank my colleague.

Now, after the votes now scheduled to start momentarily, it would be our hope--I hope we share this--that you could bring up this very important amendment you have on missile defense and that it could be debated immediately following this vote. Debate might not be concluded tonight, but at least we can cover a significant portion of it. Am I correct?

The Senator made that clear. So we begin debate right after that for such period of time as the Members involved debate--of course you, the presenter, I would be in opposition, and I am planning to have one or two others from my side in opposition--and that could consume, would the Senator estimate, maybe an hour, an hour and 20 minutes?

I thank the Senator.

I am wondering, I will inquire whether or not we could go ahead and start the votes and use that time productively.

Mr. President, I now understand that is not feasible because Members are travelling to the Senate from considerable distances.

I say to my good friend, it is exactly 1\1/2\ minutes before the votes are scheduled. I have to object at this time. This would be an amendment in the first degree. Under the rules, it is not permissible without unanimous consent.

Mr. President, I will divide such time as I have. I believe it is 2 minutes. I will take 1 minute and give the Senator a minute.

We had a very good debate. It involves an extremely sensitive subject, the handling of the remains of those who die or perish one way or another in these theaters of conflict as they are brought to the United States.

The amendment in the second degree is drawn to preserve the most important priority, and that is the privacy of the families. It is, therefore, my position that the better course of action for the Senate is to go with the amendment in the second degree which is before all parties tonight and not open this matter to great scrutiny by the press, as does the underlying amendment in the first degree.

I yield the floor.

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

Mr. President, I ask for the yeas and nays, to inform our colleagues of the need for a record vote.

I thank the Chair. Mr. President, that is on the second- degree as well as the first-degree amendment?

Let's go to the unanimous consent agreement. The Chair advised the Senate with regard to the unanimous consent agreement that was put in early this afternoon.

Mr. President, am I not correct that the vote is now scheduled for 5:30 on the second-degree amendment, and the yeas and nays have been ordered?

The Chair is correct. I accept the ruling. And the yeas and nays have been ordered; am I not correct?

I move to reconsider the vote, and I move to lay that motion on the table.

The motion to lay on the table was agreed to.

Amendment No. 3291, As Modified

Mr. President, I understand each Senator has 2 minutes; am I correct?

Mr. President, we have decided with the vote on the Warner amendment that we are going to leave it to the families to decide what they want to do when the bodies arrive at their final resting place. That has been the policy since 1991, through the gulf war and through operations of our two conflicts in Afghanistan and Iraq. I urge that it remain that way and not open up, as the Lautenberg amendment directs, the Secretary of Defense shall develop a protocol that permits the media to attend the bodies as they arrive in the United States.

I yield the floor.

Mr. President, I thank the distinguished chairman of the committee and others for setting aside their amendments, and I call up amendment No. 3197.

Mr. President, I ask unanimous consent that reading of the amendment be dispensed with.

Mr. President, my amendment strikes two sections of the bill, sections 842 and 843, which relate to ``Buy America'' and the Berry amendment, which are features that have been in existing law for quite a number of years to strengthen our national defense and our national economy.

This bill authorizes $422 billion for national defense programs for fiscal year 2005, a sum that doesn't even include the funding for ongoing operations in Iraq and Afghanistan. If you include those additional amounts, our national defense spending for the next fiscal year will be almost $500 billion.

I yield to the chairman.

Amendment No. 3461 To Amendment No. 3197

Mr. President, we are going to spend, in the next fiscal year, some $500 billion. That is a half trillion dollars, a huge amount of the taxpayers' money; in fact, about one-fourth of all the money the Federal Government will spend for everything next year, including Social Security, Medicare, health care, and education.

The purpose of these expenditures is to strengthen our national security for now and the future. The six priorities that were approved by the Senate Armed Services Committee, of which I am proudly a member, along with the Presiding Officer and others, reported in the bill before us unanimously by the committee, include such measures as combating terrorism and winning the global war against terrorism, supporting our military operations in Iraq and Afghanistan, to sustaining the readiness of our Armed Forces to conduct the full range of military operations against all current and anticipated threats.

It goes on to state: Another object is modernizing and transforming our Armed Forces to successfully counter future threats. So we need to spend this money on the immediate needs and missions of our military and support the phenomenal job they have been doing on our behalf around the globe, but we also need to try to anticipate the future. That is difficult, but it is also important. It requires us to look at the big picture, at the global picture, and into the years and even, if possible, the decades that lie ahead. It means we don't want to do something now that is expedient or briefly beneficial that will have negative consequences for us in the future.

Ideally, we want policies that strengthen our country now and in the future. That has been the compelling reason for the so-called ``Buy American'' requirements of the Department of Defense, the military branches, and all other Federal agencies for the past 70 years.

``Buy America'' came out of the depths of the Great Depression. Buy America to strengthen America is really what it should be called. Buy America to strengthen America--that was the reason, the purpose, and it has been the result for seven decades. However, the law has always provided for exceptions, exceptions that essentially give, as they should, the full authority to the Secretary of Defense to waive domestic purchase requirements whenever necessary to provide our Armed Forces with equipment, weapons, clothing, food, or anything else that is not available in the United States, that could not be produced or provided in this country when it is needed, that lacks the quality or features or advantages, or that is not priced competitively with non- U.S.-made products.

So the law has essentially said: Try to buy American, but if you can't or you shouldn't, then don't. It has worked for almost 70 years, through 11 different administrations--six Democratic, five Republican-- until last year this administration and this Senate shredded that bill. That shredding was reduced to a few slices by the strong opposition of the House conferees, led by the House Armed Services Committee chairman.

We in this body are exceedingly fortunate to have the chairman of the Senate Armed Services, who is unparalleled as a leader and public servant. Last July, I traveled to Iraq with the distinguished chairman of the Armed Services Committee, the senior Senator from Virginia, Mr. Warner. We went through the country with 115-degree temperatures. I struggled to keep

up with him as he charged fearlessly into every perilous situation. He is in every respect--leading that committee, here on the floor, or out in the field around the world--one of the most outstanding leaders and pubic servants I have ever met anywhere in my walk of life.

