[Senate Hearing 111-1222] [From the U.S. Government Publishing Office] S. Hrg. 111-1222 CURRENT SCIENCE ON PUBLIC EXPOSURES TO TOXIC CHEMICALS ======================================================================= HEARING BEFORE THE SUBCOMMITTEE ON SUPERFUND, TOXICS AND ENVIRONMENTAL HEALTH of the COMMITTEE ON ENVIRONMENT AND PUBLIC WORKS UNITED STATES SENATE ONE HUNDRED ELEVENTH CONGRESS SECOND SESSION __________ FEBRUARY 4, 2010 __________ Printed for the use of the Committee on Environment and Public Works [GRAPHIC NOT AVAILABLE IN TIFF FORMAT] Available via the World Wide Web: http://www.gpo.gov/fdsys ____________ U.S. GOVERNMENT PUBLISHING OFFICE 21-160 PDF WASHINGTON : 2016 ________________________________________________________________________________________ For sale by the Superintendent of Documents, U.S. Government Publishing Office, http://bookstore.gpo.gov. For more information, contact the GPO Customer Contact Center, U.S. Government Publishing Office. Phone 202-512-1800, or 866-512-1800 (toll-free). E-mail, [email protected]. COMMITTEE ON ENVIRONMENT AND PUBLIC WORKS ONE HUNDRED ELEVENTH CONGRESS SECOND SESSION BARBARA BOXER, California, Chairman MAX BAUCUS, Montana JAMES M. INHOFE, Oklahoma THOMAS R. CARPER, Delaware GEORGE V. VOINOVICH, Ohio FRANK R. LAUTENBERG, New Jersey DAVID VITTER, Louisiana BENJAMIN L. CARDIN, Maryland JOHN BARRASSO, Wyoming BERNARD SANDERS, Vermont MIKE CRAPO, Idaho AMY KLOBUCHAR, Minnesota CHRISTOPHER S. BOND, Missouri SHELDON WHITEHOUSE, Rhode Island LAMAR ALEXANDER, Tennessee TOM UDALL, New Mexico JEFF MERKLEY, Oregon KIRSTEN GILLIBRAND, New York ARLEN SPECTER, Pennsylvania Bettina Poirier, Staff Director Ruth Van Mark, Minority Staff Director ---------- Subcommittee on Superfund, Toxics and Environmental Health FRANK R. LAUTENBERG, New Jersey, Chairman MAX BAUCUS, Montana JAMES M. INHOFE, Oklahoma AMY KLOBUCHAR, Minnesota MIKE CRAPO, Idaho SHELDON WHITEHOUSE, Rhode Island CHRISTOPHER S. BOND, Missouri KIRSTEN GILLIBAND, New York ARLEN SPECTER, Pennsylvania BARBARA BOXER, California (ex officio) C O N T E N T S ---------- Page FEBRUARY 4, 2010 OPENING STATEMENTS Lautenberg, Hon. Frank R., U.S. Senator from the State of New Jersey......................................................... 1 Inhofe, Hon. James M., U.S. Senator from the State of Oklahoma... 2 Udall, Hon. Tom, U.S. Senator from the State of New Mexico....... 4 Vitter, Hon. David, U.S. Senator from the State of Louisiana..... 5 Cardin, Hon. Benjamin L., U.S. Senator from the State of Maryland, prepared statement................................... 186 Gillibrand, Hon. Kirsten, U.S. Senator from the State of New York, prepared statement....................................... 187 WITNESSES Owens, Stephen, Assistant Administrator, Office of Prevention, Pesticides and Toxic Substances, U.S. Environmental Protection Agency......................................................... 14 Prepared statement........................................... 17 Falk, Henry, M.D., MPH, Acting Director, National Center for Environmental Health, Centers for Disease Control and Prevention and Agency for Toxic Substances and Disease Registry, U.S. Department of Health and Human Services......... 24 Prepared statement........................................... 26 Responses to additional questions from: Senator Klobuchar........................................ 46 Senator Inhofe and Senator Vitter........................ 50 Stephenson, John, Director, National Resources and Environment, U.S. Government Accountability Office.......................... 51 Prepared statement........................................... 53 Responses to additional questions from Senator Inhofe and Senator Vitter............................................. 66 Birnbaum, Linda, Ph.D., DABT, ATS, Director, National Institute of Environmental Health Sciences, National Institutes of Health, and Director, National Toxicology Program, U.S. Department of Health and Human Services........................ 68 Prepared statement........................................... 70 Responses to additional questions from: Senator Sanders.......................................... 76 Senator Klobuchar........................................ 77 Senator Inhofe and Senator Vitter........................ 80 Gray, Molly Jones, participant in a biomonitoring study.......... 89 Prepared statement........................................... 92 McKay, Charles, M.D., FACMT, FACEP, ABIM, Division of Toxicology, Department of Emergency Medicine, Hartford Hospital, Hartford, Connecticut.................................................... 94 Prepared statement........................................... 96 Response to an additional question from Senator Klobuchar.... 113 Woodruff, Tracey J., Ph.D., MPH, Associate Professor and Director, Program on Reproductive Health and the Environment, Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Francisco.............. 115 Prepared statement........................................... 118 Responses to additional questions from Senator Inhofe and Senator Vitter............................................. 123 Cook, Kenneth A., President, Environmental Working Group......... 133 Prepared statement........................................... 136 Response to an additional question from Senator Klobuchar.... 175 Responses to additional questions from Senator Inhofe and Senator Vitter............................................. 176 ADDITIONAL MATERIAL Statement by Collin P. O'Mara, Secretary, Natural Resources and Environmental Control, State of Delaware....................... 189 CURRENT SCIENCE ON PUBLIC EXPOSURES TO TOXIC CHEMICALS ---------- THURSDAY, FEBRUARY 4, 2010 U.S. Senate, Committee on Environment and Public Works, Subcommittee on Superfund, Toxics and Environmental Health, Washington, DC. The subcommittee met, pursuant to notice, at 10 a.m. in room 406, Dirksen Senate Office Building, Hon. Frank R. Lautenberg (chairman of the subcommittee) presiding. Present: Senators Lautenberg, Inhofe, Udall, Vitter, Boxer, Klobuchar, and Whitehouse. OPENING STATEMENT OF HON. FRANK R. LAUTENBERG, U.S. SENATOR FROM THE STATE OF NEW JERSEY Senator Lautenberg. Welcome to our witnesses. We have a major matter of interest because we are really going to be working very hard to make sure that we are doing the best that we can to protect the lives and well-being of our human population. And I thank everyone for being here as we focus on protecting the health of our families by updating our chemical safety laws. Now there is no question that chemicals are essential to our modern living. They are used in household cleaners to kill germs, they are used in medical equipment that saves lives, they even help fight global warming by creating insulation for homes, better components for wind turbines, and additives to make fuels cleaner. But when we use these products the chemicals in them can end up in our bodies. So, in essence the American public has become a living, breathing repository for chemical substances. And when the chemicals used in flame retardants, plastics or rocket fuel show up in our children's bodies we have a potentially dangerous situation. We can trace this problem back to current law that covers the safety of chemicals. That law, the Toxic Substances Control Act, or TSCA as it is known, fails to give EPA the tools it needs to protect against unsafe chemicals. In fact the Government Accountability Office has identified our current law as a high risk area of law. In nearly 35 years TSCA has allowed EPA to test only 200 of the more than 80,000 chemicals in the products that we use every day. What is more, EPA has been able to ban only 5 substances on EPA's inventory of chemicals on the market. With EPA unable to require adequate testing our children have become the test subjects. And we are seeing the results in a dramatic increase in childhood cancers, birth defects and hormonal problems across the population. Studies have found that as much as 5 percent of cancers, 5 percent of cancers, 10 percent of neural behavioral disorders, and 30 percent of asthma cases in children are associated with hazardous chemicals. Our children should not be used as guinea pigs. So, it is time to update the law and protect our children. Led by a distinguished leader in Lisa Jackson--she is from New Jersey, I quickly mention--and Assistant Administrator Steve Owens, he is here with us today, the Environmental Protection Agency has taken steps to try to reduce the risks from chemicals. But they cannot protect our children with one hand tied behind their back. And that is why I will soon introduce a bill that will overhaul our Nation's chemical laws. My Safe Chemicals Bill will have a simple goal: force chemical makers to prove that their products are safe before they end up in a store, in our homes, or in our bodies. We already regulate pesticides and pharmaceuticals this way, and it is just common sense that we do the same for chemicals that are used in everyday consumer products. Everyone from the chemical manufacturers to businesses that use chemicals in their products to environmental, labor and health groups has called for a reform of our chemical laws. We cannot waste this opportunity. I will be reaching out in the coming weeks to our colleagues, Democrats and Republicans alike, to support my Safe Chemicals Bill. It is a problem that affects all of us, and we should all be committed to working on this solution. There is nothing more important in our lives than the health and well-being of our families, our children. There is a lot of susceptibility out there, and we are going to find out exactly what kind there is and what we can do to fight against it. And I am pleased to have our colleague, the Ranking Member of the committee, Senator Inhofe. OPENING STATEMENT OF HON. JAMES M. INHOFE, U.S. SENATOR FROM THE STATE OF OKLAHOMA Senator Inhofe. Thank you, my good friend Senator Lautenberg, for holding the hearing on the state of the science and human exposure of chemicals. We have talked about this for many years, and it is my understanding that this is the first of a series of hearings. I am glad we are doing this. We have had nothing but global warming hearings for the last 2 years, and there are other issues that we need to get to. I say to my friend Steve Owens, we want to build some roads and some other things. So, I am glad that today we will hear the perspectives on scientific approaches for evaluating human exposure to chemicals. In particular, I am interested in the discussion relating to biomonitoring, one of the scientific techniques used for assessing human exposure for natural and synthetic compounds in the environment. I believe that biomonitoring can be a useful tool in assessing the human chemical exposures, but it has its limits as it provides only information on exposure. It does not provide dosed information. Simply put, the presence of a substance in the body at any level cannot be interpreted as being adverse. We go through this all the time. People say, oh, we cannot have any arsenic in water. And yet there is always arsenic in water. Everybody knows that. But the level is what we are concerned with. And you cannot start legislating these levels where the science is not there in terms of causing problems in human health. I know in my State of Oklahoma we have so many people, Senator Lautenberg, in small communities, that we send those mandates out and we give them targets, I do not know if it is wastewater treatment or anything else, but it costs millions of dollars. You do not have a lot of the poor communities in New Jersey that we do in Oklahoma. And they just cannot do this. So, to me this panel is very important. The most important thing in dealing with this is that we do it on sound science. And I just cannot tell you, we went through this thing with the IPCC, with the United Nations, for 10 years. I can remember 10 years ago, when I was the Chairman of this committee, when Republicans were the majority, and we looked at the false science. I can remember 4 years ago, Senator Lautenberg, I made a speech on the floor for about an hour, talking about the scientists who had come to me and said hey, this is cooked science. Then 4 years later, right before Copenhagen, we find out in fact that is the case. ClimateGate came right before that and what happened yesterday and the day before, GlacierGate, AmazonGate, and all the rest of these things. What I am saying is it was cooked science, and this thing that we said some 4 years ago is exactly what happened. So, I would hope that on this that we are very careful to make sure that we use sound science and do not overreact to something. I am glad that we have the witnesses that we have today, and I am looking forward to hearing their comments about what they are going to do, what their opinion is, in terms of the health effect that is out there and any health to our people. That is what we are supposed to be doing up here, and that is what we are going to do, Senator Lautenberg. [The prepared statement of Senator Inhofe follows:] Statement of Hon. James M. Inhofe, U.S. Senator from the State of Oklahoma Thank you, Chairman Lautenberg, for holding this hearing on the state of the science of human exposures to chemicals. My understanding is that this is the first in a series of hearings leading up to a legislative debate on revision of the Toxic Substances Control Act (TSCA). I welcome the opportunity to discuss the strengths and weaknesses of the law and the science surrounding it. Today we will hear perspectives on scientific approaches for evaluating human exposures to chemicals. In particular I am interested in the discussion related to biomonitoring--one of the scientific techniques used for assessing human exposures to natural and synthetic compounds in the environment. I believe that biomonitoring can be a useful tool in assessing human chemical exposures. But biomonitoring has its limits as it provides only information on exposure; it does not provide dose information. Simply put the presence of a substance in the body at any level cannot be interpreted to mean that adverse effects will occur. I hope the witnesses here today remain objective in their discussions of biomonitoring and avoid the temptation to rely on detection as a surrogate for risk. Misapplying biomonitoring data only serves to scare the public and in some cases advance political agendas. By invoking notions of ``body burden'' and ``chemical trespass'' people who do not understand the limitations of biomonitoring are encouraged to reduce exposures to some substances that may increase rather than decrease their overall health risks. A perfect example is mothers refraining from breast feeding in order to avoid feeding their babies chemicals found, or that may be found, in breast milk. In almost all circumstances, the benefits of breast feeding exponentially outweigh any possible risks from the mere presence of a chemical in the milk. This same advice is given to nursing mothers by public health authorities. For over 30 years TSCA has provided a scientifically sound framework for reporting, testing, tracking and restricting chemical substances and mixtures. As I have stated before I am open to the idea of modernizing the statute. But to the proponents of radical reform and supporters of the precautionary principle let me be very clear: my principles for any regulatory or statutory changes to TSCA must be based on the best available science, including risk assessment; must include cost-benefit considerations; must protect proprietary information; and must prioritize reviews for existing chemicals. Further, I will not support changes that encourage litigation, allow for activist enforcement, or that compel product substitution. I look forward to hearing from the witnesses here today and to the upcoming debate on how best to modernize TSCA. Senator Lautenberg. Thanks