Tom Harkin

Mr. HARKIN

Mr. HARKIN. Mr. President, I ask unanimous consent that Laura Cilek and Marshall Fisher of my staff be granted the privilege of the floor for the duration of the day's proceedings.

Mr. HARKIN

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 President, I ask unanimous consent that the order for the quorum call be rescinded.

Mr. HARKIN

Mr. HARKIN. Mr. President, I come to the floor today to speak about the Federal Government's unnecessary and unacceptable delay in deciding to approve the use and sale of E15 gasoline at all the gasoline stations in this country. Last Friday, we were told by the Environmental Protection Agency and the Department of Energy that they will not make a decision on E15, a gasoline blend that includes 15 percent ethanol, until sometime this fall. Quite frankly, this is an abdication of responsibility, and it couldn't come at a worse time. To give a little history for those who don't understand this, we have for about 30 years now had approval of a blend of 10 percent ethanol with gasoline. In the old days, it was called gasohol; now it is called E10. When you pull into your gasoline station, you will see E10 pumps all over. There used to be big signs. Now it is hardly noticed because it is so widely used. I will get into that more later. There has been testing done over about the last 15 years or more as to how much ethanol you can actually use in a gasoline blend without hurting any of the engines or vehicles we use in America. A lot of testing has gone on, and the results of those tests have shown there is absolutely no problem if you increase from 10 percent to 15 percent. As a matter of fact, a lot of the tests that have been done privately show that maybe as much as 20 to 25 percent could be added without any damage whatsoever. This issue of approval of E15 has been at the EPA and the Department of Energy for a long time. Increasing the blend rate--that is what we call it, the blend rate--from 10 percent to 15 percent is critical to reducing our addiction to oil and accelerating the transition to biofuels. We all understand how important this is. It will strengthen our national security, create jobs, boost our economy, and help the environment. What makes the dithering at EPA and the Department of Energy all the more baffling and outrageous is that it is happening in the midst of the appalling catastrophe in the Gulf of Mexico. The blowout at the BP Deepwater Horizon well has cast a spotlight on the terrible price we pay for our dependency on petroleum. But instead of spurring EPA and the Department of Energy into action, they have hit the snooze button and given themselves 5 or 6 more months to try to reach a decision. We can't wait until the fall. In the face of the BP disaster, we need a decision on E15 with the utmost urgency. We have decried our dependence on oil for decades. Going back to the mid-seventies, we have talked--and we have talked and we have talked-- about the national security risks associated with our ever-increasing oil dependency. We have decried the fact that we are dependent on oil from nations that are unstable or unfriendly, or both, to the United States. We have been embroiled in conflict after conflict, war after war, in the Middle East because of oil. As we have talked, our total oil usage and our oil imports have risen steadily. In recent years, there have been some glimmers of hope. In 2007, we passed the Energy Independence and Security Act which mandates an increase in the efficiency of our automobiles and light trucks as well as increasing levels of biofuels in our transportation sector. These two steps--increasing vehicle efficiencies and encouraging the use of domestic alternative fuels--are the two fastest and most effective ways to reduce our dependency on petroleum-based fuels in transportation. In particular, I wish to highlight what we have accomplished with biofuels. In just the past decade, we have increased the contribution of biofuels for highway transportation from about 2 percent in the year 2000 to almost 10 percent today. I want to repeat that because I don't think most Americans grasp the significance of what our biofuels industry has accomplished in just one decade. Current ethanol production exceeds 9 percent and is quickly approaching 10 percent of total gasoline demand in the United States. To put that in perspective, ethanol now contributes more to our transportation fuel demand than all of our oil imports from Mexico, Venezuela, or Nigeria. I will repeat that. Ethanol contributes more to our transportation fuel than our oil imports from Mexico, or Venezuela, or Nigeria. Only imports from Canada and Saudi Arabia provide more fuel for transport than our domestic ethanol industry. So this is tremendously heartening news. Congress recognized the potential of biofuels in the 2007 Energy bill. We called for increasing levels of biofuels that roughly match what the industry has accomplished to date. In that bill, we called for that contribution to rise steadily over the next 12 years, reaching 36 billion gallons by 2022. That would put us on a trajectory to get about 25 percent of our transportation fuels from domestic biofuels by 2025. We need to stay on that trajectory because biofuels offer one of our very best alternatives for reducing dependence on petroleum. However, while our biofuels industry has stepped up to the plate, our fuel markets are lagging behind. Today, nearly all ethanol is used in the form, as I said earlier, of E10, a blend of 10 percent ethanol with gasoline, used in almost all of our cars and light trucks. Since ethanol production is very close to 10 percent of total gasoline demand, we are at what is commonly called the blend wall. In other words, our ethanol production is close to the total amount we