I also greatly admire my colleague and friend, the senior Senator from Arizona, Mr. McCain, whose military experience and expertise and whose devotion to his country and his service to it are all remarkable.

However, on that occasion last year regarding ``Buy America,'' I thanked our Founding Fathers for the wisdom of bicameralism. And I must respectfully but strongly again disagree this year with the Senate bill's provisions that would effectively destroy ``Buy America'' by its exceptions to it.

If we pass the legislation that is before us now with the language in it, the second degree to my amendment that has been put down today, we might as well eliminate the entire ``Buy America'' statute as it applies to the Department of Defense and the armed services and others that are funded by this bill because that will be the result if this current Senate language if we pass it.

I challenge those in the Bush administration and those in the Senate and those lobbying for the big multinational corporations and for the foreign governments they represent, who truly believe that we will be better off without any ``Buy America'' requirements, or certainly, in the case of the paid lobbyists, who know that they and their clients will be better off without them, and those who believe that for whatever reason, they should just say so and put the repeal before us in black and white and have us vote on that rather than just creating more exceptions and more loopholes that give more foreign countries and the corporations that operate in them more and more of the money from this bill in the products that they buy and the jobs for which they pay, because under this language that exists in the bill now, those tax dollars, those products, those jobs will go to people in other countries but not to Americans.

There will be no more ``Buy America'' to strengthen America. It will be buy abroad, because of what? Because it is cheaper? Because it is better? Because it doesn't matter?

Let's have that debate in the Senate. Is it cheaper to buy overseas? After counting all the costs of not only the product prices but also the wages that are gained or lost, the taxes paid by those wage earners in this country or somewhere else, the unemployment costs in this country, the welfare cost, the food stamp cost, not to mention the human cost of people who lose their jobs, is it better to buy these products overseas? Better for whom? Who gains, who loses, when American dollars are spent abroad to buy foreign goods made by foreign workers instead of American goods made by American workers? Does it matter? Evidently not to this President or to this Pentagon leadership. But it sure matters to the American people, who will lose their jobs or won't get new jobs or better jobs. Do they have a say in where their tax dollars are spent? Does it matter to this Senate that there are now 2\1/2\ million fewer manufacturing jobs in this country than there were when President Bush took office? Yes, 2\1/2\ million manufacturing jobs have been lost in this country in the last 3\1/2\ years, despite the so-called recovery and recent job gains in some other sectors of our economy. There are still 2\1/2\ million less manufacturing jobs today than there were in January 2001.

Many of those American jobs have been sent overseas and were replaced in other countries by low-wage jobs. Importing all those foreign- manufactured products has now produced a U.S. trade deficit that last month was $48.2 billion. That is another all-time worst trade deficit-- $48.2 billion for a single month, and it will probably be broken again next month or soon thereafter. Over the next year, if that continues, it will produce an annual trade deficit of $578 billion--almost $100 billion more than last year's record trade deficit.

We are told we cannot do anything about this massive bleeding of jobs and wages, capital investments, profits, and tax payments out of our country. We are told we should not even try; it is free trade, globalization, and it is good for America. Is 2.5 million lost manufacturing jobs good for America? Over $100 billion in lost wages and benefits every year is good for America? Over $30 billion of lost tax revenues each year for Federal, State, local governments, and school districts is good for America? Our Federal budget deficits, our State and local government deficits, U.S. trade deficit, national debt increasing, all of which are going higher and higher--is that all good for America? Jobs and wages, production of goods and services, capital investment by businesses, allowing people--as consumers buy goods and services, producing tax revenues, individual and corporate, they are the lifeblood of any economy. They are its vitality. Corporate profits, stock prices, dividends, and capital gains are all vitally important as well, but they are not enough.

This country's economic vitality is bleeding away. Our economic strength is weakening. Our economic strength is essential to our military strength. Our economic security is essential to our national security. This legislation, this authorization to spend $500 billion on our national security, had better strengthen, not weaken, our economic security as well.

I am aware of the letter to the chairman from a group calling itself the National Defense Industrial Association. It claims to represent over 1,300 member companies and purports to be the ``voice of the industrial base.'' Who are these companies? Whose industrial base are they speaking for? Many are companies that have moved their production overseas, that are making better profits from paying low wages to foreigners instead of good wages to Americans. We cannot stop them from doing so. But why should we reward them with American tax dollars going to support their foreign production? They can certainly continue that foreign production, and they will. But if they want these U.S. military contracts, they should fill them with American workers, not with foreigners.

They should make those products or provide those services in American communities, not foreign cities. They should pay taxes from those profits to our school districts and local governments, not someone else's. These are American tax dollars that are paying for our national defense, not from their corporate profits from foreign operations-- profits on which they will pay taxes to foreign governments, not our own.

Someone has to look out for the best interests of this country, and it sure is not the National Defense Industrial Association. Maybe that is not their responsibility. But the best interests of this country are our responsibility here in the Senate. So they should not tell us or try to make us or the American people believe their interests are America's interests. In their letter, they claim it would negatively impact the ability of the U.S. industrial base to compete in the international marketplace and would therefore negatively impact the Warfighter, and the bill's amendment gutting ``Buy American'' will represent important steps in the Department of Defense's transformation plans and send positive signs to our allies that the United States is supportive of existing trade agreements. I am deeply offended that American companies, most of which are headed by American citizens, would try to hide their financial self-interests behind pretenses like these. They want defense contracts they can fulfill with their existing foreign operations that provide them with greater profits. They don't want to have to shift that production back to the U.S. and employ fellow American citizens. They want only what is good for themselves, not what is best for America's military strength or our Nation's economic vitality.