very much. I am particularly interested in this subject, as I am with anything that can protect our people and improve our general environment. My dad was 42 years old, worked in a mill, and he was a health enthusiast. He used to watch his diet, and in those days we called it workout in the gym, exercise. But he fell victim to cancer, as did his brother and as did their father, all three of them dying very young. My father was 43, and he was aware of the fact that there was danger in the mill, but he needed the job, and he stuck with it and paid a price for it. So that is deep in my thoughts. Senator Inhofe. Senator Lautenberg, also in our State of Oklahoma, you know, you are familiar with the Tar Creek Superfund Site, the most devastating site in the Nation. We had people that went through the same thing that your father went through. These are lead and zinc mines. And we are to the point now where we can actually do something to preclude things like that from happening, and that is what we are talking about today. Senator Lautenberg. Thank you. Our colleague from New Mexico, Senator Udall. OPENING STATEMENT OF HON. TOM UDALL, U.S. SENATOR FROM THE STATE OF NEW MEXICO Senator Udall. Senator Lautenberg, thank you very much. I want to associate myself with your remarks. I think that you have really hit it on the head that we do not want to be experimenting with our young people, having them be guinea pigs in this experiment of putting more and more chemicals out into the environment and out in the ecosystems. So, I look forward to your piece of legislation that you are working on right now. I am reminded by my very able staff that it was 50 years ago today, Senator Lautenberg, more or less in that range, Rachel Carson wrote the book A Silent Spring. It was such a powerful book, and it said so much about how we were treating the environment, how we were treating all of the living beings in the environment. And people at that point became galvanized, and they got behind the idea of Government protecting people in terms of these toxic and hazardous chemicals. And I think people probably believe today that the Government is weighing in and doing that on a regular basis. Yet we have these national surveys, and I know there have been a lot of big national news stories, where if you take the blood of individuals in our society, there is a huge chemical, large number of chemicals, a chemical burden being carried by people. And that is something that worries me a lot. I want our panels to go forward, so, at this point, I just want to thank you for working on this issue. And I agree with Senator Inhofe, our Ranking Member. Science is the key here. We should be taking the very best science. But the Government should also be doing that work with the scientists, working with the universities, working with everybody out there that really knows the science. And then when we have the science, we put it into effect, and we protect the public. And I think that is the big gap that we have right now, would be my guess, if you ask many of the witnesses and the scientists around the country. So, thank you for doing this. It is great to be here today with you, and I look forward to hearing from the panelists. Senator Lautenberg. Thank you. Senator Vitter, the Ranking Member of the subcommittee, we welcome your comments. OPENING STATEMENT OF HON. DAVID VITTER, U.S. SENATOR FROM THE STATE OF LOUISIANA Senator Vitter. Thank you very much, Mr. Chairman, and thank you for holding this hearing today. The first thing I would like to do is simply ask unanimous consent that the written testimony of the National Petrochemical and Refiners Association and the Society of Chemical Manufacturers and Affiliates be submitted for the record. Senator Lautenberg. Without objection. [The referenced testimony follows:] [GRAPHICS NOT AVAILABLE IN TIFF FORMAT] Senator Vitter. Thank you. Mr. Chairman, I want to echo several folks' words, including Senator Inhofe. You know, there is a lot of discussion about how do we balance ensuring human health and safety and a clean environment with competitiveness, et cetera. I think the answer is exactly what Senator Inhofe and others have been saying--sound science, complete focus on, complete reliance on, sound science above all else. In that spirit I want to quickly offer five points. First, I believe EPA should redo their inventory of chemicals in commerce. There are not 80,000 chemicals in significant commerce as we often hear. The number is probably closer to one-fourth of that, and we need to home in on the true universe that we should be concerned about. Second, a European Registration Evaluation and Authorization of Chemical Substances style program would likely kill innovation in the United States in my opinion and is a recipe for hamstringing small- and medium-sized manufacturers. Third, to assume that REACH is the wave of the future is entirely premature and could actually impair human safety by preventing critical products, helpful products, from entering the marketplace. Fourth, if the EPA decides to use any given study as a reason for limiting or terminating the use of a certain chemical the results of that study need to be repeatable and proven in further supporting studies. And fifth, if the EPA is going to decide to utilize resources to re-review a chemical prior to the necessary review period I think that review, that re-review, should sure as heck be based on sound science and not some New York Times article that utilized politicized science from an environmental group attempting to scare the public. And I think that is exactly, unfortunately, what has happened with the herbicide atrozine. I look forward to this discussion so that we do move forward with the complete focus on sound science. Thank you, Mr. Chairman. Senator Lautenberg. Thank you, Senator Vitter. Now, we will hear from our panel, the first of whom will be Mr. Stephen Owens. I would ask you to keep your remarks to 5 minutes or less. Our tolerance level is guided by the fact that we have a panel after you, and I know people are anxious to ask questions. So, please, Mr. Owens. STATEMENT OF STEPHEN OWENS, ASSISTANT ADMINISTRATOR, OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES, U.S. ENVIRONMENTAL PROTECTION AGENCY Mr. Owens. Thank you, Chairman Lautenberg, Ranking Member Inhofe and other members of the subcommittee. I want to thank you for the opportunity to be here and to discuss the need for reforming chemical risk management in this country. As EPA Administrator Lisa Jackson testified before the full Environment and Public Works Committee last December the public does expect the Government to provide assurances that chemicals have been assessed with the best available science and that unacceptable risks have been eliminated, and restoring confidence in our chemical management system is a top environmental priority for not only EPA but for the Obama administration. The Toxic Substances Control Act, or TSCA as it is called, regulates chemicals in commerce. When TSCA was enacted in 1976, however, it grandfathered in the roughly 60,000 chemicals that existed at that time without any evaluation whatsoever. Manufacturers were not required to provide the data needed to adequately assess potential risks from these chemicals, and EPA was not given adequate authority to reevaluate existing chemicals as new concerns arose or as new scientific information became available. And even for new chemicals manufacturers are not required to provide the data necessary to fully assess a chemical's risk without further action by EPA. And, even when EPA has adequate data on a chemical TSCA prevents us from taking quick and effective regulatory action. Consequently, over the last 30 years, as you noted, Senator Lautenberg, EPA has been able to require testing on only around 200 of the nearly 84,000 chemicals currently listed on the TSCA inventory, and moreover to date only 5 chemicals have been regulated under TSCA's ban authority. The Obama administration has articulated several principles for modernizing TSCA. First, chemicals should be reviewed against safety standards that are based on sound science and reflect risk-based criteria protective of human health and the environment. Second, the responsibility for providing adequate health and safety data should rest on industry, and EPA should have the tools to obtain information from manufacturers without the delays and obstacles currently in place and without excessive claims of confidentiality. Third, EPA should have clear authority to take risk management actions when chemicals do not meet the safety standard with flexibility to take into account a range of considerations including children's health, economic costs, social benefits and equity concerns. Fourth, EPA should have clear authority to review and act on priority chemicals in a timely manner with firm deadlines to maintain accountability. Fifth, we must encourage innovation in green chemistry and support more sustainable chemicals and processes. And finally implementation of the law should be adequately funded with manufacturers supporting the costs of agency implementation. Because science has evolved substantially since TSCA was enacted 33 years ago we need to be able to take advantage of new approaches in modeling and testing methods that will assess risk more quickly and efficiently. With so many chemicals now being found in our bodies we need to better understand the implications of cumulative exposure to multiple chemicals. EPA's Office of Research and Development is developing computational tools that will help us address these questions and evaluate thousands of chemicals in less time and for less cost. Because we know that legislation will take time Administrator Jackson has directed my office to use our current authority under TSCA to the fullest extent possible to protect the American people and the environment. As part of this effort in December we released action plans for several chemicals, phthalates, long-chain perfluorinated chemicals, polybrominated diphenyl ethers and short-chain chlorinated paraffins. We also are currently developing action plans on benzadine dyes and bisphenol A, otherwise known as BPA. These chemicals were chosen for action by us on the basis of multiple factors including available hazard, exposure and use information, potential concern for children's health, use in consumer products, presence in human blood, persistent, bioaccumulative and toxic or PBT characteristics, toxicity, and their production volume. And we will use these criteria to select additional chemicals for future action plans as well. We are moving forward to use the tools currently available to us to increase the public's access to chemical information as well. While there are certainly legitimate reasons why a company may sometimes need to claim confidentiality it is also clear that confidentiality claims have been made far too often by far too many companies in far too many ways. Indeed, of the roughly 84,000 chemicals included on the TSCA inventory the identity of more than 16,000 of these chemicals is currently classified as confidential. That is simply unacceptable. To begin addressing this problem, last month we announced that companies will no longer be able to claim confidentiality for the identity of chemicals that present substantial health and environmental risks when those chemicals already are on the public portion of the TSCA inventory. Moreover, last summer we removed confidentiality for over 500 chemicals because the information claimed as confidential already had been made public elsewhere by companies. Mr. Chairman, as we are taking action let me reemphasize our view that the current law simply is not sufficient to adequately protect the American people and the environment. It is time to bring TSCA into the 21st century. Thank you again for the opportunity to be here, and I will be happy to answer any questions that you may have. [The prepared statement of Mr. Owens follows:] [GRAPHICS NOT AVAILABLE IN TIFF FORMAT] Senator Lautenberg. Thank you very much, Mr. Owens. Dr. Falk, we welcome your testimony. STATEMENT OF HENRY FALK, M.D., MPH, ACTING DIRECTOR, NATIONAL CENTER FOR ENVIRONMENTAL HEALTH, CENTERS FOR DISEASE CONTROL AND PREVENTION AND AGENCY FOR TOXIC SUBSTANCES AND DISEASE REGISTRY, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES Dr. Falk. Thank you very much. Good morning, Chairman Lautenberg, Senator Boxer, members of the subcommittee. My name is Henry Falk, and I am the Acting Director of the National Center for Environmental Health at the Centers for Disease Control and the Agency for Toxic Substances and Disease Registry. I am pleased to appear here today before the committee to discuss CDC's work in assessing people's exposure to chemicals. My testimony will focus on the Biomonitoring Program at CDC. For at least three decades CDC has been assessing people's exposure to chemicals through biomonitoring, which is the direct measurement of chemicals or their metabolites in people, in their blood, urine and other tissues. It determines which chemicals and how much of them get into people after they have been exposed. CDC's Biomonitoring Program assesses the U.S. population's exposure to chemicals and conducts targeted studies to examine vulnerable populations. CDC's Fourth National Report on Human Exposures to Environmental Chemicals was released in December 2009. Findings showed evidence of widespread exposure in the U.S. population to some commonly used commercial chemicals such as bisphenol A, BPA, the perfluorinated compound known as PFOA, and a type of fire retardant known as BDE-47. The report also noted continued progress in reducing children's exposure to lead. The data in the exposure report provide unique exposure information to scientists, physicians and health officials to help identify and reduce or prevent exposures and potential health effects that may result from human exposure to chemicals. Each year CDC's Environmental Health Laboratory works with States, other Federal agencies, academic institutions and international organizations on 50 to 70 studies that examine vulnerable populations, particularly newborns, children, pregnant women, and population groups or communities known or likely to have higher exposures. For example one important current partnership is with the Eunice Kennedy Shriver National Institute of Child Health and Human Development at the National Institutes of Health. This partnership involves a pilot study of 525 pregnant women in which CDC is lending analytical and biomonitoring expertise. Scientists at CDC's Environmental Health Lab will measure chemicals in pregnant women's blood and urine and after delivery in the newborns' cord blood and mothers' breast milk. Cord blood is a promising way to assess prenatal exposure to certain chemicals. Urine, at times, is a better way to measure exposures to chemicals that pass through the body more quickly. Biomonitoring is one important tool for identifying and preventing health problems. For example, biomonitoring has been a key tool in some landmark public health actions including the reduction of exposure to lead. CDC has been measuring lead since 1976. Lead is highly toxic, especially to young children, and can harm a child's brain, kidneys, bone marrow and other body systems. Our laboratory analysis showed that the American population's blood lead levels were declining in parallel with declining levels of lead in gasoline, providing critical support for the Environmental Protection Agency regulations that reduced lead in gasoline. CDC results for the period from 1999 through 2004 show that only 1.4 percent of children age 1 to 5 had elevated blood lead levels. At one time there was actually 88 percent, in the late 1970s. This progress is a direct result of collaborative efforts by CDC, EPA, NIEHS and others. In conclusion, biomonitoring