can use at that 10 percent blend rate, so we have this blend wall of 10 percent. So we have to do three things. First and second, we must transition to a fleet of cars and light trucks capable of using higher blends, and we must make higher blends available through the installation of blender pumps. Senator Lugar and I introduced a bill to accomplish both of these actions last fall. Our Consumer Fuels and Vehicles Choice Act of 2009, which is S. 1627, would mandate the manufacture of an increasing number of flex-fuel vehicles as well as installation of increasing numbers of blender pumps. Again, this is not some pie-in-the-sky thing. I would point out that in the nation of Brazil, every single car produced in Brazil--by Ford, I might add, or by General Motors, I can also add, or by the Japanese manufacturers that are manufacturing cars in Brazil--every single car is 100 percent flex-fuel, and the cost of doing that is--well, if you did it to every car, it would be almost minuscule. So we need every car produced in America to be totally flex-fuel, just as they are in Brazil. That is what our bill would mandate. Then, we need to increase the number of blender pumps out there. This is the old chicken-and-egg argument I have heard for so many years. You go to the oil companies--which we have done; Senator Lugar and I both have done this--you talk to the oil companies. Why don't you put in more blender pumps? They say: Well, we can't put in more blender pumps because there are not that many flex-fuel cars out there to use the higher blends. You go to the automobile manufacturers and say: Why don't you manufacture flex-fuel cars? They say: Well, we don't have the blender pumps to supply higher blends. Back and forth we go. So our bill would do both of those things. I also noticed that this flex-fuel vehicle mandate is a part of an energy bill Senator Lugar introduced just a few weeks ago here in the Senate. The third action we need is approval of E15 right now--right now--for use in all gasoline-fueled vehicles. The EPA has the responsibility for making this decision. A trade association called Growth Energy applied to the EPA for approval of E15 in March of 2009, more than a year ago. Under the Clean Air Act as amended in the 2007 Energy bill, the EPA is required to take final action to grant or deny such a request within 270 days. But at the end of 270 days, in November of 2009, EPA simply reported that they were going to wait for the results of more Department of Energy testing of vehicles running on E15 before making the mandated decision. However, last November, they also indicated they expected to approve E15 for all vehicles of model year 2001 or newer by mid-2010 provided that the test results continued to be supportive. But now we are being told their decision will be further delayed--further delayed. First of all, the bill is clear. They were mandated to make this decision within 270 days. That was last November. They said we need a little bit more time. The tests were all supportive. The tests all looked very good. And they told us they expected to approve E15 for all model year cars 2001 and later by June of 2010. Now what has happened? They're kicking the ball down the field again. They said maybe this fall. Again, what we are told--I do not know this is factual--what we are told is this is a consequence of testing delays and additional test requirements at the Department of Energy. I have to ask the question: If this is so, why is the Department of Energy dragging its feet? What is Secretary Chu doing about this? I think Secretary Chu needs to explain these delays. Is it because there is a bias at the Department of Energy against biofuels? There is some indication there just might be that kind of a bias. I would like to know the answer to that question. I hope, if anybody is watching at the Department of Energy, they will tell their boss that Senator Harkin intends to ask the Secretary in a more formal setting why they are dragging their feet on this in the midst of an oil crisis, the likes of which we have never seen. If I sound upset, I am. There is absolutely no reason for this foot dragging--none whatsoever. This slow walking may be business as usual for a bureaucracy in ordinary times, but these are not ordinary times, and bureaucratic business as usual is not acceptable. We are in the midst of what many consider the worst environmental disaster in American history, perhaps even world history. The root cause of this situation is our addiction to oil. We have not just an environmental and national security imperative in that addiction, now we have a profound moral imperative as well. We cannot tolerate any further delay in accelerating our transition to clean, domestically produced, renewable biofuels produced not in the Middle East or in the middle of the fragile Gulf of Mexico but in the middle of our country wherever corn or sorghum or sugarcane or sugar beets or switchgrass or any other feedstocks for ethanol are grown and renewed every single year. I have come to the floor of the Senate today not just to urge but to demand that the EPA and the Department of Energy give this decision the highest and the most urgent priority. We cannot wait until this fall. It is time for the EPA and the Department of Energy to get off that stump and move ahead aggressively. They had their 270 days last year. We have already gone over that. The law is clear. It is unacceptable that they are dragging their feet. Both the EPA and the Department of Energy owe us, the Congress, a better accounting for the current delay and the excuses we have been given. Most important, it is time for them to end the delay and the dithering around. We need a decision, and we need it now. Mr. President, I yield the floor and suggest the absence of a quorum.