In some cases, as the letter discloses, they coddle foreign governments that want to buy American military hardware and then want us to buy the same amount of their foreign-made military products from their countries. We signed, evidently--somebody in the Department of Defense signed these agreements. There are countries where our trade deficits last year totalled over $120 billion for all goods and services. But in this one sector of military goods and services, where we run a trade surplus, we agree to give up our surplus by buying more foreign products, some of which, of course, are made in those countries by--surprise--

some of the companies in the National Defense Industrial Association. Those companies win both ways, but the rest of America loses.

These memoranda of understanding are not free trade; they are certainly not fair trade. They are dumb trade. It is amazing to me that somebody would sign them. It is like something out of the movie ``Dumb and Dumber,'' where I give you $20. You are going to give me $10 back, but you say, wait a minute, I am losing my $10. You have a responsibility to make up for my $10 with your $10. So we do that. We agree to that in this memorandum. We are going to match their $10 with ours and even up that part of the deal and leave the $20 that goes to them--leave it out and let it go. That is dumb trade.

We spend more on our defense products, goods, and services than the next 10 countries in the world combined. They need our markets; we don't need theirs. They are cutting back on their military production, so they want these agreements to prop up their industries and provide jobs for their workers at our expense. They are smart enough to look for it, and we are dumb enough to give it to them. It is also dangerous trade. This month's Jane's Intelligence Review, a widely regarded international publication, reports that ``Europe Considers Ending Chinese Arms Embargo.'' The Chinese premier was in some European Union countries last month and he concluded, saying, ``I have great confidence that there will be a solution to this problem.''

I ask unanimous consent that this article be printed in the Record following my remarks.

It reads:

On the European side, the attractions of tapping China's

defense market are significant: China is the world's largest

importer of defense equipment ($3.6 billion worth in 2002),

and . . . France and Germany in particular are pushing to

lift the arms embargo; France because the government is under

pressure from its defense industry to resume arms sales; and

Germany because it wants to maintain its currently good and

close relationship with Beijing.

Opponents to lifting the ban include, most vociferously,

the USA. . . .

Richard Fisher, from the Jamestown Foundation, told [Janes

Intelligence Review]: ``The real impact of a deep and wide

EU-PLA [People's Liberation Army]--

The army of China, the People's Republic of China--

military alliance will fall on the USA, in terms of

accelerating a military-technical arms race that will burden

U.S. taxpayers and place ever greater pressure on the U.S.

political/military alliance system in Asia.''

Who are these countries protecting or helping in this language I want to strike out of this bill that have these offsetting reciprocal agreements with the United States? They include Belgium, Denmark, Germany, Netherlands, Portugal, Spain, Switzerland--all European Union countries. Others that are also exempt by other features include France, Italy, and Luxembourg--all European Union countries.

We are going to contribute to their building up their defense industries, and then they are going to turn around, most likely, soon and sell those products, that technology, those military advantages to a country in opposition to our foreign policy and against our own military interests, against our own national security interests.

That is just one example of how this kind of expediency and also the corporate pressures that drive some of it are a danger to our national security and to our future economic strength.

In conclusion, for the last 70 years, ``Buy America'' has worked for America, and it has helped Americans work in America to build a strong national defense, to build a strong national economy, and to build a strong American industrial base until this administration arrived. The Bush administration believes evidently we can have a strong national defense and a strong national economy without a strong American industrial base, without Americans making American products in American communities. They are so indifferent to that need that at a time when the United States has lost over 2.5 million manufacturing jobs held by 2.5 million American workers in the last 3\1/2\ years, they support this bill and its language to send more American taxpayers' dollars to pay for foreign products made by foreign workers.

Maybe those who do not care about other Americans' jobs should offer to give up their own job. Practice what they preach and find out for themselves what unemployment is really like. But it is our responsibility, exercising our collective wisdom, to act in the best interests of the United States of America.

I know my colleagues share that desire. We may have our honest differences and disagreements, but I beseech my colleagues in this instance to review this measure and this language and consider the consequences of it for our military strength, for our economic strength, as well as for the jobs of Americans and the quality of products and the security of products provided to the men and women serving courageously around the globe.

I yield the floor.

Exhibit 1

[From Jane's Intelligence Review, June 1, 2004]

Europe Considers Ending Chinese Arms Embargo

(By John Hill)

Chinese Premier Wen Jiabao began his first official visit

to Europe on 5 May with the issue of lifting the European

Union's (EU) ban on the sale of weapons systems to China high

on his agenda.

Beijing had hoped that a decision to end the ban would be

made at the meeting of EU foreign ministers on 26 April, but

at the annual Asia Europe Meeting (ASEM) held in Dublin a

week earlier, Irish Minister for Foreign Affairs Brian Cowen,

said that a change in the issue was unlikely during Ireland's

EU presidency. Undaunted, in Brussels on 5 May, Wen said: ``I

have great confidence that there will be a solution to this

problem.''

For months now it has appeared that the arms embargo, which

was imposed following the Tiananmen Square violence in 1989,

would be scrapped, and Beijing certainly has many powerful

European friends working on its behalf. Javier Solana, the

EU's High Representative for Foreign Policy, as well as

representatives from both France and Germany have in recent

months assured the Chinese publicly that they think the time

has come to resume arms sales.

On the European side, the attractions of tapping China's

defence market are significant: China is the world's largest

importer of defence equipment (US$3.6bn-worth in 2002), and

currently Russia is the main beneficiary. According to Jean-

Pierre Cabestan of the French National Centre for Scientific

Research, France and Germany in particular are pushing to

lift the arms embargo: France because the government is under

pressure from its defence industry to resume arms sales; and

Germany because it wants to maintain its currently good and

close relationship with Beijing. Both the European Aeronautic

Defence and Space Company (EADS) and the French electronics

company Thales told JIR that although they do not currently

export military equipment to China, they are monitoring the

situation.