provides solid human data that can assist in making important health decisions. Better exposure information means that we can make better decisions to protect the health of the public. We are fully committed to continuing our work with other Federal agencies and partners to improve the uses and benefits of biomonitoring. And with that, thank you very much. [The prepared statement of Dr. Falk follows:] [GRAPHICS NOT AVAILABLE IN TIFF FORMAT] Senator Lautenberg. Thank you very much. Mr. Stephenson. STATEMENT OF JOHN STEPHENSON, DIRECTOR, NATIONAL RESOURCES AND ENVIRONMENT, U.S. GOVERNMENT ACCOUNTABILITY OFFICE Mr. Stephenson. Thank you, Mr. Chairman, Ranking Member Inhofe, who has gone, and members of the subcommittee. Thank you for the invitation to testify on our report to this committee on EPA's use of biomonitoring data. To help EPA achieve its mission of protecting human health the Toxic Substances Control Act, or TSCA, authorizes it to regulate the manufacture, processing and distribution of chemicals. To do so it must first do chemical risk assessments to determine the extent of exposure to a chemical and assess how this exposure affects human health. EPA uses such risk assessments to determine if it needs to take any risk management actions such as prohibiting or restricting the use of a chemical. As has been mentioned there are over 80,000 chemicals in the TSCA inventory, but about 6 of these are produced in significant volume today. The growing availability of biomonitoring data has provided new insights into the general population's exposure to chemicals and can be a valuable new tool in EPA's ability to assess chemical risk. Recent advances in analytical methods have allowed scientists to measure more chemicals in smaller concentrations in blood and urine samples. Biomonitoring measurements are very relevant because they identify the amount of a chemical that actually gets into people from all environmental sources such as the air, soil, water, dust and food. In one such example, CDC estimates that 90 percent of the population has detectable levels of BPA, a chemical widely used in plastic bottles and food and beverage cans. Some studies have linked this chemical to developmental problems. This data has raised concerns, fostering additional research by FDA on the health effects and led to a ban of the chemical in children's products in several States. In our April 2009 report to the committee we found that EPA has been able to make only limited use of biomonitoring data to date. One reason is that relevant biomonitoring data exists for only about 212 of the over 6,000 significant volume chemicals that EPA must monitor. And even less data is available for children. In addition, biomonitoring data alone indicates only the presence of the chemical in the body, not the source of exposure to the chemical or its effect on human health. Much more research is needed to understand if the levels measured in people pose a health concern. We also found that while EPA has taken a number of useful steps to better understand and use biomonitoring data it has not developed a comprehensive strategy for research that takes into account its own efforts and those of the multiple other Federal agencies involved in biomonitoring research. EPA does have several important efforts underway, as have been mentioned, including research into the relationships between exposure to harmful chemicals, the resulting concentration of those chemicals in human tissue, and the corresponding health effects. However, without a plan to coordinate its efforts EPA has no means to track progress or determine the resources needed in specific areas of biomonitoring research. Moreover, there is not overarching national biomonitoring strategy to coordinate initiatives across the Federal Government. As a result biomonitoring data indicating widespread exposure to dangerous chemicals such as flame retardants may go unaddressed, according to the National Academy of Sciences. Our report recommended that EPA develop a comprehensive research strategy to improve its ability to use biomonitoring data and work with the Executive Office of the President to establish an interagency task force to coordinate and leverage limited resources across the many Federal Government agencies involved in biomonitoring research including NIH, CDC, FDA, OSHA and USDA. Finally, as with many areas of TSCA we found that EPA's authority to collect biomonitoring data from companies is untested by the courts and may be limited. We recommended that EPA clarify to authorities, provide better guidance to industry and seek additional authorities from Congress if necessary in this area. EPA attempted to test its authority in a 2005 action against DuPont regarding the chemical PFOA in Teflon. DuPont had biomonitoring data on PFOA but argued that it was not reportable under section 8 of TSCA because the data indicated only the presence of the chemical and not the health effects. DuPont settled this and other claims for $16.5 million without admission that it was required to submit the data. As a result the court never ruled on EPA's authorities. In conclusion, Mr. Chairman, we believe that biomonitoring data offers great potential as a tool in assessing the risk of dangerous chemicals, but a coordinated national strategy is needed to facilitate to realization of this potential. Mr. Chairman, that concludes this summary of my statement, and I will be pleased to answer questions at the appropriate time. [The prepared statement of Mr. Stephenson follows:] [GRAPHICS NOT AVAILABLE IN TIFF FORMAT] Senator Lautenberg. Thank you. Ms. Birnbaum, welcome. STATEMENT OF LINDA BIRNBAUM, PH.D, DABT, ATS, DIRECTOR, NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES, NATIONAL INSTITUTES OF HEALTH, AND DIRECTOR, NATIONAL TOXICOLOGY PROGRAM, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES Ms. Birnbaum. Mr. Chairman and distinguished members of the subcommittee, as Director of the NIEHS and the National Toxicology Program I am pleased to appear before you today to present testimony on recent science related to exposure assessment. This is all about understanding the environmental agents we are exposed to and then determining if these environmental exposures cause health problems for you and for me. From the days when readings from a single outdoor monitor was used to measure air pollution exposure for everyone in a city to the future when a badge is pinned on a shirt we will be able to give exposure readings of dozens of air pollutants for a single person. Our ability to measure personal exposure continues to improve significantly. While our technical capacity to measure exposures continues to improve we still have a ways to go in our general understanding of exposure in the United States. This is especially true for our most vulnerable populations like the unborn, infants and young children, and those living in poverty and disadvantaged communities. Biomonitoring, or the measurement of chemicals and their metabolites in blood, urine or other body fluids, has provided critical information on human exposure to toxic environmental agents. At NIEHS, we use biomonitoring to add precision to the measurements of exposures in our studies of specific human populations and to guide further research and understanding. For example findings of high levels of tungsten in the urine of residents of Churchill County, Nevada, the site of a childhood leukemia cluster, prompted my National Toxicology Program to initiate studies on tungsten, which have been followed by additional studies in collaboration with NIOSH for levels of tungsten in workers. NTP studies of the chemicals paraben, triclosan and oxybenzone were similarly prompted by CDC findings of widespread exposure. Other biomonitoring studies revealed unexpected rising levels of the polybrominated flame retardants in women of child bearing age and PFOA in residents near chemical plants, leading to intensive toxicological and epidemiological investigations and some changes in the use of these chemicals. Sometimes, biomonitoring is initiated for chemicals known to be toxic in order to better understand risk for an affected population. Substances like DEHP and other phthalates, certain heavy metals in pesticides, and other toxic substances fall into this category. Biomonitoring can also demonstrate the effectiveness of regulatory controls. An NIEHS study of infants in New York City documented lower cord blood levels of the harmful pesticides diazanon and chlorperifos after EPA implemented a ban on residential uses. And the good news is that the adverse effects we had seen in the infants no longer occurred when the levels of diazanon and chlorperifos dropped. Looking to the future, the NIEHS is developing 21st century methods of assessing exposures. For example, the NIEHS leads the Exposure Biology Program of the trans-NIH Genes, Environment and Health Initiative and is funding 32 research projects focusing on the development of innovative technologies to measure environmental exposures, diet, physical activities and psychosocial stress. The program also supports the development of biosensors to monitor the body's biological responses to environmental exposures. The NIEHS is even supporting the development of a robot capable of mimicking a child's floor activities so that we can measure exposures to young children more accurately. Other activities include the use of computerized geographical tracking systems like GPS to improve exposure modeling and using nanotechnology and biosensors to improve the detection of chemicals. Devices under development include a biosensor for detecting formaldehyde in air; I should have said that is a microsensor, nanobiosensors for probing chemical exposures and their effects on individual cells, wearable nanosensors, very small, 4 by 4, for monitoring diesel and gasoline exhaust, and low cost portable sensors for measuring metals such as arsenic and mercury at hazardous waste sites. In summary we are committed to advancing the science of exposure assessment to meet emerging public health challenges. We look forward to the increased contributions of exposure scientists as we work to understand the role of the environment in the etiology of disease. I would be happy to answer any questions. [The prepared statement of Ms. Birnbaum follows:] [GRAPHICS NOT AVAILABLE IN TIFF FORMAT] Senator Lautenberg. I would like to thank each of you for your testimony. As an observation, I am sorry that our colleague is not here because there is challenge as to what the number of chemicals is out there, and it is not said that all 80,000 of these chemicals are used on a regular basis. The number is quite a bit smaller. But that does not mean that these do not have an effect when in use and that we ought to be on guard. I have been joined by the Chairman of the committee, and if you are interested, Senator Boxer. Senator Boxer. I would just like to put my opening statement in the record. I will wait my turn for questions. Thank you. [The prepared statement of Senator Boxer was not received at time of print.] Senator Lautenberg. Thank you. Dr. Falk, of the more than 200 chemicals that were found in people's bodies, how many of these were known or are suspected to cause cancer or birth defects or other health problems? Dr. Falk. Of the 212 that were tested in the Fourth Exposure Report I believe that six are known carcinogens. They would be arsenic, benzene, beryllium, cadmium, environmental tobacco smoke and tetrachlorodibenzodioxen. They are categorized in that fashion. And there are a number that are characterized as possible or probably. So, yes, there are some included in there that would be considered carcinogens. Senator Lautenberg. Yes. Dr. Birnbaum, the mere presence of a chemical in the body does not necessarily mean that it is harmful. But cannot some of the chemicals cause harm to the sensitive populations in even very small amounts? Ms. Birnbaum. I think the question you are raising is a major one. The presence of a chemical does not in and of itself mean that there is a problem. It depends on the amount of the chemical. And not only how much of the chemical is present but the inherent susceptibility of the person in whom that chemical resides and the issue that I think Mr. Owens referred to of the cumulative exposure. We are not exposed to one chemical at a time. CDC has measured 212 different chemicals in our bodies. There are others that they have not yet begun to measure. And we really do not have a good handle on what happens when we have this multiplicity of chemicals in our bodies. Senator Lautenberg. Yes. Mr. Owens, there are thousands of chemicals in use every day, and EPA has to determine which of these to study and act on first. Do you feel that chemicals found in Americans' bodies ought to be prioritized for testing to determine whether the chemicals are safe in order to try and get some kind of a hold on this? Because otherwise there is so much out there that has been neglected and so much out there that is cause for alarm. What do you think about a prioritization of toxicity with the chemicals? Mr. Owens. Senator Lautenberg, we absolutely believe that there clearly are chemicals, clearly the entire 84,000 or whatever the actual number is of chemicals that are in widespread use in commerce. It would not be rated as the first order of business by the agency to look at chemicals. But the list of criteria that I laid out for what we used to develop our action plans, including a variety of things, both the PBT and the toxicity characteristics of production and early on exposure in children and the presence of chemicals in the blood, are certainly a good criteria, we believe, to use to begin that prioritization process to address the chemicals that represent what we believe would be the greatest risk to not only the population as a whole but especially to vulnerable populations like children. Senator Lautenberg. Yes. Mr. Stephenson, in your report you say that biomonitoring data alone indicate only that a person was somehow exposed to a chemical, but it does not have the source of the exposure nor its effect on the person's health. Can we identify the quantity of exposure, level of risk or the danger that a person is facing? Mr. Stephenson. Yes. That is why we are suggesting that additional research is needed on both ends to determine where the person likely obtained the exposure and what the resulting health effects might be with those quantities of that exposure and for that, for the duration that they may be in the body. That is where the research is not strong enough yet to support chemical regulation. Senator Lautenberg. Mr. Owens, the goal of my upcoming Safe Chemicals Bill is to give EPA the tools that it needs to keep dangerous chemicals out of our bodies. What changes need to be made to existing law for EPA to fulfill its mission of protecting public health and the environment from unsafe chemicals? Mr. Owens. How much time have we got? [Laughter.] Senator Lautenberg. Well, we have got enough time to listen. Mr. Owens. Senator, as I mentioned, the Obama administration, and these are Administration principles, not just EPA principles, have laid out a set of principles that identify some of the major items that we believe need to be addressed. And any updating and reform of the Toxic Substances Control Act, including setting a risk-based safety standard that is based on sound science so that the safety determinations are based solely on risk, the need to give EPA greater authority to obtain information from chemical manufacturers and shifting the burden from EPA to chemical manufacturers to produce that data and provide it to EPA, placing restrictions on the use of confidentiality when they submit data to EPA, giving us greater authority to make information public, as well as providing an adequate funding source for the agency so that when the