Mr. HARKIN

Mr. HARKIN. Mr. President, I wish to salute Dr. Raynard S. Kington and thank him for his outstanding service and leadership at the National Institutes of Health over the past decade. Dr. Kington has had an exemplary career in public service. In 1997, he joined the U.S. Department of Health and Human Services as Director of the Division of Health Examination Statistics and Director of the National Health and Nutrition Examination Survey within the National Center for Health Statistics at the Centers for Disease Control and Prevention. He joined the NIH in 2000 as Director of the Office of Behavioral and Social Sciences Research. While leading that office, he simultaneously served as Acting Director of the National Institute on Alcohol Abuse and Alcoholism. In 2003, he was promoted to Principal Deputy Director of NIH. Dr. Kington is an extraordinarily accomplished scientist, administrator and physician. His quiet leadership and wisdom were especially evident during his tenure as Acting Director of NIH from October 2008 to August 2009. Most notably, he led the agency's effort to quickly and judiciously allocate the $10.4 billion that this Congress provided to the NIH in the American Recovery and Reinvestment Act. In addition, his keen leadership skills were critical to successful implementation of President Obama's Executive order on human embryonic stem cell research and to establishing the Basic Behavioral and Social Science Opportunity Network Initiative. I am also grateful to Dr. Kington for leading NIH's efforts to strengthen conflict of interest regulations. Dr. Kington possesses a remarkable range of experience in higher education, research, management, public policy, and rigorous intellectual achievement. In 2006, he was elected to the prestigious Institute of Medicine of the National Academy of Sciences, where he currently serves as the chair of the Section on Administration of Health Services, Education, and Research. He has been a senior scientist at the RAND Corporation, and was codirector of the Charles R. Drew University/RAND Center on Health and Aging. He has served as an assistant professor of medicine at UCLA and as a visiting associate professor of Medicine at the Johns Hopkins University School of Medicine. Mr. President, at the age of 16, Dr. Kington began his postsecondary education at the University of Michigan, where he received his B.S. with distinction and his M.D. at the age of 21. He completed his residency in internal medicine at Michael Reese Medical Center in Chicago. He was appointed a Robert Wood Johnson Clinical Scholar at the University of Pennsylvania, where he completed his M.B.A. with distinction and his Ph.D. with a concentration in Health Policy and Economics at the Wharton School. He is board-certified in internal medicine, geriatric medicine, and public health and preventive medicine. Dr. Kington has a broad range of knowledge and experience in scientific, health, economic, and social issues. His research interests lie in the relationships among race, socioeconomic position, and health status, especially in older populations. He is a leading scientific researcher on the role of social factors as determinants of health. We all owe a debt of gratitude to Dr. Kington for his extraordinary public service. The scientific community and the Nation have benefited enormously from his skilled leadership. Finally, I would point out that NIH's loss is my State's great gain. On August 1, he will be inaugurated as the 13th president of Grinnell College in Iowa. I join with my Senate colleagues in thanking Dr. Kington for his past service and wishing him even greater success in his challenging new position in Iowa.

Mr. HARKIN

Mr. HARKIN. Mr. President, on the Executive Calendar, I ask unanimous consent the Senate proceed to executive session to consider en bloc Executive Calendar Nos. 427, 493, 494, 688, 500, 501, 521, 556, 581, 588, 589, and a number of others that the minority, I am sure, is aware of, and it includes all nominations on the Secretary's desk in the Air Force, Army, Foreign Service, Marine Corps and Navy--these are military people waiting to get their increases in rank. They have all been cleared and they need to be cleared so they can get their increases in rank--that the nominations be confirmed en bloc, the motions to reconsider be laid on the table en bloc, that no further motions be in order, that any statements relating to the nominations be printed in the Record, that the President be immediately notified of the Senate's action and the Senate resume legislative session. These are nominees, as I said. First of all, they are military people waiting for their increase in rank. But it is also people such as Brian Hayes, a member of the NLRB; Mark Pearce, member of the NLRB, et cetera, et cetera. Craig Becker, member of the NLRB; Anthony Coscia, Amtrak board of directors; Mark Rosekind, member of the NTSB. Here is David Lopez, general counsel of the EEOC. Here is Michael Punke, Deputy U.S. Trade Representative; Islam Siddiqui, Chief Ag Negotiator for the U.S. Trade Representative; Jeffrey Moreland, director of Amtrak; Carolyn Radelet, Deputy Director of the Peace Corps; Lana Pollack, Commissioner of U.S. International Joint Commission for the U.S. and Canada. And there are a number of others. I will not go through them all. They are a number of people who need to be in place to make our government work and run. That is who we are trying to ask unanimous consent that we can get them confirmed.

Mr. HARKIN. I object.