Opponents to lifting the ban include, most vociferously,

the USA. In January, Richard Boucher, spokeswoman for the US

Department of State, said: ``Our statutes and regulations

prohibit sales of defence items to China. We believe that

others should maintain their current arms embargoes as

well. We believe that the US and European prohibitions on

arms sales are complementary, were imposed for the same

reasons, specifically serious human rights abuses, and

that those reasons remain valid today.'' The UK is

remaining circumspect; although obviously its defence

industry would like to sell to the Chinese market, the

government is reportedly upholding the US line on the

issue.

There is debate over the consequences that lifting the ban

would have. Professor Shen Dingli, an expert in International

Relations at Shanghai's Fudan University, told JIR: ``[Ending

the embargo] won't be significant, as China has its own arms

research, development and manufacturing capability, and can

access Russia's military aircraft and ship technology.

Reportedly, soon China will acquire its own manufacturing

capability of more modern military aircraft, and by that

time, China will export its own technology.''

However, the USA remains worried that the end of the

embargo could spark an arms race. US China analyst Richard

Fisher, from the Jamestown Foundation, told JIR: ``The real

impact of a deep and wide EU-PLA [People's Liberation Army]

military alliance will fall on the USA, in terms of

accelerating a military-technical arms race that will burden

US taxpayers and place ever greater pressure on the US

political/military alliance system in Asia.'' Fisher argued

that if the ban was lifted, the French would be ``first out

of the gate'' with submarine and satellite technology. He

added that the competition would also spur on the Russians,

who ``are now openly talking about selling advanced SSK

[submarine] co-production rights to the PLA to trump the

Mr. President, I meant to say that it changes the overall law and which the Barry amendment is part of this general reference to ``Buy America.''

Mr. President, the chairman is correct in that regard.

Will the Senator yield for a question?

Does the Senator say we should apply that same principle to all of our trade agreements and require that the $478 billion we spent last year in deficits, we should require those countries buy the equivalent in U.S.-made products?

If the Senator will yield for one last question.

Then we can conclude this discussion so the Senator can leave the floor. I am glad to see the second degree would reduce the number of countries exempted to seven. I ask if the Senator and Senator McCain would consider language in the amendment that would prohibit the consequences that I just outlined of the sale of goods and military products to China, that there be language in this amendment that would preclude these countries that are getting these benefits from, then in turn providing those gains to countries that are outside of our own military and foreign policy.

I agree with that.

Exhibit 1

The Ambassador, Embassy of the Kingdom of the

Netherlands,

Washington, May 17, 2004.

Dear Senator: Mindful of the long standing and strong

relationship between the United States and the Netherlands I

would like to express support for several very important

amendments to the Defense Authorization Bill 2005 that were

agreed this week in the discussions in the Senate Armed

Services Committee.

I refer specifically to the proposals in Title VIII--

Acquisition Policy, Acquisition Management and Related

Matters, Subtitle D--Industrial Base Matters (Sections 841,

842 and 843).

I consider the Section with regard to a ``Commission on the

Future of the National Technology and Industrial Base'' as a

highly constructive proposal. Specifically the balanced

tasking of the Committee seems to inherently guarantee

certain success. Taking into account the increasingly

important subject of interoperability, specifically relevant

in the present day environment, I also value the amendment

concerning the ``Conforming standard for waiver of domestic

source or content requirements'' as an important building

block for a fertile environment for defense trade of which

the warfighter of today and of tomorrow will be able to

benefit. Also the section that deals with the ``Consistency

with United States obligations under trade agreements'' is

seen as a positive and relevant assurance for other

countries.

Although not directly related to the above referenced

proposals allow me to share with you the idea that in our

perception, part of the discussion which is seen by some as

the danger posed by foreign dependency can be satisfied by

bilateral Security of Supply agreements which can be

negotiated as more detailed arrangements under a Declaration

of Principles or a reciprocal defense procurement MOU.

In conclusion I would like to assure you of my broad

support for the proposals which I mentioned above.

Mr. President, I want to mention in the context of the discussion which has been held between the Senator from Virginia and the Senator from Nevada that I believe the second-degree amendment which I had intended to offer to Senator Brownback's second-degree amendment will be in order. I have been working throughout the weekend. The question with the Parliamentarian was whether it would be relevant. I believe we have now revised that amendment so it will be relevant.

My understanding is Senator Brownback has offered an amendment on indecency to this Defense authorization bill which came out of the Commerce Committee with respect to broadcasting. Senator Burns of Montana offered a second degree to Senator Brownback's amendment.

I would not offer an amendment that would be extraneous to the Defense authorization bill except that the amendment Senator Brownback offered came out of Commerce Committee on a matter that addressed a related issue--that is, the concentration of broadcast ownership--which I, Senator Lott, Senator Snowe, and others added in the Commerce Committee. Senator Brownback offered an amendment on the floor of the Senate excluding that provision. I understand why. I am not being critical of him at all. But I would want to add that back using a second-degree slot as soon as we can find a way in which Senator Burns' second-degree slot will be resolved.

I say to the Senator from Virginia: I am here and ready any time to offer that amendment. It would not be my intention to hold up the Defense authorization bill. In fact, I wouldn't be offering this amendment were it not for the fact that Senator Brownback's amendment on indecency was offered to the Defense bill when it came out of the Commerce Committee containing the amendment on broadcast ownership which I had previously offered with Senator Lott.

I wanted to make the Senator from Virginia aware that the second degree I will offer, along with Senator Snowe and some others, is certainly available, and I would want to find an opportunity to offer that amendment.

Mr. President, in response, my amendment would be a second-degree amendment offered to Senator Brownback, but that second- degree slot, I believe at this moment, is filled by an amendment previously offered by Senator Burns. I don't quite know how to resolve that, but at some point Senator Burns' second-degree amendment will be resolved, that second-degree slot will be open, and I will offer an amendment similar to that which we did in the Commerce Committee.

Mr. President, let me take a moment to consult with some staff on our side with respect to the parliamentary situation.