program, assuming a reform occurs, ensuring that there is adequate funding in order to do the job that Congress would task us to do. So, a lot of different things would need to be done. Senator Lautenberg. I am struck particularly by the reminder that resource has to accompany our legislation. Thank you for that. Senator Udall. Senator Udall. Thank you, Mr. Chairman. The European Union has recently enacted a comprehensive chemical rule system that many of the world's large chemical companies will comply with. Does this mean that the European environmental regulators will have better information about exposures to their populations than we will have here in the U.S.? Any of you that would like to answer. Mr. Owens. Senator, if I may take a crack at that. I think the answer is, certainly for the time being, yes. And in fact, in our conversations with representatives of industry many of them are saying to us that they think that EPA ought to have the authority to get more information from them because in fact they are providing it, or will be providing it already, to the European Union through the REACH program. We are handcuffed at EPA because of the obstacles that TSCA puts on our ability to obtain information from industry. As I mentioned in my statement the manufacturers of these chemicals are not required to provide information to us, and if we take steps to ask if they would provide the information to us we have to make a number of very difficult showings as are outlined in the law before we can even get that information from them. So, the short answer is yes. But we are hopeful that in the long run we will be able to address that gap. Senator Udall. And all those hurdles you talked about that are put in place under TSCA that we are unable to get information, I assume that they are, the European Union regulatory system is getting directly to those issues, they are getting that information and that they have it and they have it available? Mr. Owens. Yes, Senator, that is correct. Senator Udall. Would any of you, please---- Mr. Stephenson. Senator, may I make a comment on that? Senator Udall. Yes. Mr. Stephenson. The rub against REACH is that it does provide much more data on chemicals from the industry and does shift the burden, appropriately, I think, to the industry to prove its chemicals are safe rather than EPA to prove they are dangerous. But the problem is it is kind of one size fits all now. So, the problem is small chemical manufacturers may have to subscribe to the same information requirements that larger chemical manufacturers would. So, we would combine what REACH does with some sort of risk analysis of a given chemical, sort of like the Canadian program does right now, so that it is not one size fits all, and the burden of information provided by the industry is more based on the risk of the chemical that they produce. Senator Udall. Thank you. That is a good comment. Dr. Falk or Ms. Birnbaum, do you have any thoughts on this area? Ms. Birnbaum. I can make a brief comment which is I think that REACH will provide a great deal of additional information on the potential toxicity of chemicals. I do not believe that REACH will require biomonitoring in the population because the focus of REACH is to get information before chemicals begin to be used. Senator Udall. Now, Dr. Birnbaum, you said in your testimony, you said--and I think I have got this right but please tell me--we do not have a good handle on the impact of the multiplicity of chemicals in one's body. How do we--and this is for the whole panel--how do we get a good handle on that? What are the things that need to be done to get a good handle on the chemicals that we are all carrying around as a result of modern exposure? Ms. Birnbaum. I think this is a major research question, and we are beginning to try to develop ways to approach it. It has been done for small groups of chemicals. For example, the dioxin-like chemicals are looked at in toto as a group. People are beginning to look at all the chemicals that might have estrogen active activity, for example, that kind of hormonal activity and say, can we look at them as a group. We are going to have to begin to look at groups of chemicals, and then we are going to have to begin to look at the totality of the groups. And we are beginning to design approaches that we can actually ask that question in not only experimental animal or cell culture and then animal studies but also begin to ask the question in epidemiological studies. For example, we are finding effects, for example, on thyroid hormones from many, many, many different kinds of chemicals. And we need to understand if you have exposure to PFOA and if you have exposure to PCBs and if you have exposure, for example, to perchlorate, if all these things are going on, how much more likely is that going to be to impact your thyroid hormone system than exposure to one at a time? So, it is really still a research question but one which is very high priority and we are beginning to look at. Senator Udall. Thank you. Dr. Falk. Senator Udall, if I might reply to that. We have made a very extensive effort at CDC to actually organize this biomonitoring effort and develop it over the years. So, many years ago we would do individual analysis for specific chemicals. And approximately 8 or 9 years ago we began to do these biannual reports, National Exposure Reports, in which we assemble information on an ever increasing number of chemicals. So, we are up to 212 now. Undoubtedly, with advance of technology the numbers that we will be able to do in these roughly every 2-year reports will increase. So, there has been in a sense a logistical effort to organize this effort fully, the advance of the science and technology to actually be able to do more chemicals and the commitment to actually do this in a way that advances the science on the biomonitoring. Senator Udall. Thank you. Ms. Birnbaum. I would like to make---- Senator Udall. I have run out of time---- Ms. Birnbaum. OK. Senator Lautenberg. Senator Boxer, we are pleased to have the Chairman of the Environment and Public Works Committee with us. Senator Boxer. Thank you. Senator Lautenberg, first of all, I want to say how pleased I am at your leadership in this crucial issue. And I am very grateful to you. You have really run this subcommittee with an active agenda, and we are looking at the ways to protect our kids and our families, and I am on your team, you know that. I just wanted to make an announcement to the colleagues that are here that after the first vote at 12:30, we are going to meet off the Senate floor to mark up some non-controversial GSA, courthouses and such. So, if I could remind you to do that. And then if you want to start my time. I would say that we have a responsibility to America's families to ensure that the chemicals in the environment and the products they use have been scientifically tested and that they and their children are not put at risk. We do not have such a system. And it is a dangerous world out there for our kids. That is how I feel about it. The committee has the opportunity to strengthen our Nation's toxics laws to ensure that evaluations on the safety of chemicals are made based on science and public health and that all people, especially the most vulnerable, are protected. That is part of my statement. But I want to get to some questions. And then I will run out of time, and Mr. Chairman, with your permission I would like to be able to submit these questions to our witnesses. Senator Lautenberg. Without objection. Senator Boxer. The first one would be for Mr. Owens. Does the Toxic Substances Control Act give the EPA strong authority to fully understand potential health risks from chemicals and to prevent potentially dangerous chemical exposures from products purchased by consumers and used in the workplace? In other words, are you satisfied with the law as it is? Mr. Owens. No, Senator, we are not. Senator Boxer. OK. And that is why this is so crucial and Senator Lautenberg has taken the lead on making sure that this law is adjusted so that you can protect our people. Director Birnbaum, could you please describe the current state of science regarding health concerns over low level exposures to some chemicals in pregnant women, infants and children? In other words, there is an argument made by some of our colleagues who do not share our views on this that they are such small levels that they do not matter. But my view is, just from what I know about life and science, is that a pregnant woman is in great danger here for the child that she is bringing into the world. And I wonder whether that child is in great danger. So, could you discuss that? Ms. Birnbaum. I think there is growing evidence that developmental exposure can in fact have long lasting health consequences. And what we mean by low level has to be defined, and I think the important way to define it is what we actually find in people. And in fact, there are an increasing number of studies that demonstrate that the levels, these low levels that have been found in people in our animal studies are showing adverse effects on the developing animals, and in fact there are a growing number of human studies that are looking for associations in the studies where in fact we find that the low levels that are present in people are being associated with adverse impacts on their infants or as the children grow. Senator Boxer. So at this point I have to cut you off because I do not have a lot of time, but at this point we do not know of any safe level for a pregnant woman and the child she is bearing? Ms. Birnbaum. I think for many chemicals we just do not have the information about how low is low enough. Senator Boxer. OK. And Mr. Owens, I guess, Assistant Administrator Owens, some advocate, and I think this is where we are headed with Senator Lautenberg's rewrite of this law, some advocate changing the law to require the chemical industry to prove their chemicals are safe before they are put into products. Now, it seems to me that is logical. Do you think that is logical to say if there is going to be a chemical introduced, prove to us it is safe before we say fine? Mr. Owens. Well, yes, Senator, we do. In fact one of the Administration's principles is that there be a risk-based safety standard that products, I mean chemicals, would have to meet before they can go into commerce, and then if it is determined not be safe there would be risk management actions taken that include a variety of considerations that I mentioned. But yes, Senator. Senator Boxer. Thank you. Director Falk, Acting Director Falk, the CDC recently issued its Fourth National Biomonitoring Report. Can you describe the range of different chemicals this report covers, and do the findings show widespread exposure in children and adults to arrays of different types of chemicals or only to a narrow range of substances? Dr. Falk. The Fourth National Exposure Report actually covers more chemicals that we have ever looked at before. And in particular there are a number of substances that we have not measured in the past that appear to have widespread presence. Senator Boxer. Did you mention those? Dr. Falk. Yes. For example, bisphenol A, the polybrominated diphenyl ethers, PFOA, acrylamite, perchlorate, paraffins, benzophenones, triclosan, there is a whole series of new chemicals that we are measuring that we were not measuring 5, 10, 15 years ago. Senator Boxer. Because they are showing up much more now? Dr. Falk. Because they are showing up, and we are concerned about them and measure them. And also because of the science advances, and we are now able to measure more of these in the kinds of samples that we have. So, yes, we are doing more chemicals, we are seeing their presence more, and for the chemicals that I mentioned just a moment ago most of them are present in most of the people. There are detectable levels in most people. So, that presents clearly an important area for all of us to evaluate in terms of what its potential impact is. Senator Boxer. Well, Mr. Chairman, I will close with this. There are two things, I think, that your hearings you have held here just cry out to me. One is we need to change the way we look at chemicals, which is to make sure they are safe before they get out there, and suddenly they are all in all of us, and we do not know what is safe and what is not safe. And the numbers of chemicals, as you point out, that are untested is just, it has just gotten away from us, and we have got to get a handle on it. That is No. 1. And No. 2, I think the public is going to cry out for us to take action the way we did, and Senator Klobuchar really deserves so much credit, just saying we are not going to allow certain toxins in toys, we are not going to allow them, you know, in plastics, and so on and so forth, because that is the immediacy. The public is not going to allow it. I have a bill for the EPA to set a standard for perchlorate. We had better do that. We know it is out there, everywhere, and you mentioned it. And we know in California it is out there. So, we need to set a standard. And we have to move. So, to me it is a two track situation--how we go about controlling these chemicals in the first place, and then once they are out and they are ubiquitous, if they are dangerous we had better move. And I want to say this. We have such a great committee. I am so proud of the members here. And I have to say Senator Lautenberg just plugging away at this, Senator Klobuchar heading a new subcommittee that deals with the safety of kids, and of course Senator Udall is here who is in on all of this and is pushing so hard. So, you know, I need to leave to go to another meeting, but I just want to thank everybody here and just say to my subcommittee Chairs, just please do your work because I am behind you every inch of the way. Senator Lautenberg. Thank you. Senator Klobuchar. Senator Klobuchar. Well, thank you very much, Senator Lautenberg. Thank you, Chairman Boxer, for your leadership. And thank you, Senator Lautenberg. We know it is important to update this law. It has been 30 years, and think of how the world has changed and the products we are getting from other countries. So, I want to thank our witnesses for their testimony. When you talk about all these numbers as you have to do as we are setting the science here I think sometimes we forget what this really means in our communities. For me, I got interested in this when a little boy named Darnell Brown, who was 4 years old, swallowed a little charm he got with a pair of Reebok tennis shoes that his mom got. He didn't die from choking or from having his airway blocked. He died because the lead in that charm went into his bloodstream over a period of days. And when they tested the charm, it was 100 percent lead, and it led to one of, I think, the biggest fines ever against a company for what had happened there. Now we have a new chemical to fear with children's jewelry. We passed, as Chairman Boxer mentioned, the Consumer Products Safety Act. And Dr. Falk, you mentioned cadmium and that you had found it to be one of six toxic chemicals. Can you elaborate on that? Senator Schumer, Senator Gillibrand and I and a few others have a bill to ban this. I have talked to the head of the Consumer Products Safety Commission, Commissioner Tennenbaum, about what powers they have. And I do not expect you to go into that. But if you could give us some of the science and what you have seen with this chemical. Dr. Falk. As you know, we have faced in the last number of years many consumer products which have, particularly, lead, cadmium and a number of heavy metals which pose dangers to children. And this is a lengthening list of products. So, we consider this very important. Senator Klobuchar. Is this cadmium thing something, a chemical that you had seen before in---- Dr. Falk. Yes. Cadmium has appeared in the biomonitoring