Mr. HARKIN. I say to my friend from Kentucky, fairness and equity? OK. Let's talk about fairness and equity. Let's talk about this. Mr. Becker was brought up in our committee last fall, along with Mark Pearce and Mr. Brian Hayes. They all went through our committee-- bipartisan. Mr. Enzi, the ranking Republican on our committee, voted for that, and so did the Senator from Alaska, Ms. Murkowski. The names were then forwarded to the Senate. They came to the Senate, and the leadership on the Republican side decided to filibuster-- decided to filibuster. We had an agreement to move this package forward on the National Labor Relations Board. Fairness and equity? Since 1985, we have never had a hearing for a member to be on the National Labor Relations Board who wasn't nominated for Chair because when the Republicans were in power, they would have their people, we would have ours, we would agree, and they would go through. That is what we did last fall with Mr. Becker and Mr. Pearce and Mr. Hayes. And I thought things were fine. That is the way we have always done things. We agreed. We came out on the floor. And then the Republican leadership decided to filibuster--decided to filibuster. Well, what happened then was that at the end of the year--I want to set the record straight here--what happens is at the end of the last session, there is always a unanimous consent to carry over the calendar, the Executive Calendar, from one session to the next. One Senator, the Senator from Arizona, Mr. McCain, objected to Mr. Becker. Under the rules of the Senate, then Mr. Becker had to go back to the White House and get renominated and sent back to the Senate. The Republicans asked for a hearing on Mr. Becker. Now, mind you, we have never had a hearing on one of these people since 1985. As the chair of the relevant committee, I did not have to have a hearing. But I decided, Mr. Becker has nothing to hide. He is willing to confront and answer all questions in open session. So I agreed to have a hearing. I could have had a hearing on Mr. Hayes, also, the Republican, but I said: No, we do not have to do that. So I had a hearing. We brought Mr. Becker before the committee, in open session, to answer any questions anyone asked him. If I am not mistaken, I think only three people showed up to ask him questions. But what they did is they submitted questions in writing. The Republicans submitted 440 written questions to Mr. Becker, almost twice what they did for Justice Sotomayor going on the Supreme Court. There were 440 written questions, and Mr. Becker obliged and answered all of those questions. Well, the Republicans still objected--still objected. Now the minority leader says he failed a vote in the Senate. That is not true because there was a filibuster. We needed 60 votes to overcome the filibuster. When we brought up Mr. Becker's name, he got 52 votes on the Senate floor. Quite frankly, he would have had more, but there were several Senators who were absent because of weather conditions. I know who said on the Record that they would have supported him. So it is not quite right when the minority leader says Mr. Becker did not get approved on the Senate floor. He did. He just could not get the 60 votes to overcome the Republican filibuster. So, again, you know, Mr. Becker is well qualified. Even my Republican colleagues freely admitted that in the committee, that he was well qualified. Do you know what their objection was? He comes from a union background. He comes from a union background. To the Republicans, that is a mortal sin. Well, if you are Catholic, you know what that means. That is a mortal sin. That is unforgivable to Republicans to have a union background. As I said, he was willing to answer any questions. He did, in writing. I have heard nothing--nothing from the Republican side pointing to some answer he gave that would disqualify him from being on the NLRB. They have simply drawn a line in the sand and said that because he has a union background, they are not going to support him and they are going to filibuster. So here we are. We wanted to get through all of those nominations tonight. I read some of them. I did not read them all. Ambassador to the Slovak Republic, Ambassador to the Dominican Republic, Ambassador to Niger, Deputy Director of the Peace Corps--they will not let them go through. Why? Because of one person--Mr. Becker--who has a union background and they do not want him on the NLRB. Well, Mr. Becker has a recess appointment. He did get a recess appointment from the President. But they will not let him get a full appointment by the President. And they are willing to stop everything, stop every nomination because of their objections to Craig Becker even through Craig Becker got 52 votes here on the Senate floor. So when the minority leader talks about fairness and equity, well, I think the fairness and equity is on this side of the aisle on this one. I am sorry to say that a lot of these people will not get their nominations. But, again, the Republicans do not care. They do not care. They would just as soon the government stop everything. Do they care whether we have enough people in the Peace Corps to run the Peace Corps? They do not care. Do they care whether we have an Ambassador to the Slovak Republic? They do not care. Do they care if we have members on the TVA, the Tennessee Valley Authority, board of directors? Obviously not. They have been holding up these nominees for a long time. This is not the first time they have held up these nominees. So fairness and equity? Well, I wish the minority side would show a little fairness and equity when it comes to decency and to abiding by agreements. We had an agreement. We had an agreement to move these people through as a package. We did that in committee. That agreement was broken by the Republicans, not by the Democrats. I am sorry to have to take this time on the floor to correct my friend from Kentucky on fairness and equity, but I think the public has a right to know why we are where we are right now and who is responsible for the fact that we cannot get nominations through here on the Senate floor. I yield the floor, and I suggest the absence of a quorum.