Let me say again, so the Senator from Virginia is clear, and I think he is, this Defense authorization bill needs to get completed with some dispatch. I sympathize with the challenge he and the Senator from Michigan have had trying to move it along. It is not my intent in any way to delay that.

I feel obligated, as I think do others in the Senate, that when Senator Brownback offered an extraneous amendment, that amendment which previously included broadcast ownership limitation issues dealing with the FCC rules, to add that back to the indecency language.

I will consult with our side in a moment and perhaps I can make some comments about it, and if others wish to make comments, we would find a way to vote as soon as the Burns second-degree amendment is disposed of. Let me do some consultation and perhaps I can speak.

Mr. President, let me say again this amendment is not related to the subject of the Defense authorization. The only reason I offer it is because the amendment offered by Senator Brownback, which itself is not related to Defense authorization, was offered last Friday. I indicated when he offered that amendment, which I support, that I would second-degree it, because we second-degreed it in the Commerce Committee, and we merged two issues: indecency and the issue of broadcast ownership rules and regulations.

When my colleague from Kansas offers an indecency amendment to the Defense authorization bill, I don't have much choice except to offer the amendment we offered to it in the Commerce Committee. If this bill is stripped of all extraneous amendments, I will understand that and I will not complain. But if this bill is going to proceed with amendments of the type that came from the Commerce Committee, then I insist it also include the issue of broadcast ownership rules and regulations that were adopted by the Federal Communications Commission.

Let me describe what all this is about with respect to broadcast ownership. The Federal Communications Commission did a rulemaking on the issue of broadcast ownership. They had somewhere around three- quarters of a million Americans, unprecedented numbers of Americans, write and e-mail and send concerns and expressions of their interest to the Federal Communications Commission. Almost all of them said to the FCC: Don't change the rules and regulations with respect to broadcast ownership of properties in a way that injures the public interest.

It didn't matter to the FCC. They went ahead and changed the rules. The way the FCC constructed it, the rules say: It is all right if in your community--let's say you live in one of the biggest cities in America--one company owns three television stations, eight radio stations, the cable company, and the dominant newspaper. That is fine.

Well, it is not fine with me--it is not fine with, by far, the majority of the American people--to see fewer and fewer Americans, no more than a handful, who are going to have control over what the rest of the American people see, hear, and read.

Let me say again what the FCC allowed. In the biggest cities of the country, one company can come in and buy up eight radio stations, three television stations, the cable company, and the dominant newspaper--in many cases, the only newspaper. Why is this of concern? Well, it is of concern to me because we license the use of the airwaves. They don't belong to broadcasters or radio stations or television stations. They belong to the people. The airwaves belong to the American people. We license their use to certain companies in exchange for certain obligations.

One of those obligations that has never and will never be old fashioned is localism. That is not an old-fashioned requirement for broadcasters. So the question is, how do you develop or how do you maintain or how do you have localism in broadcast properties when one company owns, in this case, 1,200 radio stations. Yes, that is the case. One company owns 1,200 radio stations.

We did hearings about all these subjects. Let me tell you about something called voice tracking. This is antithetical to localism. Voice tracking is a process by which a company that owns a lot of radio stations will have someone in a basement in Baltimore, MD broadcasting. And he is broadcasting over, for example, a station in Salt Lake City, UT, saying: It is a beautiful morning here in Salt Lake City. The sun is shining over the mountains. What a great day to wake up in our city.

The problem is, that guy was broadcasting from Baltimore. He was using the Internet to find out that the sun is shining in Salt Lake City. It is called voice tracking. It is fooling the consumers into believing that announcer is there. It has nothing to do with localism or responsibilities of localism.

There is another approach used by television stations. It is called central casting. It is trying to make you believe the news team is from your city when, in fact, it is not. Central casting, voice tracking, these are mechanisms by which the large concentrations of broadcasters are trying to convince people there is localism to their broadcasts.

Some of us believe very strongly that this is moving in the wrong direction. I am not opposed to big because something is big. Good for the folks who are successful. If somebody has two radio stations and buys two more, good for them. If they have eight and buy eight more, good for them. If they have 50 and buy 50 more, I am not going to come here and complain about that. But 1,200 radio stations in the hands of one company? Or television broadcasting stations being gobbled up together under one big ownership group? Is that good for our country, especially in an area where, in most cases, you have monopolies or near monopolies and now this FCC rule says, in addition to all of that, with respect to broadcasting properties, we are going to get rid of that pernicious rule that allows cross ownership of broadcast properties with the newspaper?

At the hearing in the Commerce Committee, I held up a letter that was sent out all across the country by an investment banking company. They said: Get ready, because the FCC is fixing to change its rule, and when they

do, your newspapers can buy up a bunch of broadcast properties. And so they are already.

The FCC rule, fortunately for us, has not yet gone into effect because it was stayed by a Federal court. This issue is now in the Federal court. So there is a stay order. It may well be lifted soon when the Federal court makes its judgment. But that begs for the Congress to make its own judgment to overturn and rescind the FCC rules.

Senator Lott, Senator Snowe, myself, and others brought this issue to the Senate floor with something called a veto of an administrative rule. It is called the Congressional Accountability Act in which we have the opportunity to veto a rule by a Federal Agency. It has only been used once. We offered that. And by a very significant margin, we won. So the expression of the Senate already has been to say: We don't support the FCC rule. We believe it should be rescinded. And using the Congressional Accountability Act, the Senate, on a bipartisan vote, said: We don't want these rules to go into effect, FCC, start over and do it right. Well, that Senate vote went to the House of Representatives and it is now sitting at the desk in the House of Representatives 10 votes short. They need 218 votes. They have a letter with 208 signatures on it and they are 10 short and they cannot move.

The Speaker of the House and the administration very much oppose this. They have stymied it in the House of Representatives. My feeling is that the only opportunity we have in a circumstance such as this is to offer an amendment on a bill, such as the Brownback bill--and, incidentally, we are faithful to our determination to move this. We offered the same amendment in the Commerce Committee when Senator Brownback brought up his legislation. We prevailed there.