reports as elevated a number of times. It is a clear concern in terms of health, in terms of kidneys and other diseases---- Senator Klobuchar. Do you know what the toxic effects would be on kids? Dr. Falk. I do not want to actually comment on this specific instance. Senator Klobuchar. I understand. Dr. Falk. But of course children are very vulnerable to a variety of heavy metals, cadmium, lead and others. And I think, you know, we would very much want to limit the exposures to children of these chemicals. Senator Klobuchar. OK. Dr. Birnbaum. Ms. Birnbaum. I would just like to mention that we are funding a half-million dollar study right now to look at the impacts of cadmium exposure in children, especially focusing on cardiovascular risk. Most of the studies with cadmium previously have all looked at adults. We now know that cadmium is not only a carcinogen and a kidney toxicant and a reproductive toxicant, but it also is an endocrine disrupter, and we believe that is important to understand. So, we funded work to look at the role of cadmium and the impacts it will have long term of children's health. Senator Klobuchar. Right. And I will say, I think, for us, we banned lead, and we will put a trace level allowable, and now this new thing comes from China. So, we are very concerned about it and want to act quickly. I do think, unlike with the lead situation, the Consumer Products Safety Commission is acting quickly. A number of the retailers have taken these pieces of jewelry off their shelves, and we go from there. Just a second question. Formaldehyde. Senator Crapo and I have a bill that has vast bipartisan support and has already gone through this committee because of wood products and what we have seen there. Again, not American wood products. Our timber producers have agreed to a voluntary standard. I know there is some research going on with formaldehyde. Does anyone want to respond to that? Mr. Owens first. Mr. Owens. I'll just take a real quick crack at that. Senator, we are looking very closely at formaldehyde emissions from pressed wood products. My office, as well as the Office of Research and Development of the EPA, is looking at the emissions that come from those products, and we will be working toward trying to set a safety standard for that, a regulatory standard for that, as we get more information back based on that risk evaluation. Senator Klobuchar. Thank you. First Dr. Falk, and then Dr. Birnbaum. Dr. Falk. As you know, just about 2 years ago we did a study of 519 trailers to document the formaldehyde levels in them post-Katrina. And as part of that effort, we have been developing a longitudinal study to follow children who were exposed to formaldehyde in those trailers. So, that is in the process of being established, and that, hopefully, will add more information on the health effects in children. Senator Klobuchar. Yes. I think that is why the Senators from Louisiana are supportive of this bill. And they know we need to move quickly. Dr. Birnbaum. Ms. Birnbaum. We know that children are often subject to higher exposure just because they have a more rapid respiration rate than adults. So, we are concerned that children do have higher exposure, and you know, we have been talking to CDC about the study they are doing. I did want to mention that in our recent evaluation on the report on carcinogens, which is a congressionally mandated report, where we list chemicals as being known carcinogens or reasonably anticipate it to be a carcinogen; the expert peer panel which reviewed all the data came out with the conclusion that formaldehyde is a known human carcinogen. Senator Klobuchar. Very good. I have some additional questions on radon and carbon monoxide, also specific to the reauthorization that I will submit for the record. So, thank you very much for your time. Senator Lautenberg. Thank you very much, Senator Klobuchar. As you can see, there is a very active interest in the testimony that each of you has given, and thank you for it. It is very thoughtful and very helpful in our decisionmaking here. With that, we will bring up the next panel, which includes Molly Jones Gray, Ken Cook, Charles McKay and Tracey Woodruff. Thank you for being here with us. Your testimony is so important because while we do not necessarily want to believe the worst, what we want to do is protect again even the least. And why we have doubters who challenge whether or not there are 80,000 chemicals out there or what have you, the fact of the matter is that I know that you heard what the former panelists said, and it makes us--and I speak for myself and I think my colleagues--it makes us more determined to continue to wade through the opposition to even listen, to even accept, certain levels of conditioning that we have to get through. So we welcome you. Molly Jones Gray, we welcome you. We know you are from Seattle, Washington, and you are going to tell us something about chemicals that were present in your body during a pregnancy. I would ask you to start by giving us your testimony. It is limited to 5 minutes, but I am a little bit of a patient fellow. STATEMENT OF MOLLY JONES GRAY, PARTICIPANT IN A BIOMONITORING STUDY Ms. Gray. Thank you so much for having me. It is a great pleasure to be here today. My name is Molly Jones Gray, and I come before you today as a concerned mother. I recently participated in a study by Washington Toxics Coalition called Earliest Exposures. This was a study designed to find out what our developing fetuses are exposed to during pregnancy. The study tested for phthalates, mercury, BPA, PFCs, often referred to as Teflon chemicals, and a flame retardant. Many of these substances are known to have adverse health effects. Of the ones tested I had higher than the national average for many. Of all the pregnant women tested I had the highest rates of mercury. During the 5 years preceding the study I had struggled with fertility and repeated miscarriages. And as I searched for an answer to why, why I was having such a hard time carrying a baby to term, I discovered the connection between our environment, our toxic exposures and our health, particularly our reproductive health. So, at that time I made reasonable changes in my life to reduce my exposure. I consumed mostly organic foods, I ate seafood only on the low mercury seafood list, I used personal care products without phthalates, and I avoided plastics, both cooking and storing my foods in plastics. So you can see when I first heard of the study, I was extremely interested in participating because I wanted to see, do my best intentions make a difference? And the answer I received was incredibly disheartening. I was shocked to see that my levels were as high as they were. This made me realize that the fight to avoid toxins is so much larger than just one person. These chemicals have become so ubiquitous in our environment that as clean as I tried to be, it was not enough to protect my little baby boy. Mothers-to-be, such as myself at the time, can make many choices to ensure a healthy pregnancy. We can take prenatal vitamins, we can eat a healthy diet, we can avoid cigarettes and alcohol, we can exercise. But of all the choices that we are able to make, we do not have a choice in this one. We cannot protect our babies from the powerful influence of toxic chemicals on their developing bodies. So now that my son is 7 months old and people hear my results they often ask me if my son is healthy. And my answer is, as far as I know, he is. He is a vitally healthy wonderful little boy. And pretty cute, too. He wanted to be here today, but this whole time difference he could not quite understand, and he is sleeping away in the hotel now. But what most alarms me now is that of the unknown. We have no idea what the long-term health implications of these results are. And I do not want my son or anyone's children to be our scientific experiment. Developing babies are uniquely vulnerable. Something is terribly wrong when I, as an educated consumer, am unable to protect my vulnerable baby. I, and all families, I feel, should be able to walk into a store and buy whatever products they need without wondering if the products that they are bringing home are putting their families' health at risk. Since participating in the study I have learned that companies can put chemicals into products without ever testing whether they harm our health. I think we need to change these laws. So, on behalf of my son Paxton and all other children I am asking for your help, help in lowering our body burden from these toxic chemicals that come between us and our health. In order to do that, I think policymakers should take immediate steps to eliminate the use of persistent toxic chemicals, the ones that build up in our body over time and are passed on to the future generations. I believe legislation should reduce the use of chemicals that have known serious health effects and ensure that only the safest of chemicals are used in our everyday products. And finally I think we need standards to protect our vulnerable populations such as pregnant women and their developing babies. So, in conclusion, I believe that babies deserve to grow in a healthy environment, both in utero and out. Instead, babies are born every day already exposed to chemicals that have known serious health effects. Safe until proven harmful is not good enough for me or my baby. And throughout the hearing today I have repeatedly heard that science is the key. So, I think that my role here today is to tell you that until we have that science, children such as my own, my Paxton, and all the other children are being affected by these laws. It will take time to rid out population of this burden on our bodies. We need to start now. This is not my story alone. This is the story of all of our children, our grandchildren and future generations. I appreciate this opportunity to tell my story. Thank you. [The prepared statement of Ms. Gray follows:] [GRAPHICS NOT AVAILABLE IN TIFF FORMAT] Senator Lautenberg. Thank you very much. I am very pleased that you could sit face-to-face with some of the doubters and talk about the apprehension and the struggle that you went through to conceive and to carry. But I am sure, as you have said, that not only is our child smart and all those things, but he is cute as well. We take your word for that. And thank you. Now, please, Dr. McKay, we invite your testimony. You are from the Hartford Hospital. That is Hartford, Connecticut, is it? Dr. McKay. Yes, it is. Senator Lautenberg. OK. Please. STATEMENT OF CHARLES MCKAY, M.D., FACMT, FACEP, ABIM, DIVISION OF TOXICOLOGY, DEPARTMENT OF EMERGENCY MEDICINE, HARTFORD HOSPITAL, HARTFORD, CONNECTICUT Dr. McKay. Thank you, Chairman Lautenberg, and the rest of the committee and guests. I am coming to you today as a physician trained and certified in Internal Medicine, Medical Toxicology and Emergency Medicine and with a role to convey the information that is provided from biomonitoring data to patients and the public as well as to other professionals. I want to just comment that the comments I have are--I am a member of the Board of the American College of Medical Toxicology, but the comments here are my own and do not necessarily reflect the opinions of the Board of Directors or all of the members of ACMT. I do have material that I have provided for the written record that does come from the College as well as me. I would just mention that admission to the American College of Medical Toxicology is to advance quality care of poisoned patients and public health through physicians who specialize in consultative, emergency, environmental, forensic and occupational toxicology. And as a part of that role we do have an important mission to try and translate the information that comes from studies. I am not going to belabor the benefits of biomonitoring because I think that has already been adequately covered by the members of the first panel. But I also would like to mention some of the potential risks of taking biomonitoring information and miscommunicating that to the public. As a medical toxicologist I have to, on a daily basis, deal with people who have a concern that they have been poisoned or that their children have been poisoned because of the identification of chemicals from one study or another. And I have developed a way of responding that is, I hope, appropriately cautious while at the same time reassuring to people regarding both the response and adaptability of our bodies but also the difficulty of taking a given exposure, or exposures to mixtures, and then defining a response with any degree of surety. I would just list out for the committee several criteria that I think is very important as we try to communicate biomonitoring data. No. 1 would be that identifying a substance as being a public health concern is not the same as stating that it is causing individual harm. Biomonitoring data can help greatly here to try and identify the degree of exposure of individuals and how that does fit in with the population. Decisions about exposure need to incorporate information about at-risk populations and in particular whether the people that are expressing those concerns are actually members of that population as well as the benefits gained by use of the product or availability and potential adverse effects associated with the alternatives. Biomonitoring data alone does not answer all of these questions. But common sense certainly should play an important role. And I think members of the committee as well as the panel have mentioned some of those issues. In particular, I would like to comment on Dr. Falk's mention that we have nearly 2 percent of the population with measurable amounts of lead that exceed what are our current level of concern, whereas when most of us were growing up as children that was 90 percent. So, it is difficult as we approach zero on some chemicals to understand how there is a claim of continued, ongoing health risks from those when we were exposed to so much more as children. Or maybe it just actually identifies the degree of brain damage that we have as old adults. Claims of association of a medical condition, therefore, with historic exposures to some substances do need to be evaluated in the face of current exposures. So, for those elements and items that we have decreasing exposure to, then we need to recognize that that is true. Those that are increasing or have particular issues with biopersistence, that is where we need to focus our efforts. My point, though, is just that biomonitoring is not going to get rid of all of the potential confounders with our data that we are able to obtain. It is a very useful tool for documenting human exposure to environmental chemicals of concern, tracking trends in exposure, and prioritizing chemicals of most concern for possible regulation, restriction or substitution, consistent often with green chemistry principles that are being enunciated around the country. I would just mention that there is a role to be played by the State public health laboratories in actually rolling out some of these issues, and they should be funded for that purpose because that is what they are there for. I thank the committee for this opportunity to present my views as a practicing medical toxicologist and educator, and I would be happy to take any questions. [The prepared statement of Dr. McKay follows:] [GRAPHICS NOT AVAILABLE IN TIFF FORMAT] Senator Lautenberg. Thank you. And now, let us hear from Dr. Woodruff. You come from San Francisco, and you are--what is your responsibility? Ms. Woodruff. Should I just start then? Senator Lautenberg. OK. We will not charge you time. STATEMENT OF TRACEY J. WOODRUFF, PH.D., MPH, ASSOCIATE PROFESSOR AND DIRECTOR, PROGRAM ON REPRODUCTIVE HEALTH AND THE ENVIRONMENT, DEPARTMENT OF OBSTETRICS, GYNECOLOGY, AND REPRODUCTIVE SCIENCES, UNIVERSITY OF CALIFORNIA, SAN FRANCISCO Ms. Woodruff. Good