Mr. HARKIN

Mr. HARKIN. Mr. President, today I am joining with the distinguished senior Senator from Utah, Senator Hatch, to introduce the Dietary Supplement Full Implementation and Enforcement Act of 2010. Forty percent of Americans regularly take supplements--and I am one of them. We are taking charge of our own health. We are developing healthier habits. We are waking up to the fact that we don't live to eat, we eat to live--and we need to be mindful of what we put into our bodies. Countless people have told me how they have been helped by dietary supplements. Consumers want alternatives. They want less invasive, less expensive options. They don't want to just cure disease, they want to prevent disease. They want to feel good--and to look good. As you know, I have long championed the cause of health prevention, and I strongly believe that safe, properly labeled dietary supplements can be an important part of a healthy lifestyle. In 1994, I introduced the Dietary Supplement Health and Education Act--DSHEA--along with my good friend Senator Hatch, and we revolutionized the way that supplements are regulated and sold in the United States. DSHEA struck an important balance. On the one hand, it recognized the importance of enhancing consumer access to vitamins, minerals, and other dietary supplements, and it recognized the virtues of scientific research and education on the benefits and risk of supplements. On the other hand, it recognized the need for important regulatory safeguards to protect consumer health, including new safety standards, penalties for mislabeling or adulterating dietary supplements, and rules to ensure the scientific substantiation of claims regarding dietary supplements. As a result, over the last 15 years, Americans have enjoyed unprecedented access to a range of safe products that help improve their health. In 2006, Congress identified a need for additional regulatory safeguards, and we passed a law that requires manufacturers, packers, and distributors of dietary supplements to report to FDA serious adverse events associated with the use of supplements. Dietary supplement manufacturers are also now required to register their businesses with FDA under the BioTerrorism law we passed in 2002. S. 510, the food safety legislation approved by the Senate HELP Committee last year, which I hope will soon be considered on the Senate floor, contains additional provisions that apply to dietary supplements. The legislation gives FDA the authority to revoke the registration of a dietary supplement facility in certain instances, and it authorizes FDA to initiate a mandatory recall of any food, including a dietary supplement, that will cause serious adverse health consequences or death. In short, Congress has been active in passing laws that promote access to dietary supplements, but also ensure those products are safe for their intended uses. I am proud of our record on this issue, and I believe we have established a regulatory framework that is in the best interest of the American people and their long term health. I am concerned, however, that not enough is being done to fully implement and enforce these dietary supplement laws. I am very pleased that FDA recently issued final regulations on current Good Manufacturing Practice for dietary supplements, but it took them nearly 15 years to get those rules on the books. In the fall of 2004, FDA opened a docket and held a public meeting on new dietary ingredients, but it has still not produced guidance on that issue. Perhaps most alarming, there are still scores of illegal products being sold in this country that masquerade as dietary supplements. Some bad actors simply slap a dietary supplement label on illegal products in the hopes that the supplement label will help those products evade notice by FDA or the label will help promote sales. These products are clearly not dietary supplements and both consumers and the legitimate dietary supplement industry have a right to be upset about their sale. I am encouraged that President Obama's FDA has been sending Warning Letters on some of these illegal products, but more needs to be done. Part of the problem is that FDA's dietary supplement program has been under- resourced. But part of the problem is that enforcement of DSHEA has not been made a priority. That is why I am proud to introduce the Dietary Supplement Full Implementation and Enforcement Act of 2010. This is an updated version of a bill that Senator Hatch and I introduced in the 108th Congress. I am grateful that the Senator from Utah joins me again today in introducing this important legislation. Its basic goal is to give FDA the resources it needs to fully implement and enforce our dietary supplement laws, but also to hold FDA accountable for what it does with those resources. According to FDA, full implementation of the laws governing the regulation of dietary supplement will require substantial additional resources. My bill authorizes FDA to receive the necessary sums to implement and enforce the law. It also authorizes the Office of Dietary Supplements at NIH to receive additional sums to expand research and development of consumer information on dietary supplements. On the implementation front, the bill requires FDA to issue guidance that clarifies for consumers and industry FDA's expectations with regard to its new dietary ingredient premarket notification program. On the enforcement front, the bill directs FDA to inspect facilities to ensure compliance with the new dietary supplement good manufacturing practice regulations; to use the authority under DSHEA to protect the public from unsafe dietary supplements; and to ensure that claims made for dietary supplements are truthful, non-misleading and substantiated. It also requires FDA to notify the Drug Enforcement Administration if FDA objects to a new dietary ingredient notification because the product may contain an anabolic steroid or an analogue of an anabolic steroid. On the accountability front, the bill requires the Secretary of the Health and Human Services to submit an annual report to Congress that lists, among other things, how many people at FDA worked on supplement- related issues in the prior years; the number of times FDA inspected dietary supplement facilities; the number of times FDA issued a warning letter or initiated an enforcement action because a manufacturer was not in compliance; the number of times FDA objected to the marketing of a new dietary ingredient; and the number of dietary supplement claims the FDA determined to be false, misleading, or not substantiated. The bottom line is that dietary supplements offer tremendous health benefits to Americans, but it is not fair to consumers, the FDA, or the people who make supplements if we don't take action to clarify our current regulatory requirements, to better inform everyone about the benefits and risk of these products, and to clear the market of the clearly illegal or spiked products that masquerade as supplements. The bill that Senator Hatch and I have developed is an important and measured response to these challenges. I am heartened that a number of organizations that are deeply concerned about these issues have endorsed our bill, including, among others, the United Natural Products Alliance, the Natural Products Association, the Council for Responsible Nutrition, the Consumer Healthcare Products Association, the American Herbal Products Association, the Major League Baseball Players Association, and the NFL Players Association. The bill recognizes the need to implement and enforce current law in this area rather than simply discard the important balance we struck in 1994. And it is grounded in the firm belief that safe, properly labeled dietary supplements remain a vital part of our collective effort to help all Americans improve their health.