I support the Brownback legislation and the second-degree amendment that Senator Burns intends to offer to it as well. I hope the Senate will, once again, support my second-degree amendment once the amendment by Senator Burns is disposed of.

We had testimony before the Senate Commerce Committee, and I don't remember the fellow's name. He testified two or three times. He owns a pretty big broadcasting company in one of the States south of here. He explained the problem with the growth and concentration in broadcasting. He said: I own a good television station, but I cannot tell the folks from Hollywood or New York what I want to show in my viewing area because if they are sending out a program I think is something I don't want to show, I don't have the opportunity to say we will not show that. I will lose my network affiliate status if I do that. I don't have the capability to make any kind of local decision about this.

Look, I happen to think broadcasting, whether it is radio or television, has some of the most breathtaking, wonderful, remarkable programming; some of it is extraordinary. I also think there are programs that are shabby, trashy, and disgusting. You have both sides of it. I don't know, maybe somebody adds to their cultural interests by tuning in on HDTV and seeing someone eating maggots from a bowl in a contest. I don't know. I would expect that very few find much interest in that. I guess it does achieve some ratings from time to time.

But when you have concentrations of broadcast properties, as has been the case, dramatic increases in just the hands of a few people deciding what the rest of the American people are going to see, read, and hear, I think it ought to be of great concern to the Congress. The FCC rule caved in almost instantly to the big economic interests here.

I know those who own newspapers are upset with the position I take. Those who own broadcast properties are upset with the position I take. But the fact is, this is about the public interest, and the public interest is best served when we decide localism is not old-fashioned. I don't object to some big companies. But I object to circumstances when the big companies are given the green light by the FCC to own almost everything in a community with respect to communications--radio station, television stations, the cable company.

Whatever happened to the market system? The market system is where you have robust competition, broad-based economic ownership. I don't see much of that market system in broadcasting these days. All you see are the gobbling up by big interests.

It is interesting, we now have a 35-percent ownership cap on national viewing by the major television networks, in terms of the number of stations they can own, which has now, as a result of last year's omnibus bill, gone to 39 percent. It used to be 25 percent.

In fact, in 1996, when we had a bill on the floor called the Telecommunications Act, we had a prohibition on owning television stations beyond 25 percent of the national audience. That new bill took 35 percent. I came to the Senate floor in 1996 and offered an amendment to take it back to 25 percent--the national ownership cap--with respect to one company. It is interesting, we debated that about 4 o'clock in the afternoon and then we had a vote. It turns out I won the vote. Senator Dole, with a pretty substantial opposition on the floor of the Senate when he wanted to be, was on the other side. So we had a vote on broadcast ownership limitation and I won, I think by three or four votes. I thought that was extraordinary, to win a vote like that. Then I believe Senator D'Amato, as the vote was coming to an end, changed his vote to be on my side, the prevailing side.

I knew something was wrong, but I didn't know what until 4 hours later. What had intervened 4 hours later was dinner. Apparently, there was some epiphany over dinner for four or five Senators, who came back, and there was a motion to reconsider; these Senators who had had some glorious meal, which apparently infused them with a different wisdom, changed their vote and it turned out I had won only for 4 hours. That happens around here. You can win big and long but sometimes not permanently. That was the case in 1996.

I express that to say this is not a new issue with me. I have been concerned about this concentration of broadcast ownership for a long while. What the FCC has done is compounded the problem. Not only are we saying ``Katey bar the door,'' whatever you want to buy, buy it, but we will add to the mix the newspapers. While you are buying each other up and playing these monopoly games, throw in the newspapers as well. We don't care very much. That is the message from the FCC.

Fortunately, the Senate has sent a different message. We already voted on this subject and expressed our interest that the rules crafted by the Federal Communications Commission are completely out of sync with reality and ought to be rescinded. That was a big vote in the Senate. There was no reconsideration. We had to come back and lose that one. Senator Lott and myself and others spoke in support of overturning those rules. That is stuck in the House because the Speaker will not allow a vote on it. We are going to have to find a way, in whatever expression we can, to advance this issue.

Because Senator Brownback brought to the floor a bill that used to include this amendment when it came out of the Commerce Committee, but is not what he offered on the floor, I am required to offer this amendment to the Brownback amendment. I will offer it in the second degree.

My understanding is, while there is already a second-degree in the form of Senator Burns' amendment, when I offer this at the end of my presentation, the second-degree I will offer will be able to be disposed of when the amendment of Senator Burns is disposed.

I support the Brownback amendment and the Burns amendment. If anybody can understand all that, they are perhaps better than I am. I say to the Senator from Virginia, I would like us to finish this Defense authorization bill and deal with these issues. I encourage the Senator to accept all three of these amendments and take them to conference.

If I might get the attention of the Senator from Nevada, Senator Reid, I think we will need a unanimous consent request prior to my formally offering a second-degree amendment, since there is already a second-degree amendment in the slot. But having already spoken on this, I don't need to speak further. Perhaps Senators Snowe, or Lott, or others wish to speak in favor of the amendment. I will rely on the Senator from Virginia and

the Senator from Nevada to offer my amendment at the appropriate time when the consent is agreed to, and then mine would be disposed of following Senator Burns' second-degree amendment.

There are some interests, of course, outside of the Chamber that would not want this amendment to the Brownback bill. I want to make sure we have an understanding that I get the opportunity to do this. Otherwise, I have a much longer statement that I would be prepared to make. My preference would be to leave it at this and to simply get this pending as soon as possible.

No. If the chairman would yield, it is this Senator's intention to call for the regular order, which would bring up the Durbin amendment, and I have a second degree to the Durbin amendment. Then I will speak on that. I assume right after I finish, Senator Hatch will speak on it.

Mr. President, I ask for the regular order.

No. 3225.

Mr. President, I have a second-degree amendment. I send it to the desk on behalf of myself and Mr. Hatch. It is a second-degree amendment to amendment No. 3225.