morning, Chairman Lautenberg and members of the committee. My name is Dr. Tracey Woodruff. I am an Associate Professor and the Director of the Program on Reproductive Health and the Environment in the Department of Obstetrics, Gynecology, and Reproductive Sciences at the University of California, San Francisco. I would like to thank you for the opportunity to testify at this hearing. I am going to focus on three different things. One is concerning trends in reproductive and developmental health, current chemical exposures, and our policy needs. As Chairman Lautenberg noted, there are a number of numerous concerning trends in developmental health at the U.S. population. I am going to give a few examples of those. One is that more women in the U.S., particularly women under the age of 25, which is the peak time of fertility, are reporting difficulty in conceiving and maintaining pregnancy. The percentage has doubled from about 4.3 to 8.3 percent in the last 20 years. There are an increasing number of babies who are born too early--that is before the 37th week of gestation--which puts them at greater risk for death, learning and behavior problems and developmental delays. One out of 8 babies in the U.S. is born premature. That is a 36 percent increase since the 1980s. Birth weights are also declining, even among normal, healthy, full-term infants, which puts them more at risk for short- and long-term health complications and chronic disease. There is a new study that just came out showing that U.S. birth weights have declined about 1.5 percent between 1990 and 2005. But this drop is not explained by maternal and neonatal risk factors or obstetric practice. In my own State of California, gastroschisis, which is a birth defect where the abdominal wall does not form completely and the intestines intrude outside of the body, has increased by over 300 percent between 1987 and 2003. And we are of course seeing a number of different increases in childhood morbidity, including autism, certain childhood cancers, and obesity. I just would note that there are a number of these health trends and why there is a growing concern about toxic chemical exposures are covered in this new report titled The Health Case for Reforming the Toxic Substances Control Act. I would also say that we have very important and growing scientific evidence that there are periods of development that are more vulnerable to disruption by environmental chemicals, particularly if the exposures occur around the time of conception, during pregnancy, and early in childhood. In particular disruptions during the prenatal period can increase the risk of effects immediately, such as birth defects or pre- term birth; in childhood, such as childhood cancers and neurodevelopmental outcomes; or even in adulthood, as was previously mentioned, such as increases in diabetes and cardiovascular disease. As has been noted, there are many chemicals that are now in use in our environment, in our manufacturing and daily lives, and chemical production since World War II has increased more than 20-fold. So now, environmental contaminants are ubiquitous in our air, water, food, personal care products and everyday household items, and has been mentioned, biomonitoring demonstrates these chemicals are also in our bodies. Anywhere from 70 to 100 percent of the U.S. population have measurable levels of triclosan, PCBs, polyfluoroalkyl chemicals, parabens and bisphenol A. Many of these exposures come from every day use of products in our lives, such as personal care products, cookware and containers. These are sources that most people have previously considered to be inert, but they apparently are not. As a population, we vary in our biological susceptibility in terms of age, disease status and chemical exposures. And so when we consider the risk of adverse health effects from exposure to any one chemical that has been reported through biomonitoring studies, the National Academy of Sciences recommends that we consider this exposure in the context of existing chemical exposures and biological susceptibilities in the population. And they have concluded that we should not assume that there is a safe level of exposure to any individual chemical unless proven otherwise. As was raised by Dr. Birnbaum thyroid hormones and thyroid disrupting chemicals are reasons for concern. Thyroid hormones are essential for fetal brain development, particularly during the prenatal period, and pregnant women in the U.S., some portion of them, are already at risk for perturbations of thyroid hormone levels. Sixteen percent of women in the U.S. report having a thyroid disease, and about one-third of U.S. pregnant women have insufficient iodine intake, which is critical for maintaining sufficient levels of thyroid hormones. Some of the chemicals I have already mentioned, such as PCBs, the polyfluoroalkyl chemicals, perchlorate and triclosan, have also been shown to disrupt the thyroid system. And sometimes these chemicals can be at levels which are 300 to 1,500 times higher than the levels of thyroid hormones in our bodies. So, we can be exposed to biologically relevant levels of these chemicals, and separate studies on PCBs and perchlorate have shown that. Our current approach of using biomonitoring data as a demonstration of a problem means that it is potentially too late for people who have already been previously exposed to environmental chemicals. There are many chemicals that we have sufficient data for the Government to take action to reduce exposures. But for many chemicals we simply do not have enough information to actually ascertain whether they are a problem for the public or not. Biomonitoring provides an excellent and appropriate tool for monitoring whether policy or regulatory actions that we have taken can prevent harmful exposures and whether we have been successful in those activities, such as with lead. The scientific data clearly shows that every child in the U.S. is born with a burden of multiple chemicals in their body which can impact their future health, and by taking policy actions now we can improve, as has been noted, the health not only of ourselves, but of our future generations. Thank you. [The prepared statement of Ms. Woodruff follows:] [GRAPHICS NOT AVAILABLE IN TIFF FORMAT] Senator Lautenberg. Thank you very much. And now, Mr. Cook, we welcome your testimony. STATEMENT OF KENNETH A. COOK, PRESIDENT, ENVIRONMENTAL WORKING GROUP Mr. Cook. Mr. Chairman, thank you for convening this hearing. It is timely; it is vitally important. I very much welcome the opportunity to testify. Human exposure to toxic chemicals is exploding. You write your new legislation to fix the many problems with the Toxic Substances Control Act at a watershed moment in the science of understanding what we are exposed to and what it might mean. We got to know 10 Americans in a very unusual study a few years back. We tested them, one collection sample, 10 of them, 1 day, we tested for 413 different toxic chemicals. No group of people has ever been tested for more. And we found in just those 10 people one sample, 1 day, 287 different toxic chemicals, chemicals of the sort that are used in consumer products in this room, chemicals that had been banned 30 years before we took the blood samples. Now, Mr. Chairman, they were not exposed by virtue of the food they ate, by virtue of the water that they drank, or by virtue of the air that they breathed. We do not know very much about these people personally. About the only thing we know for sure is that when the exposures took place, all of them looked something like this. This was the first time anyone had ever studied the wide range of chemical exposures in umbilical cord blood. Decades into the Chemical Revolution, no one had bothered to look. And this was the first broad look at the full range that we were able to afford spending $10,000 per sample. Now, we learned from this study that babies come into the world polluted. Toxic, industrial pollution begins in the womb. Now, no one that I know would claim that just because a chemical shows up in people, even in a baby in the womb, that there is a health risk we can definitely point to. But what we should be able to do, and tell every parent in America, is that if a chemical is found in your child, if the exposures are taking place in the womb, we ought to be able to be very certain those exposures are safe. This baby was receiving the equivalent of 300 quarts of blood a day circulating to him that kept him alive, nourished him, gave him the oxygen he needed, and carried these pollutants with the blood. This baby did not have a fully formed blood-brain barrier to protect him from toxic chemicals. And the other thing we know about this baby, who was not in the sample, I can tell you that, this baby is my baby. He was born in June 2008. He would be here today except for other pressing business that involved a red sled. [Laughter.] Mr. Cook. But I can tell you, Mr. Chairman, just by your action in 2005 and again in 2008, just by calling your bill the Kid-Safe Chemicals Act, you have invited tens of millions of people to understand in a way that they never would have before that this debate is not abstract, it does not involve smokestacks in the distance or in another town or in another part of the world. It involves them. I know it is difficult for you to give a public speech on almost any topic without invoking your grandchildren. Now that I have a son I understand exactly why that is. Mr. Chairman, we subsequently studied another 10 Americans, minority Americans, babies of African-American, Hispanic and Asian-Pacific heritage. We found hundreds more chemicals in them, dozens of neurotoxins, dozens of carcinogens, the thyroid toxin that Senator Boxer spoke about, showing up in the womb, bisphenol A, the chemical we are all worried about showing up in this baby even at that time. And low doses matter, Mr. Chairman. We know from the literature that 358 different chemicals have been found in babies already. But we also know from some popular chemicals that we are more familiar with that at very low doses you can have both profound therapeutic effects and also some fairly profound side effects. Here, for example, for a little over 60 parts per billion you can inspire human reproduction, prevent it, and relax either way using Paxil. Low doses matter a great deal. It is true with children and industrial chemicals, too. Part per billion exposures has been associated of PFOS, an industrial chemical in PFOA, with reduced birth weight and head circumference, which Dr. Woodruff just mentioned. They have been associated in adults with difficultly in conceiving, different chemicals, PBDEs, thyroid disease, and heart disease, BPA in adults. We cannot avoid all these exposures, Mr. Chairman. We do live in the real world, and sometimes these kinds of exposures happen no matter what we try and do. But the truth of the matter is that if these exposures are going to take place we had better be careful not just because of the human toll but the economic toll. One study looking at just a small collection of childhood diseases estimated $55 billion per year in medical costs, parental leave costs, and school educational costs associated with that. And there are at least 182 other diseases associated with chemical exposure. We cannot say because the chemicals had caused it, but we can say it is an issue. And Mr. Chairman, unfortunately we are coming to this conclusion rather late. Why? We have not looked. We spend about $300 million a year testing dirt and water in this country through the Superfund program. Until very recently how much did we spend testing children under the age of 6? Almost nothing. Almost nothing. And so, Mr. Chairman, I would say, from our own studies, we have tested 200 people, we have found 482 chemicals. And there are 15,000 chemicals out there in heavy use. How many are showing up in our blood? How many of them might pose a risk alone or in combination? We do not know. One reason we do not is because the identity of these chemicals and their health effects are kept secret under current law through confidential business information claims. My little guy is doing great. I did not spend a minute during the pregnancy worrying that he was not going to turn out OK. But I spent a lot of time on Web sites, including my own at the Environmental Working Group, trying to figure out how to reduce exposures. And that is what parents want to know. When they come into a doctor's office, and they know they have a chemical in themselves or in their child, naturally they are concerned. But they are asking, is it a dangerous chemical? What can you tell me about it? Am I exposed? What levels? And if there is some way to avoid the exposure I will take that step, but why isn't the Government protecting me? Those are the questions we hear. Thank you, Mr. Chairman. [The prepared statement of Mr. Cook follows:] [GRAPHICS NOT AVAILABLE IN TIFF FORMAT] Senator Lautenberg. Thank you very much. I thank each one of you on the panel for your illuminating, to say the least, testimony. I want to ask Dr. McKay a question. Are you expressing a skepticism that is fairly deeply borne, if I heard directly what you are saying, that, for instance, using the lead example, taking some comfort that the presence of lead has gone down substantially? I do not know whether you are subscribing that to a natural phenomenon, but there is--lead is outlawed in many, many places. And as a consequence it looks like we have done the right thing. So, I am not sure where you were going when you made the comparison during the greater exposure to lead in our day, and my day was way ahead of yours. What was the point of that, please? Dr. McKay. Well, I think it is very complex. But the thing I would state is that when we demonstrate decreasing evidence or evidence of decreasing exposure to certain chemicals, we should not then argue that those lower levels are responsible for increasingly severe clinical effects, because that does not make sense. It also is a difficult thing for people to interpret, and they do not pay attention then to things that maybe are more important. Senator Klobuchar's efforts with the Consumer Products Safety Initiative are, I think, one example of that. If we eliminate lead that is in 100 percent concentration, in other words, a completely 100 percent lead charm that some child swallows and dies, that is a very good thing. To try and chase after 100 parts per million of lead in any component, or 200 parts per million of lead, something that is a small fraction of a percent of lead in that product, not even being taken into the child in that amount, that is inappropriate because it takes the focus off of the---- Senator Lautenberg. What would you, repeat for me please, what was a good thing that you saw? Dr. McKay. To take and eliminate the availability of heavily leaded products. That is a very good thing. Senator Lautenberg. And you use the term heavily? Dr. McKay. Yes. Senator Lautenberg. Low levels do not give you concern? Dr. McKay. Lower levels, as was mentioned by several of the speakers on the first panel, that is something that needs to be defined. I am saying that levels that have been put forward in legislation are so low as to not contribute to health problems. And it is difficult for people to then sort out those things they ought to be paying attention to---- Senator Lautenberg. I guess I am one of those. I am not a paranoiac about a lot of things, but I am about children's health. And thanks, Mr. Cook, for mentioning my 10 grandchildren. [Laughter.] Senator Lautenberg. You know, I keep a picture of them in my mind every day when I go to work because among the things that I do here is I keep the focus on children. And nothing is more painful than to see children with a disease that debilitates them and not be able to do things that healthy children