Mr. HARKIN

Mr. HARKIN. Mr. President, today I am joining with the distinguished senior Senator from Utah, Senator Hatch, to introduce the Dietary Supplement Full Implementation and Enforcement Act of 2010. Forty percent of Americans regularly take supplements--and I am one of them. We are taking charge of our own health. We are developing healthier habits. We are waking up to the fact that we don't live to eat, we eat to live--and we need to be mindful of what we put into our bodies. Countless people have told me how they have been helped by dietary supplements. Consumers want alternatives. They want less invasive, less expensive options. They don't want to just cure disease, they want to prevent disease. They want to feel good--and to look good. As you know, I have long championed the cause of health prevention, and I strongly believe that safe, properly labeled dietary supplements can be an important part of a healthy lifestyle. In 1994, I introduced the Dietary Supplement Health and Education Act--DSHEA--along with my good friend Senator Hatch, and we revolutionized the way that supplements are regulated and sold in the United States. DSHEA struck an important balance. On the one hand, it recognized the importance of enhancing consumer access to vitamins, minerals, and other dietary supplements, and it recognized the virtues of scientific research and education on the benefits and risk of supplements. On the other hand, it recognized the need for important regulatory safeguards to protect consumer health, including new safety standards, penalties for mislabeling or adulterating dietary supplements, and rules to ensure the scientific substantiation of claims regarding dietary supplements. As a result, over the last 15 years, Americans have enjoyed unprecedented access to a range of safe products that help improve their health. In 2006, Congress identified a need for additional regulatory safeguards, and we passed a law that requires manufacturers, packers, and distributors of dietary supplements to report to FDA serious adverse events associated with the use of supplements. Dietary supplement manufacturers are also now required to register their businesses with FDA under the BioTerrorism law we passed in 2002. S. 510, the food safety legislation approved by the Senate HELP Committee last year, which I hope will soon be considered on the Senate floor, contains additional provisions that apply to dietary supplements. The legislation gives FDA the authority to revoke the registration of a dietary supplement facility in certain instances, and it authorizes FDA to initiate a mandatory recall of any food, including a dietary supplement, that will cause serious adverse health consequences or death. In short, Congress has been active in passing laws that promote access to dietary supplements, but also ensure those products are safe for their intended uses. I am proud of our record on this issue, and I believe we have established a regulatory framework that is in the best interest of the American people and their long term health. I am concerned, however, that not enough is being done to fully implement and enforce these dietary supplement laws. I am very pleased that FDA recently issued final regulations on current Good Manufacturing Practice for dietary supplements, but it took them nearly 15 years to get those rules on the books. In the fall of 2004, FDA opened a docket and held a public meeting on new dietary ingredients, but it has still not produced guidance on that issue. Perhaps most alarming, there are still scores of illegal products being sold in this country that masquerade as dietary supplements. Some bad actors simply slap a dietary supplement label on illegal products in the hopes that the supplement label will help those products evade notice by FDA or the label will help promote sales. These products are clearly not dietary supplements and both consumers and the legitimate dietary supplement industry have a right to be upset about their sale. I am encouraged that President Obama's FDA has been sending Warning Letters on some of these illegal products, but more needs to be done. Part of the problem is that FDA's dietary supplement program has been under- resourced. But part of the problem is that enforcement of DSHEA has not been made a priority. That is why I am proud to introduce the Dietary Supplement Full Implementation and Enforcement Act of 2010. This is an updated version of a bill that Senator Hatch and I introduced in the 108th Congress. I am grateful that the Senator from Utah joins me again today in introducing this important legislation. Its basic goal is to give FDA the resources it needs to fully implement and enforce our dietary supplement laws, but also to hold FDA accountable for what it does with those resources. According to FDA, full implementation of the laws governing the regulation of dietary supplement will require substantial additional resources. My bill authorizes FDA to receive the necessary sums to implement and enforce the law. It also authorizes the Office of Dietary Supplements at NIH to receive additional sums to expand research and development of consumer information on dietary supplements. On the implementation front, the bill requires FDA to issue guidance that clarifies for consumers and industry FDA's expectations with regard to its new dietary ingredient premarket notification program. On the enforcement front, the bill directs FDA to inspect facilities to ensure compliance with the new dietary supplement good manufacturing practice regulations; to use the authority under DSHEA to protect the public from unsafe dietary supplements; and to ensure that claims made for dietary supplements are truthful, non-misleading and substantiated. It also requires FDA to notify the Drug Enforcement Administration if FDA objects to a new dietary ingredient notification because the product may contain an anabolic steroid or an analogue of an anabolic steroid. On the accountability front, the bill requires the Secretary of the Health and Human Services to submit an annual report to Congress that lists, among other things, how many people at FDA worked on supplement- related issues in the prior years; the number of times FDA inspected dietary supplement facilities; the number of times FDA issued a warning letter or initiated an enforcement action because a manufacturer was not in compliance; the number of times FDA objected to the marketing of a new dietary ingredient; and the number of dietary supplement claims the FDA determined to be false, misleading, or not substantiated. The bottom line is that dietary supplements offer tremendous health benefits to Americans, but it is not fair to consumers, the FDA, or the people who make supplements if we don't take action to clarify our current regulatory requirements, to better inform everyone about the benefits and risk of these products, and to clear the market of the clearly illegal or spiked products that masquerade as supplements. The bill that Senator Hatch and I have developed is an important and measured response to these challenges. I am heartened that a number of organizations that are deeply concerned about these issues have endorsed our bill, including, among others, the United Natural Products Alliance, the Natural Products Association, the Council for Responsible Nutrition, the Consumer Healthcare Products Association, the American Herbal Products Association, the Major League Baseball Players Association, and the NFL Players Association. The bill recognizes the need to implement and enforce current law in this area rather than simply discard the important balance we struck in 1994. And it is grounded in the firm belief that safe, properly labeled dietary supplements remain a vital part of our collective effort to help all Americans improve their health.