I ask unanimous consent that the reading of the amendment be dispensed with.

Mr. President, I wish to speak to the pending amendment by my colleague from Illinois, Senator Durbin, and then to outline what this second-degree amendment does.

I have to say I feel somewhat uneasy about this because I so rarely find myself in disagreement with my friend from Illinois. He and I see eye to eye on many issues. On this, while I believe we have some of the same objectives, we disagree on the appropriate approach.

I wanted to set the context for my remarks in somewhat broader terms. For well over a decade, I have spoken out about the need to fundamentally reorient health care in America, reorient it toward prevention and wellness and self-care.

When it comes to helping people stay healthy in the first place, we have very little in the way of help or incentives or information. In fact, I have long said we do not have a health care system here in America, we have a sick care system. It is costing us dearly both in terms of health care costs and premature deaths.

This is not to say we have not made any progress in the recent past. In the last decade, we have taken some steps toward fixing this major flaw. We have expanded coverage of cancer screenings, we have increased childhood immunization rates, we have expanded prenatal care, and we have more aggressively gone after the promotion of tobacco to children.

Another step we took in the last decade toward keeping people healthy in the first place is the passage of the Dietary Supplement Health and Education Act of 1994, otherwise known by its acronym DSHEA.

Over 158 million Americans take dietary supplements to maintain and improve their health, this Senator included, from vitamin C to calcium to glucosamine to beta carotene to ginko biloba. There is a full range of health supplements that are part of the daily lives of people all over this country. Consumer expenditures on these products reached a reported $17.1 billion in 2000, double the amount spent just 6 years earlier.

According to a recent report by the Food and Drug Administration, the use of dietary supplements is likely to grow, due to factors such as the aging of the baby boom generation, increased interest in self- sufficiency, and advances in science that are uncovering new relationships between diet and disease.

In response to efforts by the Food and Drug Administration to inappropriately cut off consumers' access to vitamins, minerals, and supplements, in 1994 the House and Senate unanimously approved the Dietary Supplement Health and Education Act, DSHEA. Both Senator Hatch and I were pleased to have played a role in crafting this important legislation and getting it through the Congress. This law balanced continued consumer access to vitamins, minerals, and other dietary supplements. It has also resulted in nearly $100 million in new rigorous scientific research on the benefits and risks of supplements.

DSHEA provides a number of important consumer protections. First, it requires that claims made on supplement labels, packaging, and accompanying material be, and I quote here from the law, ``truthful, nonmisleading and substantiated.''

Let me repeat that. The law, DSHEA, requires that anything put on labels, packaging, and accompanying material be ``truthful, nonmisleading and substantiated.''

In addition, the act prohibits manufacturers from making claims that products are intended to diagnose, treat, cure, or prevent disease.

DSHEA also provides for good manufacturing practice standards setting requirements for potency, cleanliness, and the stability of products. That is in the law.

The FDA was supposed to publish regulations on these good manufacturing practices after the bill was passed in 1994.

Finally, after 10 years of pushing and prodding by Senator Hatch, others, and me, the FDA has finally, this year, proposed good manufacturing practices regulations. They expect to have final regulations out by the end of this year. It took them 10 years, but I point out that the law requires it.

DSHEA also requires that manufacturers submit adequate information as to the safety of any new ingredients contained in dietary supplements before those products can be sold.

Again, I want to repeat that for the Record because when I listened to Senator Durbin last week, you would think someone could put a dietary supplement out there without ever having anything reviewed or looked at or reported to FDA. The law requires that manufacturers submit adequate information as to the safety of any new ingredients contained in dietary supplements before they can be sold.

I might point out that the FDA has rejected over half of the proposals to market new dietary ingredients using existing authority.

To listen to my good friend from Illinois, you would think everyone could put anything they want out there. That is absolutely not true.

DSHEA also provided the Federal Government a number of avenues for the removal of unsafe dietary supplements from the marketplace. If the Secretary of Health and Human Services determines that a product poses an unreasonable risk when taken as directed, the product can be removed from the market. The Secretary utilized this authority earlier in the year to remove products containing ephedra from the market.

DSHEA gives the Secretary yet another tool to protect the public from unsafe supplements. If the Secretary determines that a product poses an imminent hazard to the public health, he can remove the product from sale.

Finally, in order to promote expanded scientific research on the benefits and health effects of dietary supplements, DSHEA mandated the establishment of the Office of Dietary Supplements within the National Institutes of Health. This has resulted in roughly $100 million in new scientific research that is crucial to expanding reliable information to the American people.

Unfortunately, despite some recent improvements, the history of implementation of DSHEA by FDA has been lax.

I want to point out here that I serve on the HELP Committee. That is the committee that gives approval to nominees to be FDA Commissioners. Since DSHEA was passed, I have asked every FDA Commissioner for the record, both under the previous administration and under this administration, whether DSHEA gives the FDA enough authority to remove from the shelves harmful products for public consumption. Everyone who has come before us has said, yes, that DSHEA gives them all the authority they need to remove harmful products from the shelf.

The problem is the FDA has failed to use all of the tools we provided DSHEA. They have failed to carefully review substantiation of claims. For 10 years they failed to put in place good manufacturing practice standards. It has failed to aggressively remove from the market the illegal street drug knockoffs and other products that are in clear violation of DSHEA requirements.

I recently met with the FDA Commissioner and told him about some of the things I have seen in some of the gasoline stations that have these stores attached to them where they have knockoff items which are clearly harmful to people, and yet the FDA is not removing them.

Part of the problem has been resources. The FDA needs adequate resources to implement and enforce DSHEA. Congress last responded by regularly providing funds over the last several years beyond those requested in the Presidents' budgets--both the previous President and this President--reaching $9.7 million in fiscal year 2003. This is to provide oversight of dietary supplements.