should be able to do. In my 10 grandchildren, I have one with asthma. He does pretty well. But my daughter makes sure she knows where the nearest emergency clinic is when he goes out to play one sport or another. I have another child who came up with juvenile diabetes, and I am pleased at the progress that she is making and was pleasantly, pleasantly surprised to see her complexion and everything else at the first administration of insulin. It was just was wonderful. And among the other eight we have a very adequate distribution of allergies to all kinds of things. And if I could, if I did nothing in this, my term in the Senate, which has been pretty long, but to say to parents, do not worry about chemicals in kids' bodies because we know that those chemicals that are present cannot bring any harm, you cannot say that. And I do not know that it will ever be able to be said. But we are going to work on that. I have a mission. We spend billions of dollars purportedly protecting our society, protecting our people who live in America, to protect them from terrorism and violence and all that. But what kind of protection do we owe those beautiful little babies? I now consider myself a professional grandfather, and when I see kids, if they are just cute and nice, it makes me feel good, I can tell you, even though they are not mine. I would take them all, but I do not have room. [Laughter.] Senator Lautenberg. But I do want to ask you this, Mr. Cook. Your biomonitoring studies found more than 212 chemicals that were found by CDC. Could there be even more in our bodies than biomonitoring sciences have revealed so far? You mentioned that there were over 400. Is that--do you think that you have done the full gamut of study that has to be done? Mr. Cook. Mr. Chairman, not even close. I think because we have not been looking we have not found the chemicals that are in people. We have only just begun. We spent $10,000 per sample to study our first set of 10 cord blood samples. We were able to study more chemicals because we were studying a smaller group. We do not purport that this is a group that is representative of the U.S. population or babies at all. It was a quick survey. But just developing the methods is important. Chemical companies are not obligated to tell EPA, under TSCA, how to find toxic chemicals in people, babies or otherwise. So, in many cases we have had to spend money to have the laboratory techniques developed to find some of these chemicals. And now we are finding them. Every time we look for more of them we are finding them. I would expect if you had enough money and you had enough sample, which you do not with cord blood, of course, you would probably find hundreds and hundreds if not thousands more chemicals in people in this country. And these are not people who are exposed occupationally necessarily. These are folks like all the rest of us go to work, type on a computer, talk on the phone, drive in a car, eat regular food. The chemicals are there. Senator Lautenberg. Thank you. Dr. Woodruff, EPA has overseen the regulation of pesticides for years and succeeded in taking some of the most dangerous pesticides off the market. My Safe Chemicals Bill will require testing of all chemicals under a standard similar to the one that applies to pesticides. Has EPA's restricting the most dangerous uses of pesticides substantially damaged that industry? Do you know? Ms. Woodruff. Well, I am not going to speak completely for the industrial healthiness of the agricultural industry, but suffice it to say we still have adequate food available for us in this country as well, which is one of the primary uses of pesticides in this country. I would say that, you know, EPA has gone through a process, because of the regulatory requirements for pesticides, to require data on active ingredients in pesticides, which gives them a pretty good indication about the potential for harm for active ingredient pesticides, which then allows them to assess the risks. And as mentioned by the previous panel some pesticides have been removed from the market, like chlorperifos, because of their identification as a potential developmental neural toxicant. And that has been very successful, also, as has been noted by some of the studies in New York City before and after the ban by EPA. What we have as a challenge is that for many chemicals we simply just do not know because we have no information. And I would point out that the absence of information right now is being used to assume something is safe. But really all it means is that we do not know anything about a chemical. And I think, as Mr. Cook was saying, that every time we find something new in these biomonitoring studies it appears that we have reached a threshold. But really what we have done is sort of identified the next set and that actually there are many, many more chemicals that could be out there, but we just do not know if they have been measured. I would offer an example of xyloxene, which is a chemical that has been proposed as a substitute for perchlorethylene in dry cleaning in California. I know about this chemical because we at UCSF are participating in partnership with a State of California biomonitoring study to measure chemicals in pregnant women and their infants. We have an interest in xyloxene because people have reported that this may be a chemical of interest and may be ubiquitous in the population. And we have been working with the State of California laboratories, as well as had some discussions with CDC, about could we measure this chemical, which we think is likely to be rather ubiquitous in the population. It has been very challenging because xyloxene is in many consumer products. It is so ubiquitous that CDC has not yet been able to develop a method that would--a clean method room such that their samples would not be contaminated, meaning that it is ubiquitous everywhere in our environment. We are not quite measuring it in people, and yet none of us really are talking about it because it has not emerged as something that we can measure, though there is concern about it for exposures generally in the population and as potential health effects. Senator Lautenberg. Let me ask you this. So, are there new techniques for testing toxicity being developed so that scientists can move faster and with more accurate results without relying on animal testing? What might Congress do to accelerate the development and use of these newer testing techniques? Ms. Woodruff. This is actually a really very exciting area of research. There has been a report by the National Academy of Sciences, Toxicity Testing in the 21st Century, which has noted that we are entering a phase where we have the ability to test chemicals in cellular assays that we previously had not had before. And I know the National Institute for Environmental Health Sciences has been actively supporting a program for rapid testing of chemicals using non-animal methods but in cellular assays. I think there are sort of two keys pieces to this. One is further investments in the research side of this. But I think also, and I think EPA has mentioned this in their testimony earlier, is that we are going to be getting a lot of data from these things as the toxicogenome, epigenome evaluations. And how do we take that data and interpret it for the policymaking context? We are going to see lots of different signaling pathways perturbed. And yet we need to have more resources into the side that looks at, well, now that we have all of this data, how do we interpret it in the context of when we need to make a decision? Because as people have noted you are going to see probably many different signals going off, and how do we assess that in terms of the goals of trying to evaluate health risks from environmental chemicals? So, that would be my--I think you need to have both a research side, but you need to also focus on the research interpretation because science is very important. And as everyone has mentioned here, but it is very hard sometimes to interpret the science in the way that policymakers need, and I think we need to invest in that part as well. Senator Lautenberg. Thank you. Ms. Gray, the chemicals found in our bodies get there from many sources, air pollution, water pollution, food, and household products to name some of the biggest. Some of these sources are currently regulated by agencies other than EPA. Do you think that EPA ought to be able to review all exposure sources when deciding if a chemical is safe? I am kind of asking you an inside question here because it is--we do a lot of this review on this side of the table. Ms. Gray. It is an interesting question. I think for chemical reform to be meaningful, that the EPA has to take it all into account. Where are these sources? How are they ending up in our body? What are all the uses? How do they all add together? From a consumer standpoint, before preparing for today I most certainly did not know that different agencies regulated certain chemicals and others regulated other chemicals. And so, from that standpoint as a consumer, for me that piece does not matter as much as that we are not seeing these wind up in our bodies. And so I think in order to do that, we do. We have to think in the broadest of terms and really look at the big picture to see how this is happening. Senator Lautenberg. You cannot go far enough or deep enough to satisfy our obligation to make sure that things that are dangerous are discovered and at an early enough point in time so that they do not do any harm. Ms. Gray. Exactly. Senator Lautenberg. We have noticed, for instance, a growth in the number of asthmatics in children who come up with other diseases at birth and whether or not we are seeing an evolution of disease that is connected to the chemical exposures or other exposures. But we sure ought to find out because these conditions are tough. And you see the growing number of autistic children being born on a relative basis. It is a worrisome thing. And it has got to be more than a coincidence that things that they are exposed to. So, we have to do our research more thoroughly, finance wherever we can do it. And I thank you. We are joined by Senator Whitehouse. And what I am going to do, Senator, is to promote you to be Chairman. We have an excellent panel here, and I am sure that, knowing you, you have interesting questions to put forward. I know you are concerned about children's health and the environment generally, and during our working together I believe that you have a good way of getting to the bottom of things. Senator Whitehouse. Does this give me budgetary priority so I can---- Senator Lautenberg. If I can give them. [Laughter.] Senator Lautenberg. And I want to say thank you to the witnesses. Senator Whitehouse [presiding]. I want to join the Chairman in thanking the witnesses but also take a moment to reflect on his own ardent leadership on these issues. It is important in the Senate for issues to have champions. When an issue has a strong champion, it is more persistently pursued, it is more vigorously pursued, it is more thoughtfully pursued, and it is ultimately more effectively pursued. And Senator Lautenberg has for a long time been a very significant champion on these health issues, particularly as it affects children's health. So, I am delighted to join him and feel, frankly, honored to share this panel with him. Senator Lautenberg. If I might---- Senator Whitehouse. Are you going to rebut that? [Laughter.] Senator Lautenberg. No, I am not going to take it back. I am pleased with what you said, and I could listen for a long time. [Laughter.] Senator Lautenberg. But I want to enter two things into the record, if I might. One article that appears in Environmental News Focus about whether or not there are any safe levels of lead, which we seem to have a little bit difference of view here, and also a statement by the American Chemistry Council where they say that the Association and its member welcome congressional review of the Toxic Substances Act and lending their support to it. So, with that, I reinstate your Chairmanship. [Laughter.] [The referenced information was not received at time of print.] Senator Whitehouse. Well, I would like to ask two questions, and then I will conclude the hearing because I know that everyone has been here a long time. And I appreciate your testimony. The first has to do with the notion of asymmetry. We talk about, in the military context, asymmetrical warfare. And it strikes me that when you look at the number of chemicals that EPA actually regulates versus the explosion of chemicals that industry has produced in recent years, which we are, at this point, largely taking on faith, are not harmful, it is hard to see how under existing practices the EPA could ever catch up. They simply do not have the resources to do it. I do not know if you had the chance to talk in this hearing about what preferred model there is for addressing that asymmetry. We obviously do not want to stop industry from producing legitimate helpful products. But we also want to make sure that harmful products are kept out of our environment and kept out of our bodies as effectively as possible. I suspect that this situation is going to get, in terms of the asymmetry, is going to get a lot worse in the wake of the very surprising decision by the right wing activists of the U.S. Supreme Court that said that there could be no limit on what corporations could spend to influence political campaigns. When you get to a potentially narrow issue like whether a chemical should be regulated, the corporation that produces that chemical has an enormous interest in all of that. But in the array of interests that a public is concerned with at the time of an election it is not a very big one compared to everything else that is out there. It has to compete with every other issue for attention in a different way than the manufacturer sees that particular chemical. So, it worries me that that is going to get very asymmetrical, too, because a corporation could come into a candidate and say unless you support us on this, it is a minor matter, nobody ever needs to know about it, we are going to run a $3 million smear campaign against you the last 2 weeks of the election. We are going to do it through phony-baloney corporations that are very easy for us to set up, it is going to have a wonderful name like People for Trust, Justice, Apple Pie and the American Way, and it is going to point out everything negative that we can find out about you, and we are going to blanket the airways. Your choice. Are you with us, or are you against us? And I think that is a very dangerous proposition. So, I think the imbalance presently between the public health effort to protect against these chemicals is about to undergo a systemic blow which makes the question of trying to fix it and resolve the asymmetry all the more important. Let me ask Dr. McKay if he would speak first to that and then perhaps Ms. Woodruff. Dr. McKay. Well, I obviously cannot speak to any of the manufacturers testing and all, but Dr. Falk and Dr. Birnbaum spoke earlier on the possibility and likelihood of being able to cluster compounds within areas of effect or likely effect. And several things have been mentioned throughout this hearing about the importance of thyroid function, particularly during neonatal development. So, that would be a way of addressing classes of compounds by likely areas of effect. The problem with blaming a given compound for an effect that it turns out not to have, we have seen, unfortunately, very well exhibited by the discredited studies looking at thimerosal as a preservative in vaccines, multi-dose vaccines. Now that that study that started the anti-vaccine campaigns has been withdrawn, all that is left in its wake for the last 20 or so years is the number of children who have developed Hepatitis B, measles, and died