Mr. HARKIN

Mr. HARKIN. Madam President, AARP does not come to this in a neutral position, not a neutral position at all. They have their own annuities, but they are not indexed annuities. With their product. When the downturn comes, people can lose. People can lose money in annuities but not in indexed annuities if held to term. They do not get the upside; the insurance companies get that. But they are protected. If the market goes down, they lose none of their annuity. That is exactly what happened in the last downturn. I would like to call up my amendment, but I guess I am precluded from doing so. I was waiting for the ranking member to come back before I made a request. I was waiting for the ranking member to come back because I had been discussing this with him. I know we are going out at 10:30; is that right, Madam President?

Mr. HARKIN. What time does the Senate reconvene?

Mr. HARKIN. Has there been a consent agreement entered as to a certain time for a vote on cloture?

Mr. HARKIN. Madam President, I am going to ask unanimous consent to call up my amendment. I ask unanimous consent to set aside the pending amendment and to call up my amendment No. 3920.

Mr. HARKIN. Madam President, I ask unanimous consent then to call up my amendment No. 3920, with 20 minutes evenly divided, with a vote on the amendment prior to the cloture vote.

Mr. HARKIN. Madam President, the Senator from Hawaii objects to even having a vote on this amendment. I can see the Senator wanting to object to the unanimous-consent request. I just asked unanimous consent to have a vote on the amendment, and the Senator from Hawaii objects to even having an up-or-down vote. I wish the Senator would explain why he is afraid to have an up-or-down vote. That is just what I asked for. Isn't that what the Senate is for, to try to vote on issues? I want the record to show that only one person objected to having a vote on this amendment, and that is my friend from Hawaii--and he is my friend--to say we cannot even have a vote. I did not hear any objection from the Republican side or anybody else. All I ask for is an up-or- down vote. Why does the Senator from Hawaii not even want an up-or-down vote on this amendment? I yield the floor.

Mr. HARKIN. Madam President, I also ask unanimous consent to have printed in the Record a letter dated April 30 from the National Association of Insurance Commissioners.

Mr. HARKIN. Madam President, parliamentary inquiry: What is before the Senate at the present time?