Last year, the Senate adopted an amendment that Senator Hatch, Senator Durbin, and I proposed to increase funding for implementation and enforcement of DSHEA--to increase it by 17.5 percent. It required FDA to spend no less than $11.4 million for this purpose, $1 million more than requested by the administration. This was a substantial and necessary increase. In fact, I would like to see even more devoted to this purpose.

In fact, S. 1538, legislation Senator Hatch and I introduced earlier this session would increase FDA funding to $20 million next year, rising to $65 million per year within 5 years. We will continue to work to gain adoption of this more aggressive approach.

That is sort of the background. What I wanted to point out in my remarks is that we passed DSHEA to give people

access to vitamins, minerals, and supplements to keep them healthy in the first place.

We provided in the law all that was necessary for the FDA to take harmful products off the shelf. We provided in the law that any claims have to be truthful, not misleading, and substance indicated. We provided that any new ingredients put into these dietary supplements must be approved by FDA.

I did not hear Mr. Durbin, the Senator from Illinois, mention any of that in his comments last week.

I want to point out that there are more than adequate safeguards in DSHEA to keep the public safe and informed about dietary supplements, minerals, and vitamins.

Turning to the direct subject of the amendment of the Senator from Illinois, I support what I think is the basic essence of the Senator's amendment--getting good and timely information about safety concerns with anything that Americans consume or use--whether that be drugs over the counter, medical devices, foods, or dietary supplements.

In any of that area, if there are safety concerns, yes, we need good and timely information.

In fact, as I said, Senator Hatch and I have fought to increase the resources that FDA dedicate to implementing an effective adverse events reporting system. Today, we spend about $1.5 million a year for the monitoring of serious adverse events associated with ingesting dietary supplements.

Again, I agree with the Senator from Illinois that a mandatory adverse events reporting system for dietary supplements and over-the- counter drugs is something we should consider. However, the issue has to be dealt with in a more comprehensive fashion to be effective and efficient. We need to make sure we have a reporting system that will provide timely, accurate, and useful information. Senator Durbin's amendment in its current form is too limited and does not ensure that we will have a workable system. Therefore, while I support the creation of a mandatory national adverse events reporting system that is broader in scope to protect the American people, I cannot support Senator Durbin's amendment.

First, serious adverse health events resulting from consumption of a dietary supplement is a national issue. Any reporting system for such events needs to be national, not just pertaining to Army bases. And it should apply to all supplements, not just those containing caffeine.

As a matter of fairness and protection of the public health, it should apply to over-the-counter drugs as well.

My colleague from Illinois said on Friday in describing his amendment that over-the-counter drugmakers are required to report serious adverse events associated with their products. I am sorry, that is simply not the case for the vast majority of these over-the-counter drugs. This leads to a number of inconsistencies. I will point out one example that will result from this omission in Senator Durbin's amendment.

Under his proposed amendment, one could buy a product whose brand name is No-Doz or similar over-the-counter products with a substantial amount of caffeine, yet be blocked from buying a dietary supplement that contained just a fraction of that stimulant. That simply does not make sense. If we are going to require reporting for dietary supplements, the same should be required of over-the-counter medication.

Under Senator Durbin's amendment, on an Army base you could buy No- Doz, which is packed with caffeine, but could not buy a dietary supplement that might have a third, a half or a tenth as much caffeine in it. It makes no sense.

Senator Durbin's amendment also excludes drinks that contain stimulants. Again, you could buy Red Bull--this is another brand name product, Red Bull--chock full of caffeine. There is no reporting requirement. But one could not purchase a supplement which had much less caffeine in it. This does not make sense.

Second, while I support a broader system, as I have said, the Defense authorization bill is not the place to work out the details of such an important public health matter. As our experience with mandatory adverse events reporting for drugs and medical devices has shown, implementing a mandatory system involves significant practical, technical, and legal issues that must be carefully worked out.

Third, there are serious shortcomings in the existing adverse event reporting system that need to be reformed before, or at least in tandem with, a mandatory reporting scheme. One need look no further than a recent report by the GAO.

Before we have a mandatory reporting scheme, let's look at the adverse event reporting system. Let's fix it. It is broken. Let's fix that before we have a mandatory scheme that relies upon an adverse reporting system that is totally inadequate. I may have more to say later regarding the GAO study.

These are serious shortcomings that clearly need to be addressed regarding a dietary supplement adverse event reporting system to effectively protect public health.

While I agree with much of what the Senator from Illinois is aiming to do, his approach is not something we should be approving. Therefore, Senator Hatch and I are offering a more comprehensive approach to Mr. Durbin's amendment.

Our amendment says three things. First, the FDA should make it a priority to fully and effectively implement the Dietary Supplement Health and Education Act of 1994, including taking appropriate enforcement action against unsafe dietary supplements. They have the authority to do that. It is in the law. Every FDA Commissioner has said they have that authority.

Secondly, our amendment says within 180 days of enactment of this provision, the Department of Health and Human Services should develop a plan for mandatory reporting of serious adverse events occurring as a result of the ingestion of any dietary supplement or over-the-counter drug and provide that plan for review and consideration by Congress. That is the logical way to proceed.

Third, our amendment says adequate resources should be made available for the effective oversight of dietary supplements and for sound scientific research on dietary supplements. This is a more important response. It deals with the real and broader issues at hand.

I look forward to working with my colleagues, including the Senator from Illinois, Mr. Durbin, to assure that consumers continue to benefit from healthful dietary supplements and we have a strong quality assurance system that includes good manufacturing practice standards and an improved serious adverse event reporting system.

I hope our colleagues will join in supporting our amendment which will permit people to have access to vitamins, minerals, and supplements which will tighten up the adverse event reporting system and which will also get adequate resources to the FDA to provide the adequate oversight of dietary supplements.

I see my good friend from Utah, one of the great leaders on this issue. Regarding enactment of DSHEA, I am proud to be a cosponsor with him, working to make sure all of our people get vitamins, minerals, and supplements to keep them healthy.