because of lack of vaccination. But none of them have been prevented from harm from exposure to that ethylmercury compound. Senator Whitehouse. So, we want to get it right on both sides. You do not want false alarms. Dr. McKay. Right. Exactly. So you want to be able to identify substances that truly do have a high likelihood of having an adverse effect. If they are already out in commerce those are the ones to be removed or regulated restricted. But at the same time the benefit of whatever those products are that they are in should not be lost. And you know flame retardants are one that has been discussed, and I think that is important if we identify those as the culprit for some of the effects that are blamed on them. But I would not want to have more fires because of the lack of flame retardants. Senator Whitehouse. So, your best recommendation at this point is to expand the scope of the regulatory process so that it is by chemical category and not just by individual chemical so that more can be, the regulatory process can be used more efficiently. Dr. McKay. I think that is a component of it. But then, each, you would still have to regulate each chemical within that category based on some decision process. And to determine whether something is safe or not is really a difficult question because everybody's definition of safe has to incorporate the substance that that chemical is in, what is provided by it. The people in Haiti right now are I think very happy to get the water that is being delivered to them in a plastic jug that has bisphenol A leaking out of it. That cannot be done through glass containers or other kind of distribution networks. There is always a risk-benefit process, and if there are chemicals that are identified as high risk, and that I believe is EPA's job, it is the manufacturer's responsibility I think to do that as well. But then decision has to be made about which ones have to have the highest priority and where the line is drawn between more benefit and more risk. Senator Whitehouse. Ms. Woodruff. Ms. Woodruff. Yes, I think you bring up a really excellent point because as people have mentioned there are thousands of chemicals, yet EPA has been very challenged in terms of evaluating them and often when they do do the risk assessments they can be extraordinarily slow, formaldehyde, trichlorethylene, dioxin, all chemicals which EPA is still doing a risk assessment on even though it has been 10 to 20 years. And I think there are two parts to the answer to your question. The first is the research part, which is, as I had previously mentioned, we have a whole new arena of scientific tools in terms of toxicity testing that are before us that we should invest in. I think also we need to move what we have called upstream to looking at more of early biological perturbations in terms of adverse health effects. Thyroid hormones is a perfect example where we should be looking to see if chemicals cause thyroid hormone disruption and not wait to see the note about metal outcome. The science is quite clear in this area, and EPA is quite legitimate in terms of moving up to more early indicators which would make the testing process more efficient. Senator Whitehouse. Unfortunately, the---- Ms. Woodruff. Could I just say one more thing? Senator Whitehouse. I was just elaborating on the one point you made, then please go ahead back to it. Unfortunately, industry has gotten quite good about sewing doubt about whatever scientific uncertainty there may be, even if it is only a 1 percent doubt. Ms. Woodruff. I should have listened to you because you actually led me to my next point, which was that science is only one part of the decisionmaking process. Clearly part of the challenge for EPA is making their decisions in the face of uncertainty and the fact that, as you mentioned, many different people have a stake in the outcome, and some people have more resources than others to sort of engage in that activity in terms of influencing the outcome. I think that it is challenging to try and address this through the policy process. But there are tools that have been identified, primarily through the research in the tobacco literature and the pharmaceutical industry influence on pharmaceutical drug literature, that show both how the industry can influence science but also tools that the Government can use to try and counter that type of influence. They include Sunshine Laws so that there is complete disclosure of information about who is participating in scientific research. There are also conflict of interest policies that can be put in place. The International Agency for Research on Cancer has a very nice set of conflict of interest policies that helps to minimize the influence of people who may have a vested interest in the research outcome. And then I would also say that this is an area that is ripe for research itself, much like the tobacco industry and the pharmaceutical industry, what we know about how the industry can influence the scientific and public policy process comes from actually basic research on that actual subject matter. We have no such research on the environmental health field. But you can imagine that it would be an appropriate place to have better information so that we can learn. I mean, it is a very difficult thing, as you mentioned, to try and counter. But currently we are not really actually applying all of the tools we could to really make a difference in terms of trying to minimize the conflict of interest and trying to balance the playing field in terms of how decisions are made. Senator Whitehouse. Well, it gets particularly difficult around here when members of the Senate reject the precautionary principle, which I think, Dr. McKay you have in your testimony. It seems a reasonable thought. Where there are threats of serious or irreversible environmental damage, lack of full scientific certainty shall not be used as a reason for postponing cost-effective measures to prevent degradation. It seems like a non-controversial principle. It is one that I suspect every one of us applies in our daily lives, taking reasonable precautions. If the fire alarm goes off in the night, and your children are asleep, there is of course a less than complete scientific certainty that there is a fire. It could be a spider got into the alarm system, it could be any number of things. But I think a prudent parent wakes up and goes downstairs and checks. And our blindness to that, particularly in this body, I think is a very dangerous development, and frankly it is an irrational development. It puts articles of faith ahead of logic and takes us back to, well, we had enlightenment for a reason, we had a year of rationality for a reason. But the time has expired. I just want to say I appreciate so much all of your testimony. I am sorry I did not have the chance to talk longer. Anybody seeking to add anything to the record of this proceeding has, I believe, a week to do so, and then the record will close. Again, with my gratitude to both panels of witnesses, this hearing is adjourned. [Whereupon, at 12:07 p.m. the subcommittee was adjourned.] [Additional statements submitted for the record follow:] Statement of Hon. Benjamin L. Cardin, U.S. Senator from the State of Maryland Mr. Chairman, thank you for holding this hearing today. Senator Lautenberg, I applaud your tireless efforts to reform toxic chemical regulation and look forward to working with you on forthcoming legislation to reform the Toxic Substances Control Act because reform of the process and methods for chemical testing and use determinations is desperately needed to protect the public health. There is no denying that the chemical industry has done miraculous things in the development of medical science, aeronautics and vehicle safety, energy efficiency and home improvement and many other modern conveniences. However, lax regulation backed by weak public protection laws has placed the public's safety at risk. The fact that water bottles, including baby bottles, containing bisphenol A, a known endocrine disruptor, are still being sold in this country is a perfect example of how ineffective our toxic chemical laws are at protecting the public. Fortunately, many large chain retailers like REI and Whole Foods Markets took it upon themselves to protect their customers by removing plastic bottles containing BPA from their shelves, thus sending a strong message to industry. Companies like Nalgene, makers of popular and durable water bottles reacted responsibly and quickly to market demands and changed their products to BPA-free plastics. While it's refreshing to know there are good actors in marketplace, we must not overlook that BPA plastic baby bottles are still manufactured and sold by retailers all across the country. By and large this is an environmental injustice that impacts the health of children because people living in underserved communities often do not have access to retailers that sell a wide variety of alternative plastic products that are known to be safe. Since chemical labeling is not required many consumers lack information about the safety of the chemical composition of the products they use every day. I am pleased that there is an effort underway right now in Annapolis to pass legislation to protect Marylanders, particularly children, from products containing BPA. However, reforms to Federal law to protect the public from BPA and other harmful chemicals are the more prudent way of addressing this issue. BPA, for better or worse, has become the poster child of the hundreds of potentially dangerous and loosely regulated chemicals that millions of Americans are exposed to on a daily basis. As we are sure to hear from testimony today, independent results from a variety of voluntary biomonitoring studies have found a wide range of chemicals in people from all walks of life. One particular study revealed the environmental justice component of this problem that I alluded to earlier. Biomonitoring tests were done of five environmental justice leaders who live and work in communities like the Gulf Coasts of Texas and Louisiana and Richmond, California, where residents breathe the air, drink the water, and share the land of their community with major chemical plants and oil refineries. The startling findings from the biomonitoring reports of leaders in communities that are subject to high chemical exposure revealed that they were in the higher percentiles of Americans with extremely elevated levels of chemicals like BPA, polycylic musks, mercury, perchlorate and lead. Beyond that these people tested positive for 37 or 45 of the 75 chemicals they were screened for. Many of the residents of these communities livelihoods are dependent on these companies, yet the chemicals these plants expose residents to also threaten their health as well. Children growing up in these communities and who are exposed to these chemicals during times in their lives when they are most vulnerable are the most at risk. Persistent exposure to certain chemicals affects brain and cognitive development, bone density, pulmonary and respiratory function, endocrine disruption and can cause cancer. I want to address a wide range of issues on chemical safety and work toward enacting legislation that improves regulatory authority and increases the public's access to information on the toxicity of the chemicals that pervade our daily lives. I thank the Chairman for holding this hearing, and I look forward to working with my colleagues on the committee to reform our national chemical control policy. Statement of Hon. Kirsten Gillibrand, U.S. Senator from the State of New York Thank you, Chairman Lautenberg, for holding this very important hearing. I'd also like to thank our witnesses who are here today and look forward to their testimony on these critical issues Mr. Chairman, the issues being explored today are central to the health and welfare of our country. As a mother of two young children, I am deeply and personally concerned about the exposure of the most vulnerable in our society to toxic substances. Over the past 34 years Americans have been unknowingly exposed to over 80,000 industrial chemicals through our air, food and water. Of this number, a staggering 60,000 were grandfathered into current law with little or no testing to determine the safety of these chemicals. The Toxic Substances Control Act or TSCA--signed into law in 1976--was designed to safeguard the Nation's health. This statute has failed. Today we see an increased risk of chronic diseases--some of which are attributable to environmental chemical exposure. The Safer Chemicals, Healthy Families Campaign recently issued a report that makes the case for reforming TSCA, which in turn may lead to reduced health care costs. Their report draws from over 30 years of environmental health studies that demonstrate that chemicals are playing a role in the increase in chronic diseases and disorders our Nation is facing. A study released in 2002 from researchers from the Mt. Sinai School of Medicine Center for Children's Health and the Environment in my home State of New York estimated that the toxic chemicals that our children are exposed to in air, food and water in the places we live, work, study and play are linked to 5 percent of childhood cancers, 10 percent of neurobehavioral disorders and 30 percent of asthma. As the mother of a child with asthma, this is a staggering statistic. The Mt. Sinai study further illustrates the quantitative cost of these exposures. It estimates that every year we spend more than $2.3 billion on medical costs related to childhood cancer, asthma and neurobehavioral disorders linked to exposures to toxic chemicals. Asthma is the leading cause of school absences for children aged 5 to 17 due to a chronic illness. Direct costs for asthma related medical expenses, including hospitalizations, account for nearly $10 billion. 300,000 school-age children in New York State have asthma, with nearly 200,000 of those being elementary school age. In 2005 alone the total cost of asthma hospitalizations in New York State was approximately $502 million for an average cost of $12,700 per hospitalization. If exposure to harmful chemicals is contributing to negative health effects in our children, it is our responsibility to act. Mr. Chairman, one chemical that has received a lot of attention lately is bisphenol A--commonly referred to as BPA. This is a chemical that has been linked to birth defects, obesity, certain cancers, and other neurological disorders. I am working with my colleagues, Senators Feinstein and Schumer, on two pieces of legislation concentrating on the threats of BPA. The BPA Free Kids Act and the Ban Poisonous Additives Act take significant steps to address the threats posed by BPA in food containers and products for our children. According to the Fourth National Report on Human Exposure to Environmental Chemicals, published by the Centers for Disease Control's National Center for Environmental Health, 90 percent of Americans show traces of BPA in their urine. The widespread exposure of BPA currently in the bodies of every day Americans is staggering. Mr. Chairman, as I stated at the previous hearing on TSCA, when considering ways to modernize TSCA we must use the best science to dictate our efforts. We must learn from the failures of the past to ensure timely consideration and regulation of these chemicals. We must put forward the resources to ensure that regulators can do the work that Congress asks of them. We must work with industry to promote the development of new products that are both competitive in a global economy and safe for consumers. Mr. Chairman, thank you again for holding this important hearing, and I look forward to working with you and my fellow Senators on the committee as we look to bring the Toxic Substances Control Act into the 21st century. [AdditionS NOT AVAILABLE IN TIFF FORMAT] [all]