Mr. HARKIN. Madam President, I have been, for some time, trying to bring up an amendment that has been filed which deals with a kind of, some might say, a little-known part of the insurance industry, called indexed annuities. A little bit of background. Indexed annuities have been sold for some time. They are an annuity that people would buy, and there is an upside limit. In other words, if the S&P index goes up by, let's say, 500 percent, the holder of the annuity does not get all of that 500 percent; the insurance company gets a big portion of that. But in exchange for that, there is no downside risk. The holder of that annuity, if the S&P goes down 500 percent, doesn't lose anything if held to its term. It has been a very valuable instrument for a lot of people to have these indexed annuities. During the recent recession of 2008 and 2009, no one lost any capital in any of their indexed annuities based on the stock market going down. They lost nothing because they had that downside protection. That was not true of other instruments, obviously. If you had a security, obviously, you lost a lot of money in the downturn of the stock market. Owners of the indexed annuities didn't lose any principal whatsoever when they held it to term. That is the value of these indexed annuities. Two years ago in the waning days of the last administration, the Securities and Exchange Commission decided they wanted to have jurisdiction over these. There had been some abuses by sellers of indexed annuities sold to individuals--mostly elderly individuals--when it was not the best investment for them. They were sold an annuity instrument that was not in their best interest. The SEC, under Chairman Cox, decided they were going to take jurisdiction of this. They were going to have this within their jurisdiction. It was a divided vote at the SEC as to whether they would do this, but the vote was in favor, so the SEC pulled this under their umbrella. The SEC was taken to court by certain companies. It went to the district court and then it was appealed to the circuit court of appeals in the District of Columbia. The circuit court of appeals decided this on July 21, 2009, not even 1 year ago. The circuit court said: We hold that the Commission's consideration-- That is the Securities and Exchange Commission, SEC-- We hold that the Commission's consideration of the effect of Rule 151A-- That was the rule that would govern the indexed annuities over which the SEC now wants to have jurisdiction, which they never had before. We hold that the Commission's consideration of the effect of Rule 151A on efficiency, competition, and capital formation was arbitrary and capricious. ``Arbitrary and capricious,'' held by the circuit court. What did the circuit court say? They said: We remand this. Having determined that their analysis is lacking, ``we conclude that this matter should be remanded to the SEC to address the deficiencies with its 2(b) analysis.'' It is back at the SEC. The SEC could at some point jiggle things around and decide, yes, now they have a better analysis and now they have jurisdiction. They will be taken to court again, and this will go on and on. In the meantime, the status of the companies selling indexed annuities, are in limbo. Again, if someone says: We had some problems with this in the past, I understand that. But the insurance commissioners who have jurisdiction over insurance fix the problems. In fact, the National Association of Insurance Commissioners, in a letter to Senator Dodd, the chairman of the committee, dated April 30, basically points out what they have done to fix this problem. The insurance commissioners said: Yes, there is a problem. Let's get together. Let's change the rules and regulations under which these are sold. And they did. Some might say: Why shouldn't we give this to the SEC? Is the SEC the final and best word and the best protector of consumers, I ask you? Is the SEC the best protector of consumers in this country when it comes to financial instruments? Ask Bernie Madoff's customers. Did we say because of Bernie Madoff and all the money he cheated and stole from people--and he was under the jurisdiction of the SEC--we have to take that jurisdiction away from the SEC now and give it to somebody else? No. We said: SEC, change your policies and change your regulations so a Bernie Madoff cannot happen again. That is what we are doing. These indexed annuities have always been insurance products, governed by the insurance commissioners in each State and the National Association of Insurance Commissioners. If there was a problem, it went to them. They addressed the problem. They fixed it. We have a new regulatory regime in which indexed annuities can be sold so the problems that occurred in the past will not happen again. Will there be violations? Yes, but now there are strong enforced regulatory rules in place. The SEC wants the oversight shared. But, two regulators in conflict create problems and considerable costs. I am not one who says to protect the consumer against everything we have to give it to the SEC. The SEC did a lousy job--a lousy job--in protecting consumers who held securities. I mean stocks, securities. Not one person who had an indexed annuity lost one single dime in the downturn in 2008, 2009. We cannot say that about Bernie Madoff's accounts, can we? I have been trying to get my amendment up to basically say: Look, the SEC does not have jurisdiction right now over these insurance instruments--that is what they principally are, insurance instruments. We left insurance to the States. If the SEC is able to grab hold of this kind of an instrument, what is to keep them from whole life? Now we are going to take over whole life insurance policies, too, because we have had problems in whole life policies, too and the value of their cash value can change with the markets, I say to my colleagues. Insurance commissioners keep track of this, they strengthened their regulation. They change their rules and regulations to cover these kinds of happenings. Unless we are to the point where we are saying we are going to have federal regulation of insurance in America, if we are there, OK. I would like to see that vote happen. This is one more overreaching by a Federal department to gain jurisdiction over an area of State regulation over which they have never had jurisdiction. SEC has never had jurisdiction, and the circuit court said the analysis on which they reached their basis to grab this was ``arbitrary and capricious.'' I have an amendment, amendment No. 3920, at the desk. It has broad cosponsorship on both sides of the aisle--Democrats, Republicans, conservatives, liberals, up and down--to say, no, this ought to stay with the insurance commissioners because it is, in its essence, an insurance product. The new rules that have been promulgated by the insurance commissioners basically cover the problems that happened in the past. The rules require certain amounts of liquidity and take into account the age of the consumer. That was the problem in the past. They were selling these to people who were way too old who would not live long enough to get their annuities. They look at the tax status, the financial objectives of the consumer, and whether this is some kind of churning policies. These are all new regulations instituted by the insurance commissioners to answer a problem that came up because of, let's face it, some agents out there who were taking advantage of elderly people. There are always going to be some bad actors. I do not care if it is under SEC or the insurance commissioners, there is always going to be someone trying to game the system. This has always been under the insurance commissioners' jurisdictions. They have taken these steps. We have a letter from the AARP saying they were opposed to my amendment. I have a great deal of respect for the AARP. I do a lot of work with them. More often than not, they do good things. But here is an article from the April 10, 2007, New York Times, titled ``Income for Life? Sounds Good, But Do Your Homework.'' It points out that AARP has teamed up with New York Life Insurance to--guess what--to sell annuities. I detect, I smell a little bit of a flavor of a conflict of interest. Oh, the AARP does not want the indexed annuities sold out there. They want the elderly to buy their annuities. I don't care. Fine. If they want to be in the business of selling annuities, I don't care if AARP does that. But to send out a letter dated May 19 to the chairman of the Banking Committee talking about how bad my amendment is--did they say in their letter to the chairman of the committee, in all due candor, the AARP has joined with New York Life Insurance to sell annuities? No, they did not say that at all. So there is a little hint of a conflict of interest. Madam President, I ask unanimous consent to have printed in the Record two items: a letter from AARP dated May 19 to the Honorable Christopher Dodd; and immediately following that, an article from the New York Times dated April 10, 2007.

Mr. HARKIN

Mr. HARKIN. I call up amendment No. 4085 and ask for its immediate consideration.

Mr. HARKIN. Parliamentary inquiry.

Mr. HARKIN. What is the pending amendment?

Mr. HARKIN. Mr. President, I wish to be heard on this amendment. We were told to stay here tonight so we could offer amendments. I have had an amendment pending since this bill was brought to the floor. I have not been able to bring it up. We were told we could stay here tonight and offer amendments. In good faith, I stayed here to offer an amendment. Now I am told we can't offer amendments because of the pending amendment, and we can't set it aside. What kind of games are being played around here? I had this amendment pending ever since the beginning, and I have not been allowed to bring it up. With cloture tomorrow, it would fall. What does it mean that we should stay around here to offer amendments tonight, when there is a pending amendment we can't set aside? If that is the game we are going to play, I am going to put in a quorum call and we will not call it off.

Mr. HARKIN. Without losing my right to the floor, I yield to the majority leader.

Mr. HARKIN. I can't hear.

Mr. HARKIN. Well, I have my ATM amendment, and then there is an annuities amendment.